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Statin didn’t slow hepatic steatosis in HIV patients
SAN DIEGO – Statin therapy wasn’t effective against a rising rate of hepatic steatosis in HIV patients, and may increase nonalcoholic fatty liver disease (NAFLD) risk, according to a small study.
The findings are contrary to the limited data currently available, which suggest statins can have a beneficial effect on hepatic steatosis, according to the study’s investigators.
NAFLD is one of the leading causes of mortality and morbidity in people living with HIV, said Vanessa El Kamari, MD, of Case Western Reserve University, Cleveland, and rates are continuing to increase. With a lack of therapeutic interventions for NAFLD in patients with HIV, finding effective treatments is a major concern for providers.
Dr. El Kamari and her colleagues conducted a secondary analysis of the SATURN-HIV trial, a randomized, placebo-controlled trial of 147 patients with HIV who were on stable antiretroviral therapy (ART) with LDL cholesterol levels at or below 130 mg/dL. Patients were either treated with 10 mg rosuvastatin or placebo.
Patients in the treatment and placebo arms were an average age of 45 years, most patients were male (81% and 76%, respectively), and a majority was African American (69% and 67%, respectively). The two groups reported average CD4+ counts of 644 and 636, respectively.
Investigators used validated scores to determine hepatic steatosis in patients, although researchers acknowledged that liver biopsy is the gold standard for hepatic steatosis measurement.
“We understand liver fat score has its limitation,” said Dr. El Kamari in a question and answer session following the presentation at an annual scientific meeting on infectious diseases. “Further studies are needed in this area in order to detect, in noninvasive ways, hepatic steatosis.”
Liver fat scores (LFS) were measured on entry, at week 48, and week 96.
After 96 weeks, investigators saw significant increases in LFS in both the placebo and rosuvastatin groups (P = .01 and P less than .01, respectively). Progression from nonsteatosis at baseline to steatosis over 96 weeks was greater in patients given rosuvastatin than in those given placebo (odds ratio, 4.3; P = .03).
Studying predictors for LFS changes, a trend toward insignificance among the randomization group led investigators to the conclusion that statin may have negatively affected the liver fat score of patients over the 96-week time period.
The study researchers identified 92 patients who did not have hepatic steatosis at baseline to study how statins influenced the development of hepatic steatosis.
Of the 13 patients who developed steatosis during the trial period, 10 were part of the rosuvastatin group, while only 3 were from the placebo group.
Increases in LFS were associated with increases in insulin resistance, detected presence of HIV-1 RNA, and higher interferon-inducible proteins, according to Dr. El Kamari.
While increased homeostatic assessment of insulin resistance was associated with increased hepatic homeostasis, Dr. El Kamari was not able to determine if statins that are not associated with insulin resistance will have different outcomes.
The investigators cautioned that the findings may not be generalizable to the entire HIV population due to the overwhelming majority of African American patients with increased inflammation, as well as the study patients’ LDL cholesterol levels of less than or equal to 130 mg/dL.
The National Institutes of Health funded the study. Dr. El Kamari had no disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
SAN DIEGO – Statin therapy wasn’t effective against a rising rate of hepatic steatosis in HIV patients, and may increase nonalcoholic fatty liver disease (NAFLD) risk, according to a small study.
The findings are contrary to the limited data currently available, which suggest statins can have a beneficial effect on hepatic steatosis, according to the study’s investigators.
NAFLD is one of the leading causes of mortality and morbidity in people living with HIV, said Vanessa El Kamari, MD, of Case Western Reserve University, Cleveland, and rates are continuing to increase. With a lack of therapeutic interventions for NAFLD in patients with HIV, finding effective treatments is a major concern for providers.
Dr. El Kamari and her colleagues conducted a secondary analysis of the SATURN-HIV trial, a randomized, placebo-controlled trial of 147 patients with HIV who were on stable antiretroviral therapy (ART) with LDL cholesterol levels at or below 130 mg/dL. Patients were either treated with 10 mg rosuvastatin or placebo.
Patients in the treatment and placebo arms were an average age of 45 years, most patients were male (81% and 76%, respectively), and a majority was African American (69% and 67%, respectively). The two groups reported average CD4+ counts of 644 and 636, respectively.
Investigators used validated scores to determine hepatic steatosis in patients, although researchers acknowledged that liver biopsy is the gold standard for hepatic steatosis measurement.
“We understand liver fat score has its limitation,” said Dr. El Kamari in a question and answer session following the presentation at an annual scientific meeting on infectious diseases. “Further studies are needed in this area in order to detect, in noninvasive ways, hepatic steatosis.”
Liver fat scores (LFS) were measured on entry, at week 48, and week 96.
After 96 weeks, investigators saw significant increases in LFS in both the placebo and rosuvastatin groups (P = .01 and P less than .01, respectively). Progression from nonsteatosis at baseline to steatosis over 96 weeks was greater in patients given rosuvastatin than in those given placebo (odds ratio, 4.3; P = .03).
Studying predictors for LFS changes, a trend toward insignificance among the randomization group led investigators to the conclusion that statin may have negatively affected the liver fat score of patients over the 96-week time period.
The study researchers identified 92 patients who did not have hepatic steatosis at baseline to study how statins influenced the development of hepatic steatosis.
Of the 13 patients who developed steatosis during the trial period, 10 were part of the rosuvastatin group, while only 3 were from the placebo group.
Increases in LFS were associated with increases in insulin resistance, detected presence of HIV-1 RNA, and higher interferon-inducible proteins, according to Dr. El Kamari.
While increased homeostatic assessment of insulin resistance was associated with increased hepatic homeostasis, Dr. El Kamari was not able to determine if statins that are not associated with insulin resistance will have different outcomes.
The investigators cautioned that the findings may not be generalizable to the entire HIV population due to the overwhelming majority of African American patients with increased inflammation, as well as the study patients’ LDL cholesterol levels of less than or equal to 130 mg/dL.
The National Institutes of Health funded the study. Dr. El Kamari had no disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
SAN DIEGO – Statin therapy wasn’t effective against a rising rate of hepatic steatosis in HIV patients, and may increase nonalcoholic fatty liver disease (NAFLD) risk, according to a small study.
The findings are contrary to the limited data currently available, which suggest statins can have a beneficial effect on hepatic steatosis, according to the study’s investigators.
NAFLD is one of the leading causes of mortality and morbidity in people living with HIV, said Vanessa El Kamari, MD, of Case Western Reserve University, Cleveland, and rates are continuing to increase. With a lack of therapeutic interventions for NAFLD in patients with HIV, finding effective treatments is a major concern for providers.
Dr. El Kamari and her colleagues conducted a secondary analysis of the SATURN-HIV trial, a randomized, placebo-controlled trial of 147 patients with HIV who were on stable antiretroviral therapy (ART) with LDL cholesterol levels at or below 130 mg/dL. Patients were either treated with 10 mg rosuvastatin or placebo.
Patients in the treatment and placebo arms were an average age of 45 years, most patients were male (81% and 76%, respectively), and a majority was African American (69% and 67%, respectively). The two groups reported average CD4+ counts of 644 and 636, respectively.
Investigators used validated scores to determine hepatic steatosis in patients, although researchers acknowledged that liver biopsy is the gold standard for hepatic steatosis measurement.
“We understand liver fat score has its limitation,” said Dr. El Kamari in a question and answer session following the presentation at an annual scientific meeting on infectious diseases. “Further studies are needed in this area in order to detect, in noninvasive ways, hepatic steatosis.”
Liver fat scores (LFS) were measured on entry, at week 48, and week 96.
After 96 weeks, investigators saw significant increases in LFS in both the placebo and rosuvastatin groups (P = .01 and P less than .01, respectively). Progression from nonsteatosis at baseline to steatosis over 96 weeks was greater in patients given rosuvastatin than in those given placebo (odds ratio, 4.3; P = .03).
Studying predictors for LFS changes, a trend toward insignificance among the randomization group led investigators to the conclusion that statin may have negatively affected the liver fat score of patients over the 96-week time period.
The study researchers identified 92 patients who did not have hepatic steatosis at baseline to study how statins influenced the development of hepatic steatosis.
Of the 13 patients who developed steatosis during the trial period, 10 were part of the rosuvastatin group, while only 3 were from the placebo group.
Increases in LFS were associated with increases in insulin resistance, detected presence of HIV-1 RNA, and higher interferon-inducible proteins, according to Dr. El Kamari.
While increased homeostatic assessment of insulin resistance was associated with increased hepatic homeostasis, Dr. El Kamari was not able to determine if statins that are not associated with insulin resistance will have different outcomes.
The investigators cautioned that the findings may not be generalizable to the entire HIV population due to the overwhelming majority of African American patients with increased inflammation, as well as the study patients’ LDL cholesterol levels of less than or equal to 130 mg/dL.
The National Institutes of Health funded the study. Dr. El Kamari had no disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT IDWEEK 2017
Key clinical point:
Major finding: Progression from nonsteatosis at baseline to steatosis over 96 weeks was greater in patients given rosuvastatin than in those given placebo (odds ratio, 4.3; P = .03).
Data source: A randomized, placebo-controlled study of 147 patients with HIV on stable ART.
Disclosures: The National Institutes of Health funded the study. Dr. El Kamari had no disclosures.
Fibroids associated with lower chance of unsuspected malignancy
NATIONAL HARBOR, MD. – Women undergoing hysterectomy or myomectomy for benign indications, who also had fibroids, were less likely to have a malignant diagnosis, according to a study presented at the AAGL Global Congress.
These findings could change the conversation when it comes to counseling patients about the risks associated with morcellation, a procedure that was strongly discouraged by the FDA in 2014 due to the concern that it might have the potential to spread malignancy.
“There’s a lot of things going on in the media about morcellation and risk of malignancy at the time of benign fibroid surgery, but this research actually makes apparent the higher risk of malignancy when fibroids are not present,” Farah Alvi, MD, a second-year fellow at Northwestern University, Chicago, said in an interview. Despite the concerns regarding morcellation and malignancy, this research suggests that patients who have fibroids at time of surgery may have a lower chance of malignancy, compared with patients who have other indications for surgery, she explained.
Dr. Alvi and her colleagues studied 2,987 hysterectomy or myomectomy patients with benign indications between January 2005 and December 2014.
Among patients studied, researchers found 33 confirmed malignant or borderline tumors, 16 of 1,790 (0.89%) in the leiomyoma group and 17 of 1,197 (1.42%) in the group with other indications (P = 0.04). The malignancies/borderline tumors included three leiomyosarcomas, two endometrial sarcomas, two endometrioid adenocarcinomas, one granulose cell tumor, three smooth muscle tumors of uncertain malignant potential, three atypical leiomyoma, and one serous papillary borderline ovarian tumor.
Of those with leiomyomata, 1 in 600 patients were diagnosed with leiomyosarcoma, compared with a risk of 1 in 350 for unanticipated malignancy in general.
Patients with surgical indications of symptomatic leiomyoma had an odds ratio of 0.63 (P = .18) for diagnosis of an unanticipated malignancy, compared with those without leiomyoma, according to Dr. Alvi. The odds of malignancy were also reduced in patients with uterine sizes of 15-20 weeks (OR, 0.65; P = .43) and those with specimen sizes of 250-500 grams (OR, 0.68; P = .64).
These findings will have implications for how physicians counsel women undergoing minimally invasive hysterectomy or myomectomy, Dr. Alvi said.
“In counseling patients about morcellation, we often have quoted them an estimated risk of 1 in 458 for leiomyosarcoma, based on the FDA morcellation warnings, and one thing we can learn is that risk is actually much lower than we think it is,” Dr. Alvi said.
The findings also suggest a shift in focus toward identifying the factors that put women at higher risk for malignancy. For example, older age is one of the most significant risk factors identified in the study, she added.
Dr. Alvi reported having no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Women undergoing hysterectomy or myomectomy for benign indications, who also had fibroids, were less likely to have a malignant diagnosis, according to a study presented at the AAGL Global Congress.
These findings could change the conversation when it comes to counseling patients about the risks associated with morcellation, a procedure that was strongly discouraged by the FDA in 2014 due to the concern that it might have the potential to spread malignancy.
“There’s a lot of things going on in the media about morcellation and risk of malignancy at the time of benign fibroid surgery, but this research actually makes apparent the higher risk of malignancy when fibroids are not present,” Farah Alvi, MD, a second-year fellow at Northwestern University, Chicago, said in an interview. Despite the concerns regarding morcellation and malignancy, this research suggests that patients who have fibroids at time of surgery may have a lower chance of malignancy, compared with patients who have other indications for surgery, she explained.
Dr. Alvi and her colleagues studied 2,987 hysterectomy or myomectomy patients with benign indications between January 2005 and December 2014.
Among patients studied, researchers found 33 confirmed malignant or borderline tumors, 16 of 1,790 (0.89%) in the leiomyoma group and 17 of 1,197 (1.42%) in the group with other indications (P = 0.04). The malignancies/borderline tumors included three leiomyosarcomas, two endometrial sarcomas, two endometrioid adenocarcinomas, one granulose cell tumor, three smooth muscle tumors of uncertain malignant potential, three atypical leiomyoma, and one serous papillary borderline ovarian tumor.
Of those with leiomyomata, 1 in 600 patients were diagnosed with leiomyosarcoma, compared with a risk of 1 in 350 for unanticipated malignancy in general.
Patients with surgical indications of symptomatic leiomyoma had an odds ratio of 0.63 (P = .18) for diagnosis of an unanticipated malignancy, compared with those without leiomyoma, according to Dr. Alvi. The odds of malignancy were also reduced in patients with uterine sizes of 15-20 weeks (OR, 0.65; P = .43) and those with specimen sizes of 250-500 grams (OR, 0.68; P = .64).
These findings will have implications for how physicians counsel women undergoing minimally invasive hysterectomy or myomectomy, Dr. Alvi said.
“In counseling patients about morcellation, we often have quoted them an estimated risk of 1 in 458 for leiomyosarcoma, based on the FDA morcellation warnings, and one thing we can learn is that risk is actually much lower than we think it is,” Dr. Alvi said.
The findings also suggest a shift in focus toward identifying the factors that put women at higher risk for malignancy. For example, older age is one of the most significant risk factors identified in the study, she added.
Dr. Alvi reported having no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Women undergoing hysterectomy or myomectomy for benign indications, who also had fibroids, were less likely to have a malignant diagnosis, according to a study presented at the AAGL Global Congress.
These findings could change the conversation when it comes to counseling patients about the risks associated with morcellation, a procedure that was strongly discouraged by the FDA in 2014 due to the concern that it might have the potential to spread malignancy.
“There’s a lot of things going on in the media about morcellation and risk of malignancy at the time of benign fibroid surgery, but this research actually makes apparent the higher risk of malignancy when fibroids are not present,” Farah Alvi, MD, a second-year fellow at Northwestern University, Chicago, said in an interview. Despite the concerns regarding morcellation and malignancy, this research suggests that patients who have fibroids at time of surgery may have a lower chance of malignancy, compared with patients who have other indications for surgery, she explained.
Dr. Alvi and her colleagues studied 2,987 hysterectomy or myomectomy patients with benign indications between January 2005 and December 2014.
Among patients studied, researchers found 33 confirmed malignant or borderline tumors, 16 of 1,790 (0.89%) in the leiomyoma group and 17 of 1,197 (1.42%) in the group with other indications (P = 0.04). The malignancies/borderline tumors included three leiomyosarcomas, two endometrial sarcomas, two endometrioid adenocarcinomas, one granulose cell tumor, three smooth muscle tumors of uncertain malignant potential, three atypical leiomyoma, and one serous papillary borderline ovarian tumor.
Of those with leiomyomata, 1 in 600 patients were diagnosed with leiomyosarcoma, compared with a risk of 1 in 350 for unanticipated malignancy in general.
Patients with surgical indications of symptomatic leiomyoma had an odds ratio of 0.63 (P = .18) for diagnosis of an unanticipated malignancy, compared with those without leiomyoma, according to Dr. Alvi. The odds of malignancy were also reduced in patients with uterine sizes of 15-20 weeks (OR, 0.65; P = .43) and those with specimen sizes of 250-500 grams (OR, 0.68; P = .64).
These findings will have implications for how physicians counsel women undergoing minimally invasive hysterectomy or myomectomy, Dr. Alvi said.
“In counseling patients about morcellation, we often have quoted them an estimated risk of 1 in 458 for leiomyosarcoma, based on the FDA morcellation warnings, and one thing we can learn is that risk is actually much lower than we think it is,” Dr. Alvi said.
The findings also suggest a shift in focus toward identifying the factors that put women at higher risk for malignancy. For example, older age is one of the most significant risk factors identified in the study, she added.
Dr. Alvi reported having no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT AAGL 2017
Key clinical point:
Major finding: Patients with preoperative indication of symptomatic leiomyoma had an odds ratio of 0.63 (P = .18) of having a diagnosis of malignancy.
Data source: Retrospective study of 2,987 hysterectomies or myomectomies between January 2005 and December 2014.
Disclosures: Dr. Alvi reported having no relevant financial disclosures.
Pain is a risk factor for endometrial ablation failure
NATIONAL HARBOR, MD. – Second-generation endometrial ablations performed for an indication related to pain were significantly more likely to fail, according to findings presented at the AAGL Global Congress.
“We know that endometrial ablation carries a reasonable risk of failure – meaning a second ablation or hysterectomy procedure – and that rate can vary institutionally,” Matthew Hoffman, MD, chair of obstetrics and gynecology at Christiana Care Health Center, Newark, Del., said in an interview prior to the meeting. “Part of our goal is to examine patients who had pain as an indication for their procedure and to better understand if that served as an independent risk factor for women who would ultimately require additional surgical intervention.”
In a retrospective study, researchers identified 5,818 women who had undergone an ablation between October 2003 and March 2016 at a community hospital affiliated with the Christina Care Health System. Patients had either a radiofrequency ablation (3,706), hydrothermablation (1,786), or uterine balloon ablation (326).
The majority of the patients were white. Pain indications included pelvic pain, dysmenorrhea, dyspareunia, lower abdominal pain, endometriosis, and adenomyosis.
Investigators found a hysterectomy rate of 19.2% among the 437 patients who had pain as an indication for ablation, compared with 13.5% of patients with different indications (P = .001).
Secondary outcomes showed older women who underwent ablation for pain were still less likely to fail than were younger patients (odds ratio, 0.96, 95% confidence interval, .95-.97). “Older age, especially age 50 years or older, with the indication of pain, was actually protective against hysterectomy,” Meagan Cramer, MD, a resident physician at Christina Care Health System and one of the study researchers, said in an interview. “So even though pain itself was a risk factor, if you were in pain and older than 50 you were less likely to need a hysterectomy.”
The data used were collected at a single center, potentially limiting the generalizability of the findings.
Dr. Hoffman and Dr. Cramer suggested using hormonal IUDs as an alternative treatment when counseling patients who may be at risk for a failed ablation.
“This is a call for folks to look at a diverse number of risk factors and to look at this data to better counsel patients in how they choose and select procedures to get to the endpoints that you want,” Dr. Hoffman said.
The researchers reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Second-generation endometrial ablations performed for an indication related to pain were significantly more likely to fail, according to findings presented at the AAGL Global Congress.
“We know that endometrial ablation carries a reasonable risk of failure – meaning a second ablation or hysterectomy procedure – and that rate can vary institutionally,” Matthew Hoffman, MD, chair of obstetrics and gynecology at Christiana Care Health Center, Newark, Del., said in an interview prior to the meeting. “Part of our goal is to examine patients who had pain as an indication for their procedure and to better understand if that served as an independent risk factor for women who would ultimately require additional surgical intervention.”
In a retrospective study, researchers identified 5,818 women who had undergone an ablation between October 2003 and March 2016 at a community hospital affiliated with the Christina Care Health System. Patients had either a radiofrequency ablation (3,706), hydrothermablation (1,786), or uterine balloon ablation (326).
The majority of the patients were white. Pain indications included pelvic pain, dysmenorrhea, dyspareunia, lower abdominal pain, endometriosis, and adenomyosis.
Investigators found a hysterectomy rate of 19.2% among the 437 patients who had pain as an indication for ablation, compared with 13.5% of patients with different indications (P = .001).
Secondary outcomes showed older women who underwent ablation for pain were still less likely to fail than were younger patients (odds ratio, 0.96, 95% confidence interval, .95-.97). “Older age, especially age 50 years or older, with the indication of pain, was actually protective against hysterectomy,” Meagan Cramer, MD, a resident physician at Christina Care Health System and one of the study researchers, said in an interview. “So even though pain itself was a risk factor, if you were in pain and older than 50 you were less likely to need a hysterectomy.”
The data used were collected at a single center, potentially limiting the generalizability of the findings.
Dr. Hoffman and Dr. Cramer suggested using hormonal IUDs as an alternative treatment when counseling patients who may be at risk for a failed ablation.
“This is a call for folks to look at a diverse number of risk factors and to look at this data to better counsel patients in how they choose and select procedures to get to the endpoints that you want,” Dr. Hoffman said.
The researchers reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
NATIONAL HARBOR, MD. – Second-generation endometrial ablations performed for an indication related to pain were significantly more likely to fail, according to findings presented at the AAGL Global Congress.
“We know that endometrial ablation carries a reasonable risk of failure – meaning a second ablation or hysterectomy procedure – and that rate can vary institutionally,” Matthew Hoffman, MD, chair of obstetrics and gynecology at Christiana Care Health Center, Newark, Del., said in an interview prior to the meeting. “Part of our goal is to examine patients who had pain as an indication for their procedure and to better understand if that served as an independent risk factor for women who would ultimately require additional surgical intervention.”
In a retrospective study, researchers identified 5,818 women who had undergone an ablation between October 2003 and March 2016 at a community hospital affiliated with the Christina Care Health System. Patients had either a radiofrequency ablation (3,706), hydrothermablation (1,786), or uterine balloon ablation (326).
The majority of the patients were white. Pain indications included pelvic pain, dysmenorrhea, dyspareunia, lower abdominal pain, endometriosis, and adenomyosis.
Investigators found a hysterectomy rate of 19.2% among the 437 patients who had pain as an indication for ablation, compared with 13.5% of patients with different indications (P = .001).
Secondary outcomes showed older women who underwent ablation for pain were still less likely to fail than were younger patients (odds ratio, 0.96, 95% confidence interval, .95-.97). “Older age, especially age 50 years or older, with the indication of pain, was actually protective against hysterectomy,” Meagan Cramer, MD, a resident physician at Christina Care Health System and one of the study researchers, said in an interview. “So even though pain itself was a risk factor, if you were in pain and older than 50 you were less likely to need a hysterectomy.”
The data used were collected at a single center, potentially limiting the generalizability of the findings.
Dr. Hoffman and Dr. Cramer suggested using hormonal IUDs as an alternative treatment when counseling patients who may be at risk for a failed ablation.
“This is a call for folks to look at a diverse number of risk factors and to look at this data to better counsel patients in how they choose and select procedures to get to the endpoints that you want,” Dr. Hoffman said.
The researchers reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT AAGL 2017
Key clinical point:
Major finding: Ablation had a hysterectomy rate of 19.2% when pain was an indication, compared with 13.5% for other indications.
Data source: Retrospective study of 5,818 endometrial ablations conducted between October 2003 and March 2016 at a single institution.
Disclosures: The researchers reported no relevant financial disclosures.
FDA approves first two-dose HBV vaccine
When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.
Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.
“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”
Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.
From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.
The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.
In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).
Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.
The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.
During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).
The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.
“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”
Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.
“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.
Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.
“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”
Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.
From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.
The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.
In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).
Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.
The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.
During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).
The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.
“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”
Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.
“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
When the Food and Drug Administration approved Heplisav-B Nov. 9, it marked the first new vaccine for hepatitis B virus (HBV) to be sanctioned in over 25 years.
Heplisav-B is the only two-dose regimen that protects against all known subtypes of HBV in adults 18 years and older, according to a statement released by Dynavax Technologies, the creator of the drug.
“Heplisav-B is the first FDA-approved product for Dynavax and demonstrates our ability to develop innovative products and progress them from discovery to commercialization,” according to Eddie Gray, chief executive officer of Dynavax. “We expect that it will become an essential tool in the public health community’s fight to prevent hepatitis B [infection], and we look forward to making Heplisav-B available to clinicians and their adult patients.”
Incidence of HBV has increased sharply from 2012 to 2015 in the United States, with reported cases rising from 2,895 to 3,370, according to the Centers for Disease Control and Prevention.
From 2014 to 2015, acute HBV infection increased 20.7%, according to the CDC report.
The new vaccine’s approval came after review of safety and efficacy data from three phase 3 trials comparing Heplisav-B with Engerix-B, another HBV vaccine currently available, that is given in a three-dose regimen.
In one study of 2,032 patients between the ages of 18 and 55 years, seroprotection rate in the Heplisav-B group (1,511) was 95%, compared with 81.5% in the Engerix-B group (521).
Heplisav-B patients were given a two-dose regimen of the drug at 0 and 1 months, followed by a placebo at 6 months, while investigators administered Engerix-B at all three intervals in the comparator subjects.
The FDA’s decision to green-light the new vaccine follows a recommendation for approval from the FDA’s Vaccines and Related Biological Products Advisory Committee, held at the end of July this year.
During the advisory committee meeting, members were concerned about an increased relative risk for acute myocardial infarction of 6.97 in Heplisav-B patients (14), compared with Engerix-B patients (1).
The recommendation for approval came with the caveat of conducting postmarketing analysis for the risk of AMI in Heplisav-B patients, which Dynavax is conducting through the Kaiser Permanente system in California.
“To evaluate the risk of AMIs, the study will enroll 25,000 Heplisav-B patients and 25,000 Engerix-B patients over approximately 10 months and follow them for 1 year after vaccination,” according to a statement from Dynavax. “In addition we will evaluate the rate of immune-mediated diseases in these patients in an additional 5,000 Heplisav-B recipients and 5,000 Engerix-B recipients.”
Dynavax is currently set to introduce Heplisav-B commercially in the United States in 2018, with the cost of the drug set to be released soon.
“Dynavax is in the process of finalizing the price of a two-dose series of Heplisav-B, and they plan to disclose it shortly after approval,” according to the company. “Their pricing and access strategy will be aimed at ensuring that populations at risk of infection are able to access this new vaccine, while recognizing the value it brings to the health care system with a two-dose regimen and higher rates of protection compared to Engerix-B.”
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
Young adult HIV patients may be at increased risk of hypertension
SAN DIEGO – Young adults with perinatally-acquired HIV are at an increased risk of developing hypertension, according to a study presented at IDWeek 2017, an infectious diseases conference.
With advances in HIV care and treatment increasing the lifespan of perinatally infected children, patients are seeing increased risks of HIV-associated, non-AIDS conditions like hypertension.
While the prevalence of hypertension in older HIV patients has been studied thoroughly, rates among younger, perinatal HIV populations is relatively unexplored, said Dr. Ryscavage.
Investigators examined 324 patients between the ages of 18-29 years, split between three arms for a cross sectional study: 108 patients with perinatally-acquired (PA) HIV, 108 patients with non-perinatally acquired (NPA) HIV, and 108 uninfected (UI) patients. The 3 study arms were a median age of 24 years, 95% black, and a slight majority female.
Dr. Ryscavage and fellow investigators defined systemic hypertension as two systolic blood pressure measurements greater than or equal to 140 mmHg, or diastolic measurements greater or equal to 90 mmHG within 3 months, or if a physician prescribed antihypertensive mediation.
The researchers discovered that, while UI patients had the highest prevalence of obesity, PA patients reported the highest rate of chronic kidney disease (19%) and dysplidemia (13%), compared to NPA (1% and 3% respectively) and UI (0% and 5% respectively) patients.
Hypertension prevalence was highest among PA patients, followed by NPA patients, and then UI at 23%, 10%, and 9% respectively.
Young adults with PA HIV were nearly 5 times as likely to have hypertension (aOR 4.7; CI 95% [1.9-11.5]) compared to the uninfected population, while NPA showed no significant difference compared to the uninfected (aOR 1.7; CI 95% [.7-4.6]).
Investigators checked to see if the increase in hypertension could be related to the high rate of chronic kidney disease, but were not successful.
“We found [chronic kidney disease] to be approximately one third increased odds of association with chronic kidney disease,” Dr. Ryscavage explained. “However excluding kidney disease, the prevalence odds ratios remained significant and in the context of the cross sectional study…it was difficult to establish a directional relationship between chronic kidney diseases and hypertension.”
This study was limited by using one center in West Baltimore. Also, due to a majority of patients having at least one deceased parent, investigators were not able to collect a complete family history.
Dr. Ryscavage and his colleagues are next looking for what specific factors in HIV groups are causing an increased prevalence. Meanwhile, the investigators implored other researchers to initiate studies in poorer nations where HIV is much more prevalent.
“These findings need to be explored in the developing world where we have the largest population of aging, perinatally infected patients,” said Dr. Ryscavage.
Presenters reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
SAN DIEGO – Young adults with perinatally-acquired HIV are at an increased risk of developing hypertension, according to a study presented at IDWeek 2017, an infectious diseases conference.
With advances in HIV care and treatment increasing the lifespan of perinatally infected children, patients are seeing increased risks of HIV-associated, non-AIDS conditions like hypertension.
While the prevalence of hypertension in older HIV patients has been studied thoroughly, rates among younger, perinatal HIV populations is relatively unexplored, said Dr. Ryscavage.
Investigators examined 324 patients between the ages of 18-29 years, split between three arms for a cross sectional study: 108 patients with perinatally-acquired (PA) HIV, 108 patients with non-perinatally acquired (NPA) HIV, and 108 uninfected (UI) patients. The 3 study arms were a median age of 24 years, 95% black, and a slight majority female.
Dr. Ryscavage and fellow investigators defined systemic hypertension as two systolic blood pressure measurements greater than or equal to 140 mmHg, or diastolic measurements greater or equal to 90 mmHG within 3 months, or if a physician prescribed antihypertensive mediation.
The researchers discovered that, while UI patients had the highest prevalence of obesity, PA patients reported the highest rate of chronic kidney disease (19%) and dysplidemia (13%), compared to NPA (1% and 3% respectively) and UI (0% and 5% respectively) patients.
Hypertension prevalence was highest among PA patients, followed by NPA patients, and then UI at 23%, 10%, and 9% respectively.
Young adults with PA HIV were nearly 5 times as likely to have hypertension (aOR 4.7; CI 95% [1.9-11.5]) compared to the uninfected population, while NPA showed no significant difference compared to the uninfected (aOR 1.7; CI 95% [.7-4.6]).
Investigators checked to see if the increase in hypertension could be related to the high rate of chronic kidney disease, but were not successful.
“We found [chronic kidney disease] to be approximately one third increased odds of association with chronic kidney disease,” Dr. Ryscavage explained. “However excluding kidney disease, the prevalence odds ratios remained significant and in the context of the cross sectional study…it was difficult to establish a directional relationship between chronic kidney diseases and hypertension.”
This study was limited by using one center in West Baltimore. Also, due to a majority of patients having at least one deceased parent, investigators were not able to collect a complete family history.
Dr. Ryscavage and his colleagues are next looking for what specific factors in HIV groups are causing an increased prevalence. Meanwhile, the investigators implored other researchers to initiate studies in poorer nations where HIV is much more prevalent.
“These findings need to be explored in the developing world where we have the largest population of aging, perinatally infected patients,” said Dr. Ryscavage.
Presenters reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
SAN DIEGO – Young adults with perinatally-acquired HIV are at an increased risk of developing hypertension, according to a study presented at IDWeek 2017, an infectious diseases conference.
With advances in HIV care and treatment increasing the lifespan of perinatally infected children, patients are seeing increased risks of HIV-associated, non-AIDS conditions like hypertension.
While the prevalence of hypertension in older HIV patients has been studied thoroughly, rates among younger, perinatal HIV populations is relatively unexplored, said Dr. Ryscavage.
Investigators examined 324 patients between the ages of 18-29 years, split between three arms for a cross sectional study: 108 patients with perinatally-acquired (PA) HIV, 108 patients with non-perinatally acquired (NPA) HIV, and 108 uninfected (UI) patients. The 3 study arms were a median age of 24 years, 95% black, and a slight majority female.
Dr. Ryscavage and fellow investigators defined systemic hypertension as two systolic blood pressure measurements greater than or equal to 140 mmHg, or diastolic measurements greater or equal to 90 mmHG within 3 months, or if a physician prescribed antihypertensive mediation.
The researchers discovered that, while UI patients had the highest prevalence of obesity, PA patients reported the highest rate of chronic kidney disease (19%) and dysplidemia (13%), compared to NPA (1% and 3% respectively) and UI (0% and 5% respectively) patients.
Hypertension prevalence was highest among PA patients, followed by NPA patients, and then UI at 23%, 10%, and 9% respectively.
Young adults with PA HIV were nearly 5 times as likely to have hypertension (aOR 4.7; CI 95% [1.9-11.5]) compared to the uninfected population, while NPA showed no significant difference compared to the uninfected (aOR 1.7; CI 95% [.7-4.6]).
Investigators checked to see if the increase in hypertension could be related to the high rate of chronic kidney disease, but were not successful.
“We found [chronic kidney disease] to be approximately one third increased odds of association with chronic kidney disease,” Dr. Ryscavage explained. “However excluding kidney disease, the prevalence odds ratios remained significant and in the context of the cross sectional study…it was difficult to establish a directional relationship between chronic kidney diseases and hypertension.”
This study was limited by using one center in West Baltimore. Also, due to a majority of patients having at least one deceased parent, investigators were not able to collect a complete family history.
Dr. Ryscavage and his colleagues are next looking for what specific factors in HIV groups are causing an increased prevalence. Meanwhile, the investigators implored other researchers to initiate studies in poorer nations where HIV is much more prevalent.
“These findings need to be explored in the developing world where we have the largest population of aging, perinatally infected patients,” said Dr. Ryscavage.
Presenters reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT IDWEEK 2017
Key clinical point:
Major finding: The prevalence of hypertension was 23% among perinatally infected patients, compared with 10% among nonperinatally infected patients and 9% among uninfected patients.
Data source: A cross-sectional study of 324 young adults between 18-29 years as of Sept. 1, 2014, from West Baltimore.
Disclosures: The presenters reported no relevant financial disclosures.
White House opioid panel calls for more addiction specialists
Increased addiction education, treatment certifications, and prescription drug monitoring program adherence were among the physician-focused recommendations in the final report of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, released Nov. 1.
The report recommends more than 50 action points for President Trump and Congress to employ to address opioid and substance misuse, which the president declared a public health emergency.
Strategies focusing specifically on health providers targeted insufficient training and education regarding responsible prescribing, addiction prevention, and substance use disorder treatment.
“Estimates suggest there are currently about 4,400 actively practicing certified addiction specialist physicians (addiction medicine and addiction psychiatry) in the country, but data on the specialty workforce is limited,” according to the report. “About 8 years ago, an estimate was made of the need for 6,000 addiction specialists, but that number is now insufficient given the growth of the opioid epidemic.“
The report recommended increasing the number of medical schools accredited to offer addiction medicine fellowships from 46 to 125 over the next 5 years and recommends using funds allocated to the Health Resources and Services Administration by the 21st Century Cures Act to do so starting in 2018.
Increased counseling on addiction risk when patients receive an opioid prescription also is crucial, according to the report, which cited a survey in which only 36% of patients reported they were properly informed before or while taking their medication.
The low number of physicians holding waivers to dispense buprenorphine (medication-assisted treatment) was another source of concern, especially among rural communities.
“None of the large central metro counties, and 72% of the rural counties, did not have a waived physician,” according to the committee report, which cited registration data from the Drug Enforcement Administration. “Findings from focus groups of counselors in rural areas noted a dearth of good facilities, poor access due to clients living far away from treatment centers, reliance on friends or family for transportation, and a need for basic medical and dental services.”
The committee has advised increased outreach to physicians regarding buprenorphine prescribing waivers, although it acknowledged that with the cap on patients per waived physician, increasing the number of waived physicians “is not necessarily indicative of sufficient access.”
The report also stressed a need for physicians to adhere more strictly to opioid prescribing guidelines from the Centers for Disease Control & Prevention and regular registration of opioid prescriptions in state-level prescription drug monitoring programs (PDMPs).
“Providers often resist using PDMPs because these systems are not well integrated into the electronic health record systems they currently use in practice,” the report noted. “Simplifying the method of access to PDMPs for providers by integrating PDMP data into health information exchanges [may increase] the likelihood that prescription history information will be used in clinical decision-making.”
Despite the recommendation, the committee recommended $12 million be spent on restructuring the program in the fiscal year 2018 federal budget, $1 million less than in 2017.
The committee also encouraged CMS to revise payment policies, including some bundled payments, that currently disincentivize the use of nonopioid treatment options as well as remove pain management measurements from patient surveys.
CMS announced in 2016 it would work to revise patient surveys starting in January 2017.
The American Medical Association, in a statement, expressed support of the committee’s recommendations.
“The AMA commends The President’s Commission on Combating Drug Addiction and the Opioid Crisis for delivering a comprehensive report that provides an excellent road map for increasing access to medication-assisted treatment for patients with substance-use disorders and also demonstrates the need to eliminate barriers to accessing the full spectrum of multidisciplinary pain treatment options,” said Patrice A. Harris, MD, chair of the AMA opioid task force. “The AMA is pleased that the commission agreed with many of the AMA’s previous suggestions, and we look forward to working with the Administration and Congress on next steps, including the needed financial resources.”
The President’s Commission on Combating Drug Addition and the Opioid Crisis is comprised of Gov. Chris Christie (R-N.J.), chairman; Gov. Charlie Baker (R-Mass.); Gov. Roy Cooper (D-N.C.); former Rep. Patrick Kennedy (D-RI.); Bertha K. Madras, PhD, Harvard Medical School, Boston; and Attorney General Pam Bondi (R-Fla.).*
*This article was updated Nov. 8, 2017.
Increased addiction education, treatment certifications, and prescription drug monitoring program adherence were among the physician-focused recommendations in the final report of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, released Nov. 1.
The report recommends more than 50 action points for President Trump and Congress to employ to address opioid and substance misuse, which the president declared a public health emergency.
Strategies focusing specifically on health providers targeted insufficient training and education regarding responsible prescribing, addiction prevention, and substance use disorder treatment.
“Estimates suggest there are currently about 4,400 actively practicing certified addiction specialist physicians (addiction medicine and addiction psychiatry) in the country, but data on the specialty workforce is limited,” according to the report. “About 8 years ago, an estimate was made of the need for 6,000 addiction specialists, but that number is now insufficient given the growth of the opioid epidemic.“
The report recommended increasing the number of medical schools accredited to offer addiction medicine fellowships from 46 to 125 over the next 5 years and recommends using funds allocated to the Health Resources and Services Administration by the 21st Century Cures Act to do so starting in 2018.
Increased counseling on addiction risk when patients receive an opioid prescription also is crucial, according to the report, which cited a survey in which only 36% of patients reported they were properly informed before or while taking their medication.
The low number of physicians holding waivers to dispense buprenorphine (medication-assisted treatment) was another source of concern, especially among rural communities.
“None of the large central metro counties, and 72% of the rural counties, did not have a waived physician,” according to the committee report, which cited registration data from the Drug Enforcement Administration. “Findings from focus groups of counselors in rural areas noted a dearth of good facilities, poor access due to clients living far away from treatment centers, reliance on friends or family for transportation, and a need for basic medical and dental services.”
The committee has advised increased outreach to physicians regarding buprenorphine prescribing waivers, although it acknowledged that with the cap on patients per waived physician, increasing the number of waived physicians “is not necessarily indicative of sufficient access.”
The report also stressed a need for physicians to adhere more strictly to opioid prescribing guidelines from the Centers for Disease Control & Prevention and regular registration of opioid prescriptions in state-level prescription drug monitoring programs (PDMPs).
“Providers often resist using PDMPs because these systems are not well integrated into the electronic health record systems they currently use in practice,” the report noted. “Simplifying the method of access to PDMPs for providers by integrating PDMP data into health information exchanges [may increase] the likelihood that prescription history information will be used in clinical decision-making.”
Despite the recommendation, the committee recommended $12 million be spent on restructuring the program in the fiscal year 2018 federal budget, $1 million less than in 2017.
The committee also encouraged CMS to revise payment policies, including some bundled payments, that currently disincentivize the use of nonopioid treatment options as well as remove pain management measurements from patient surveys.
CMS announced in 2016 it would work to revise patient surveys starting in January 2017.
The American Medical Association, in a statement, expressed support of the committee’s recommendations.
“The AMA commends The President’s Commission on Combating Drug Addiction and the Opioid Crisis for delivering a comprehensive report that provides an excellent road map for increasing access to medication-assisted treatment for patients with substance-use disorders and also demonstrates the need to eliminate barriers to accessing the full spectrum of multidisciplinary pain treatment options,” said Patrice A. Harris, MD, chair of the AMA opioid task force. “The AMA is pleased that the commission agreed with many of the AMA’s previous suggestions, and we look forward to working with the Administration and Congress on next steps, including the needed financial resources.”
The President’s Commission on Combating Drug Addition and the Opioid Crisis is comprised of Gov. Chris Christie (R-N.J.), chairman; Gov. Charlie Baker (R-Mass.); Gov. Roy Cooper (D-N.C.); former Rep. Patrick Kennedy (D-RI.); Bertha K. Madras, PhD, Harvard Medical School, Boston; and Attorney General Pam Bondi (R-Fla.).*
*This article was updated Nov. 8, 2017.
Increased addiction education, treatment certifications, and prescription drug monitoring program adherence were among the physician-focused recommendations in the final report of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, released Nov. 1.
The report recommends more than 50 action points for President Trump and Congress to employ to address opioid and substance misuse, which the president declared a public health emergency.
Strategies focusing specifically on health providers targeted insufficient training and education regarding responsible prescribing, addiction prevention, and substance use disorder treatment.
“Estimates suggest there are currently about 4,400 actively practicing certified addiction specialist physicians (addiction medicine and addiction psychiatry) in the country, but data on the specialty workforce is limited,” according to the report. “About 8 years ago, an estimate was made of the need for 6,000 addiction specialists, but that number is now insufficient given the growth of the opioid epidemic.“
The report recommended increasing the number of medical schools accredited to offer addiction medicine fellowships from 46 to 125 over the next 5 years and recommends using funds allocated to the Health Resources and Services Administration by the 21st Century Cures Act to do so starting in 2018.
Increased counseling on addiction risk when patients receive an opioid prescription also is crucial, according to the report, which cited a survey in which only 36% of patients reported they were properly informed before or while taking their medication.
The low number of physicians holding waivers to dispense buprenorphine (medication-assisted treatment) was another source of concern, especially among rural communities.
“None of the large central metro counties, and 72% of the rural counties, did not have a waived physician,” according to the committee report, which cited registration data from the Drug Enforcement Administration. “Findings from focus groups of counselors in rural areas noted a dearth of good facilities, poor access due to clients living far away from treatment centers, reliance on friends or family for transportation, and a need for basic medical and dental services.”
The committee has advised increased outreach to physicians regarding buprenorphine prescribing waivers, although it acknowledged that with the cap on patients per waived physician, increasing the number of waived physicians “is not necessarily indicative of sufficient access.”
The report also stressed a need for physicians to adhere more strictly to opioid prescribing guidelines from the Centers for Disease Control & Prevention and regular registration of opioid prescriptions in state-level prescription drug monitoring programs (PDMPs).
“Providers often resist using PDMPs because these systems are not well integrated into the electronic health record systems they currently use in practice,” the report noted. “Simplifying the method of access to PDMPs for providers by integrating PDMP data into health information exchanges [may increase] the likelihood that prescription history information will be used in clinical decision-making.”
Despite the recommendation, the committee recommended $12 million be spent on restructuring the program in the fiscal year 2018 federal budget, $1 million less than in 2017.
The committee also encouraged CMS to revise payment policies, including some bundled payments, that currently disincentivize the use of nonopioid treatment options as well as remove pain management measurements from patient surveys.
CMS announced in 2016 it would work to revise patient surveys starting in January 2017.
The American Medical Association, in a statement, expressed support of the committee’s recommendations.
“The AMA commends The President’s Commission on Combating Drug Addiction and the Opioid Crisis for delivering a comprehensive report that provides an excellent road map for increasing access to medication-assisted treatment for patients with substance-use disorders and also demonstrates the need to eliminate barriers to accessing the full spectrum of multidisciplinary pain treatment options,” said Patrice A. Harris, MD, chair of the AMA opioid task force. “The AMA is pleased that the commission agreed with many of the AMA’s previous suggestions, and we look forward to working with the Administration and Congress on next steps, including the needed financial resources.”
The President’s Commission on Combating Drug Addition and the Opioid Crisis is comprised of Gov. Chris Christie (R-N.J.), chairman; Gov. Charlie Baker (R-Mass.); Gov. Roy Cooper (D-N.C.); former Rep. Patrick Kennedy (D-RI.); Bertha K. Madras, PhD, Harvard Medical School, Boston; and Attorney General Pam Bondi (R-Fla.).*
*This article was updated Nov. 8, 2017.
VIDEO: Metabolic regulator FGF21 improves fibrosis in NASH patients
WASHINGTON – Fibroblast growth factor 21 (FGF21), a nonmitogenic hormone, improved fibrosis, liver injury, and steatosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the American Association for the Study of Liver Disease’s annual meeting.
There is no drug therapy currently available for NASH, the most advanced form of nonalcoholic fatty liver disease (NAFLD), creating a strong need for effective treatments, according to Arun Sanyal, MD, of the Virginia Commonwealth University, Richmond, said in a video interview.
This treatment “relative to placebo was associated with improvements in biomarkers of fibrosis, metabolic parameters, and markers of hepatic injury,” said Dr. Sanyal. “These results suggest BMS-986036 [FGF21] has beneficial effects on steatosis, liver injury, and fibrosis in NASH.”
Investigators conducted a phase 2 multicenter, double-blind, placebo-controlled study of 74 NASH patients to test BMS-986036, a pegylated version of FGF21.
Patients were an average of 51 years old, most were women (64%), who were predominantly white (96%), with a mean hepatic fat fraction of 19%.
Patients received either a 10-mg treatment daily, a 20-mg treatment weekly, or placebo, over the course of 16 weeks, with patients distributed equally among the three arms.
Overall hepatic fat fraction among the daily and weekly treatment groups reduced by 6.8% and 5.2%, respectively, compared with the placebo group, which reduced by 1.3% (P less than .001).
Patients in the treatment arms also saw improvement in average adiponectin levels, growing 15.3% in the daily arm and 15.7% in the weekly arm. Meanwhile, adiponectin levels dropped by an average of 3.5% in the placebo group.
In investigating serum Pro-C3 levels, which are associated with fibrosis, patients in the daily and weekly treatment group saw an average drop of 29% and 19%, respectively, as opposed to an increase of 2% in the placebo group (P less than .0001).
Patients in the treatment groups saw no serious adverse effects, and no patients died during the study.
Dr. Sanyal received funding for this study from Bristol-Myers Squibb and reported receiving financial compensation from Pfizer, Nimbus, Novartis, AstraZeneca, and other similar companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Fibroblast growth factor 21 (FGF21), a nonmitogenic hormone, improved fibrosis, liver injury, and steatosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the American Association for the Study of Liver Disease’s annual meeting.
There is no drug therapy currently available for NASH, the most advanced form of nonalcoholic fatty liver disease (NAFLD), creating a strong need for effective treatments, according to Arun Sanyal, MD, of the Virginia Commonwealth University, Richmond, said in a video interview.
This treatment “relative to placebo was associated with improvements in biomarkers of fibrosis, metabolic parameters, and markers of hepatic injury,” said Dr. Sanyal. “These results suggest BMS-986036 [FGF21] has beneficial effects on steatosis, liver injury, and fibrosis in NASH.”
Investigators conducted a phase 2 multicenter, double-blind, placebo-controlled study of 74 NASH patients to test BMS-986036, a pegylated version of FGF21.
Patients were an average of 51 years old, most were women (64%), who were predominantly white (96%), with a mean hepatic fat fraction of 19%.
Patients received either a 10-mg treatment daily, a 20-mg treatment weekly, or placebo, over the course of 16 weeks, with patients distributed equally among the three arms.
Overall hepatic fat fraction among the daily and weekly treatment groups reduced by 6.8% and 5.2%, respectively, compared with the placebo group, which reduced by 1.3% (P less than .001).
Patients in the treatment arms also saw improvement in average adiponectin levels, growing 15.3% in the daily arm and 15.7% in the weekly arm. Meanwhile, adiponectin levels dropped by an average of 3.5% in the placebo group.
In investigating serum Pro-C3 levels, which are associated with fibrosis, patients in the daily and weekly treatment group saw an average drop of 29% and 19%, respectively, as opposed to an increase of 2% in the placebo group (P less than .0001).
Patients in the treatment groups saw no serious adverse effects, and no patients died during the study.
Dr. Sanyal received funding for this study from Bristol-Myers Squibb and reported receiving financial compensation from Pfizer, Nimbus, Novartis, AstraZeneca, and other similar companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Fibroblast growth factor 21 (FGF21), a nonmitogenic hormone, improved fibrosis, liver injury, and steatosis in patients with nonalcoholic steatohepatitis (NASH), according to a study presented at the American Association for the Study of Liver Disease’s annual meeting.
There is no drug therapy currently available for NASH, the most advanced form of nonalcoholic fatty liver disease (NAFLD), creating a strong need for effective treatments, according to Arun Sanyal, MD, of the Virginia Commonwealth University, Richmond, said in a video interview.
This treatment “relative to placebo was associated with improvements in biomarkers of fibrosis, metabolic parameters, and markers of hepatic injury,” said Dr. Sanyal. “These results suggest BMS-986036 [FGF21] has beneficial effects on steatosis, liver injury, and fibrosis in NASH.”
Investigators conducted a phase 2 multicenter, double-blind, placebo-controlled study of 74 NASH patients to test BMS-986036, a pegylated version of FGF21.
Patients were an average of 51 years old, most were women (64%), who were predominantly white (96%), with a mean hepatic fat fraction of 19%.
Patients received either a 10-mg treatment daily, a 20-mg treatment weekly, or placebo, over the course of 16 weeks, with patients distributed equally among the three arms.
Overall hepatic fat fraction among the daily and weekly treatment groups reduced by 6.8% and 5.2%, respectively, compared with the placebo group, which reduced by 1.3% (P less than .001).
Patients in the treatment arms also saw improvement in average adiponectin levels, growing 15.3% in the daily arm and 15.7% in the weekly arm. Meanwhile, adiponectin levels dropped by an average of 3.5% in the placebo group.
In investigating serum Pro-C3 levels, which are associated with fibrosis, patients in the daily and weekly treatment group saw an average drop of 29% and 19%, respectively, as opposed to an increase of 2% in the placebo group (P less than .0001).
Patients in the treatment groups saw no serious adverse effects, and no patients died during the study.
Dr. Sanyal received funding for this study from Bristol-Myers Squibb and reported receiving financial compensation from Pfizer, Nimbus, Novartis, AstraZeneca, and other similar companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT THE LIVER MEETING 2017
Middle-aged hepatocellular carcinoma patients increasingly ineligible for transplant
WASHINGTON – Fewer than half of studied hepatocellular carcinoma patients born between 1945 and 1965 were eligible for transplant, despite a 58% increase in HCC rate during the past decade, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases 2017.
This disparity is a cause for concern given that this cohort constitutes nearly 75% of hepatitis C virus (HCV) infections in the United States.
“Understanding hepatocellular carcinoma trends among the 1945-1965 birth cohort is particularly important given the increasing number of chronic liver diseases in that group,” said presenter Ann Robinson, MD, of Highland Hospital, Oakland, Calif.
In a retrospective study, researchers evaluated 38,045 patients born between 1945 and 1965 and who were on the Surveillance, Epidemiology, and End Results (SEER) registry and diagnosed with HCC between 2004 and 2014.
Patients were predominantly male (81.6%), white (50%), insured by Medicare or private insurance (66.2%), and diagnosed with localized tumors (52%).
White and Hispanic patients displayed the largest increase in HCC diagnoses during the study period, growing by 67.6% and 66.1%, respectively, followed by Native American and African American patients, whose HCC diagnoses increased by 61% and 57.2%, respectively.
Overall, 57.2% of patients studied did not meet the Milan criteria, according to Dr. Robinson.
Disparities in patients’ meeting the Milan criteria were apparent once researchers adjusted for patients’ sex, race, insurance status, or cancer subtype.
The largest disparity was seen among patients who were uninsured or on Medicaid, who were half as likely to meet Milan criteria at time of diagnosis, compared with insured patients (odds ratio, less than 0.5; P less than .001).
African Americans also saw lower odds of eligibility for transplantation (OR, less than 0.75; P less than .001), compared with white patients.
While the difference between men and women was statistically significant (OR, 0.875; P = .022), the difference in odds was not as prominent as that of uninsured patients or African American patients was.
These disparities may have to do with a lack of patient knowledge or less frequent screening among these patients, as well as an overall rise in nonalcoholic fatty liver disease, according to Dr. Robinson and her fellow investigators.
“It’s been well documented in prior studies that there is an underutilization of screenings both for one-time hepatitis and baby boomer population, despite recommendations by the CDC [Centers for Disease Control and Prevention]” said Dr. Robinson. Other factors may include whether patients know they should be receive these screenings, whether providers have educated their patients about this, and how much the provider knows about the screening guidelines.
The number of patients who meet the Milan criteria are growing, however, according to investigators. In 2013-2014, 46.3% of baby boomers met the Milan criteria, compared with 36.4% in 2004-2006.
Identifying vulnerabilities within these cohorts and increasing education for both providers and patients will help narrow the gap even further, explained Dr. Robinson.
“Looking at etiology-specific differences to know which populations are not receiving screening, [focusing on] things that can help us communicate this with patients, as well as distribute this information among care providers, and breaking down barriers to treatment,” are all important factors, according to Dr. Robinson.
Investigators were limited by SEER’s exclusion of etiology of HCC and comorbidities. Additionally, the researchers were unaware whether patients were receiving surveillance that was within practice guidelines.
Presenters reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Fewer than half of studied hepatocellular carcinoma patients born between 1945 and 1965 were eligible for transplant, despite a 58% increase in HCC rate during the past decade, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases 2017.
This disparity is a cause for concern given that this cohort constitutes nearly 75% of hepatitis C virus (HCV) infections in the United States.
“Understanding hepatocellular carcinoma trends among the 1945-1965 birth cohort is particularly important given the increasing number of chronic liver diseases in that group,” said presenter Ann Robinson, MD, of Highland Hospital, Oakland, Calif.
In a retrospective study, researchers evaluated 38,045 patients born between 1945 and 1965 and who were on the Surveillance, Epidemiology, and End Results (SEER) registry and diagnosed with HCC between 2004 and 2014.
Patients were predominantly male (81.6%), white (50%), insured by Medicare or private insurance (66.2%), and diagnosed with localized tumors (52%).
White and Hispanic patients displayed the largest increase in HCC diagnoses during the study period, growing by 67.6% and 66.1%, respectively, followed by Native American and African American patients, whose HCC diagnoses increased by 61% and 57.2%, respectively.
Overall, 57.2% of patients studied did not meet the Milan criteria, according to Dr. Robinson.
Disparities in patients’ meeting the Milan criteria were apparent once researchers adjusted for patients’ sex, race, insurance status, or cancer subtype.
The largest disparity was seen among patients who were uninsured or on Medicaid, who were half as likely to meet Milan criteria at time of diagnosis, compared with insured patients (odds ratio, less than 0.5; P less than .001).
African Americans also saw lower odds of eligibility for transplantation (OR, less than 0.75; P less than .001), compared with white patients.
While the difference between men and women was statistically significant (OR, 0.875; P = .022), the difference in odds was not as prominent as that of uninsured patients or African American patients was.
These disparities may have to do with a lack of patient knowledge or less frequent screening among these patients, as well as an overall rise in nonalcoholic fatty liver disease, according to Dr. Robinson and her fellow investigators.
“It’s been well documented in prior studies that there is an underutilization of screenings both for one-time hepatitis and baby boomer population, despite recommendations by the CDC [Centers for Disease Control and Prevention]” said Dr. Robinson. Other factors may include whether patients know they should be receive these screenings, whether providers have educated their patients about this, and how much the provider knows about the screening guidelines.
The number of patients who meet the Milan criteria are growing, however, according to investigators. In 2013-2014, 46.3% of baby boomers met the Milan criteria, compared with 36.4% in 2004-2006.
Identifying vulnerabilities within these cohorts and increasing education for both providers and patients will help narrow the gap even further, explained Dr. Robinson.
“Looking at etiology-specific differences to know which populations are not receiving screening, [focusing on] things that can help us communicate this with patients, as well as distribute this information among care providers, and breaking down barriers to treatment,” are all important factors, according to Dr. Robinson.
Investigators were limited by SEER’s exclusion of etiology of HCC and comorbidities. Additionally, the researchers were unaware whether patients were receiving surveillance that was within practice guidelines.
Presenters reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Fewer than half of studied hepatocellular carcinoma patients born between 1945 and 1965 were eligible for transplant, despite a 58% increase in HCC rate during the past decade, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases 2017.
This disparity is a cause for concern given that this cohort constitutes nearly 75% of hepatitis C virus (HCV) infections in the United States.
“Understanding hepatocellular carcinoma trends among the 1945-1965 birth cohort is particularly important given the increasing number of chronic liver diseases in that group,” said presenter Ann Robinson, MD, of Highland Hospital, Oakland, Calif.
In a retrospective study, researchers evaluated 38,045 patients born between 1945 and 1965 and who were on the Surveillance, Epidemiology, and End Results (SEER) registry and diagnosed with HCC between 2004 and 2014.
Patients were predominantly male (81.6%), white (50%), insured by Medicare or private insurance (66.2%), and diagnosed with localized tumors (52%).
White and Hispanic patients displayed the largest increase in HCC diagnoses during the study period, growing by 67.6% and 66.1%, respectively, followed by Native American and African American patients, whose HCC diagnoses increased by 61% and 57.2%, respectively.
Overall, 57.2% of patients studied did not meet the Milan criteria, according to Dr. Robinson.
Disparities in patients’ meeting the Milan criteria were apparent once researchers adjusted for patients’ sex, race, insurance status, or cancer subtype.
The largest disparity was seen among patients who were uninsured or on Medicaid, who were half as likely to meet Milan criteria at time of diagnosis, compared with insured patients (odds ratio, less than 0.5; P less than .001).
African Americans also saw lower odds of eligibility for transplantation (OR, less than 0.75; P less than .001), compared with white patients.
While the difference between men and women was statistically significant (OR, 0.875; P = .022), the difference in odds was not as prominent as that of uninsured patients or African American patients was.
These disparities may have to do with a lack of patient knowledge or less frequent screening among these patients, as well as an overall rise in nonalcoholic fatty liver disease, according to Dr. Robinson and her fellow investigators.
“It’s been well documented in prior studies that there is an underutilization of screenings both for one-time hepatitis and baby boomer population, despite recommendations by the CDC [Centers for Disease Control and Prevention]” said Dr. Robinson. Other factors may include whether patients know they should be receive these screenings, whether providers have educated their patients about this, and how much the provider knows about the screening guidelines.
The number of patients who meet the Milan criteria are growing, however, according to investigators. In 2013-2014, 46.3% of baby boomers met the Milan criteria, compared with 36.4% in 2004-2006.
Identifying vulnerabilities within these cohorts and increasing education for both providers and patients will help narrow the gap even further, explained Dr. Robinson.
“Looking at etiology-specific differences to know which populations are not receiving screening, [focusing on] things that can help us communicate this with patients, as well as distribute this information among care providers, and breaking down barriers to treatment,” are all important factors, according to Dr. Robinson.
Investigators were limited by SEER’s exclusion of etiology of HCC and comorbidities. Additionally, the researchers were unaware whether patients were receiving surveillance that was within practice guidelines.
Presenters reported no relevant financial disclosures.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT THE LIVER MEETING 2017
Key clinical point:
Major finding: Of HCC patients born between 1945 and 1965, 57.2% did not meet the Milan criteria.
Data source: Retrospective study of 38,045 patients born between 1945 and 1965 who were diagnosed with HCC during 2004-2014 and who were added to the SEER registry.
Disclosures: Presenters reported no relevant financial disclosures.
VIDEO: Liver transplant center competition tied to delisting patients
WASHINGTON – Low market competition among liver transplant centers may affect which patients are considered too sick to transplant, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
With 20% of patients dying while on the transplant wait list, including those who were delisted, understanding the distribution of organs among donor service areas (DSAs) is crucial to lowering mortality during the current organ shortage, according to presenter Yanik Babekov, MD, of Massachusetts General Hospital, Boston.
Investigators studied 3,131 patients who were delisted after being classified as “too sick” from 116 centers in 51 DSAs, between 2002 and 2012.
Researchers used the Herfindahl-Hirschman Index (HHI), which analyzes the market share of each participant to determine the overall level of competition. Measurements on the HHI range between 0 and 1, with 0 being the most competitive and 1 being the least.
Mean delisting Model for End-Stage Liver Disease (MELD) scores considered to be “too sick to transplant” were 26.1, and average HHI among DSAs was 0.46, according to investigators. They found that, for every 1% increase in HHI, the delisting MELD score increased by 0.06, according to a risk-adjustment analysis.
“In other words, more competitive DSAs delist patients for [being] ‘too sick’ at lower MELD scores,” Dr. Babekov explained in a video interview. “Interestingly, race, education, citizenship, and other DSA factors also impacted delisting MELD for ‘too sick.’ ”
While market competition may not be the only factor to explain the phenomenon of patients delisted for being ‘too sick,’ it is important to identify how having more transplant centers in DSAs can help more patients be added to, and stay on, these wait lists, according to investigators.
Dr. Babekov had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Low market competition among liver transplant centers may affect which patients are considered too sick to transplant, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
With 20% of patients dying while on the transplant wait list, including those who were delisted, understanding the distribution of organs among donor service areas (DSAs) is crucial to lowering mortality during the current organ shortage, according to presenter Yanik Babekov, MD, of Massachusetts General Hospital, Boston.
Investigators studied 3,131 patients who were delisted after being classified as “too sick” from 116 centers in 51 DSAs, between 2002 and 2012.
Researchers used the Herfindahl-Hirschman Index (HHI), which analyzes the market share of each participant to determine the overall level of competition. Measurements on the HHI range between 0 and 1, with 0 being the most competitive and 1 being the least.
Mean delisting Model for End-Stage Liver Disease (MELD) scores considered to be “too sick to transplant” were 26.1, and average HHI among DSAs was 0.46, according to investigators. They found that, for every 1% increase in HHI, the delisting MELD score increased by 0.06, according to a risk-adjustment analysis.
“In other words, more competitive DSAs delist patients for [being] ‘too sick’ at lower MELD scores,” Dr. Babekov explained in a video interview. “Interestingly, race, education, citizenship, and other DSA factors also impacted delisting MELD for ‘too sick.’ ”
While market competition may not be the only factor to explain the phenomenon of patients delisted for being ‘too sick,’ it is important to identify how having more transplant centers in DSAs can help more patients be added to, and stay on, these wait lists, according to investigators.
Dr. Babekov had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
WASHINGTON – Low market competition among liver transplant centers may affect which patients are considered too sick to transplant, according to a study presented at the annual meeting of the American Association for the Study of Liver Diseases.
With 20% of patients dying while on the transplant wait list, including those who were delisted, understanding the distribution of organs among donor service areas (DSAs) is crucial to lowering mortality during the current organ shortage, according to presenter Yanik Babekov, MD, of Massachusetts General Hospital, Boston.
Investigators studied 3,131 patients who were delisted after being classified as “too sick” from 116 centers in 51 DSAs, between 2002 and 2012.
Researchers used the Herfindahl-Hirschman Index (HHI), which analyzes the market share of each participant to determine the overall level of competition. Measurements on the HHI range between 0 and 1, with 0 being the most competitive and 1 being the least.
Mean delisting Model for End-Stage Liver Disease (MELD) scores considered to be “too sick to transplant” were 26.1, and average HHI among DSAs was 0.46, according to investigators. They found that, for every 1% increase in HHI, the delisting MELD score increased by 0.06, according to a risk-adjustment analysis.
“In other words, more competitive DSAs delist patients for [being] ‘too sick’ at lower MELD scores,” Dr. Babekov explained in a video interview. “Interestingly, race, education, citizenship, and other DSA factors also impacted delisting MELD for ‘too sick.’ ”
While market competition may not be the only factor to explain the phenomenon of patients delisted for being ‘too sick,’ it is important to identify how having more transplant centers in DSAs can help more patients be added to, and stay on, these wait lists, according to investigators.
Dr. Babekov had no relevant financial disclosures.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
AT THE LIVER MEETING 2017
Emphasizing an entrepreneurial spirit: Raman Palabindala, MD
Venkatraraman “Raman” Palabindala, MD, FACP, SFHM, was destined to be a doctor since his first breath. Born in India, his father decided Dr. Palabindala would take the mantle as the doctor of the family, while his siblings took to other professions like engineering.
Eager to be in the thick of things, Dr. Palabindala has voraciously pursued leadership positions, leading to his current role as chief of the Division of Hospital Medicine at the University of Mississippi Medical Center, Jackson.
Dr. Palabindala is enthusiastic about his role as one of the eight new members of The Hospitalist editorial advisory board, and took time to tell us more about himself in a recent interview.
Q: How did you get into medicine?
A: It’s all because of my dad’s motivation. My father believed in education, so when I was born, he said, “He’s going to be a doctor,” and as I grew up, I just worked towards being a physician and nothing else. I didn’t even have an option of choosing anything else. My dad said that I would be a doctor, and I am a doctor. I feel like that was the best thing that happened to me, though; it worked out well.
Q: How and when did you decide to go into hospital medicine?
A: After I came to the U.S., I joined residency in internal medicine at GBMC – that’s Greater Baltimore Medical Center – it’s affiliated with Johns Hopkins. I always wanted to be an internist, but my experiences in the clinic world were not so great. But I really enjoyed inpatient medicine, so in my 3rd year, when I was doing my chief residency year, I did get opportunities to join a fellowship, but I decided just to be a hospitalist at that time.
Q: What do you find to be rewarding about hospital medicine?
Q: What is one of the biggest challenges in hospital medicine?
A: I think talking about the business aspect of medicine, because it is like a taboo. We don’t really want to talk about whether the patient is covered or not covered by insurance, how much we are billing, and why we must discuss business issues while we are trying to focus on patient care, but these things are going to indirectly affect patient care, too. If you didn’t note the patient status accurately, they are going to get an inappropriate bill.
Q: What’s the best advice you have received that you try to pass on to your students?
A: Do the rounds at the bedside. We have the tendency of doing everything outside and then going in the room and just telling the patient what we are going to do. Instead, I encourage everyone to be at the bedside. Even without students, I go and sit at the bedside and then review the data in terms the patient can understand, and then explain the care plan, so they actually feel like we are at the bedside for a longer time. We are with the patient for at least 10 to 15 minutes, but at the same time, we are getting things done. I encourage my students and residents to do this.
Q: What is the worst advice you’ve received?
A: I don’t know if this is the “worst” advice, but in my second year, I was trying to take some leadership positions and was told I should wait, that leadership skills come with experience. I do think that’s a bad piece of advice. It’s all about learning how hard you work and then how fast you learn, and then how fast you implement. People who work, learn, and implement quickly can make a difference.
Q: Outside of patient care, what other career interests do you have?
A: I’m interested in smart clinics, and I actually have a patent for smart clinic chains. I’m a big fan of primary care, because, like hospitalists revolutionized inpatient care, I think we can revolutionize the outpatient care experience as well. I don’t think we are being very efficient with outpatient care.
But if I was not practicing medicine, I probably would be a chef. I like to cook, and I would open up my own restaurant if I was not doing this.
Q: Where do you see yourself in 10 years?
A: I want to be a consultant, evaluating hospitalist programs and guiding programs to grow and be more efficient. That, I think, would be the primary job that I would like to be doing, along with giving lectures and teaching about patient safety and quality, and educating younger physicians about the business of medicine.
Q: What experience with SHM has made the most lasting impact on you?
A: I would say the best impression was from the Academic Hospitalist Academy meeting I attended in Denver. I think that was helpful, because it was like a boot camp where you have only a limited number of attendees with a dedicated mentor. That was amazing, and I learned a lot. It helped me in redesigning my approach to where I would like to be both short- and long-term. I implemented at least 50 percent of what I learned at that meeting.
Q: What’s the best book that you’ve read recently and why was it the best?
A: Being Mortal by Atul Gawande. It’s a really beautiful book.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
Venkatraraman “Raman” Palabindala, MD, FACP, SFHM, was destined to be a doctor since his first breath. Born in India, his father decided Dr. Palabindala would take the mantle as the doctor of the family, while his siblings took to other professions like engineering.
Eager to be in the thick of things, Dr. Palabindala has voraciously pursued leadership positions, leading to his current role as chief of the Division of Hospital Medicine at the University of Mississippi Medical Center, Jackson.
Dr. Palabindala is enthusiastic about his role as one of the eight new members of The Hospitalist editorial advisory board, and took time to tell us more about himself in a recent interview.
Q: How did you get into medicine?
A: It’s all because of my dad’s motivation. My father believed in education, so when I was born, he said, “He’s going to be a doctor,” and as I grew up, I just worked towards being a physician and nothing else. I didn’t even have an option of choosing anything else. My dad said that I would be a doctor, and I am a doctor. I feel like that was the best thing that happened to me, though; it worked out well.
Q: How and when did you decide to go into hospital medicine?
A: After I came to the U.S., I joined residency in internal medicine at GBMC – that’s Greater Baltimore Medical Center – it’s affiliated with Johns Hopkins. I always wanted to be an internist, but my experiences in the clinic world were not so great. But I really enjoyed inpatient medicine, so in my 3rd year, when I was doing my chief residency year, I did get opportunities to join a fellowship, but I decided just to be a hospitalist at that time.
Q: What do you find to be rewarding about hospital medicine?
Q: What is one of the biggest challenges in hospital medicine?
A: I think talking about the business aspect of medicine, because it is like a taboo. We don’t really want to talk about whether the patient is covered or not covered by insurance, how much we are billing, and why we must discuss business issues while we are trying to focus on patient care, but these things are going to indirectly affect patient care, too. If you didn’t note the patient status accurately, they are going to get an inappropriate bill.
Q: What’s the best advice you have received that you try to pass on to your students?
A: Do the rounds at the bedside. We have the tendency of doing everything outside and then going in the room and just telling the patient what we are going to do. Instead, I encourage everyone to be at the bedside. Even without students, I go and sit at the bedside and then review the data in terms the patient can understand, and then explain the care plan, so they actually feel like we are at the bedside for a longer time. We are with the patient for at least 10 to 15 minutes, but at the same time, we are getting things done. I encourage my students and residents to do this.
Q: What is the worst advice you’ve received?
A: I don’t know if this is the “worst” advice, but in my second year, I was trying to take some leadership positions and was told I should wait, that leadership skills come with experience. I do think that’s a bad piece of advice. It’s all about learning how hard you work and then how fast you learn, and then how fast you implement. People who work, learn, and implement quickly can make a difference.
Q: Outside of patient care, what other career interests do you have?
A: I’m interested in smart clinics, and I actually have a patent for smart clinic chains. I’m a big fan of primary care, because, like hospitalists revolutionized inpatient care, I think we can revolutionize the outpatient care experience as well. I don’t think we are being very efficient with outpatient care.
But if I was not practicing medicine, I probably would be a chef. I like to cook, and I would open up my own restaurant if I was not doing this.
Q: Where do you see yourself in 10 years?
A: I want to be a consultant, evaluating hospitalist programs and guiding programs to grow and be more efficient. That, I think, would be the primary job that I would like to be doing, along with giving lectures and teaching about patient safety and quality, and educating younger physicians about the business of medicine.
Q: What experience with SHM has made the most lasting impact on you?
A: I would say the best impression was from the Academic Hospitalist Academy meeting I attended in Denver. I think that was helpful, because it was like a boot camp where you have only a limited number of attendees with a dedicated mentor. That was amazing, and I learned a lot. It helped me in redesigning my approach to where I would like to be both short- and long-term. I implemented at least 50 percent of what I learned at that meeting.
Q: What’s the best book that you’ve read recently and why was it the best?
A: Being Mortal by Atul Gawande. It’s a really beautiful book.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets
Venkatraraman “Raman” Palabindala, MD, FACP, SFHM, was destined to be a doctor since his first breath. Born in India, his father decided Dr. Palabindala would take the mantle as the doctor of the family, while his siblings took to other professions like engineering.
Eager to be in the thick of things, Dr. Palabindala has voraciously pursued leadership positions, leading to his current role as chief of the Division of Hospital Medicine at the University of Mississippi Medical Center, Jackson.
Dr. Palabindala is enthusiastic about his role as one of the eight new members of The Hospitalist editorial advisory board, and took time to tell us more about himself in a recent interview.
Q: How did you get into medicine?
A: It’s all because of my dad’s motivation. My father believed in education, so when I was born, he said, “He’s going to be a doctor,” and as I grew up, I just worked towards being a physician and nothing else. I didn’t even have an option of choosing anything else. My dad said that I would be a doctor, and I am a doctor. I feel like that was the best thing that happened to me, though; it worked out well.
Q: How and when did you decide to go into hospital medicine?
A: After I came to the U.S., I joined residency in internal medicine at GBMC – that’s Greater Baltimore Medical Center – it’s affiliated with Johns Hopkins. I always wanted to be an internist, but my experiences in the clinic world were not so great. But I really enjoyed inpatient medicine, so in my 3rd year, when I was doing my chief residency year, I did get opportunities to join a fellowship, but I decided just to be a hospitalist at that time.
Q: What do you find to be rewarding about hospital medicine?
Q: What is one of the biggest challenges in hospital medicine?
A: I think talking about the business aspect of medicine, because it is like a taboo. We don’t really want to talk about whether the patient is covered or not covered by insurance, how much we are billing, and why we must discuss business issues while we are trying to focus on patient care, but these things are going to indirectly affect patient care, too. If you didn’t note the patient status accurately, they are going to get an inappropriate bill.
Q: What’s the best advice you have received that you try to pass on to your students?
A: Do the rounds at the bedside. We have the tendency of doing everything outside and then going in the room and just telling the patient what we are going to do. Instead, I encourage everyone to be at the bedside. Even without students, I go and sit at the bedside and then review the data in terms the patient can understand, and then explain the care plan, so they actually feel like we are at the bedside for a longer time. We are with the patient for at least 10 to 15 minutes, but at the same time, we are getting things done. I encourage my students and residents to do this.
Q: What is the worst advice you’ve received?
A: I don’t know if this is the “worst” advice, but in my second year, I was trying to take some leadership positions and was told I should wait, that leadership skills come with experience. I do think that’s a bad piece of advice. It’s all about learning how hard you work and then how fast you learn, and then how fast you implement. People who work, learn, and implement quickly can make a difference.
Q: Outside of patient care, what other career interests do you have?
A: I’m interested in smart clinics, and I actually have a patent for smart clinic chains. I’m a big fan of primary care, because, like hospitalists revolutionized inpatient care, I think we can revolutionize the outpatient care experience as well. I don’t think we are being very efficient with outpatient care.
But if I was not practicing medicine, I probably would be a chef. I like to cook, and I would open up my own restaurant if I was not doing this.
Q: Where do you see yourself in 10 years?
A: I want to be a consultant, evaluating hospitalist programs and guiding programs to grow and be more efficient. That, I think, would be the primary job that I would like to be doing, along with giving lectures and teaching about patient safety and quality, and educating younger physicians about the business of medicine.
Q: What experience with SHM has made the most lasting impact on you?
A: I would say the best impression was from the Academic Hospitalist Academy meeting I attended in Denver. I think that was helpful, because it was like a boot camp where you have only a limited number of attendees with a dedicated mentor. That was amazing, and I learned a lot. It helped me in redesigning my approach to where I would like to be both short- and long-term. I implemented at least 50 percent of what I learned at that meeting.
Q: What’s the best book that you’ve read recently and why was it the best?
A: Being Mortal by Atul Gawande. It’s a really beautiful book.
ezimmerman@frontlinemedcom.com
On Twitter @eaztweets