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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Intrahepatic Interferon Signaling May Predict Hepatitis C Outcome
Restoration of type I intrahepatic interferon signaling by the end of direct-acting antiviral treatment in patients with hepatitis C virus appears to facilitate HCV eradication and relapse prevention, according to findings from a clinical trial.
Of 60 patients treated with the direct-acting antiviral agent (DAA) sofosbuvir plus ribavirin (SOF/RBV), 69% achieved sustained virologic response and 31% relapsed within 12 weeks of treatment completion. A reduction of intrahepatic expression of type II and III interferons (IFNs) and their receptors in a sample of the patients with SVRs paralleled a decrease in hepatic and blood interferon-stimulating gene expression during HCV suppression – a finding that suggested that reactivation of hepatic type I IFN signaling at the end of treatment might be important for a favorable outcome.
A subsequent comparison of microarray mRNA expression profiling in unpaired liver biopsies obtained at the end of treatment showed that type I IFN expression was indeed higher in 17 patients who achieved sustained virologic response (SVR) than in 8 patients who relapsed, Dr. Eric G. Meissner of the National Institute of Allergy and Infectious Diseases, Bethesda, Md., and his colleagues reported online July 2 in the Journal of Clinical Investigation.
IFN signaling was identified as a top pathway distinguishing SVR from relapse, with lower expression of an IFN gene signature at the end of treatment in patients who relapsed, the investigators said (J. Clin. Invest. 2014 July 2 [doi: 10.1172/jci75938]).
"Our present results demonstrate for the first time that HCV clearance achieved during IFN-free treatment with the DAA regimen of SOF/RBV is accompanied by hepatic down-regulation of type II and III IFNs, their receptors, and interferon-stimulated genes (ISGs). Down-regulation of ISGs was associated with on-treatment viral suppression and occurred regardless of treatment outcome, since all patients achieved virologic suppression on therapy. However, patients who achieved SVR unexpectedly had higher intrahepatic expression of ISGs at end of treatment compared with patients who relapsed," the authors wrote.
They noted that the increase in IFNA2 expression in those who achieved SVR suggested that the higher end-of-treatment ISG expression might be driven by an enhanced type I IFN response.
This suggests a model in which aberrant expression of hepatic ISGs triggered by HCV and/or type II/III IFNs decreases early during treatment, and after prolonged viral suppression, higher activation of ISG expression at the end of treatment may be induced by type I IFNs, which in turn might promote elimination of residual virus, they suggested.
As has been recognized in other conditions involving prolonged immune stimulation, resolution of infection and inflammation can be followed by a period of relative immune suppression. HCV patients who are able to reestablish IFN homeostasis by the end of DAA treatment may be more likely to achieve SVR, while those who aren’t able to reestablish IFN homeostasis may be more prone to relapse, they noted. "The ability to mount an endogenous, intrahepatic type I IFN response could be important for achieving SVR, even with IFN-alpha–free DAA regimens," they added
The findings are important because although injectable IFN-alpha formulations have been the mainstay of HCV treatment, they are associated with significant side effects and often are ineffective; treatment is rapidly evolving to IFN-alpha–free oral regimens that consist of DAAs. DAAs have been shown in clinical trials to induce rapid and sustained viral suppression, and to have improved tolerability, compared with IFN-alpha treatments, the investigators said.
However, on-treatment viral breakthrough or relapse after DAA therapy is a common cause of treatment failure. The current findings, although limited by the small sample size, suggest that the ability to restore intrahepatic type I IFN signaling "may be biologically important for eradication of residual virus in the setting of prolonged HCV suppression with IFN-free therapy."
"Knowledge of expression variability in components of the IFN system could help determine the optimal duration of therapy for patients, especially in resource-limited settings, a concept that will be pursued in future studies. As HCV therapy evolves from IFN-based to DAA-only regimens, our study fosters a role for the host in determining favorable treatment outcomes in chronically infected patients treated with SOF/RBV," they concluded.
This study was funded by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Institutes of Health Clinical Center, and the German Research Foundation. Gilead Sciences provided sofosbuvir. Coauthor John McHutchison is an employee of Gilead. The other authors reported having no disclosures.
Restoration of type I intrahepatic interferon signaling by the end of direct-acting antiviral treatment in patients with hepatitis C virus appears to facilitate HCV eradication and relapse prevention, according to findings from a clinical trial.
Of 60 patients treated with the direct-acting antiviral agent (DAA) sofosbuvir plus ribavirin (SOF/RBV), 69% achieved sustained virologic response and 31% relapsed within 12 weeks of treatment completion. A reduction of intrahepatic expression of type II and III interferons (IFNs) and their receptors in a sample of the patients with SVRs paralleled a decrease in hepatic and blood interferon-stimulating gene expression during HCV suppression – a finding that suggested that reactivation of hepatic type I IFN signaling at the end of treatment might be important for a favorable outcome.
A subsequent comparison of microarray mRNA expression profiling in unpaired liver biopsies obtained at the end of treatment showed that type I IFN expression was indeed higher in 17 patients who achieved sustained virologic response (SVR) than in 8 patients who relapsed, Dr. Eric G. Meissner of the National Institute of Allergy and Infectious Diseases, Bethesda, Md., and his colleagues reported online July 2 in the Journal of Clinical Investigation.
IFN signaling was identified as a top pathway distinguishing SVR from relapse, with lower expression of an IFN gene signature at the end of treatment in patients who relapsed, the investigators said (J. Clin. Invest. 2014 July 2 [doi: 10.1172/jci75938]).
"Our present results demonstrate for the first time that HCV clearance achieved during IFN-free treatment with the DAA regimen of SOF/RBV is accompanied by hepatic down-regulation of type II and III IFNs, their receptors, and interferon-stimulated genes (ISGs). Down-regulation of ISGs was associated with on-treatment viral suppression and occurred regardless of treatment outcome, since all patients achieved virologic suppression on therapy. However, patients who achieved SVR unexpectedly had higher intrahepatic expression of ISGs at end of treatment compared with patients who relapsed," the authors wrote.
They noted that the increase in IFNA2 expression in those who achieved SVR suggested that the higher end-of-treatment ISG expression might be driven by an enhanced type I IFN response.
This suggests a model in which aberrant expression of hepatic ISGs triggered by HCV and/or type II/III IFNs decreases early during treatment, and after prolonged viral suppression, higher activation of ISG expression at the end of treatment may be induced by type I IFNs, which in turn might promote elimination of residual virus, they suggested.
As has been recognized in other conditions involving prolonged immune stimulation, resolution of infection and inflammation can be followed by a period of relative immune suppression. HCV patients who are able to reestablish IFN homeostasis by the end of DAA treatment may be more likely to achieve SVR, while those who aren’t able to reestablish IFN homeostasis may be more prone to relapse, they noted. "The ability to mount an endogenous, intrahepatic type I IFN response could be important for achieving SVR, even with IFN-alpha–free DAA regimens," they added
The findings are important because although injectable IFN-alpha formulations have been the mainstay of HCV treatment, they are associated with significant side effects and often are ineffective; treatment is rapidly evolving to IFN-alpha–free oral regimens that consist of DAAs. DAAs have been shown in clinical trials to induce rapid and sustained viral suppression, and to have improved tolerability, compared with IFN-alpha treatments, the investigators said.
However, on-treatment viral breakthrough or relapse after DAA therapy is a common cause of treatment failure. The current findings, although limited by the small sample size, suggest that the ability to restore intrahepatic type I IFN signaling "may be biologically important for eradication of residual virus in the setting of prolonged HCV suppression with IFN-free therapy."
"Knowledge of expression variability in components of the IFN system could help determine the optimal duration of therapy for patients, especially in resource-limited settings, a concept that will be pursued in future studies. As HCV therapy evolves from IFN-based to DAA-only regimens, our study fosters a role for the host in determining favorable treatment outcomes in chronically infected patients treated with SOF/RBV," they concluded.
This study was funded by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Institutes of Health Clinical Center, and the German Research Foundation. Gilead Sciences provided sofosbuvir. Coauthor John McHutchison is an employee of Gilead. The other authors reported having no disclosures.
Restoration of type I intrahepatic interferon signaling by the end of direct-acting antiviral treatment in patients with hepatitis C virus appears to facilitate HCV eradication and relapse prevention, according to findings from a clinical trial.
Of 60 patients treated with the direct-acting antiviral agent (DAA) sofosbuvir plus ribavirin (SOF/RBV), 69% achieved sustained virologic response and 31% relapsed within 12 weeks of treatment completion. A reduction of intrahepatic expression of type II and III interferons (IFNs) and their receptors in a sample of the patients with SVRs paralleled a decrease in hepatic and blood interferon-stimulating gene expression during HCV suppression – a finding that suggested that reactivation of hepatic type I IFN signaling at the end of treatment might be important for a favorable outcome.
A subsequent comparison of microarray mRNA expression profiling in unpaired liver biopsies obtained at the end of treatment showed that type I IFN expression was indeed higher in 17 patients who achieved sustained virologic response (SVR) than in 8 patients who relapsed, Dr. Eric G. Meissner of the National Institute of Allergy and Infectious Diseases, Bethesda, Md., and his colleagues reported online July 2 in the Journal of Clinical Investigation.
IFN signaling was identified as a top pathway distinguishing SVR from relapse, with lower expression of an IFN gene signature at the end of treatment in patients who relapsed, the investigators said (J. Clin. Invest. 2014 July 2 [doi: 10.1172/jci75938]).
"Our present results demonstrate for the first time that HCV clearance achieved during IFN-free treatment with the DAA regimen of SOF/RBV is accompanied by hepatic down-regulation of type II and III IFNs, their receptors, and interferon-stimulated genes (ISGs). Down-regulation of ISGs was associated with on-treatment viral suppression and occurred regardless of treatment outcome, since all patients achieved virologic suppression on therapy. However, patients who achieved SVR unexpectedly had higher intrahepatic expression of ISGs at end of treatment compared with patients who relapsed," the authors wrote.
They noted that the increase in IFNA2 expression in those who achieved SVR suggested that the higher end-of-treatment ISG expression might be driven by an enhanced type I IFN response.
This suggests a model in which aberrant expression of hepatic ISGs triggered by HCV and/or type II/III IFNs decreases early during treatment, and after prolonged viral suppression, higher activation of ISG expression at the end of treatment may be induced by type I IFNs, which in turn might promote elimination of residual virus, they suggested.
As has been recognized in other conditions involving prolonged immune stimulation, resolution of infection and inflammation can be followed by a period of relative immune suppression. HCV patients who are able to reestablish IFN homeostasis by the end of DAA treatment may be more likely to achieve SVR, while those who aren’t able to reestablish IFN homeostasis may be more prone to relapse, they noted. "The ability to mount an endogenous, intrahepatic type I IFN response could be important for achieving SVR, even with IFN-alpha–free DAA regimens," they added
The findings are important because although injectable IFN-alpha formulations have been the mainstay of HCV treatment, they are associated with significant side effects and often are ineffective; treatment is rapidly evolving to IFN-alpha–free oral regimens that consist of DAAs. DAAs have been shown in clinical trials to induce rapid and sustained viral suppression, and to have improved tolerability, compared with IFN-alpha treatments, the investigators said.
However, on-treatment viral breakthrough or relapse after DAA therapy is a common cause of treatment failure. The current findings, although limited by the small sample size, suggest that the ability to restore intrahepatic type I IFN signaling "may be biologically important for eradication of residual virus in the setting of prolonged HCV suppression with IFN-free therapy."
"Knowledge of expression variability in components of the IFN system could help determine the optimal duration of therapy for patients, especially in resource-limited settings, a concept that will be pursued in future studies. As HCV therapy evolves from IFN-based to DAA-only regimens, our study fosters a role for the host in determining favorable treatment outcomes in chronically infected patients treated with SOF/RBV," they concluded.
This study was funded by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Institutes of Health Clinical Center, and the German Research Foundation. Gilead Sciences provided sofosbuvir. Coauthor John McHutchison is an employee of Gilead. The other authors reported having no disclosures.
FROM THE JOURNAL OF CLINICAL INVESTIGATION
Intrahepatic interferon signaling may predict hepatitis C outcome
Restoration of type I intrahepatic interferon signaling by the end of direct-acting antiviral treatment in patients with hepatitis C virus appears to facilitate HCV eradication and relapse prevention, according to findings from a clinical trial.
Of 60 patients treated with the direct-acting antiviral agent (DAA) sofosbuvir plus ribavirin (SOF/RBV), 69% achieved sustained virologic response and 31% relapsed within 12 weeks of treatment completion. A reduction of intrahepatic expression of type II and III interferons (IFNs) and their receptors in a sample of the patients with SVRs paralleled a decrease in hepatic and blood interferon-stimulating gene expression during HCV suppression – a finding that suggested that reactivation of hepatic type I IFN signaling at the end of treatment might be important for a favorable outcome.
A subsequent comparison of microarray mRNA expression profiling in unpaired liver biopsies obtained at the end of treatment showed that type I IFN expression was indeed higher in 17 patients who achieved sustained virologic response (SVR) than in 8 patients who relapsed, Dr. Eric G. Meissner of the National Institute of Allergy and Infectious Diseases, Bethesda, Md., and his colleagues reported online July 2 in the Journal of Clinical Investigation.
IFN signaling was identified as a top pathway distinguishing SVR from relapse, with lower expression of an IFN gene signature at the end of treatment in patients who relapsed, the investigators said (J. Clin. Invest. 2014 July 2 [doi: 10.1172/jci75938]).
"Our present results demonstrate for the first time that HCV clearance achieved during IFN-free treatment with the DAA regimen of SOF/RBV is accompanied by hepatic down-regulation of type II and III IFNs, their receptors, and interferon-stimulated genes (ISGs). Down-regulation of ISGs was associated with on-treatment viral suppression and occurred regardless of treatment outcome, since all patients achieved virologic suppression on therapy. However, patients who achieved SVR unexpectedly had higher intrahepatic expression of ISGs at end of treatment compared with patients who relapsed," the authors wrote.
They noted that the increase in IFNA2 expression in those who achieved SVR suggested that the higher end-of-treatment ISG expression might be driven by an enhanced type I IFN response.
This suggests a model in which aberrant expression of hepatic ISGs triggered by HCV and/or type II/III IFNs decreases early during treatment, and after prolonged viral suppression, higher activation of ISG expression at the end of treatment may be induced by type I IFNs, which in turn might promote elimination of residual virus, they suggested.
As has been recognized in other conditions involving prolonged immune stimulation, resolution of infection and inflammation can be followed by a period of relative immune suppression. HCV patients who are able to reestablish IFN homeostasis by the end of DAA treatment may be more likely to achieve SVR, while those who aren’t able to reestablish IFN homeostasis may be more prone to relapse, they noted. "The ability to mount an endogenous, intrahepatic type I IFN response could be important for achieving SVR, even with IFN-alpha–free DAA regimens," they added
The findings are important because although injectable IFN-alpha formulations have been the mainstay of HCV treatment, they are associated with significant side effects and often are ineffective; treatment is rapidly evolving to IFN-alpha–free oral regimens that consist of DAAs. DAAs have been shown in clinical trials to induce rapid and sustained viral suppression, and to have improved tolerability, compared with IFN-alpha treatments, the investigators said.
However, on-treatment viral breakthrough or relapse after DAA therapy is a common cause of treatment failure. The current findings, although limited by the small sample size, suggest that the ability to restore intrahepatic type I IFN signaling "may be biologically important for eradication of residual virus in the setting of prolonged HCV suppression with IFN-free therapy."
"Knowledge of expression variability in components of the IFN system could help determine the optimal duration of therapy for patients, especially in resource-limited settings, a concept that will be pursued in future studies. As HCV therapy evolves from IFN-based to DAA-only regimens, our study fosters a role for the host in determining favorable treatment outcomes in chronically infected patients treated with SOF/RBV," they concluded.
This study was funded by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Institutes of Health Clinical Center, and the German Research Foundation. Gilead Sciences provided sofosbuvir. Coauthor John McHutchison is an employee of Gilead. The other authors reported having no disclosures.
Restoration of type I intrahepatic interferon signaling by the end of direct-acting antiviral treatment in patients with hepatitis C virus appears to facilitate HCV eradication and relapse prevention, according to findings from a clinical trial.
Of 60 patients treated with the direct-acting antiviral agent (DAA) sofosbuvir plus ribavirin (SOF/RBV), 69% achieved sustained virologic response and 31% relapsed within 12 weeks of treatment completion. A reduction of intrahepatic expression of type II and III interferons (IFNs) and their receptors in a sample of the patients with SVRs paralleled a decrease in hepatic and blood interferon-stimulating gene expression during HCV suppression – a finding that suggested that reactivation of hepatic type I IFN signaling at the end of treatment might be important for a favorable outcome.
A subsequent comparison of microarray mRNA expression profiling in unpaired liver biopsies obtained at the end of treatment showed that type I IFN expression was indeed higher in 17 patients who achieved sustained virologic response (SVR) than in 8 patients who relapsed, Dr. Eric G. Meissner of the National Institute of Allergy and Infectious Diseases, Bethesda, Md., and his colleagues reported online July 2 in the Journal of Clinical Investigation.
IFN signaling was identified as a top pathway distinguishing SVR from relapse, with lower expression of an IFN gene signature at the end of treatment in patients who relapsed, the investigators said (J. Clin. Invest. 2014 July 2 [doi: 10.1172/jci75938]).
"Our present results demonstrate for the first time that HCV clearance achieved during IFN-free treatment with the DAA regimen of SOF/RBV is accompanied by hepatic down-regulation of type II and III IFNs, their receptors, and interferon-stimulated genes (ISGs). Down-regulation of ISGs was associated with on-treatment viral suppression and occurred regardless of treatment outcome, since all patients achieved virologic suppression on therapy. However, patients who achieved SVR unexpectedly had higher intrahepatic expression of ISGs at end of treatment compared with patients who relapsed," the authors wrote.
They noted that the increase in IFNA2 expression in those who achieved SVR suggested that the higher end-of-treatment ISG expression might be driven by an enhanced type I IFN response.
This suggests a model in which aberrant expression of hepatic ISGs triggered by HCV and/or type II/III IFNs decreases early during treatment, and after prolonged viral suppression, higher activation of ISG expression at the end of treatment may be induced by type I IFNs, which in turn might promote elimination of residual virus, they suggested.
As has been recognized in other conditions involving prolonged immune stimulation, resolution of infection and inflammation can be followed by a period of relative immune suppression. HCV patients who are able to reestablish IFN homeostasis by the end of DAA treatment may be more likely to achieve SVR, while those who aren’t able to reestablish IFN homeostasis may be more prone to relapse, they noted. "The ability to mount an endogenous, intrahepatic type I IFN response could be important for achieving SVR, even with IFN-alpha–free DAA regimens," they added
The findings are important because although injectable IFN-alpha formulations have been the mainstay of HCV treatment, they are associated with significant side effects and often are ineffective; treatment is rapidly evolving to IFN-alpha–free oral regimens that consist of DAAs. DAAs have been shown in clinical trials to induce rapid and sustained viral suppression, and to have improved tolerability, compared with IFN-alpha treatments, the investigators said.
However, on-treatment viral breakthrough or relapse after DAA therapy is a common cause of treatment failure. The current findings, although limited by the small sample size, suggest that the ability to restore intrahepatic type I IFN signaling "may be biologically important for eradication of residual virus in the setting of prolonged HCV suppression with IFN-free therapy."
"Knowledge of expression variability in components of the IFN system could help determine the optimal duration of therapy for patients, especially in resource-limited settings, a concept that will be pursued in future studies. As HCV therapy evolves from IFN-based to DAA-only regimens, our study fosters a role for the host in determining favorable treatment outcomes in chronically infected patients treated with SOF/RBV," they concluded.
This study was funded by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Institutes of Health Clinical Center, and the German Research Foundation. Gilead Sciences provided sofosbuvir. Coauthor John McHutchison is an employee of Gilead. The other authors reported having no disclosures.
Restoration of type I intrahepatic interferon signaling by the end of direct-acting antiviral treatment in patients with hepatitis C virus appears to facilitate HCV eradication and relapse prevention, according to findings from a clinical trial.
Of 60 patients treated with the direct-acting antiviral agent (DAA) sofosbuvir plus ribavirin (SOF/RBV), 69% achieved sustained virologic response and 31% relapsed within 12 weeks of treatment completion. A reduction of intrahepatic expression of type II and III interferons (IFNs) and their receptors in a sample of the patients with SVRs paralleled a decrease in hepatic and blood interferon-stimulating gene expression during HCV suppression – a finding that suggested that reactivation of hepatic type I IFN signaling at the end of treatment might be important for a favorable outcome.
A subsequent comparison of microarray mRNA expression profiling in unpaired liver biopsies obtained at the end of treatment showed that type I IFN expression was indeed higher in 17 patients who achieved sustained virologic response (SVR) than in 8 patients who relapsed, Dr. Eric G. Meissner of the National Institute of Allergy and Infectious Diseases, Bethesda, Md., and his colleagues reported online July 2 in the Journal of Clinical Investigation.
IFN signaling was identified as a top pathway distinguishing SVR from relapse, with lower expression of an IFN gene signature at the end of treatment in patients who relapsed, the investigators said (J. Clin. Invest. 2014 July 2 [doi: 10.1172/jci75938]).
"Our present results demonstrate for the first time that HCV clearance achieved during IFN-free treatment with the DAA regimen of SOF/RBV is accompanied by hepatic down-regulation of type II and III IFNs, their receptors, and interferon-stimulated genes (ISGs). Down-regulation of ISGs was associated with on-treatment viral suppression and occurred regardless of treatment outcome, since all patients achieved virologic suppression on therapy. However, patients who achieved SVR unexpectedly had higher intrahepatic expression of ISGs at end of treatment compared with patients who relapsed," the authors wrote.
They noted that the increase in IFNA2 expression in those who achieved SVR suggested that the higher end-of-treatment ISG expression might be driven by an enhanced type I IFN response.
This suggests a model in which aberrant expression of hepatic ISGs triggered by HCV and/or type II/III IFNs decreases early during treatment, and after prolonged viral suppression, higher activation of ISG expression at the end of treatment may be induced by type I IFNs, which in turn might promote elimination of residual virus, they suggested.
As has been recognized in other conditions involving prolonged immune stimulation, resolution of infection and inflammation can be followed by a period of relative immune suppression. HCV patients who are able to reestablish IFN homeostasis by the end of DAA treatment may be more likely to achieve SVR, while those who aren’t able to reestablish IFN homeostasis may be more prone to relapse, they noted. "The ability to mount an endogenous, intrahepatic type I IFN response could be important for achieving SVR, even with IFN-alpha–free DAA regimens," they added
The findings are important because although injectable IFN-alpha formulations have been the mainstay of HCV treatment, they are associated with significant side effects and often are ineffective; treatment is rapidly evolving to IFN-alpha–free oral regimens that consist of DAAs. DAAs have been shown in clinical trials to induce rapid and sustained viral suppression, and to have improved tolerability, compared with IFN-alpha treatments, the investigators said.
However, on-treatment viral breakthrough or relapse after DAA therapy is a common cause of treatment failure. The current findings, although limited by the small sample size, suggest that the ability to restore intrahepatic type I IFN signaling "may be biologically important for eradication of residual virus in the setting of prolonged HCV suppression with IFN-free therapy."
"Knowledge of expression variability in components of the IFN system could help determine the optimal duration of therapy for patients, especially in resource-limited settings, a concept that will be pursued in future studies. As HCV therapy evolves from IFN-based to DAA-only regimens, our study fosters a role for the host in determining favorable treatment outcomes in chronically infected patients treated with SOF/RBV," they concluded.
This study was funded by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Institutes of Health Clinical Center, and the German Research Foundation. Gilead Sciences provided sofosbuvir. Coauthor John McHutchison is an employee of Gilead. The other authors reported having no disclosures.
FROM THE JOURNAL OF CLINICAL INVESTIGATION
Key clinical point: Type I interferon expression may be a way to predict relapse in HCV patients receiving direct-acting antiviral therapy.
Major finding: Type I interferon expression was higher in 17 patients who achieved SVR than in 8 patients who relapsed.
Data source: A clinical trial involving 60 patients.
Disclosures: This study was funded by the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the National Institutes of Health Clinical Center, and the German Research Foundation. Gilead Sciences provided sofosbuvir. Coauthor John McHutchison is an employee of Gilead. The other authors reported having no disclosures.
Stress, negative emotions may up stroke and TIA risk
Stress, hostility, and depressive symptoms appear to increase the risk of stroke and transient ischemic attack in middle-aged and older adults, according to findings from the Multi-Ethnic Study of Atherosclerosis (MESA).
In 6,749 adults aged 45-84 years in MESA, a longitudinal population-based cohort study, 195 incident events –147 strokes and 48 TIAs – occurred during a median follow-up of 8.5 years.
After adjustment for age, demographics, and site, the risk was greatest among those with the highest vs. lowest scores for depressive symptoms (hazard ratio, 1.86), chronic stress (HR, 1.59), and hostility (HR, 2.22). Each additional point on the depression, stress, and hostility scales was associated with increased stroke risk after researchers controlled for race, sex, age, education, and site, reported Susan Everson-Rose, Ph.D., of the University of Minnesota, Minneapolis.
The report was published online July 10 in Stroke.
The risk was attenuated but remained significant in models that adjusted for traditional stroke risk factors, inflammatory markers, and subclinical atherosclerosis, wrote Dr. Everson-Rose and her colleagues (Stroke 2014 July 10 [doi:10/1161/STROKEAHA.114.004815).
The findings highlight the importance of considering nontraditional risk factors when assessing patients for stroke and TIA risk, the investigators concluded, adding that "better understanding of important, potentially modifiable stroke risk factors, including stress and negative emotions, is needed given the aging population and increasing burden of stroke."
MESA was supported by the National Heart, Lung, and Blood Institute and by grants from the National Center for Research Resources. Dr Everson-Rose received support from the NHLBI and the Applied Clinical Research Program and Program in Health Disparities Research at the University of Minnesota. Dr. Diez Roux was supported in part by the Michigan Center for Integrative Approaches to Health Disparities.
Stress, hostility, and depressive symptoms appear to increase the risk of stroke and transient ischemic attack in middle-aged and older adults, according to findings from the Multi-Ethnic Study of Atherosclerosis (MESA).
In 6,749 adults aged 45-84 years in MESA, a longitudinal population-based cohort study, 195 incident events –147 strokes and 48 TIAs – occurred during a median follow-up of 8.5 years.
After adjustment for age, demographics, and site, the risk was greatest among those with the highest vs. lowest scores for depressive symptoms (hazard ratio, 1.86), chronic stress (HR, 1.59), and hostility (HR, 2.22). Each additional point on the depression, stress, and hostility scales was associated with increased stroke risk after researchers controlled for race, sex, age, education, and site, reported Susan Everson-Rose, Ph.D., of the University of Minnesota, Minneapolis.
The report was published online July 10 in Stroke.
The risk was attenuated but remained significant in models that adjusted for traditional stroke risk factors, inflammatory markers, and subclinical atherosclerosis, wrote Dr. Everson-Rose and her colleagues (Stroke 2014 July 10 [doi:10/1161/STROKEAHA.114.004815).
The findings highlight the importance of considering nontraditional risk factors when assessing patients for stroke and TIA risk, the investigators concluded, adding that "better understanding of important, potentially modifiable stroke risk factors, including stress and negative emotions, is needed given the aging population and increasing burden of stroke."
MESA was supported by the National Heart, Lung, and Blood Institute and by grants from the National Center for Research Resources. Dr Everson-Rose received support from the NHLBI and the Applied Clinical Research Program and Program in Health Disparities Research at the University of Minnesota. Dr. Diez Roux was supported in part by the Michigan Center for Integrative Approaches to Health Disparities.
Stress, hostility, and depressive symptoms appear to increase the risk of stroke and transient ischemic attack in middle-aged and older adults, according to findings from the Multi-Ethnic Study of Atherosclerosis (MESA).
In 6,749 adults aged 45-84 years in MESA, a longitudinal population-based cohort study, 195 incident events –147 strokes and 48 TIAs – occurred during a median follow-up of 8.5 years.
After adjustment for age, demographics, and site, the risk was greatest among those with the highest vs. lowest scores for depressive symptoms (hazard ratio, 1.86), chronic stress (HR, 1.59), and hostility (HR, 2.22). Each additional point on the depression, stress, and hostility scales was associated with increased stroke risk after researchers controlled for race, sex, age, education, and site, reported Susan Everson-Rose, Ph.D., of the University of Minnesota, Minneapolis.
The report was published online July 10 in Stroke.
The risk was attenuated but remained significant in models that adjusted for traditional stroke risk factors, inflammatory markers, and subclinical atherosclerosis, wrote Dr. Everson-Rose and her colleagues (Stroke 2014 July 10 [doi:10/1161/STROKEAHA.114.004815).
The findings highlight the importance of considering nontraditional risk factors when assessing patients for stroke and TIA risk, the investigators concluded, adding that "better understanding of important, potentially modifiable stroke risk factors, including stress and negative emotions, is needed given the aging population and increasing burden of stroke."
MESA was supported by the National Heart, Lung, and Blood Institute and by grants from the National Center for Research Resources. Dr Everson-Rose received support from the NHLBI and the Applied Clinical Research Program and Program in Health Disparities Research at the University of Minnesota. Dr. Diez Roux was supported in part by the Michigan Center for Integrative Approaches to Health Disparities.
FROM STROKE
Key clinical point: Nontraditional factors should be considered when assessing patients for stroke and TIA risk.
Major finding: Each 1-point increase on depression, stress, and hostility scores was associated with increased stroke risk.
Data source: The longitudinal prospective MESA study involving 6,749 adults.
Disclosures: MESA was supported by the National Heart, Lung, and Blood Institute and by grants from the National Center for Research Resources. Dr Everson-Rose received support from the NHLBI and the Applied Clinical Research Program and Program in Health Disparities Research at the University of Minnesota. Dr. Diez Roux was supported in part by the Michigan Center for Integrative Approaches to Health Disparities.
Secukinumab bests etanercept, placebo for sustained improvement of psoriasis
At least two-thirds of adults with plaque psoriasis treated with the fully human anti-interleukin-17A monoclonal antibody secukinumab achieved PASI 75 at 12 weeks in two related randomized phase III trials. The findings were reported online July 9 in the New England Journal of Medicine.
In the ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) trial, a multicenter, double-blind study involving 738 patients, the proportions of patients who achieved a 75% or greater reduction in Psoriasis Area and Severity Index (PASI 75) score at 12 weeks were 81.6%, 71.6%, and 4.5% with 300 mg of secukinumab, 150 mg of secukinumab, and placebo, respectively.
In the FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens) study, a multicenter, double-blind, active-controlled study involving 1,306 patients, the proportions meeting PASI 75 were 77.1% and 67% for 300 and 150 mg, respectively, compared with 44% for etanercept and 4.9% for placebo.
The difference between each secukinumab dose and its comparators was statistically significant in both studies, Dr. Richard G. Langley of Dalhousie University, Halifax, N.S., Dr. Boni Elewski of the University of Alabama, Birmingham, and their colleagues reported on behalf of the ERASURE and FIXTURE Study Groups.
The investigators also found that the proportions of patients with a response of 0 or 1 on the modified investigator’s global assessment at 12 weeks were 65.3%, 51.2%, and 2.4% for the 300- and 150-mg secukinumab doses and placebo, respectively, in ERASURE; and 62.5% and 51.1% for the 300- and 150-mg doses, 27.2% for etanercept, and 2.8% for placebo in FIXTURE (N. Engl. J. Med. 2014 July 9 [doi: 10.1056/NE/NEJMoa314258]).
The differences between each secukinumab dose and its comparators were significant for this measure as well, the investigators reported.
Secukinumab at the 300- and 150-mg doses in both ERASURE and FIXTURE was also superior to placebo (and in FIXTURE, superior to etanercept) for all secondary efficacy endpoints, including PASI 90 and PASI 100 response at week 12; patient reports of itching, pain, and scaling on the Psoriasis Symptom Diary at week 12; and Dermatology Life Quality Index scores.
Both ERASURE and FIXTURE were designed to evaluate the safety of secukinumab as induction therapy with assessment at week 12, and as maintenance therapy with assessment at week 52. Subjects were aged 18 years or older with poorly controlled, moderate to severe plaque psoriasis that had been diagnosed at least 6 months prior, and with a PASI score of 12 or higher, a modified investigator’s global assessment score of 3 or 4, and involvement of 10% or more of their body surface area.
ERASURE was conducted from June 2011 to April 2013 at 88 sites worldwide, and FIXTURE was conducted from June 2011 to June 2013 at 231 sites. Patients in the 300-mg groups received two 150-mg subcutaneous injections of secukinumab, and those in the 150-mg group received one 150-mg injection of secukinumab, and one placebo injection. Etanercept was given at a dose of 50 mg administered subcutaneously twice weekly from baseline until week 12, and then once weekly through week 51.
Adverse events were more common in patients treated with secukinumab in ERASURE; 55% of patients in the 300-mg group, 60.4% in the 150-mg group, and 47% in the placebo group experienced at least one adverse event during the induction period, and 29.4%, 26.9%, and 16.2% in those groups, respectively, experienced infections and/or infestations. The most common adverse events were nasopharyngitis, headache, and upper respiratory tract infection.
The incidence of adverse events in FIXTURE was similar in those receiving secukinumab and etanercept, and was greater in both groups than in the placebo group. Infections and infestations occurred in 26.7%, 30.9%, 24.5%, and 19.3% of those receiving 300 mg of secukinumab, 150 mg of secukinumab, etanercept, and placebo, respectively. However, candida infections were more common with secukinumab than with etanercept (4.7%, 2.3%, and 1.2% of patients in the 300- and 150-mg secukinumab groups and the etanercept group, respectively, had candida infections). All candida infections in the secukinumab group were mild or moderate, and two of four infections in the etanercept group were severe.
Grade 3 neutropenia occurred in nine patients receiving secukinumab and in no patients receiving etanercept.
"The results of these phase 3 studies validate interleukin-17A as an important therapeutic target in moderate to severe plaque psoriasis, confirming earlier findings from basic research and phase 2 trials of secukinumab that suggested that interleukin-17A plays a role in the pathogenesis of psoriasis," the investigators said.
Interleukin-17A plays a key role in host defense, specifically in mucocutaneous microbial surveillance, they added.
"Continued vigilance with respect to the potential for candida infection will be necessary for interleukin-17A inhibitors. Neutropenia may also be of potential concern because of the reported role of interleukin-17A in the stimulation of granulopoiesis and neutrophil trafficking," they noted.
A limitation of both ERASURE and FIXTURE was that few patients continued to receive placebo after week 12, thus limiting the comparisons with the placebo group during the maintenance periods. Also, the study populations may have been too small to detect rare adverse events, the authors wrote, noting that extension studies to evaluate long-term efficacy are ongoing.
ERASURE and FIXTURE were supported by Novartis Pharmaceuticals. Dr. Langley reported no conflicts related to these studies. Dr. Elewski disclosed funding from Novartis during the study period.
At least two-thirds of adults with plaque psoriasis treated with the fully human anti-interleukin-17A monoclonal antibody secukinumab achieved PASI 75 at 12 weeks in two related randomized phase III trials. The findings were reported online July 9 in the New England Journal of Medicine.
In the ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) trial, a multicenter, double-blind study involving 738 patients, the proportions of patients who achieved a 75% or greater reduction in Psoriasis Area and Severity Index (PASI 75) score at 12 weeks were 81.6%, 71.6%, and 4.5% with 300 mg of secukinumab, 150 mg of secukinumab, and placebo, respectively.
In the FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens) study, a multicenter, double-blind, active-controlled study involving 1,306 patients, the proportions meeting PASI 75 were 77.1% and 67% for 300 and 150 mg, respectively, compared with 44% for etanercept and 4.9% for placebo.
The difference between each secukinumab dose and its comparators was statistically significant in both studies, Dr. Richard G. Langley of Dalhousie University, Halifax, N.S., Dr. Boni Elewski of the University of Alabama, Birmingham, and their colleagues reported on behalf of the ERASURE and FIXTURE Study Groups.
The investigators also found that the proportions of patients with a response of 0 or 1 on the modified investigator’s global assessment at 12 weeks were 65.3%, 51.2%, and 2.4% for the 300- and 150-mg secukinumab doses and placebo, respectively, in ERASURE; and 62.5% and 51.1% for the 300- and 150-mg doses, 27.2% for etanercept, and 2.8% for placebo in FIXTURE (N. Engl. J. Med. 2014 July 9 [doi: 10.1056/NE/NEJMoa314258]).
The differences between each secukinumab dose and its comparators were significant for this measure as well, the investigators reported.
Secukinumab at the 300- and 150-mg doses in both ERASURE and FIXTURE was also superior to placebo (and in FIXTURE, superior to etanercept) for all secondary efficacy endpoints, including PASI 90 and PASI 100 response at week 12; patient reports of itching, pain, and scaling on the Psoriasis Symptom Diary at week 12; and Dermatology Life Quality Index scores.
Both ERASURE and FIXTURE were designed to evaluate the safety of secukinumab as induction therapy with assessment at week 12, and as maintenance therapy with assessment at week 52. Subjects were aged 18 years or older with poorly controlled, moderate to severe plaque psoriasis that had been diagnosed at least 6 months prior, and with a PASI score of 12 or higher, a modified investigator’s global assessment score of 3 or 4, and involvement of 10% or more of their body surface area.
ERASURE was conducted from June 2011 to April 2013 at 88 sites worldwide, and FIXTURE was conducted from June 2011 to June 2013 at 231 sites. Patients in the 300-mg groups received two 150-mg subcutaneous injections of secukinumab, and those in the 150-mg group received one 150-mg injection of secukinumab, and one placebo injection. Etanercept was given at a dose of 50 mg administered subcutaneously twice weekly from baseline until week 12, and then once weekly through week 51.
Adverse events were more common in patients treated with secukinumab in ERASURE; 55% of patients in the 300-mg group, 60.4% in the 150-mg group, and 47% in the placebo group experienced at least one adverse event during the induction period, and 29.4%, 26.9%, and 16.2% in those groups, respectively, experienced infections and/or infestations. The most common adverse events were nasopharyngitis, headache, and upper respiratory tract infection.
The incidence of adverse events in FIXTURE was similar in those receiving secukinumab and etanercept, and was greater in both groups than in the placebo group. Infections and infestations occurred in 26.7%, 30.9%, 24.5%, and 19.3% of those receiving 300 mg of secukinumab, 150 mg of secukinumab, etanercept, and placebo, respectively. However, candida infections were more common with secukinumab than with etanercept (4.7%, 2.3%, and 1.2% of patients in the 300- and 150-mg secukinumab groups and the etanercept group, respectively, had candida infections). All candida infections in the secukinumab group were mild or moderate, and two of four infections in the etanercept group were severe.
Grade 3 neutropenia occurred in nine patients receiving secukinumab and in no patients receiving etanercept.
"The results of these phase 3 studies validate interleukin-17A as an important therapeutic target in moderate to severe plaque psoriasis, confirming earlier findings from basic research and phase 2 trials of secukinumab that suggested that interleukin-17A plays a role in the pathogenesis of psoriasis," the investigators said.
Interleukin-17A plays a key role in host defense, specifically in mucocutaneous microbial surveillance, they added.
"Continued vigilance with respect to the potential for candida infection will be necessary for interleukin-17A inhibitors. Neutropenia may also be of potential concern because of the reported role of interleukin-17A in the stimulation of granulopoiesis and neutrophil trafficking," they noted.
A limitation of both ERASURE and FIXTURE was that few patients continued to receive placebo after week 12, thus limiting the comparisons with the placebo group during the maintenance periods. Also, the study populations may have been too small to detect rare adverse events, the authors wrote, noting that extension studies to evaluate long-term efficacy are ongoing.
ERASURE and FIXTURE were supported by Novartis Pharmaceuticals. Dr. Langley reported no conflicts related to these studies. Dr. Elewski disclosed funding from Novartis during the study period.
At least two-thirds of adults with plaque psoriasis treated with the fully human anti-interleukin-17A monoclonal antibody secukinumab achieved PASI 75 at 12 weeks in two related randomized phase III trials. The findings were reported online July 9 in the New England Journal of Medicine.
In the ERASURE (Efficacy of Response and Safety of Two Fixed Secukinumab Regimens in Psoriasis) trial, a multicenter, double-blind study involving 738 patients, the proportions of patients who achieved a 75% or greater reduction in Psoriasis Area and Severity Index (PASI 75) score at 12 weeks were 81.6%, 71.6%, and 4.5% with 300 mg of secukinumab, 150 mg of secukinumab, and placebo, respectively.
In the FIXTURE (Full Year Investigative Examination of Secukinumab vs. Etanercept Using Two Dosing Regimens) study, a multicenter, double-blind, active-controlled study involving 1,306 patients, the proportions meeting PASI 75 were 77.1% and 67% for 300 and 150 mg, respectively, compared with 44% for etanercept and 4.9% for placebo.
The difference between each secukinumab dose and its comparators was statistically significant in both studies, Dr. Richard G. Langley of Dalhousie University, Halifax, N.S., Dr. Boni Elewski of the University of Alabama, Birmingham, and their colleagues reported on behalf of the ERASURE and FIXTURE Study Groups.
The investigators also found that the proportions of patients with a response of 0 or 1 on the modified investigator’s global assessment at 12 weeks were 65.3%, 51.2%, and 2.4% for the 300- and 150-mg secukinumab doses and placebo, respectively, in ERASURE; and 62.5% and 51.1% for the 300- and 150-mg doses, 27.2% for etanercept, and 2.8% for placebo in FIXTURE (N. Engl. J. Med. 2014 July 9 [doi: 10.1056/NE/NEJMoa314258]).
The differences between each secukinumab dose and its comparators were significant for this measure as well, the investigators reported.
Secukinumab at the 300- and 150-mg doses in both ERASURE and FIXTURE was also superior to placebo (and in FIXTURE, superior to etanercept) for all secondary efficacy endpoints, including PASI 90 and PASI 100 response at week 12; patient reports of itching, pain, and scaling on the Psoriasis Symptom Diary at week 12; and Dermatology Life Quality Index scores.
Both ERASURE and FIXTURE were designed to evaluate the safety of secukinumab as induction therapy with assessment at week 12, and as maintenance therapy with assessment at week 52. Subjects were aged 18 years or older with poorly controlled, moderate to severe plaque psoriasis that had been diagnosed at least 6 months prior, and with a PASI score of 12 or higher, a modified investigator’s global assessment score of 3 or 4, and involvement of 10% or more of their body surface area.
ERASURE was conducted from June 2011 to April 2013 at 88 sites worldwide, and FIXTURE was conducted from June 2011 to June 2013 at 231 sites. Patients in the 300-mg groups received two 150-mg subcutaneous injections of secukinumab, and those in the 150-mg group received one 150-mg injection of secukinumab, and one placebo injection. Etanercept was given at a dose of 50 mg administered subcutaneously twice weekly from baseline until week 12, and then once weekly through week 51.
Adverse events were more common in patients treated with secukinumab in ERASURE; 55% of patients in the 300-mg group, 60.4% in the 150-mg group, and 47% in the placebo group experienced at least one adverse event during the induction period, and 29.4%, 26.9%, and 16.2% in those groups, respectively, experienced infections and/or infestations. The most common adverse events were nasopharyngitis, headache, and upper respiratory tract infection.
The incidence of adverse events in FIXTURE was similar in those receiving secukinumab and etanercept, and was greater in both groups than in the placebo group. Infections and infestations occurred in 26.7%, 30.9%, 24.5%, and 19.3% of those receiving 300 mg of secukinumab, 150 mg of secukinumab, etanercept, and placebo, respectively. However, candida infections were more common with secukinumab than with etanercept (4.7%, 2.3%, and 1.2% of patients in the 300- and 150-mg secukinumab groups and the etanercept group, respectively, had candida infections). All candida infections in the secukinumab group were mild or moderate, and two of four infections in the etanercept group were severe.
Grade 3 neutropenia occurred in nine patients receiving secukinumab and in no patients receiving etanercept.
"The results of these phase 3 studies validate interleukin-17A as an important therapeutic target in moderate to severe plaque psoriasis, confirming earlier findings from basic research and phase 2 trials of secukinumab that suggested that interleukin-17A plays a role in the pathogenesis of psoriasis," the investigators said.
Interleukin-17A plays a key role in host defense, specifically in mucocutaneous microbial surveillance, they added.
"Continued vigilance with respect to the potential for candida infection will be necessary for interleukin-17A inhibitors. Neutropenia may also be of potential concern because of the reported role of interleukin-17A in the stimulation of granulopoiesis and neutrophil trafficking," they noted.
A limitation of both ERASURE and FIXTURE was that few patients continued to receive placebo after week 12, thus limiting the comparisons with the placebo group during the maintenance periods. Also, the study populations may have been too small to detect rare adverse events, the authors wrote, noting that extension studies to evaluate long-term efficacy are ongoing.
ERASURE and FIXTURE were supported by Novartis Pharmaceuticals. Dr. Langley reported no conflicts related to these studies. Dr. Elewski disclosed funding from Novartis during the study period.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: The study findings validate interleukin-17A as a therapeutic target for moderate to severe plaque psoriasis, and a majority of patients maintained a clinical response for up to a year with treatments every 4 weeks.
Major finding: In ERASURE, the proportions of patients achieving PASI 75 at 12 weeks were 81.6%, 71.6%, and 4.5% with 300 mg of secukinumab, 150 mg of secukinumab, and placebo, respectively. In FIXTURE, they were 77.1% and 67% for 300 and 150 mg of secukinumab, respectively, compared with 44% for etanercept and 4.9% for placebo.
Data source: Two randomized, controlled trials: ERASURE, which included 738 patients, and FIXTURE, which included 1,306 patients.
Disclosures: ERASURE and FIXTURE were supported by Novartis Pharmaceuticals. Dr. Langley reported no conflicts related to these studies. Dr. Elewski disclosed funding from Novartis during the study period.
Genital warts incidence drops among college students in wake of HPV vaccine
ATLANTA – The annual incidence of genital warts declined by 69% between 2006 and 2013 at a large public university after human papillomavirus vaccination was available, despite a relatively low intake among adolescents and college students less than 18 years old.
The proportion of students diagnosed with genital warts at a health center at the University of Wisconsin, Madison, in 2006 was 1.3% (222 students), compared with 0.5% (88 students) in 2013, Craig M. Roberts reported in a late-breaking poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
About 90% of cases of external genital warts are caused by HPV types 6 or 11, which are included in the quadrivalent HPV vaccine that was licensed in the United States in 2006.
In this study, genital warts were used as a surrogate marker for HPV infection. The incidence declined each year from 2008 to 2013, noted Mr. Roberts, an epidemiologist and clinical assistant professor at the University of Wisconsin.
Among students entering the university between 2006 and 2013, 64% of women but only 15% of men reported receiving at least one dose of HPV vaccine. Despite the large difference in vaccination coverage, the reduction in the incidence of genital warts was similar between genders (75.7% for women and 67.6% for men).
In 2006, the overall incidence of genital warts was 15.7 per 1,000 (10.8 for women and 26.0 for men), compared with 4.8 per 1,000 (2.6 for women and 8.4 for men) in 2014.
The rates of vaccine completion did, however, increase each year between 2006 and 2013, Mr. Roberts noted. Vaccine uptake among women was 58.5% in 2006 and 69.7% in 2013; vaccination among men was 0.5% in 2006 and 36.9% in 2013.
The findings were based on a review of medical records for visits to the health center between January 2008 and December 2013. The data were compared with baseline records from 2006. Only initial genital warts diagnoses were included in the analysis.
"These data demonstrate the striking decreases in the incidence of genital wart diagnoses in a population of college students after the introduction of a quadrivalent HPV vaccine in the United States. Declines occurred rapidly over 7 years in this population of sexually active young adults, despite less than optimal levels of vaccine coverage," Mr. Roberts wrote.
The findings suggest that cross-protection for male partners occurred as immunization rates increased among women; the incidence in men began to decline even before a recommendation for HPV vaccination for men was in place.
The findings were limited by the study design, and by the possibility that students may have been diagnosed in settings other than the student health center. However, the results suggest that colleges and universities should continue to promote and provide HPV vaccine to students to achieve further reductions in disease incidence, Mr. Roberts concluded.
Mr. Roberts reported having no disclosures.
ATLANTA – The annual incidence of genital warts declined by 69% between 2006 and 2013 at a large public university after human papillomavirus vaccination was available, despite a relatively low intake among adolescents and college students less than 18 years old.
The proportion of students diagnosed with genital warts at a health center at the University of Wisconsin, Madison, in 2006 was 1.3% (222 students), compared with 0.5% (88 students) in 2013, Craig M. Roberts reported in a late-breaking poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
About 90% of cases of external genital warts are caused by HPV types 6 or 11, which are included in the quadrivalent HPV vaccine that was licensed in the United States in 2006.
In this study, genital warts were used as a surrogate marker for HPV infection. The incidence declined each year from 2008 to 2013, noted Mr. Roberts, an epidemiologist and clinical assistant professor at the University of Wisconsin.
Among students entering the university between 2006 and 2013, 64% of women but only 15% of men reported receiving at least one dose of HPV vaccine. Despite the large difference in vaccination coverage, the reduction in the incidence of genital warts was similar between genders (75.7% for women and 67.6% for men).
In 2006, the overall incidence of genital warts was 15.7 per 1,000 (10.8 for women and 26.0 for men), compared with 4.8 per 1,000 (2.6 for women and 8.4 for men) in 2014.
The rates of vaccine completion did, however, increase each year between 2006 and 2013, Mr. Roberts noted. Vaccine uptake among women was 58.5% in 2006 and 69.7% in 2013; vaccination among men was 0.5% in 2006 and 36.9% in 2013.
The findings were based on a review of medical records for visits to the health center between January 2008 and December 2013. The data were compared with baseline records from 2006. Only initial genital warts diagnoses were included in the analysis.
"These data demonstrate the striking decreases in the incidence of genital wart diagnoses in a population of college students after the introduction of a quadrivalent HPV vaccine in the United States. Declines occurred rapidly over 7 years in this population of sexually active young adults, despite less than optimal levels of vaccine coverage," Mr. Roberts wrote.
The findings suggest that cross-protection for male partners occurred as immunization rates increased among women; the incidence in men began to decline even before a recommendation for HPV vaccination for men was in place.
The findings were limited by the study design, and by the possibility that students may have been diagnosed in settings other than the student health center. However, the results suggest that colleges and universities should continue to promote and provide HPV vaccine to students to achieve further reductions in disease incidence, Mr. Roberts concluded.
Mr. Roberts reported having no disclosures.
ATLANTA – The annual incidence of genital warts declined by 69% between 2006 and 2013 at a large public university after human papillomavirus vaccination was available, despite a relatively low intake among adolescents and college students less than 18 years old.
The proportion of students diagnosed with genital warts at a health center at the University of Wisconsin, Madison, in 2006 was 1.3% (222 students), compared with 0.5% (88 students) in 2013, Craig M. Roberts reported in a late-breaking poster at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
About 90% of cases of external genital warts are caused by HPV types 6 or 11, which are included in the quadrivalent HPV vaccine that was licensed in the United States in 2006.
In this study, genital warts were used as a surrogate marker for HPV infection. The incidence declined each year from 2008 to 2013, noted Mr. Roberts, an epidemiologist and clinical assistant professor at the University of Wisconsin.
Among students entering the university between 2006 and 2013, 64% of women but only 15% of men reported receiving at least one dose of HPV vaccine. Despite the large difference in vaccination coverage, the reduction in the incidence of genital warts was similar between genders (75.7% for women and 67.6% for men).
In 2006, the overall incidence of genital warts was 15.7 per 1,000 (10.8 for women and 26.0 for men), compared with 4.8 per 1,000 (2.6 for women and 8.4 for men) in 2014.
The rates of vaccine completion did, however, increase each year between 2006 and 2013, Mr. Roberts noted. Vaccine uptake among women was 58.5% in 2006 and 69.7% in 2013; vaccination among men was 0.5% in 2006 and 36.9% in 2013.
The findings were based on a review of medical records for visits to the health center between January 2008 and December 2013. The data were compared with baseline records from 2006. Only initial genital warts diagnoses were included in the analysis.
"These data demonstrate the striking decreases in the incidence of genital wart diagnoses in a population of college students after the introduction of a quadrivalent HPV vaccine in the United States. Declines occurred rapidly over 7 years in this population of sexually active young adults, despite less than optimal levels of vaccine coverage," Mr. Roberts wrote.
The findings suggest that cross-protection for male partners occurred as immunization rates increased among women; the incidence in men began to decline even before a recommendation for HPV vaccination for men was in place.
The findings were limited by the study design, and by the possibility that students may have been diagnosed in settings other than the student health center. However, the results suggest that colleges and universities should continue to promote and provide HPV vaccine to students to achieve further reductions in disease incidence, Mr. Roberts concluded.
Mr. Roberts reported having no disclosures.
AT THE 2014 STD PREVENTION CONFERENCE
Key clinical point: College and university health centers should continue to promote HPV vaccination to students to further reduce disease.
Major finding: The incidence of genital warts declined by 69% during the study period.
Data source: A review of medical records at a university health center that serves more than 43,000 students.
Disclosures: Mr. Roberts reported having no disclosures.
Fewer than 10% of HCV-infected patients complete treatment
Few patients with hepatitis C virus infection complete all of the steps along a proposed HCV treatment cascade, according to a systematic literature review and meta-analysis.
The findings identify large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States, and demonstrate that the proposed cascade provides a framework for evaluating the delivery of HCV care and would be useful for monitoring the impact of screening efforts and treatment advances, according to Dr. Baligh R. Yehia of the University of Pennsylvania, Philadelphia, and colleagues.
The report was published online July 2 in PLoS One.
The systematic review identified 10 articles published between January 2003 and July 2013 that addressed each of the following seven steps in the proposed treatment cascade:
1. Chronic HCV infection occurs.
2. The infection is diagnosed and the patient is made aware of the infection.
3. Access to outpatient care is obtained.
4. HCV RNA is confirmed.
5. Biopsy staging of liver fibrosis is performed.
6. HCV treatment is prescribed.
7. A sustained virologic response is achieved.
Based on the studies included in the review, an estimated 3.5 million people have chronic HCV in the United States, and only about 50% are diagnosed and aware of their infection.
The findings also suggest that only 43% of those patients have access to outpatient care (cascade step 3); only 27% achieve the first 4 steps, including confirmation of HCV RNA; only 17% achieve the first 5 steps, including undergoing liver fibrosis staging; only 16% achieve the first 6 steps, including being prescribed treatment; and only 9% achieve all 7 steps, including a sustained virologic response, the investigators said (PLoS One 2014 July 2 [doi:10.1371/journal.pone.0101554]).
The HCV treatment cascade proposed by the authors is similar to a cascade commonly used for evaluating and monitoring HIV care, and is based on the fact that people with chronic HCV infection, much like those living with HIV infection, need to fulfill multiple steps along a care continuum if they are to achieve optimal health outcomes.
"This HCV treatment cascade aligns with the goals of the U.S. [Department of Health & Human Services] Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis, which established early identification, linkage to care and treatment, and improved quality of care as top priorities for combating the silent epidemic of chronic HCV infection," the investigators wrote, adding that monitoring the HCV treatment cascade will become increasingly important to clinicians, public health officials, and federal agencies as advances in HCV treatment emerge.
The findings of the current analysis help identify key deficits in care that will be important in the development of programs to improve diagnosis, linkage to care, and management, the investigators said.
Future studies should explore the value of adding and/or deleting steps in the cascade to best assist public health officials in monitoring HCV care, they added, also noting that monitoring the steps over time, rather than evaluating them at one time point as was done in this study, may help define overall progress toward population-based goals and barriers at each step.
The study is also limited by the exclusion of certain populations – such as prisoners and the homeless – in the studies reviewed, and by other factors that may have led to underestimation of achievement of various steps in the cascade. For example, liver biopsy was used as the marker for HCV disease staging, but some patients may have been staged through the use of noninvasive tests, the investigators said.
Nonetheless, the results suggest that continued efforts are needed to improve HCV care in the United States, Dr. Baligh R. Yehia and colleagues said.
"In a field that is changing rapidly, with increased attention on HCV screening and approval of new, effective direct-acting antiviral agents, this proposed HCV treatment cascade provides a framework for identifying gaps in care. This framework will be useful in monitoring the impact of new public health initiatives, care models, and treatments," they wrote, adding that achieving the goals of the U.S. action plan requires an increase in the number of patients completing each step in the cascade.
This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.
Few patients with hepatitis C virus infection complete all of the steps along a proposed HCV treatment cascade, according to a systematic literature review and meta-analysis.
The findings identify large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States, and demonstrate that the proposed cascade provides a framework for evaluating the delivery of HCV care and would be useful for monitoring the impact of screening efforts and treatment advances, according to Dr. Baligh R. Yehia of the University of Pennsylvania, Philadelphia, and colleagues.
The report was published online July 2 in PLoS One.
The systematic review identified 10 articles published between January 2003 and July 2013 that addressed each of the following seven steps in the proposed treatment cascade:
1. Chronic HCV infection occurs.
2. The infection is diagnosed and the patient is made aware of the infection.
3. Access to outpatient care is obtained.
4. HCV RNA is confirmed.
5. Biopsy staging of liver fibrosis is performed.
6. HCV treatment is prescribed.
7. A sustained virologic response is achieved.
Based on the studies included in the review, an estimated 3.5 million people have chronic HCV in the United States, and only about 50% are diagnosed and aware of their infection.
The findings also suggest that only 43% of those patients have access to outpatient care (cascade step 3); only 27% achieve the first 4 steps, including confirmation of HCV RNA; only 17% achieve the first 5 steps, including undergoing liver fibrosis staging; only 16% achieve the first 6 steps, including being prescribed treatment; and only 9% achieve all 7 steps, including a sustained virologic response, the investigators said (PLoS One 2014 July 2 [doi:10.1371/journal.pone.0101554]).
The HCV treatment cascade proposed by the authors is similar to a cascade commonly used for evaluating and monitoring HIV care, and is based on the fact that people with chronic HCV infection, much like those living with HIV infection, need to fulfill multiple steps along a care continuum if they are to achieve optimal health outcomes.
"This HCV treatment cascade aligns with the goals of the U.S. [Department of Health & Human Services] Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis, which established early identification, linkage to care and treatment, and improved quality of care as top priorities for combating the silent epidemic of chronic HCV infection," the investigators wrote, adding that monitoring the HCV treatment cascade will become increasingly important to clinicians, public health officials, and federal agencies as advances in HCV treatment emerge.
The findings of the current analysis help identify key deficits in care that will be important in the development of programs to improve diagnosis, linkage to care, and management, the investigators said.
Future studies should explore the value of adding and/or deleting steps in the cascade to best assist public health officials in monitoring HCV care, they added, also noting that monitoring the steps over time, rather than evaluating them at one time point as was done in this study, may help define overall progress toward population-based goals and barriers at each step.
The study is also limited by the exclusion of certain populations – such as prisoners and the homeless – in the studies reviewed, and by other factors that may have led to underestimation of achievement of various steps in the cascade. For example, liver biopsy was used as the marker for HCV disease staging, but some patients may have been staged through the use of noninvasive tests, the investigators said.
Nonetheless, the results suggest that continued efforts are needed to improve HCV care in the United States, Dr. Baligh R. Yehia and colleagues said.
"In a field that is changing rapidly, with increased attention on HCV screening and approval of new, effective direct-acting antiviral agents, this proposed HCV treatment cascade provides a framework for identifying gaps in care. This framework will be useful in monitoring the impact of new public health initiatives, care models, and treatments," they wrote, adding that achieving the goals of the U.S. action plan requires an increase in the number of patients completing each step in the cascade.
This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.
Few patients with hepatitis C virus infection complete all of the steps along a proposed HCV treatment cascade, according to a systematic literature review and meta-analysis.
The findings identify large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States, and demonstrate that the proposed cascade provides a framework for evaluating the delivery of HCV care and would be useful for monitoring the impact of screening efforts and treatment advances, according to Dr. Baligh R. Yehia of the University of Pennsylvania, Philadelphia, and colleagues.
The report was published online July 2 in PLoS One.
The systematic review identified 10 articles published between January 2003 and July 2013 that addressed each of the following seven steps in the proposed treatment cascade:
1. Chronic HCV infection occurs.
2. The infection is diagnosed and the patient is made aware of the infection.
3. Access to outpatient care is obtained.
4. HCV RNA is confirmed.
5. Biopsy staging of liver fibrosis is performed.
6. HCV treatment is prescribed.
7. A sustained virologic response is achieved.
Based on the studies included in the review, an estimated 3.5 million people have chronic HCV in the United States, and only about 50% are diagnosed and aware of their infection.
The findings also suggest that only 43% of those patients have access to outpatient care (cascade step 3); only 27% achieve the first 4 steps, including confirmation of HCV RNA; only 17% achieve the first 5 steps, including undergoing liver fibrosis staging; only 16% achieve the first 6 steps, including being prescribed treatment; and only 9% achieve all 7 steps, including a sustained virologic response, the investigators said (PLoS One 2014 July 2 [doi:10.1371/journal.pone.0101554]).
The HCV treatment cascade proposed by the authors is similar to a cascade commonly used for evaluating and monitoring HIV care, and is based on the fact that people with chronic HCV infection, much like those living with HIV infection, need to fulfill multiple steps along a care continuum if they are to achieve optimal health outcomes.
"This HCV treatment cascade aligns with the goals of the U.S. [Department of Health & Human Services] Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis, which established early identification, linkage to care and treatment, and improved quality of care as top priorities for combating the silent epidemic of chronic HCV infection," the investigators wrote, adding that monitoring the HCV treatment cascade will become increasingly important to clinicians, public health officials, and federal agencies as advances in HCV treatment emerge.
The findings of the current analysis help identify key deficits in care that will be important in the development of programs to improve diagnosis, linkage to care, and management, the investigators said.
Future studies should explore the value of adding and/or deleting steps in the cascade to best assist public health officials in monitoring HCV care, they added, also noting that monitoring the steps over time, rather than evaluating them at one time point as was done in this study, may help define overall progress toward population-based goals and barriers at each step.
The study is also limited by the exclusion of certain populations – such as prisoners and the homeless – in the studies reviewed, and by other factors that may have led to underestimation of achievement of various steps in the cascade. For example, liver biopsy was used as the marker for HCV disease staging, but some patients may have been staged through the use of noninvasive tests, the investigators said.
Nonetheless, the results suggest that continued efforts are needed to improve HCV care in the United States, Dr. Baligh R. Yehia and colleagues said.
"In a field that is changing rapidly, with increased attention on HCV screening and approval of new, effective direct-acting antiviral agents, this proposed HCV treatment cascade provides a framework for identifying gaps in care. This framework will be useful in monitoring the impact of new public health initiatives, care models, and treatments," they wrote, adding that achieving the goals of the U.S. action plan requires an increase in the number of patients completing each step in the cascade.
This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.
FROM PLOS ONE
Key clinical point: There are large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States; the proposed cascade provides a framework for evaluating the delivery of HCV care.
Major finding: Only about 50% of patients with HCV are diagnosed and aware of their disease.
Data source: A systematic review and meta-analysis of 10 articles.
Disclosures: This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.
Fewer than 10% of HCV-infected patients complete treatment
Few patients with hepatitis C virus infection complete all of the steps along a proposed HCV treatment cascade, according to a systematic literature review and meta-analysis.
The findings identify large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States, and demonstrate that the proposed cascade provides a framework for evaluating the delivery of HCV care and would be useful for monitoring the impact of screening efforts and treatment advances, according to Dr. Baligh R. Yehia of the University of Pennsylvania, Philadelphia, and colleagues.
The report was published online July 2 in PLoS One.
The systematic review identified 10 articles published between January 2003 and July 2013 that addressed each of the following seven steps in the proposed treatment cascade:
1. Chronic HCV infection occurs.
2. The infection is diagnosed and the patient is made aware of the infection.
3. Access to outpatient care is obtained.
4. HCV RNA is confirmed.
5. Biopsy staging of liver fibrosis is performed.
6. HCV treatment is prescribed.
7. A sustained virologic response is achieved.
Based on the studies included in the review, an estimated 3.5 million people have chronic HCV in the United States, and only about 50% are diagnosed and aware of their infection.
The findings also suggest that only 43% of those patients have access to outpatient care (cascade step 3); only 27% achieve the first 4 steps, including confirmation of HCV RNA; only 17% achieve the first 5 steps, including undergoing liver fibrosis staging; only 16% achieve the first 6 steps, including being prescribed treatment; and only 9% achieve all 7 steps, including a sustained virologic response, the investigators said (PLoS One 2014 July 2 [doi:10.1371/journal.pone.0101554]).
The HCV treatment cascade proposed by the authors is similar to a cascade commonly used for evaluating and monitoring HIV care, and is based on the fact that people with chronic HCV infection, much like those living with HIV infection, need to fulfill multiple steps along a care continuum if they are to achieve optimal health outcomes.
"This HCV treatment cascade aligns with the goals of the U.S. [Department of Health & Human Services] Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis, which established early identification, linkage to care and treatment, and improved quality of care as top priorities for combating the silent epidemic of chronic HCV infection," the investigators wrote, adding that monitoring the HCV treatment cascade will become increasingly important to clinicians, public health officials, and federal agencies as advances in HCV treatment emerge.
The findings of the current analysis help identify key deficits in care that will be important in the development of programs to improve diagnosis, linkage to care, and management, the investigators said.
Future studies should explore the value of adding and/or deleting steps in the cascade to best assist public health officials in monitoring HCV care, they added, also noting that monitoring the steps over time, rather than evaluating them at one time point as was done in this study, may help define overall progress toward population-based goals and barriers at each step.
The study is also limited by the exclusion of certain populations – such as prisoners and the homeless – in the studies reviewed, and by other factors that may have led to underestimation of achievement of various steps in the cascade. For example, liver biopsy was used as the marker for HCV disease staging, but some patients may have been staged through the use of noninvasive tests, the investigators said.
Nonetheless, the results suggest that continued efforts are needed to improve HCV care in the United States, Dr. Baligh R. Yehia and colleagues said.
"In a field that is changing rapidly, with increased attention on HCV screening and approval of new, effective direct-acting antiviral agents, this proposed HCV treatment cascade provides a framework for identifying gaps in care. This framework will be useful in monitoring the impact of new public health initiatives, care models, and treatments," they wrote, adding that achieving the goals of the U.S. action plan requires an increase in the number of patients completing each step in the cascade.
This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.
Few patients with hepatitis C virus infection complete all of the steps along a proposed HCV treatment cascade, according to a systematic literature review and meta-analysis.
The findings identify large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States, and demonstrate that the proposed cascade provides a framework for evaluating the delivery of HCV care and would be useful for monitoring the impact of screening efforts and treatment advances, according to Dr. Baligh R. Yehia of the University of Pennsylvania, Philadelphia, and colleagues.
The report was published online July 2 in PLoS One.
The systematic review identified 10 articles published between January 2003 and July 2013 that addressed each of the following seven steps in the proposed treatment cascade:
1. Chronic HCV infection occurs.
2. The infection is diagnosed and the patient is made aware of the infection.
3. Access to outpatient care is obtained.
4. HCV RNA is confirmed.
5. Biopsy staging of liver fibrosis is performed.
6. HCV treatment is prescribed.
7. A sustained virologic response is achieved.
Based on the studies included in the review, an estimated 3.5 million people have chronic HCV in the United States, and only about 50% are diagnosed and aware of their infection.
The findings also suggest that only 43% of those patients have access to outpatient care (cascade step 3); only 27% achieve the first 4 steps, including confirmation of HCV RNA; only 17% achieve the first 5 steps, including undergoing liver fibrosis staging; only 16% achieve the first 6 steps, including being prescribed treatment; and only 9% achieve all 7 steps, including a sustained virologic response, the investigators said (PLoS One 2014 July 2 [doi:10.1371/journal.pone.0101554]).
The HCV treatment cascade proposed by the authors is similar to a cascade commonly used for evaluating and monitoring HIV care, and is based on the fact that people with chronic HCV infection, much like those living with HIV infection, need to fulfill multiple steps along a care continuum if they are to achieve optimal health outcomes.
"This HCV treatment cascade aligns with the goals of the U.S. [Department of Health & Human Services] Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis, which established early identification, linkage to care and treatment, and improved quality of care as top priorities for combating the silent epidemic of chronic HCV infection," the investigators wrote, adding that monitoring the HCV treatment cascade will become increasingly important to clinicians, public health officials, and federal agencies as advances in HCV treatment emerge.
The findings of the current analysis help identify key deficits in care that will be important in the development of programs to improve diagnosis, linkage to care, and management, the investigators said.
Future studies should explore the value of adding and/or deleting steps in the cascade to best assist public health officials in monitoring HCV care, they added, also noting that monitoring the steps over time, rather than evaluating them at one time point as was done in this study, may help define overall progress toward population-based goals and barriers at each step.
The study is also limited by the exclusion of certain populations – such as prisoners and the homeless – in the studies reviewed, and by other factors that may have led to underestimation of achievement of various steps in the cascade. For example, liver biopsy was used as the marker for HCV disease staging, but some patients may have been staged through the use of noninvasive tests, the investigators said.
Nonetheless, the results suggest that continued efforts are needed to improve HCV care in the United States, Dr. Baligh R. Yehia and colleagues said.
"In a field that is changing rapidly, with increased attention on HCV screening and approval of new, effective direct-acting antiviral agents, this proposed HCV treatment cascade provides a framework for identifying gaps in care. This framework will be useful in monitoring the impact of new public health initiatives, care models, and treatments," they wrote, adding that achieving the goals of the U.S. action plan requires an increase in the number of patients completing each step in the cascade.
This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.
Few patients with hepatitis C virus infection complete all of the steps along a proposed HCV treatment cascade, according to a systematic literature review and meta-analysis.
The findings identify large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States, and demonstrate that the proposed cascade provides a framework for evaluating the delivery of HCV care and would be useful for monitoring the impact of screening efforts and treatment advances, according to Dr. Baligh R. Yehia of the University of Pennsylvania, Philadelphia, and colleagues.
The report was published online July 2 in PLoS One.
The systematic review identified 10 articles published between January 2003 and July 2013 that addressed each of the following seven steps in the proposed treatment cascade:
1. Chronic HCV infection occurs.
2. The infection is diagnosed and the patient is made aware of the infection.
3. Access to outpatient care is obtained.
4. HCV RNA is confirmed.
5. Biopsy staging of liver fibrosis is performed.
6. HCV treatment is prescribed.
7. A sustained virologic response is achieved.
Based on the studies included in the review, an estimated 3.5 million people have chronic HCV in the United States, and only about 50% are diagnosed and aware of their infection.
The findings also suggest that only 43% of those patients have access to outpatient care (cascade step 3); only 27% achieve the first 4 steps, including confirmation of HCV RNA; only 17% achieve the first 5 steps, including undergoing liver fibrosis staging; only 16% achieve the first 6 steps, including being prescribed treatment; and only 9% achieve all 7 steps, including a sustained virologic response, the investigators said (PLoS One 2014 July 2 [doi:10.1371/journal.pone.0101554]).
The HCV treatment cascade proposed by the authors is similar to a cascade commonly used for evaluating and monitoring HIV care, and is based on the fact that people with chronic HCV infection, much like those living with HIV infection, need to fulfill multiple steps along a care continuum if they are to achieve optimal health outcomes.
"This HCV treatment cascade aligns with the goals of the U.S. [Department of Health & Human Services] Action Plan for the Prevention, Care, and Treatment of Viral Hepatitis, which established early identification, linkage to care and treatment, and improved quality of care as top priorities for combating the silent epidemic of chronic HCV infection," the investigators wrote, adding that monitoring the HCV treatment cascade will become increasingly important to clinicians, public health officials, and federal agencies as advances in HCV treatment emerge.
The findings of the current analysis help identify key deficits in care that will be important in the development of programs to improve diagnosis, linkage to care, and management, the investigators said.
Future studies should explore the value of adding and/or deleting steps in the cascade to best assist public health officials in monitoring HCV care, they added, also noting that monitoring the steps over time, rather than evaluating them at one time point as was done in this study, may help define overall progress toward population-based goals and barriers at each step.
The study is also limited by the exclusion of certain populations – such as prisoners and the homeless – in the studies reviewed, and by other factors that may have led to underestimation of achievement of various steps in the cascade. For example, liver biopsy was used as the marker for HCV disease staging, but some patients may have been staged through the use of noninvasive tests, the investigators said.
Nonetheless, the results suggest that continued efforts are needed to improve HCV care in the United States, Dr. Baligh R. Yehia and colleagues said.
"In a field that is changing rapidly, with increased attention on HCV screening and approval of new, effective direct-acting antiviral agents, this proposed HCV treatment cascade provides a framework for identifying gaps in care. This framework will be useful in monitoring the impact of new public health initiatives, care models, and treatments," they wrote, adding that achieving the goals of the U.S. action plan requires an increase in the number of patients completing each step in the cascade.
This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.
FROM PLOS ONE
Key clinical point: There are large gaps between current practice and treatment goals for patients with chronic HCV infection in the United States; the proposed cascade provides a framework for evaluating the delivery of HCV care.
Major finding: Only about 50% of patients with HCV are diagnosed and aware of their disease.
Data source: A systematic review and meta-analysis of 10 articles.
Disclosures: This study was supported by the National Institutes of Health. Dr. Yehia and coauthor Asher J. Schranz reported receiving investigator-initiated research support (to the University of Pennsylvania) from Gilead Sciences. Dr. Schranz also received such support from AstraZeneca, Bristol Myers-Squibb, and Merck.
How to Improve STD Retesting Rates
ATLANTA – Educating patients treated for chlamydia or gonorrhea about reinfection and retesting, and providing customized options for follow-up care, increased patient retest return rates by 15% in a prospective cohort study.
The return rate at 1-6 months after treatment among 1,454 patients who received enhanced educational information about reinfection and the importance of retesting during the first phase of the InTOUCH study was 59%, and the return rate among 575 patients who received that educational information along with customized reminders and/or a mailed-in home testing kit in a second phase was 62%, compared with a return rate of 54% among 2,696 historical controls, Holly Howard reported at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
The increases in return rates were statistically significant, said Ms. Howard of the California Department of Public Health, Richmond.
The initial education phase of the multicenter study occurred in 2010 and 2011 at six geographically diverse California Title X clinics. Participants were clients of the California Family Planning, Access, Care, and Treatment Program, which provides care to more than 2 million low-income women each year.
The patients were counseled about the risks and dangers of re-infection and the importance of retesting, and were given tips for remembering to return for retesting. Additionally, educational materials were updated to improve readability and user friendliness.
During 2011 and 2012, patients from the educational phase who tested positive for chlamydia or gonorrhea, and who were treated for the infections, were officially enrolled in the second phase of the study, during which they were offered the option of receiving retest reminders via postcard, text, and/or e-mail, as well as the option of retesting with a home test sent to their address 3 months after treatment.
Most patients (90%) opted to receive retest reminders, and most of those chose text and e-mail reminders. Only 5% chose to use the home test kit.
The findings have implications for improving the notoriously low return rates among women who test positive for chlamydia and gonorrhea infection. These infections are common and are associated with serious reproductive health sequelae, including an increased risk of pelvic inflammatory disease and ectopic pregnancy, Ms. Howard noted.
Routine retesting within a few months of treatment allows for early identification of reinfection, and for retreatment that can reduce the risk of adverse outcomes.
For more than a decade, national guidelines have recommended retesting of patients with chlamydia or gonorrhea, but retesting rates have remained stubbornly below 50%. Effective strategies for increasing patient retest return rates have been elusive, she noted.
In the year leading up to the InTOUCH study, only 44% of clinic patients overall were retested, and that was found to be a result both of the low (62%) return rate and low (69%) retesting rate among those who did return, she said.
The overall retesting rate improved to nearly 60% during the course of the study.
"So with a very moderate increase in patient return rates and in clinic retesting rates among returning patients, you can see that we cumulatively increased our overall retesting rates by more than 30%," she said, noting that given the consistently low return rates in prior years, this was "a very exciting result."
The current findings suggest that addressing the factors that contribute to low return rates, including lack of information about the importance of returning, forgetting to return, and difficulties getting to the clinic, can lead to significant improvement in return rates, Ms. Howard said.
"Improving is dependent on addressing both patient and clinic level causes. Through a combination of these very feasible interventions, we were able to increase the overall retesting rates by 32%," she said.
The InTOUCH study was funded by a grant from the Office of Population Affairs as a Title X Service Delivery Improvement Research Project. Ms. Howard reported having no other disclosures.
ATLANTA – Educating patients treated for chlamydia or gonorrhea about reinfection and retesting, and providing customized options for follow-up care, increased patient retest return rates by 15% in a prospective cohort study.
The return rate at 1-6 months after treatment among 1,454 patients who received enhanced educational information about reinfection and the importance of retesting during the first phase of the InTOUCH study was 59%, and the return rate among 575 patients who received that educational information along with customized reminders and/or a mailed-in home testing kit in a second phase was 62%, compared with a return rate of 54% among 2,696 historical controls, Holly Howard reported at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
The increases in return rates were statistically significant, said Ms. Howard of the California Department of Public Health, Richmond.
The initial education phase of the multicenter study occurred in 2010 and 2011 at six geographically diverse California Title X clinics. Participants were clients of the California Family Planning, Access, Care, and Treatment Program, which provides care to more than 2 million low-income women each year.
The patients were counseled about the risks and dangers of re-infection and the importance of retesting, and were given tips for remembering to return for retesting. Additionally, educational materials were updated to improve readability and user friendliness.
During 2011 and 2012, patients from the educational phase who tested positive for chlamydia or gonorrhea, and who were treated for the infections, were officially enrolled in the second phase of the study, during which they were offered the option of receiving retest reminders via postcard, text, and/or e-mail, as well as the option of retesting with a home test sent to their address 3 months after treatment.
Most patients (90%) opted to receive retest reminders, and most of those chose text and e-mail reminders. Only 5% chose to use the home test kit.
The findings have implications for improving the notoriously low return rates among women who test positive for chlamydia and gonorrhea infection. These infections are common and are associated with serious reproductive health sequelae, including an increased risk of pelvic inflammatory disease and ectopic pregnancy, Ms. Howard noted.
Routine retesting within a few months of treatment allows for early identification of reinfection, and for retreatment that can reduce the risk of adverse outcomes.
For more than a decade, national guidelines have recommended retesting of patients with chlamydia or gonorrhea, but retesting rates have remained stubbornly below 50%. Effective strategies for increasing patient retest return rates have been elusive, she noted.
In the year leading up to the InTOUCH study, only 44% of clinic patients overall were retested, and that was found to be a result both of the low (62%) return rate and low (69%) retesting rate among those who did return, she said.
The overall retesting rate improved to nearly 60% during the course of the study.
"So with a very moderate increase in patient return rates and in clinic retesting rates among returning patients, you can see that we cumulatively increased our overall retesting rates by more than 30%," she said, noting that given the consistently low return rates in prior years, this was "a very exciting result."
The current findings suggest that addressing the factors that contribute to low return rates, including lack of information about the importance of returning, forgetting to return, and difficulties getting to the clinic, can lead to significant improvement in return rates, Ms. Howard said.
"Improving is dependent on addressing both patient and clinic level causes. Through a combination of these very feasible interventions, we were able to increase the overall retesting rates by 32%," she said.
The InTOUCH study was funded by a grant from the Office of Population Affairs as a Title X Service Delivery Improvement Research Project. Ms. Howard reported having no other disclosures.
ATLANTA – Educating patients treated for chlamydia or gonorrhea about reinfection and retesting, and providing customized options for follow-up care, increased patient retest return rates by 15% in a prospective cohort study.
The return rate at 1-6 months after treatment among 1,454 patients who received enhanced educational information about reinfection and the importance of retesting during the first phase of the InTOUCH study was 59%, and the return rate among 575 patients who received that educational information along with customized reminders and/or a mailed-in home testing kit in a second phase was 62%, compared with a return rate of 54% among 2,696 historical controls, Holly Howard reported at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
The increases in return rates were statistically significant, said Ms. Howard of the California Department of Public Health, Richmond.
The initial education phase of the multicenter study occurred in 2010 and 2011 at six geographically diverse California Title X clinics. Participants were clients of the California Family Planning, Access, Care, and Treatment Program, which provides care to more than 2 million low-income women each year.
The patients were counseled about the risks and dangers of re-infection and the importance of retesting, and were given tips for remembering to return for retesting. Additionally, educational materials were updated to improve readability and user friendliness.
During 2011 and 2012, patients from the educational phase who tested positive for chlamydia or gonorrhea, and who were treated for the infections, were officially enrolled in the second phase of the study, during which they were offered the option of receiving retest reminders via postcard, text, and/or e-mail, as well as the option of retesting with a home test sent to their address 3 months after treatment.
Most patients (90%) opted to receive retest reminders, and most of those chose text and e-mail reminders. Only 5% chose to use the home test kit.
The findings have implications for improving the notoriously low return rates among women who test positive for chlamydia and gonorrhea infection. These infections are common and are associated with serious reproductive health sequelae, including an increased risk of pelvic inflammatory disease and ectopic pregnancy, Ms. Howard noted.
Routine retesting within a few months of treatment allows for early identification of reinfection, and for retreatment that can reduce the risk of adverse outcomes.
For more than a decade, national guidelines have recommended retesting of patients with chlamydia or gonorrhea, but retesting rates have remained stubbornly below 50%. Effective strategies for increasing patient retest return rates have been elusive, she noted.
In the year leading up to the InTOUCH study, only 44% of clinic patients overall were retested, and that was found to be a result both of the low (62%) return rate and low (69%) retesting rate among those who did return, she said.
The overall retesting rate improved to nearly 60% during the course of the study.
"So with a very moderate increase in patient return rates and in clinic retesting rates among returning patients, you can see that we cumulatively increased our overall retesting rates by more than 30%," she said, noting that given the consistently low return rates in prior years, this was "a very exciting result."
The current findings suggest that addressing the factors that contribute to low return rates, including lack of information about the importance of returning, forgetting to return, and difficulties getting to the clinic, can lead to significant improvement in return rates, Ms. Howard said.
"Improving is dependent on addressing both patient and clinic level causes. Through a combination of these very feasible interventions, we were able to increase the overall retesting rates by 32%," she said.
The InTOUCH study was funded by a grant from the Office of Population Affairs as a Title X Service Delivery Improvement Research Project. Ms. Howard reported having no other disclosures.
AT THE 2014 STD PREVENTION CONFERENCE
Enhanced education, customized follow-up options improve STD retesting rates
ATLANTA – Educating patients treated for chlamydia or gonorrhea about reinfection and retesting, and providing customized options for follow-up care, increased patient retest return rates by 15% in a prospective cohort study.
The return rate at 1-6 months after treatment among 1,454 patients who received enhanced educational information about reinfection and the importance of retesting during the first phase of the InTOUCH study was 59%, and the return rate among 575 patients who received that educational information along with customized reminders and/or a mailed-in home testing kit in a second phase was 62%, compared with a return rate of 54% among 2,696 historical controls, Holly Howard reported at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
The increases in return rates were statistically significant, said Ms. Howard of the California Department of Public Health, Richmond.
The initial education phase of the multicenter study occurred in 2010 and 2011 at six geographically diverse California Title X clinics. Participants were clients of the California Family Planning, Access, Care, and Treatment Program, which provides care to more than 2 million low-income women each year.
The patients were counseled about the risks and dangers of re-infection and the importance of retesting, and were given tips for remembering to return for retesting. Additionally, educational materials were updated to improve readability and user friendliness.
During 2011 and 2012, patients from the educational phase who tested positive for chlamydia or gonorrhea, and who were treated for the infections, were officially enrolled in the second phase of the study, during which they were offered the option of receiving retest reminders via postcard, text, and/or e-mail, as well as the option of retesting with a home test sent to their address 3 months after treatment.
Most patients (90%) opted to receive retest reminders, and most of those chose text and e-mail reminders. Only 5% chose to use the home test kit.
The findings have implications for improving the notoriously low return rates among women who test positive for chlamydia and gonorrhea infection. These infections are common and are associated with serious reproductive health sequelae, including an increased risk of pelvic inflammatory disease and ectopic pregnancy, Ms. Howard noted.
Routine retesting within a few months of treatment allows for early identification of reinfection, and for retreatment that can reduce the risk of adverse outcomes.
For more than a decade, national guidelines have recommended retesting of patients with chlamydia or gonorrhea, but retesting rates have remained stubbornly below 50%. Effective strategies for increasing patient retest return rates have been elusive, she noted.
In the year leading up to the InTOUCH study, only 44% of clinic patients overall were retested, and that was found to be a result both of the low (62%) return rate and low (69%) retesting rate among those who did return, she said.
The overall retesting rate improved to nearly 60% during the course of the study.
"So with a very moderate increase in patient return rates and in clinic retesting rates among returning patients, you can see that we cumulatively increased our overall retesting rates by more than 30%," she said, noting that given the consistently low return rates in prior years, this was "a very exciting result."
The current findings suggest that addressing the factors that contribute to low return rates, including lack of information about the importance of returning, forgetting to return, and difficulties getting to the clinic, can lead to significant improvement in return rates, Ms. Howard said.
"Improving is dependent on addressing both patient and clinic level causes. Through a combination of these very feasible interventions, we were able to increase the overall retesting rates by 32%," she said.
The InTOUCH study was funded by a grant from the Office of Population Affairs as a Title X Service Delivery Improvement Research Project. Ms. Howard reported having no other disclosures.
ATLANTA – Educating patients treated for chlamydia or gonorrhea about reinfection and retesting, and providing customized options for follow-up care, increased patient retest return rates by 15% in a prospective cohort study.
The return rate at 1-6 months after treatment among 1,454 patients who received enhanced educational information about reinfection and the importance of retesting during the first phase of the InTOUCH study was 59%, and the return rate among 575 patients who received that educational information along with customized reminders and/or a mailed-in home testing kit in a second phase was 62%, compared with a return rate of 54% among 2,696 historical controls, Holly Howard reported at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
The increases in return rates were statistically significant, said Ms. Howard of the California Department of Public Health, Richmond.
The initial education phase of the multicenter study occurred in 2010 and 2011 at six geographically diverse California Title X clinics. Participants were clients of the California Family Planning, Access, Care, and Treatment Program, which provides care to more than 2 million low-income women each year.
The patients were counseled about the risks and dangers of re-infection and the importance of retesting, and were given tips for remembering to return for retesting. Additionally, educational materials were updated to improve readability and user friendliness.
During 2011 and 2012, patients from the educational phase who tested positive for chlamydia or gonorrhea, and who were treated for the infections, were officially enrolled in the second phase of the study, during which they were offered the option of receiving retest reminders via postcard, text, and/or e-mail, as well as the option of retesting with a home test sent to their address 3 months after treatment.
Most patients (90%) opted to receive retest reminders, and most of those chose text and e-mail reminders. Only 5% chose to use the home test kit.
The findings have implications for improving the notoriously low return rates among women who test positive for chlamydia and gonorrhea infection. These infections are common and are associated with serious reproductive health sequelae, including an increased risk of pelvic inflammatory disease and ectopic pregnancy, Ms. Howard noted.
Routine retesting within a few months of treatment allows for early identification of reinfection, and for retreatment that can reduce the risk of adverse outcomes.
For more than a decade, national guidelines have recommended retesting of patients with chlamydia or gonorrhea, but retesting rates have remained stubbornly below 50%. Effective strategies for increasing patient retest return rates have been elusive, she noted.
In the year leading up to the InTOUCH study, only 44% of clinic patients overall were retested, and that was found to be a result both of the low (62%) return rate and low (69%) retesting rate among those who did return, she said.
The overall retesting rate improved to nearly 60% during the course of the study.
"So with a very moderate increase in patient return rates and in clinic retesting rates among returning patients, you can see that we cumulatively increased our overall retesting rates by more than 30%," she said, noting that given the consistently low return rates in prior years, this was "a very exciting result."
The current findings suggest that addressing the factors that contribute to low return rates, including lack of information about the importance of returning, forgetting to return, and difficulties getting to the clinic, can lead to significant improvement in return rates, Ms. Howard said.
"Improving is dependent on addressing both patient and clinic level causes. Through a combination of these very feasible interventions, we were able to increase the overall retesting rates by 32%," she said.
The InTOUCH study was funded by a grant from the Office of Population Affairs as a Title X Service Delivery Improvement Research Project. Ms. Howard reported having no other disclosures.
ATLANTA – Educating patients treated for chlamydia or gonorrhea about reinfection and retesting, and providing customized options for follow-up care, increased patient retest return rates by 15% in a prospective cohort study.
The return rate at 1-6 months after treatment among 1,454 patients who received enhanced educational information about reinfection and the importance of retesting during the first phase of the InTOUCH study was 59%, and the return rate among 575 patients who received that educational information along with customized reminders and/or a mailed-in home testing kit in a second phase was 62%, compared with a return rate of 54% among 2,696 historical controls, Holly Howard reported at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
The increases in return rates were statistically significant, said Ms. Howard of the California Department of Public Health, Richmond.
The initial education phase of the multicenter study occurred in 2010 and 2011 at six geographically diverse California Title X clinics. Participants were clients of the California Family Planning, Access, Care, and Treatment Program, which provides care to more than 2 million low-income women each year.
The patients were counseled about the risks and dangers of re-infection and the importance of retesting, and were given tips for remembering to return for retesting. Additionally, educational materials were updated to improve readability and user friendliness.
During 2011 and 2012, patients from the educational phase who tested positive for chlamydia or gonorrhea, and who were treated for the infections, were officially enrolled in the second phase of the study, during which they were offered the option of receiving retest reminders via postcard, text, and/or e-mail, as well as the option of retesting with a home test sent to their address 3 months after treatment.
Most patients (90%) opted to receive retest reminders, and most of those chose text and e-mail reminders. Only 5% chose to use the home test kit.
The findings have implications for improving the notoriously low return rates among women who test positive for chlamydia and gonorrhea infection. These infections are common and are associated with serious reproductive health sequelae, including an increased risk of pelvic inflammatory disease and ectopic pregnancy, Ms. Howard noted.
Routine retesting within a few months of treatment allows for early identification of reinfection, and for retreatment that can reduce the risk of adverse outcomes.
For more than a decade, national guidelines have recommended retesting of patients with chlamydia or gonorrhea, but retesting rates have remained stubbornly below 50%. Effective strategies for increasing patient retest return rates have been elusive, she noted.
In the year leading up to the InTOUCH study, only 44% of clinic patients overall were retested, and that was found to be a result both of the low (62%) return rate and low (69%) retesting rate among those who did return, she said.
The overall retesting rate improved to nearly 60% during the course of the study.
"So with a very moderate increase in patient return rates and in clinic retesting rates among returning patients, you can see that we cumulatively increased our overall retesting rates by more than 30%," she said, noting that given the consistently low return rates in prior years, this was "a very exciting result."
The current findings suggest that addressing the factors that contribute to low return rates, including lack of information about the importance of returning, forgetting to return, and difficulties getting to the clinic, can lead to significant improvement in return rates, Ms. Howard said.
"Improving is dependent on addressing both patient and clinic level causes. Through a combination of these very feasible interventions, we were able to increase the overall retesting rates by 32%," she said.
The InTOUCH study was funded by a grant from the Office of Population Affairs as a Title X Service Delivery Improvement Research Project. Ms. Howard reported having no other disclosures.
AT THE 2014 STD PREVENTION CONFERENCE
Key clinical point: Education about retesting and customizing reminders appear to be the keys to improving retesting rates for chlamydia.
Major finding: The overall retesting rate improved by 32%.
Data source: A prospective cohort study (InTOUCH) of 4,725 patients.
Disclosures: The InTOUCH study was funded by a grant from the Office of Population Affairs as a Title X Service Delivery Improvement Research Project. Ms. Howard reported having no other disclosures.
New Pap testing recommendations raise concerns about prenatal STD screening
ATLANTA – Prenatal screening for chlamydia and gonorrhea is commonly performed in conjunction with Pap testing, which results in low screening rates among those who don’t undergo Pap testing, a retrospective cohort study showed.
These findings are concerning because recent changes in cervical cancer screening recommendations that increase the screening interval for many women could further reduce the rates of screening for chlamydia and gonorrhea if clinicians don’t "untie" Pap testing and STD screening, Dr. Christine Ross said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
Among 63,332 pregnant women with a live birth who were included in a 12-state Medicaid claims database in 2009-2010, 79% were tested for chlamydia, 72% were tested for gonorrhea, and 74% underwent cervical cancer screening by Pap test. Of the 46,966 who underwent Pap testing, 89% and 80% were tested for chlamydia and gonorrhea, respectively, and of those who did not undergo Pap testing, only 51% and 48% were tested for chlamydia and gonorrhea, said Dr. Ross of the division of STD prevention at the CDC.
"We found that 13% of women in our study population had neither a Pap test nor a chlamydia or gonorrhea screening test," she said.
Women included in the current analysis were aged 15-24 years, and were enrolled in Medicaid continuously for at least 210 days at the time of delivery. The women had numerous prenatal visits, and thus had ample opportunity for screening.
The CDC recommends universal chlamydia screening in pregnant women, with screening at the first prenatal visit, and recommends gonorrhea screening of pregnant women at risk, which includes those under age 25 years and those with a prior infection. Repeat screening in the third trimester is recommended for certain high-risk patients.
In 2012 the U.S. Preventive Services Task Force revised its cervical cancer screening guidelines, and screening is no longer recommended in women younger than 21 years. Also, the interval for screening was extended to 3 years for those over age 21 years, Dr. Ross noted.
The findings are concerning for several reasons, she said.
The vast majority of chlamydia and gonorrhea infections are asymptomatic, including those occurring during pregnancy. Studies show that only 5%-35% of patients with laboratory-confirmed infections develop symptoms. Furthermore, both chlamydia and gonorrhea can affect neonates and can lead to adverse outcomes in pregnant women, she explained.
Furthermore, in one large study involving laboratory data for 1.3 million pregnant women, nearly 16% of 16-year-olds tested positive for chlamydia, and 3% tested positive for gonorrhea. The rate of positive tests declined with advancing maternal age – a finding that is consistent with CDC data, Dr. Ross noted.
Yet, under the revised guidelines, the younger women – who are at the highest risk of infection – would be less likely to be tested.
For many years, screening for chlamydia and gonorrhea was performed at the time of Pap testing, using the endocervical sample, but improved understanding of human papillomavirus infection in young women led to the revision of the guidelines.
Although limited by factors inherent in using administrative data, and by the underrepresentation of Hispanics, who comprised only 3.6% of the sample, the current findings suggest that a reduction in chlamydia and gonorrhea screening may be an inadvertent consequence of the changes.
Future studies are warranted to evaluate this potential consequence as more providers implement the new cervical cancer screening recommendations, Dr. Ross said.
"In the meantime, we recommended informing prenatal providers about the importance of screening all pregnant women for chlamydia and those at risk for gonorrhea, and that alternative specimen collection methods that do not require a pelvic examination that is done during a Pap test are available – and in fact are preferred," she said, noting that patient- or provider-collected vaginal swabs are the preferred specimen, and that urine also can be used.
Dr. Ross reported having no disclosures.
ATLANTA – Prenatal screening for chlamydia and gonorrhea is commonly performed in conjunction with Pap testing, which results in low screening rates among those who don’t undergo Pap testing, a retrospective cohort study showed.
These findings are concerning because recent changes in cervical cancer screening recommendations that increase the screening interval for many women could further reduce the rates of screening for chlamydia and gonorrhea if clinicians don’t "untie" Pap testing and STD screening, Dr. Christine Ross said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
Among 63,332 pregnant women with a live birth who were included in a 12-state Medicaid claims database in 2009-2010, 79% were tested for chlamydia, 72% were tested for gonorrhea, and 74% underwent cervical cancer screening by Pap test. Of the 46,966 who underwent Pap testing, 89% and 80% were tested for chlamydia and gonorrhea, respectively, and of those who did not undergo Pap testing, only 51% and 48% were tested for chlamydia and gonorrhea, said Dr. Ross of the division of STD prevention at the CDC.
"We found that 13% of women in our study population had neither a Pap test nor a chlamydia or gonorrhea screening test," she said.
Women included in the current analysis were aged 15-24 years, and were enrolled in Medicaid continuously for at least 210 days at the time of delivery. The women had numerous prenatal visits, and thus had ample opportunity for screening.
The CDC recommends universal chlamydia screening in pregnant women, with screening at the first prenatal visit, and recommends gonorrhea screening of pregnant women at risk, which includes those under age 25 years and those with a prior infection. Repeat screening in the third trimester is recommended for certain high-risk patients.
In 2012 the U.S. Preventive Services Task Force revised its cervical cancer screening guidelines, and screening is no longer recommended in women younger than 21 years. Also, the interval for screening was extended to 3 years for those over age 21 years, Dr. Ross noted.
The findings are concerning for several reasons, she said.
The vast majority of chlamydia and gonorrhea infections are asymptomatic, including those occurring during pregnancy. Studies show that only 5%-35% of patients with laboratory-confirmed infections develop symptoms. Furthermore, both chlamydia and gonorrhea can affect neonates and can lead to adverse outcomes in pregnant women, she explained.
Furthermore, in one large study involving laboratory data for 1.3 million pregnant women, nearly 16% of 16-year-olds tested positive for chlamydia, and 3% tested positive for gonorrhea. The rate of positive tests declined with advancing maternal age – a finding that is consistent with CDC data, Dr. Ross noted.
Yet, under the revised guidelines, the younger women – who are at the highest risk of infection – would be less likely to be tested.
For many years, screening for chlamydia and gonorrhea was performed at the time of Pap testing, using the endocervical sample, but improved understanding of human papillomavirus infection in young women led to the revision of the guidelines.
Although limited by factors inherent in using administrative data, and by the underrepresentation of Hispanics, who comprised only 3.6% of the sample, the current findings suggest that a reduction in chlamydia and gonorrhea screening may be an inadvertent consequence of the changes.
Future studies are warranted to evaluate this potential consequence as more providers implement the new cervical cancer screening recommendations, Dr. Ross said.
"In the meantime, we recommended informing prenatal providers about the importance of screening all pregnant women for chlamydia and those at risk for gonorrhea, and that alternative specimen collection methods that do not require a pelvic examination that is done during a Pap test are available – and in fact are preferred," she said, noting that patient- or provider-collected vaginal swabs are the preferred specimen, and that urine also can be used.
Dr. Ross reported having no disclosures.
ATLANTA – Prenatal screening for chlamydia and gonorrhea is commonly performed in conjunction with Pap testing, which results in low screening rates among those who don’t undergo Pap testing, a retrospective cohort study showed.
These findings are concerning because recent changes in cervical cancer screening recommendations that increase the screening interval for many women could further reduce the rates of screening for chlamydia and gonorrhea if clinicians don’t "untie" Pap testing and STD screening, Dr. Christine Ross said at a conference on STD prevention sponsored by the Centers for Disease Control and Prevention.
Among 63,332 pregnant women with a live birth who were included in a 12-state Medicaid claims database in 2009-2010, 79% were tested for chlamydia, 72% were tested for gonorrhea, and 74% underwent cervical cancer screening by Pap test. Of the 46,966 who underwent Pap testing, 89% and 80% were tested for chlamydia and gonorrhea, respectively, and of those who did not undergo Pap testing, only 51% and 48% were tested for chlamydia and gonorrhea, said Dr. Ross of the division of STD prevention at the CDC.
"We found that 13% of women in our study population had neither a Pap test nor a chlamydia or gonorrhea screening test," she said.
Women included in the current analysis were aged 15-24 years, and were enrolled in Medicaid continuously for at least 210 days at the time of delivery. The women had numerous prenatal visits, and thus had ample opportunity for screening.
The CDC recommends universal chlamydia screening in pregnant women, with screening at the first prenatal visit, and recommends gonorrhea screening of pregnant women at risk, which includes those under age 25 years and those with a prior infection. Repeat screening in the third trimester is recommended for certain high-risk patients.
In 2012 the U.S. Preventive Services Task Force revised its cervical cancer screening guidelines, and screening is no longer recommended in women younger than 21 years. Also, the interval for screening was extended to 3 years for those over age 21 years, Dr. Ross noted.
The findings are concerning for several reasons, she said.
The vast majority of chlamydia and gonorrhea infections are asymptomatic, including those occurring during pregnancy. Studies show that only 5%-35% of patients with laboratory-confirmed infections develop symptoms. Furthermore, both chlamydia and gonorrhea can affect neonates and can lead to adverse outcomes in pregnant women, she explained.
Furthermore, in one large study involving laboratory data for 1.3 million pregnant women, nearly 16% of 16-year-olds tested positive for chlamydia, and 3% tested positive for gonorrhea. The rate of positive tests declined with advancing maternal age – a finding that is consistent with CDC data, Dr. Ross noted.
Yet, under the revised guidelines, the younger women – who are at the highest risk of infection – would be less likely to be tested.
For many years, screening for chlamydia and gonorrhea was performed at the time of Pap testing, using the endocervical sample, but improved understanding of human papillomavirus infection in young women led to the revision of the guidelines.
Although limited by factors inherent in using administrative data, and by the underrepresentation of Hispanics, who comprised only 3.6% of the sample, the current findings suggest that a reduction in chlamydia and gonorrhea screening may be an inadvertent consequence of the changes.
Future studies are warranted to evaluate this potential consequence as more providers implement the new cervical cancer screening recommendations, Dr. Ross said.
"In the meantime, we recommended informing prenatal providers about the importance of screening all pregnant women for chlamydia and those at risk for gonorrhea, and that alternative specimen collection methods that do not require a pelvic examination that is done during a Pap test are available – and in fact are preferred," she said, noting that patient- or provider-collected vaginal swabs are the preferred specimen, and that urine also can be used.
Dr. Ross reported having no disclosures.
AT THE 2014 STD PREVENTION CONFERENCE
Key clinical point: Teens and pregnant patients may not be screened for chlamydia and gonorrhea because of changes in Pap screening guidelines.
Major finding: Only 51% and 48% of patients who didn’t undergo Pap testing were screened for chlamydia and gonorrhea, respectively.
Data source: A retrospective cohort study involving 63,332 patients.
Disclosures: Dr. Ross reported having no disclosures.