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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Transplant waiting-list registrations dropped after direct acting–antiviral approval
SAN FRANCISCO – The number of new waiting-list registrations for liver transplantation among patients with hepatitis C virus declined significantly after the introduction of second-generation direct-acting antiviral agents, according to a review of United Network for Organ Sharing data.
New waiting-list registrations (NWRs) through March 31, 2015 – based on the most recent data available as of September 2015 – ranged from 740 to 976 per month between August 2012 and March 2015, and a review of the data show that HCV-specific NWRs declined by 23% overall in the 15 months after the Food and Drug Administration approved simeprevir (Nov. 22, 2013) and sofosbuvir (Dec. 6, 2013) vs. the 15 months prior (from 34.8% to 26.8%), Dr. Ryan B. Perumpail reported at the annual meeting of the American Association for the Study of Liver Diseases.
Further, the proportion of HCV patients without hepatocellular carcinoma among new waiting-list registrations declined by 33% (from 23.0% to 15.4%) and there was a significant decline in NWRs for liver transplants in nonhepatocellular-carcinoma HCV patients from January 2014 to March 2015 (153 per month) vs. August 2012 to October 2013 (mean 188 per month), for a mean difference of 35.0, said Dr. Perumpail of Stanford University Medical Center, Palo Alto, Calif.
Among the HCV-related NWRs for liver transplantation, the proportion without hepatocellular carcinoma declined 12.5% (from 66.3% to 58.0%).
Direct-acting antiviral therapy has been prioritized in patients with HCV-related cirrhosis in an effort to slow clinical disease progress and to induce regression of hepatic histologic damage, Dr. Perumpail explained.
Thought limited by the retrospective design of the study, the findings suggest that the use of direct-acting antivirals contributed to a downward trend in NWRs for liver transplantation among HCV patients without hepatocellular carcinoma.
Dr. Perumpail reported having no disclosures.
SAN FRANCISCO – The number of new waiting-list registrations for liver transplantation among patients with hepatitis C virus declined significantly after the introduction of second-generation direct-acting antiviral agents, according to a review of United Network for Organ Sharing data.
New waiting-list registrations (NWRs) through March 31, 2015 – based on the most recent data available as of September 2015 – ranged from 740 to 976 per month between August 2012 and March 2015, and a review of the data show that HCV-specific NWRs declined by 23% overall in the 15 months after the Food and Drug Administration approved simeprevir (Nov. 22, 2013) and sofosbuvir (Dec. 6, 2013) vs. the 15 months prior (from 34.8% to 26.8%), Dr. Ryan B. Perumpail reported at the annual meeting of the American Association for the Study of Liver Diseases.
Further, the proportion of HCV patients without hepatocellular carcinoma among new waiting-list registrations declined by 33% (from 23.0% to 15.4%) and there was a significant decline in NWRs for liver transplants in nonhepatocellular-carcinoma HCV patients from January 2014 to March 2015 (153 per month) vs. August 2012 to October 2013 (mean 188 per month), for a mean difference of 35.0, said Dr. Perumpail of Stanford University Medical Center, Palo Alto, Calif.
Among the HCV-related NWRs for liver transplantation, the proportion without hepatocellular carcinoma declined 12.5% (from 66.3% to 58.0%).
Direct-acting antiviral therapy has been prioritized in patients with HCV-related cirrhosis in an effort to slow clinical disease progress and to induce regression of hepatic histologic damage, Dr. Perumpail explained.
Thought limited by the retrospective design of the study, the findings suggest that the use of direct-acting antivirals contributed to a downward trend in NWRs for liver transplantation among HCV patients without hepatocellular carcinoma.
Dr. Perumpail reported having no disclosures.
SAN FRANCISCO – The number of new waiting-list registrations for liver transplantation among patients with hepatitis C virus declined significantly after the introduction of second-generation direct-acting antiviral agents, according to a review of United Network for Organ Sharing data.
New waiting-list registrations (NWRs) through March 31, 2015 – based on the most recent data available as of September 2015 – ranged from 740 to 976 per month between August 2012 and March 2015, and a review of the data show that HCV-specific NWRs declined by 23% overall in the 15 months after the Food and Drug Administration approved simeprevir (Nov. 22, 2013) and sofosbuvir (Dec. 6, 2013) vs. the 15 months prior (from 34.8% to 26.8%), Dr. Ryan B. Perumpail reported at the annual meeting of the American Association for the Study of Liver Diseases.
Further, the proportion of HCV patients without hepatocellular carcinoma among new waiting-list registrations declined by 33% (from 23.0% to 15.4%) and there was a significant decline in NWRs for liver transplants in nonhepatocellular-carcinoma HCV patients from January 2014 to March 2015 (153 per month) vs. August 2012 to October 2013 (mean 188 per month), for a mean difference of 35.0, said Dr. Perumpail of Stanford University Medical Center, Palo Alto, Calif.
Among the HCV-related NWRs for liver transplantation, the proportion without hepatocellular carcinoma declined 12.5% (from 66.3% to 58.0%).
Direct-acting antiviral therapy has been prioritized in patients with HCV-related cirrhosis in an effort to slow clinical disease progress and to induce regression of hepatic histologic damage, Dr. Perumpail explained.
Thought limited by the retrospective design of the study, the findings suggest that the use of direct-acting antivirals contributed to a downward trend in NWRs for liver transplantation among HCV patients without hepatocellular carcinoma.
Dr. Perumpail reported having no disclosures.
AT THE LIVER MEETING 2015
Key clinical point: New waiting-list registrations for liver transplantation in patients with hepatitis C virus declined significantly after introduction of second-generation direct-acting antiviral agents.
Major finding: HCV-specific waiting-list registrations declined by 23% in the 15 months after vs. before FDA approval of simeprevir and sofosbuvir (34.8% vs. 26.8%).
Data source: A review of United Network for Organ Sharing data.
Disclosures: Dr. Perumpail reported having no disclosures.
Interferon-free treatment combo looks promising for HCV GT2, GT3 infection
SAN FRANCISCO – The investigational combination of ombitasvir, paritaprevir, and ritonavir when given with sofosbuvir (OBV/PTV/r + SOF) for 12 weeks appears to be a highly effective treatment option for patients with hepatitis C virus genotype 3 infection, according to findings from the open-label, phase II QUARTZ-II/III study.
The treatment, when given with ribavirin for 8 weeks, also appears highly effective for genotype 2 infection, Dr. Stephen Shafran reported in a late-breaking poster at the annual meeting of the American Association for the Study of Liver Diseases.
In the multicenter study, 20 patients with HCV genotype 3 (GT3) infection, including 10 with prior treatment experience, were randomized to receive OBV/PTC/r + SOF either with or without ribavirin (11 and 9 patients, respectively), and with the exception of 1 patient who discontinued the study because of nonserious events, all had HCV RNA suppressed less than 25 IU/mL by treatment week 2 and through the end of treatment.
Sustained virologic response (SVR) at 12 weeks was achieved in 9 of 9 patients who had been treated with OBV/PTV/r + SOF for 12 weeks, and in 10 of 11 who were treated with OBV/PTV/r + SOF + ribavirin for 12 weeks, said Dr. Shafran, a professor at the University of Alberta, Canada.
Additionally, 10 patients with HCV GT2 infection in the study, including 2 with treatment experience, were treated with OBV/PTV/r + SOF + ribavirin for 8 weeks, and all were HCV RNA–suppressed at the end of treatment. SVR4 was 90%, Dr. Shafran said.
Treatment in both GT3 and GT2 patients was well tolerated, with only one patient experiencing a serious adverse event (pneumonia), which was not considered related to study drugs.
The findings are notable, as few interferon-free treatments are approved for HCV GT3 and GT2 infection, and those that are available are associated with SVR rates that are lower at 12 weeks among those with cirrhosis or prior treatment failure, he said.
The current findings, however, suggest that OBV/PTV/r + SOF is a promising interferon- and ribavirin-free treatment option for patients with GT3 infection, and a highly effective combination when administered with ribavirin in patients with GT2 infection, including among patients with cirrhosis or prior treatment failure, he concluded.
Dr. Shafran is an advisory committee or review panel member for Bristol-Myers Squibb, Gilead Sciences, and Merck, and has received grant or research support from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, and Merck.
SAN FRANCISCO – The investigational combination of ombitasvir, paritaprevir, and ritonavir when given with sofosbuvir (OBV/PTV/r + SOF) for 12 weeks appears to be a highly effective treatment option for patients with hepatitis C virus genotype 3 infection, according to findings from the open-label, phase II QUARTZ-II/III study.
The treatment, when given with ribavirin for 8 weeks, also appears highly effective for genotype 2 infection, Dr. Stephen Shafran reported in a late-breaking poster at the annual meeting of the American Association for the Study of Liver Diseases.
In the multicenter study, 20 patients with HCV genotype 3 (GT3) infection, including 10 with prior treatment experience, were randomized to receive OBV/PTC/r + SOF either with or without ribavirin (11 and 9 patients, respectively), and with the exception of 1 patient who discontinued the study because of nonserious events, all had HCV RNA suppressed less than 25 IU/mL by treatment week 2 and through the end of treatment.
Sustained virologic response (SVR) at 12 weeks was achieved in 9 of 9 patients who had been treated with OBV/PTV/r + SOF for 12 weeks, and in 10 of 11 who were treated with OBV/PTV/r + SOF + ribavirin for 12 weeks, said Dr. Shafran, a professor at the University of Alberta, Canada.
Additionally, 10 patients with HCV GT2 infection in the study, including 2 with treatment experience, were treated with OBV/PTV/r + SOF + ribavirin for 8 weeks, and all were HCV RNA–suppressed at the end of treatment. SVR4 was 90%, Dr. Shafran said.
Treatment in both GT3 and GT2 patients was well tolerated, with only one patient experiencing a serious adverse event (pneumonia), which was not considered related to study drugs.
The findings are notable, as few interferon-free treatments are approved for HCV GT3 and GT2 infection, and those that are available are associated with SVR rates that are lower at 12 weeks among those with cirrhosis or prior treatment failure, he said.
The current findings, however, suggest that OBV/PTV/r + SOF is a promising interferon- and ribavirin-free treatment option for patients with GT3 infection, and a highly effective combination when administered with ribavirin in patients with GT2 infection, including among patients with cirrhosis or prior treatment failure, he concluded.
Dr. Shafran is an advisory committee or review panel member for Bristol-Myers Squibb, Gilead Sciences, and Merck, and has received grant or research support from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, and Merck.
SAN FRANCISCO – The investigational combination of ombitasvir, paritaprevir, and ritonavir when given with sofosbuvir (OBV/PTV/r + SOF) for 12 weeks appears to be a highly effective treatment option for patients with hepatitis C virus genotype 3 infection, according to findings from the open-label, phase II QUARTZ-II/III study.
The treatment, when given with ribavirin for 8 weeks, also appears highly effective for genotype 2 infection, Dr. Stephen Shafran reported in a late-breaking poster at the annual meeting of the American Association for the Study of Liver Diseases.
In the multicenter study, 20 patients with HCV genotype 3 (GT3) infection, including 10 with prior treatment experience, were randomized to receive OBV/PTC/r + SOF either with or without ribavirin (11 and 9 patients, respectively), and with the exception of 1 patient who discontinued the study because of nonserious events, all had HCV RNA suppressed less than 25 IU/mL by treatment week 2 and through the end of treatment.
Sustained virologic response (SVR) at 12 weeks was achieved in 9 of 9 patients who had been treated with OBV/PTV/r + SOF for 12 weeks, and in 10 of 11 who were treated with OBV/PTV/r + SOF + ribavirin for 12 weeks, said Dr. Shafran, a professor at the University of Alberta, Canada.
Additionally, 10 patients with HCV GT2 infection in the study, including 2 with treatment experience, were treated with OBV/PTV/r + SOF + ribavirin for 8 weeks, and all were HCV RNA–suppressed at the end of treatment. SVR4 was 90%, Dr. Shafran said.
Treatment in both GT3 and GT2 patients was well tolerated, with only one patient experiencing a serious adverse event (pneumonia), which was not considered related to study drugs.
The findings are notable, as few interferon-free treatments are approved for HCV GT3 and GT2 infection, and those that are available are associated with SVR rates that are lower at 12 weeks among those with cirrhosis or prior treatment failure, he said.
The current findings, however, suggest that OBV/PTV/r + SOF is a promising interferon- and ribavirin-free treatment option for patients with GT3 infection, and a highly effective combination when administered with ribavirin in patients with GT2 infection, including among patients with cirrhosis or prior treatment failure, he concluded.
Dr. Shafran is an advisory committee or review panel member for Bristol-Myers Squibb, Gilead Sciences, and Merck, and has received grant or research support from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, and Merck.
AT THE LIVER MEETING 2015
Key clinical point: The investigational combination of ombitasvir, paritaprevir, and ritonavir given with sofosbuvir (OBV/PTV/r + SOF) appears to be a highly effective treatment option for patients with hepatitis C virus genotype 2 or 3 infections.
Major finding: SVR12 was achieved in 9 of 9 HCV GT3 patients treated with OBV/PTV/r + SOF for 12 weeks; 10 of 11 HCV GT3 patients treated with OBV/PTV/r + SOF + ribavirin for 12 weeks; and 9 of 10 HCV GT2 patients treated with OBV/PTV/r + SOF + ribavirin for 8 weeks.
Data source: An open-label, multicenter phase II study of 30 patients.
Disclosures: Dr. Shafran is an advisory committee or review panel member for Bristol-Myers Squibb, Gilead Sciences, and Merck, and has received grant or research support from AbbVie, Bristol-Myers Squibb, Gilead Sciences, Janssen, and Merck.
Novel botanical drug reduces hepatic fat content
SAN FRANCISCO – Twelve weeks of treatment with a novel botanical drug extracted from Magnolia officinalis safely and significantly reduced hepatic fat content in a dose-dependent manner among patients in a randomized, placebo-controlled phase II trial.
In 73 subjects with nonalcoholic fatty liver disease (NAFLD) who were randomized to receive 300 mg daily of the botanical drug (tablet), 100 mg daily, or placebo; hepatic fat content after 12 weeks was reduced by 12.14% with 300 mg daily and by 3.21% with 100 mg daily; fat content increased by 7.56% with placebo, Dr. Yeon Kim reported at the annual meeting of the American Association for the Study of Liver Diseases.
Serum aspartate aminotransferase and alanine aminotransferase were also reduced in the active treatment groups, and other factors, including cholesterol, triglycerides, free fatty acids, homeostatic model assessment (HOMA) insulin resistance, and body mass index, remained unchanged in both the treatment and placebo groups.
No drug-related safety issues occurred during the study, said Dr. Kim of Huons Co. Ltd., Ansan, South Korea.
Magnolia officinalis is a traditional herbal medicine that has been used to treat various liver diseases. Given the demand for new drugs for the treatment of NAFLD, Dr. Kim and his colleagues aimed to evaluate the effect and safety of the botanical tablet for the treatment of NAFLD.
Subjects were diagnosed with NAFLD by ultrasonic examination, and treatment was given twice daily for 12 weeks. Pre- and posttreatment hepatic fat content was measured using magnetic resonance spectroscopy.
The findings show that even with short treatment duration, this novel botanical drug was associated with hepatic fat content reduction without any negative lipid profile, body mass index change, or adverse effects, Dr. Kim said, concluding that larger extended trials to assess its long-term efficacy are warranted.
Dr. Kim reported having no disclosures.
SAN FRANCISCO – Twelve weeks of treatment with a novel botanical drug extracted from Magnolia officinalis safely and significantly reduced hepatic fat content in a dose-dependent manner among patients in a randomized, placebo-controlled phase II trial.
In 73 subjects with nonalcoholic fatty liver disease (NAFLD) who were randomized to receive 300 mg daily of the botanical drug (tablet), 100 mg daily, or placebo; hepatic fat content after 12 weeks was reduced by 12.14% with 300 mg daily and by 3.21% with 100 mg daily; fat content increased by 7.56% with placebo, Dr. Yeon Kim reported at the annual meeting of the American Association for the Study of Liver Diseases.
Serum aspartate aminotransferase and alanine aminotransferase were also reduced in the active treatment groups, and other factors, including cholesterol, triglycerides, free fatty acids, homeostatic model assessment (HOMA) insulin resistance, and body mass index, remained unchanged in both the treatment and placebo groups.
No drug-related safety issues occurred during the study, said Dr. Kim of Huons Co. Ltd., Ansan, South Korea.
Magnolia officinalis is a traditional herbal medicine that has been used to treat various liver diseases. Given the demand for new drugs for the treatment of NAFLD, Dr. Kim and his colleagues aimed to evaluate the effect and safety of the botanical tablet for the treatment of NAFLD.
Subjects were diagnosed with NAFLD by ultrasonic examination, and treatment was given twice daily for 12 weeks. Pre- and posttreatment hepatic fat content was measured using magnetic resonance spectroscopy.
The findings show that even with short treatment duration, this novel botanical drug was associated with hepatic fat content reduction without any negative lipid profile, body mass index change, or adverse effects, Dr. Kim said, concluding that larger extended trials to assess its long-term efficacy are warranted.
Dr. Kim reported having no disclosures.
SAN FRANCISCO – Twelve weeks of treatment with a novel botanical drug extracted from Magnolia officinalis safely and significantly reduced hepatic fat content in a dose-dependent manner among patients in a randomized, placebo-controlled phase II trial.
In 73 subjects with nonalcoholic fatty liver disease (NAFLD) who were randomized to receive 300 mg daily of the botanical drug (tablet), 100 mg daily, or placebo; hepatic fat content after 12 weeks was reduced by 12.14% with 300 mg daily and by 3.21% with 100 mg daily; fat content increased by 7.56% with placebo, Dr. Yeon Kim reported at the annual meeting of the American Association for the Study of Liver Diseases.
Serum aspartate aminotransferase and alanine aminotransferase were also reduced in the active treatment groups, and other factors, including cholesterol, triglycerides, free fatty acids, homeostatic model assessment (HOMA) insulin resistance, and body mass index, remained unchanged in both the treatment and placebo groups.
No drug-related safety issues occurred during the study, said Dr. Kim of Huons Co. Ltd., Ansan, South Korea.
Magnolia officinalis is a traditional herbal medicine that has been used to treat various liver diseases. Given the demand for new drugs for the treatment of NAFLD, Dr. Kim and his colleagues aimed to evaluate the effect and safety of the botanical tablet for the treatment of NAFLD.
Subjects were diagnosed with NAFLD by ultrasonic examination, and treatment was given twice daily for 12 weeks. Pre- and posttreatment hepatic fat content was measured using magnetic resonance spectroscopy.
The findings show that even with short treatment duration, this novel botanical drug was associated with hepatic fat content reduction without any negative lipid profile, body mass index change, or adverse effects, Dr. Kim said, concluding that larger extended trials to assess its long-term efficacy are warranted.
Dr. Kim reported having no disclosures.
AT THE LIVER MEETING 2015
Key clinical point: Twelve weeks of treatment with a novel botanical drug extracted from Magnolia officinalis safely and significantly reduced hepatic fat content in a dose-dependent manner among patients in a randomized, placebo-controlled phase II trial.
Major finding: Hepatic fat content was reduced by 12.14% and 3.21% with 300 and 100 mg daily of the botanical, respectively, compared with an increase of 7.56% with placebo.
Data source: A randomized, placebo-controlled phase II study of 73 patients.
Disclosures: Dr. Kim reported having no disclosures.
Cysteamine bitartrate provides no histologic improvement in children with NAFLD
SAN FRANCISCO – One year of treatment with delayed-release cysteamine bitartrate was safe and associated with substantial and rapid improvements in liver enzymes in children with nonalcoholic fatty liver disease, but did not improve liver histology.
That finding emerged from the randomized, placebo-controlled phase IIb Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease trial (CyNCh).
The rate of histologic improvement in 88 children with nonalcoholic fatty liver disease (NAFLD) who received twice-daily oral delayed-release cysteamine bitartrate (CyB) in the trial was 28%, compared with 22% in 81 children who received placebo (relative improvement ratio, 1.3). An intent-to-treat analysis showed no significant difference between CyB and placebo with respect to initial vs. end-of-treatment improvement in steatosis (30% vs. 41%), ballooning (19% vs. 26%), lobular inflammation (36% vs. 21%), or fibrosis (28% vs. 28%), Dr. Jeffrey B. Schwimmer of the University of California, San Diego, said at the annual meeting of the American Association for the Study of Liver Diseases.
CyB was, however, associated with greater mean change in alanine aminotransferase (–53 vs. –8 U/L) and aspartate aminotransferase (–31 vs. –4 U/L), compared with placebo, he noted, adding that the reduction in aminotransferases with CyB occurred within 4 weeks and was sustained through 52 weeks of treatment.
No changes were seen in serum lipids, cholesterol, or insulin sensitivity, and there were no differences in adverse events with CyB vs. placebo.
NAFLD is the most common cause of chronic liver disease in children, yet there is no approved treatment for the disease in this population, Dr. Schwimmer said.
The current study was initiated based on preliminary evidence showing decreased alanine aminotransferase and aspartate aminotransferase, and increased adiponectin in children treated with cysteamine in a 6-month pilot study. Subjects were children aged 8-17 years from June 2012 to August 2015 with an NAFLD activity score (NAS) of 4 or less. They were randomized to receive twice daily oral CyB at a dose of 300 mg if weight was 65 kg or less, 375 mg if weight was greater than 65 kg to 80 kg, or 450 mg if weight was greater than 80 kg, or to receive matching placebo. All received standardized lifestyle advice.
Histologic improvement was defined as a decrease in NAS of at least 2 points without worsening of fibrosis.
The lessons learned in CyNCh should guide future clinical trials for pediatric NAFLD, Dr. Schwimmer concluded.
He reported having no disclosures.
SAN FRANCISCO – One year of treatment with delayed-release cysteamine bitartrate was safe and associated with substantial and rapid improvements in liver enzymes in children with nonalcoholic fatty liver disease, but did not improve liver histology.
That finding emerged from the randomized, placebo-controlled phase IIb Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease trial (CyNCh).
The rate of histologic improvement in 88 children with nonalcoholic fatty liver disease (NAFLD) who received twice-daily oral delayed-release cysteamine bitartrate (CyB) in the trial was 28%, compared with 22% in 81 children who received placebo (relative improvement ratio, 1.3). An intent-to-treat analysis showed no significant difference between CyB and placebo with respect to initial vs. end-of-treatment improvement in steatosis (30% vs. 41%), ballooning (19% vs. 26%), lobular inflammation (36% vs. 21%), or fibrosis (28% vs. 28%), Dr. Jeffrey B. Schwimmer of the University of California, San Diego, said at the annual meeting of the American Association for the Study of Liver Diseases.
CyB was, however, associated with greater mean change in alanine aminotransferase (–53 vs. –8 U/L) and aspartate aminotransferase (–31 vs. –4 U/L), compared with placebo, he noted, adding that the reduction in aminotransferases with CyB occurred within 4 weeks and was sustained through 52 weeks of treatment.
No changes were seen in serum lipids, cholesterol, or insulin sensitivity, and there were no differences in adverse events with CyB vs. placebo.
NAFLD is the most common cause of chronic liver disease in children, yet there is no approved treatment for the disease in this population, Dr. Schwimmer said.
The current study was initiated based on preliminary evidence showing decreased alanine aminotransferase and aspartate aminotransferase, and increased adiponectin in children treated with cysteamine in a 6-month pilot study. Subjects were children aged 8-17 years from June 2012 to August 2015 with an NAFLD activity score (NAS) of 4 or less. They were randomized to receive twice daily oral CyB at a dose of 300 mg if weight was 65 kg or less, 375 mg if weight was greater than 65 kg to 80 kg, or 450 mg if weight was greater than 80 kg, or to receive matching placebo. All received standardized lifestyle advice.
Histologic improvement was defined as a decrease in NAS of at least 2 points without worsening of fibrosis.
The lessons learned in CyNCh should guide future clinical trials for pediatric NAFLD, Dr. Schwimmer concluded.
He reported having no disclosures.
SAN FRANCISCO – One year of treatment with delayed-release cysteamine bitartrate was safe and associated with substantial and rapid improvements in liver enzymes in children with nonalcoholic fatty liver disease, but did not improve liver histology.
That finding emerged from the randomized, placebo-controlled phase IIb Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease trial (CyNCh).
The rate of histologic improvement in 88 children with nonalcoholic fatty liver disease (NAFLD) who received twice-daily oral delayed-release cysteamine bitartrate (CyB) in the trial was 28%, compared with 22% in 81 children who received placebo (relative improvement ratio, 1.3). An intent-to-treat analysis showed no significant difference between CyB and placebo with respect to initial vs. end-of-treatment improvement in steatosis (30% vs. 41%), ballooning (19% vs. 26%), lobular inflammation (36% vs. 21%), or fibrosis (28% vs. 28%), Dr. Jeffrey B. Schwimmer of the University of California, San Diego, said at the annual meeting of the American Association for the Study of Liver Diseases.
CyB was, however, associated with greater mean change in alanine aminotransferase (–53 vs. –8 U/L) and aspartate aminotransferase (–31 vs. –4 U/L), compared with placebo, he noted, adding that the reduction in aminotransferases with CyB occurred within 4 weeks and was sustained through 52 weeks of treatment.
No changes were seen in serum lipids, cholesterol, or insulin sensitivity, and there were no differences in adverse events with CyB vs. placebo.
NAFLD is the most common cause of chronic liver disease in children, yet there is no approved treatment for the disease in this population, Dr. Schwimmer said.
The current study was initiated based on preliminary evidence showing decreased alanine aminotransferase and aspartate aminotransferase, and increased adiponectin in children treated with cysteamine in a 6-month pilot study. Subjects were children aged 8-17 years from June 2012 to August 2015 with an NAFLD activity score (NAS) of 4 or less. They were randomized to receive twice daily oral CyB at a dose of 300 mg if weight was 65 kg or less, 375 mg if weight was greater than 65 kg to 80 kg, or 450 mg if weight was greater than 80 kg, or to receive matching placebo. All received standardized lifestyle advice.
Histologic improvement was defined as a decrease in NAS of at least 2 points without worsening of fibrosis.
The lessons learned in CyNCh should guide future clinical trials for pediatric NAFLD, Dr. Schwimmer concluded.
He reported having no disclosures.
AT THE LIVER MEETING 2015
Key clinical point: One year of treatment with delayed-release cysteamine bitartrate was safe and associated with substantial and rapid improvements in liver enzymes in children with nonalcoholic fatty liver disease, but did not improve liver histology.
Major finding: The rate of histologic improvement was 28% vs. 22% with CyB vs. placebo (relative improvement ratio, 1.3).
Data source: A randomized, placebo-controlled phase IIb study of 169 children.
Disclosures: Dr. Schwimmer reported having no disclosures.
ASTRAL-1: High SVR12 with sofosbuvir/velpatasvir combo for HCV
SAN FRANCISCO – Once-daily treatment with fixed-dose combination sofosbuvir/velpatasvir for 12 weeks was well tolerated and resulted in high sustained virologic response rates in hepatitis C–infected patients in the phase III ASTRAL-1 study.
Of 740 patients with genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection, with or without cirrhosis, who were enrolled at 81 sites in North America, Europe, or Hong Kong, 624 were randomized to receive active treatment with 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) daily for 12 weeks, and 116 received placebo.
Of the patients in the SOF/VEL group, 53% had genotype 1 disease, 17% had genotype 2, 19% had genotype 4, 6% had genotype 5, and 7% had genotype 6; all genotype 5 patients were in the treatment group, and genotype 3 patients are being evaluated in a separate study, Dr. Jordan J. Feld reported at the annual meeting of the American Association for the Study of Liver Diseases.
The overall sustained virologic response at 12 or more weeks after treatment (SVR12) among treated patients was 99%, thus the study met the prespecified primary efficacy endpoint of 85% SVR12, said Dr. Feld of Toronto Western Hospital Liver Centre, Ontario.
The SVR12 was 98.5% and 97.1% in patients with genotypes 1 and 5, respectively, and 100% in those with genotypes 2, 4, and 6, respectively. The percentage of patients with cirrhosis in those with genotypes 1, 2, 4, 5, and 6 was 22.3%, 9.6%, 23.3%, 14.3%, and 14.6%, respectively (19.4% overall).
Two patients, both with genotype 1 infection (0.6% of genotype 1 patients), experienced virologic relapse. One had genotype 1b infection and was a treatment-experienced patient with cirrhosis, and 1 was a genotype 1a treatment-naive patient without cirrhosis.
None of the other patients, including 48 with cirrhosis, experienced virologic failure, but 4 were considered to have not achieved SVR12 for nonvirologic reasons, including loss to follow-up.
Overall, the type, frequency, and severity of adverse events and laboratory abnormalities were similar in the treatment and placebo group patients, Dr. Feld said, noting that severe adverse events occurred in 15 (2.4%) of the treatment group patients, and in none of the placebo-treated patients, but none of the severe adverse events were considered to be related to the study drug combination.
SOF/VEL combination therapy is an all-oral single tablet regimen shown in phase II studies to result in high SVR12 in patients with genotype 1-6 HCV. Those findings were confirmed in this phase III, placebo-controlled, double-blind study involving both treatment-naive and treatment-experienced genotype 1, 2, 4, 5, and 6 HCV patients with and without cirrhosis.
The current findings demonstrate that the regimen is “simple, safe, and highly effective,” Dr. Feld concluded.
Gilead Sciences sponsored ASTRAL-1. Dr. Feld disclosed ties with Merck, Janssen, Gilead, AbbVie, Theravance, Bristol-Myers Squibb, and Boehringer Ingelheim.
SAN FRANCISCO – Once-daily treatment with fixed-dose combination sofosbuvir/velpatasvir for 12 weeks was well tolerated and resulted in high sustained virologic response rates in hepatitis C–infected patients in the phase III ASTRAL-1 study.
Of 740 patients with genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection, with or without cirrhosis, who were enrolled at 81 sites in North America, Europe, or Hong Kong, 624 were randomized to receive active treatment with 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) daily for 12 weeks, and 116 received placebo.
Of the patients in the SOF/VEL group, 53% had genotype 1 disease, 17% had genotype 2, 19% had genotype 4, 6% had genotype 5, and 7% had genotype 6; all genotype 5 patients were in the treatment group, and genotype 3 patients are being evaluated in a separate study, Dr. Jordan J. Feld reported at the annual meeting of the American Association for the Study of Liver Diseases.
The overall sustained virologic response at 12 or more weeks after treatment (SVR12) among treated patients was 99%, thus the study met the prespecified primary efficacy endpoint of 85% SVR12, said Dr. Feld of Toronto Western Hospital Liver Centre, Ontario.
The SVR12 was 98.5% and 97.1% in patients with genotypes 1 and 5, respectively, and 100% in those with genotypes 2, 4, and 6, respectively. The percentage of patients with cirrhosis in those with genotypes 1, 2, 4, 5, and 6 was 22.3%, 9.6%, 23.3%, 14.3%, and 14.6%, respectively (19.4% overall).
Two patients, both with genotype 1 infection (0.6% of genotype 1 patients), experienced virologic relapse. One had genotype 1b infection and was a treatment-experienced patient with cirrhosis, and 1 was a genotype 1a treatment-naive patient without cirrhosis.
None of the other patients, including 48 with cirrhosis, experienced virologic failure, but 4 were considered to have not achieved SVR12 for nonvirologic reasons, including loss to follow-up.
Overall, the type, frequency, and severity of adverse events and laboratory abnormalities were similar in the treatment and placebo group patients, Dr. Feld said, noting that severe adverse events occurred in 15 (2.4%) of the treatment group patients, and in none of the placebo-treated patients, but none of the severe adverse events were considered to be related to the study drug combination.
SOF/VEL combination therapy is an all-oral single tablet regimen shown in phase II studies to result in high SVR12 in patients with genotype 1-6 HCV. Those findings were confirmed in this phase III, placebo-controlled, double-blind study involving both treatment-naive and treatment-experienced genotype 1, 2, 4, 5, and 6 HCV patients with and without cirrhosis.
The current findings demonstrate that the regimen is “simple, safe, and highly effective,” Dr. Feld concluded.
Gilead Sciences sponsored ASTRAL-1. Dr. Feld disclosed ties with Merck, Janssen, Gilead, AbbVie, Theravance, Bristol-Myers Squibb, and Boehringer Ingelheim.
SAN FRANCISCO – Once-daily treatment with fixed-dose combination sofosbuvir/velpatasvir for 12 weeks was well tolerated and resulted in high sustained virologic response rates in hepatitis C–infected patients in the phase III ASTRAL-1 study.
Of 740 patients with genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection, with or without cirrhosis, who were enrolled at 81 sites in North America, Europe, or Hong Kong, 624 were randomized to receive active treatment with 400 mg of sofosbuvir (SOF) and 100 mg of velpatasvir (VEL) daily for 12 weeks, and 116 received placebo.
Of the patients in the SOF/VEL group, 53% had genotype 1 disease, 17% had genotype 2, 19% had genotype 4, 6% had genotype 5, and 7% had genotype 6; all genotype 5 patients were in the treatment group, and genotype 3 patients are being evaluated in a separate study, Dr. Jordan J. Feld reported at the annual meeting of the American Association for the Study of Liver Diseases.
The overall sustained virologic response at 12 or more weeks after treatment (SVR12) among treated patients was 99%, thus the study met the prespecified primary efficacy endpoint of 85% SVR12, said Dr. Feld of Toronto Western Hospital Liver Centre, Ontario.
The SVR12 was 98.5% and 97.1% in patients with genotypes 1 and 5, respectively, and 100% in those with genotypes 2, 4, and 6, respectively. The percentage of patients with cirrhosis in those with genotypes 1, 2, 4, 5, and 6 was 22.3%, 9.6%, 23.3%, 14.3%, and 14.6%, respectively (19.4% overall).
Two patients, both with genotype 1 infection (0.6% of genotype 1 patients), experienced virologic relapse. One had genotype 1b infection and was a treatment-experienced patient with cirrhosis, and 1 was a genotype 1a treatment-naive patient without cirrhosis.
None of the other patients, including 48 with cirrhosis, experienced virologic failure, but 4 were considered to have not achieved SVR12 for nonvirologic reasons, including loss to follow-up.
Overall, the type, frequency, and severity of adverse events and laboratory abnormalities were similar in the treatment and placebo group patients, Dr. Feld said, noting that severe adverse events occurred in 15 (2.4%) of the treatment group patients, and in none of the placebo-treated patients, but none of the severe adverse events were considered to be related to the study drug combination.
SOF/VEL combination therapy is an all-oral single tablet regimen shown in phase II studies to result in high SVR12 in patients with genotype 1-6 HCV. Those findings were confirmed in this phase III, placebo-controlled, double-blind study involving both treatment-naive and treatment-experienced genotype 1, 2, 4, 5, and 6 HCV patients with and without cirrhosis.
The current findings demonstrate that the regimen is “simple, safe, and highly effective,” Dr. Feld concluded.
Gilead Sciences sponsored ASTRAL-1. Dr. Feld disclosed ties with Merck, Janssen, Gilead, AbbVie, Theravance, Bristol-Myers Squibb, and Boehringer Ingelheim.
AT THE LIVER MEETING 2015
Key clinical point: Once-daily treatment with fixed-dose combination sofosbuvir/velpatasvir for 12 weeks was well tolerated and resulted in high sustained virologic response rates in hepatitis C–infected patients in the phase III ASTRAL-1 study.
Major finding: The overall SVR12 among treated patients was 99%.
Data source: The phase III ASTRAL-1 trial of 740 patients.
Disclosures: Gilead Sciences sponsored ASTRAL-1. Dr. Feld disclosed ties with Merck, Janssen, Gilead, AbbVie, Theravance, Bristol-Myers Squibb, and Boehringer Ingelheim.
VIDEO: Ledipasvir/sofosbuvir highly effective in treatment-naive HCV GT1
SAN FRANCISCO – Combination treatment with ledipasvir/sofosbuvir is highly effective for treatment-naive hepatitis C virus genotype 1 patients in routine medical practices, according to findings from a large observational cohort study.
Of 4,365 treatment-naive genotype 1 hepatitis C virus (GT1 HCV)–infected patients identified from the Veterans Affairs Clinical Case Registries who initiated 8 or 12 weeks of ledipasvir/sofosbuvir (LDV/SOF) with or without ribavirin, more than 90% had undetectable levels of HCV RNA at the end of treatment, Dr. Lisa I. Backus of the VA Palo Alto (Calif.) Health Care System reported at the annual meeting of the American Association for the Study of Liver Diseases.
Sustained virologic response rates were “amazingly high” in this large, real-world cohort, Dr. Backus said, explaining that, historically, the veteran population has had substantially lower response rates than those seen in clinical trials.
“To our surprise and great delight, the SVR rates we’re seeing … nearly match those seen in clinical trials,” she said.
In this interview at the meeting, she discusses her findings and some of the clinical implications, including the possibility that 8 weeks of treatment may be more cost-effective than 12 weeks in non-cirrhotic treatment-naive HCV GT1 patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Combination treatment with ledipasvir/sofosbuvir is highly effective for treatment-naive hepatitis C virus genotype 1 patients in routine medical practices, according to findings from a large observational cohort study.
Of 4,365 treatment-naive genotype 1 hepatitis C virus (GT1 HCV)–infected patients identified from the Veterans Affairs Clinical Case Registries who initiated 8 or 12 weeks of ledipasvir/sofosbuvir (LDV/SOF) with or without ribavirin, more than 90% had undetectable levels of HCV RNA at the end of treatment, Dr. Lisa I. Backus of the VA Palo Alto (Calif.) Health Care System reported at the annual meeting of the American Association for the Study of Liver Diseases.
Sustained virologic response rates were “amazingly high” in this large, real-world cohort, Dr. Backus said, explaining that, historically, the veteran population has had substantially lower response rates than those seen in clinical trials.
“To our surprise and great delight, the SVR rates we’re seeing … nearly match those seen in clinical trials,” she said.
In this interview at the meeting, she discusses her findings and some of the clinical implications, including the possibility that 8 weeks of treatment may be more cost-effective than 12 weeks in non-cirrhotic treatment-naive HCV GT1 patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
SAN FRANCISCO – Combination treatment with ledipasvir/sofosbuvir is highly effective for treatment-naive hepatitis C virus genotype 1 patients in routine medical practices, according to findings from a large observational cohort study.
Of 4,365 treatment-naive genotype 1 hepatitis C virus (GT1 HCV)–infected patients identified from the Veterans Affairs Clinical Case Registries who initiated 8 or 12 weeks of ledipasvir/sofosbuvir (LDV/SOF) with or without ribavirin, more than 90% had undetectable levels of HCV RNA at the end of treatment, Dr. Lisa I. Backus of the VA Palo Alto (Calif.) Health Care System reported at the annual meeting of the American Association for the Study of Liver Diseases.
Sustained virologic response rates were “amazingly high” in this large, real-world cohort, Dr. Backus said, explaining that, historically, the veteran population has had substantially lower response rates than those seen in clinical trials.
“To our surprise and great delight, the SVR rates we’re seeing … nearly match those seen in clinical trials,” she said.
In this interview at the meeting, she discusses her findings and some of the clinical implications, including the possibility that 8 weeks of treatment may be more cost-effective than 12 weeks in non-cirrhotic treatment-naive HCV GT1 patients.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
AT THE LIVER MEETING 2015
Iron deficiency may explain persistent hypothyroidism symptoms
LAKE BUENA VISTA, FLA. – Between 30% and 50% of hypothyroid patients with persistent symptoms despite adequate levothyroxine therapy may have covert iron deficiency, findings from a small study suggest.
The findings cast “a dark shadow of doubt on the validity of the studies on the effect of T3 therapy in these patients,” Dr. Esa Soppi reported in a poster at the International Thyroid Congress.
Study subjects were women with a history of overt hypothyroidism who had persistent symptoms after appropriate and ongoing treatment with L-T4. L-T4 dosing was adjusted as necessary to achieve a thyroid-stimulating hormone concentration of 1-2 mU/L, and diabetes, B12-vitamin deficiency, celiac disease, hypercalcemia, and vitamin D deficiency were ruled out as causes for the persistent symptoms.
Further, none of the patients had anemia, and red cell indices were within the reference range.
Five of the women had serum ferritin of less than 15 mcg/L, and two of those had serum iron, transferrin, or soluble transferrin receptor concentration or transferrin saturation out of range, suggesting iron deficiency. The remaining 20 women had a serum ferritin concentration between 15 mcg/L and 60 mcg/L, Dr. Soppi of Eira Hospital, Helsinki, noted at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association , European Thyroid Association, and Latin American Thyroid Society.
Four of the five women with serum ferritin less than 15 mcg/L, and 14 of the 20 with less than 15-60 mcg/L became symptom free when treated with oral iron substitution therapy for 6-12 months, Dr. Soppi said.
“All patients were advised to take their thyroxine dose at the fasting state in the morning and start breakfast 30 minutes later. The interval between the iron and thyroxine was at least 4 hours. The response was observed at a serum ferritin concentration approaching 70-100 mcg/L,” Dr. Soppi wrote, noting that in one patient – a 28-year-old woman with type 1 diabetes and hypothyroidism – all symptoms of fatigue, failure to thrive, and lethargy experienced before the start of the iron therapy disappeared after about 4 months of oral iron therapy at a dose of 100 mg twice daily.
However, another patient – an 18-year-old woman with hypothyroidism after total thyroidectomy performed because of a suspected thyroid malignancy – was found to have no malignancy; disabling tiredness, and failure to thrive emerged after the thyroidectomy and persisted despite iron therapy given at 100 mg twice daily.
“Iron deficiency is as common as hypothyroidism and its symptoms resemble those of hypothyroidism. However, the diagnosis of iron deficiency without anemia is extremely challenging since all indicators of iron status may be ‘normal.’ A clinical suspicion is key to diagnosis of covert iron deficiency,” Dr. Soppi wrote, noting that the serum ferritin concentration may be helpful, and restoration of ferritin above 100 mcg/L seems to ameliorate symptoms in about two-thirds of patients, and that it is not currently known why some iron-deficient patients fail to respond to restoration of their functional iron stores.
LAKE BUENA VISTA, FLA. – Between 30% and 50% of hypothyroid patients with persistent symptoms despite adequate levothyroxine therapy may have covert iron deficiency, findings from a small study suggest.
The findings cast “a dark shadow of doubt on the validity of the studies on the effect of T3 therapy in these patients,” Dr. Esa Soppi reported in a poster at the International Thyroid Congress.
Study subjects were women with a history of overt hypothyroidism who had persistent symptoms after appropriate and ongoing treatment with L-T4. L-T4 dosing was adjusted as necessary to achieve a thyroid-stimulating hormone concentration of 1-2 mU/L, and diabetes, B12-vitamin deficiency, celiac disease, hypercalcemia, and vitamin D deficiency were ruled out as causes for the persistent symptoms.
Further, none of the patients had anemia, and red cell indices were within the reference range.
Five of the women had serum ferritin of less than 15 mcg/L, and two of those had serum iron, transferrin, or soluble transferrin receptor concentration or transferrin saturation out of range, suggesting iron deficiency. The remaining 20 women had a serum ferritin concentration between 15 mcg/L and 60 mcg/L, Dr. Soppi of Eira Hospital, Helsinki, noted at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association , European Thyroid Association, and Latin American Thyroid Society.
Four of the five women with serum ferritin less than 15 mcg/L, and 14 of the 20 with less than 15-60 mcg/L became symptom free when treated with oral iron substitution therapy for 6-12 months, Dr. Soppi said.
“All patients were advised to take their thyroxine dose at the fasting state in the morning and start breakfast 30 minutes later. The interval between the iron and thyroxine was at least 4 hours. The response was observed at a serum ferritin concentration approaching 70-100 mcg/L,” Dr. Soppi wrote, noting that in one patient – a 28-year-old woman with type 1 diabetes and hypothyroidism – all symptoms of fatigue, failure to thrive, and lethargy experienced before the start of the iron therapy disappeared after about 4 months of oral iron therapy at a dose of 100 mg twice daily.
However, another patient – an 18-year-old woman with hypothyroidism after total thyroidectomy performed because of a suspected thyroid malignancy – was found to have no malignancy; disabling tiredness, and failure to thrive emerged after the thyroidectomy and persisted despite iron therapy given at 100 mg twice daily.
“Iron deficiency is as common as hypothyroidism and its symptoms resemble those of hypothyroidism. However, the diagnosis of iron deficiency without anemia is extremely challenging since all indicators of iron status may be ‘normal.’ A clinical suspicion is key to diagnosis of covert iron deficiency,” Dr. Soppi wrote, noting that the serum ferritin concentration may be helpful, and restoration of ferritin above 100 mcg/L seems to ameliorate symptoms in about two-thirds of patients, and that it is not currently known why some iron-deficient patients fail to respond to restoration of their functional iron stores.
LAKE BUENA VISTA, FLA. – Between 30% and 50% of hypothyroid patients with persistent symptoms despite adequate levothyroxine therapy may have covert iron deficiency, findings from a small study suggest.
The findings cast “a dark shadow of doubt on the validity of the studies on the effect of T3 therapy in these patients,” Dr. Esa Soppi reported in a poster at the International Thyroid Congress.
Study subjects were women with a history of overt hypothyroidism who had persistent symptoms after appropriate and ongoing treatment with L-T4. L-T4 dosing was adjusted as necessary to achieve a thyroid-stimulating hormone concentration of 1-2 mU/L, and diabetes, B12-vitamin deficiency, celiac disease, hypercalcemia, and vitamin D deficiency were ruled out as causes for the persistent symptoms.
Further, none of the patients had anemia, and red cell indices were within the reference range.
Five of the women had serum ferritin of less than 15 mcg/L, and two of those had serum iron, transferrin, or soluble transferrin receptor concentration or transferrin saturation out of range, suggesting iron deficiency. The remaining 20 women had a serum ferritin concentration between 15 mcg/L and 60 mcg/L, Dr. Soppi of Eira Hospital, Helsinki, noted at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association , European Thyroid Association, and Latin American Thyroid Society.
Four of the five women with serum ferritin less than 15 mcg/L, and 14 of the 20 with less than 15-60 mcg/L became symptom free when treated with oral iron substitution therapy for 6-12 months, Dr. Soppi said.
“All patients were advised to take their thyroxine dose at the fasting state in the morning and start breakfast 30 minutes later. The interval between the iron and thyroxine was at least 4 hours. The response was observed at a serum ferritin concentration approaching 70-100 mcg/L,” Dr. Soppi wrote, noting that in one patient – a 28-year-old woman with type 1 diabetes and hypothyroidism – all symptoms of fatigue, failure to thrive, and lethargy experienced before the start of the iron therapy disappeared after about 4 months of oral iron therapy at a dose of 100 mg twice daily.
However, another patient – an 18-year-old woman with hypothyroidism after total thyroidectomy performed because of a suspected thyroid malignancy – was found to have no malignancy; disabling tiredness, and failure to thrive emerged after the thyroidectomy and persisted despite iron therapy given at 100 mg twice daily.
“Iron deficiency is as common as hypothyroidism and its symptoms resemble those of hypothyroidism. However, the diagnosis of iron deficiency without anemia is extremely challenging since all indicators of iron status may be ‘normal.’ A clinical suspicion is key to diagnosis of covert iron deficiency,” Dr. Soppi wrote, noting that the serum ferritin concentration may be helpful, and restoration of ferritin above 100 mcg/L seems to ameliorate symptoms in about two-thirds of patients, and that it is not currently known why some iron-deficient patients fail to respond to restoration of their functional iron stores.
AT THE INTERNATIONAL THYROID CONGRESS
Key clinical point: Between 30% and 50% of hypothyroid patients with persistent symptoms despite adequate levothyroxine therapy may have covert iron deficiency, findings from a small study suggest.
Major finding: Four of five women with serum ferritin less than 15 mcg/L, and 14 of 20 with less than 15-60 mcg/L became symptom free when treated with oral iron substitution therapy for 6-12 months.
Data source: A prospective study of 25 women.
Disclosures: Dr. Soppi reported having no disclosures.
LT4 therapy for SCH may improve pregnancy outcomes
LAKE BUENA VISTA, FLA. – Levothyroxine therapy during pregnancy in women with subclinical hypothyroidism was associated with a decrease in low birth weight and low Apgar scores but not with a significant decrease in pregnancy loss in a large retrospective cohort study.
In 79 pregnant women with subclinical hypothyroidism (SCH) who received therapy with levothyroxine (LT4), and 285 with SCH who did not receive LT4 therapy, the frequency of low birth weight (less than 2,500 g) was 1.3% vs. 10%, respectively, and the frequency of Apgar scores of 7 or less at 5 minutes was 0% vs. 6.9%, Dr. S. Maraka reported at the International Thyroid Congress.
The rate of pregnancy loss was clinically, but not significantly, lower in the treated group (5.1% vs. 8.8%), and there was no difference between the groups with respect to 11 other maternal and neonatal outcomes, Dr. Maraka of the Mayo Clinic, Rochester, Minn., said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
Study subjects were women evaluated at the Mayo Clinic, Rochester, between January 2011 and December 2013, who had SCH during pregnancy. SCH was defined as thyroid stimulating hormone levels greater than 2.5 mIU/L during the first trimester, or greater than 3 mIU/L but no more than 10 mIU/L during the second and third trimesters. Those with a twin pregnancy or who used medications that might affect thyroid function were excluded.
The treated and untreated groups were similar with regard to age, history of pregnancy loss, and smoking status, but the treated group had higher body mass index and higher TSH levels, Dr. Maraka noted.
The findings that LT4 may improve pregnancy outcome in women with SCH are important because SCH has been associated with an increased risk of adverse pregnancy outcomes in some studies and it has been unclear whether LT4 therapy improves outcomes.
However, the association seen in the current study, which involves the largest cohort reporting pregnancy outcomes of women with SCH treated vs. untreated with LT4 therapy, requires confirmation in randomized trials before widespread use of LT4 therapy for SCH can be recommended, she concluded.
Dr. Maraka reported having no disclosures.
LAKE BUENA VISTA, FLA. – Levothyroxine therapy during pregnancy in women with subclinical hypothyroidism was associated with a decrease in low birth weight and low Apgar scores but not with a significant decrease in pregnancy loss in a large retrospective cohort study.
In 79 pregnant women with subclinical hypothyroidism (SCH) who received therapy with levothyroxine (LT4), and 285 with SCH who did not receive LT4 therapy, the frequency of low birth weight (less than 2,500 g) was 1.3% vs. 10%, respectively, and the frequency of Apgar scores of 7 or less at 5 minutes was 0% vs. 6.9%, Dr. S. Maraka reported at the International Thyroid Congress.
The rate of pregnancy loss was clinically, but not significantly, lower in the treated group (5.1% vs. 8.8%), and there was no difference between the groups with respect to 11 other maternal and neonatal outcomes, Dr. Maraka of the Mayo Clinic, Rochester, Minn., said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
Study subjects were women evaluated at the Mayo Clinic, Rochester, between January 2011 and December 2013, who had SCH during pregnancy. SCH was defined as thyroid stimulating hormone levels greater than 2.5 mIU/L during the first trimester, or greater than 3 mIU/L but no more than 10 mIU/L during the second and third trimesters. Those with a twin pregnancy or who used medications that might affect thyroid function were excluded.
The treated and untreated groups were similar with regard to age, history of pregnancy loss, and smoking status, but the treated group had higher body mass index and higher TSH levels, Dr. Maraka noted.
The findings that LT4 may improve pregnancy outcome in women with SCH are important because SCH has been associated with an increased risk of adverse pregnancy outcomes in some studies and it has been unclear whether LT4 therapy improves outcomes.
However, the association seen in the current study, which involves the largest cohort reporting pregnancy outcomes of women with SCH treated vs. untreated with LT4 therapy, requires confirmation in randomized trials before widespread use of LT4 therapy for SCH can be recommended, she concluded.
Dr. Maraka reported having no disclosures.
LAKE BUENA VISTA, FLA. – Levothyroxine therapy during pregnancy in women with subclinical hypothyroidism was associated with a decrease in low birth weight and low Apgar scores but not with a significant decrease in pregnancy loss in a large retrospective cohort study.
In 79 pregnant women with subclinical hypothyroidism (SCH) who received therapy with levothyroxine (LT4), and 285 with SCH who did not receive LT4 therapy, the frequency of low birth weight (less than 2,500 g) was 1.3% vs. 10%, respectively, and the frequency of Apgar scores of 7 or less at 5 minutes was 0% vs. 6.9%, Dr. S. Maraka reported at the International Thyroid Congress.
The rate of pregnancy loss was clinically, but not significantly, lower in the treated group (5.1% vs. 8.8%), and there was no difference between the groups with respect to 11 other maternal and neonatal outcomes, Dr. Maraka of the Mayo Clinic, Rochester, Minn., said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
Study subjects were women evaluated at the Mayo Clinic, Rochester, between January 2011 and December 2013, who had SCH during pregnancy. SCH was defined as thyroid stimulating hormone levels greater than 2.5 mIU/L during the first trimester, or greater than 3 mIU/L but no more than 10 mIU/L during the second and third trimesters. Those with a twin pregnancy or who used medications that might affect thyroid function were excluded.
The treated and untreated groups were similar with regard to age, history of pregnancy loss, and smoking status, but the treated group had higher body mass index and higher TSH levels, Dr. Maraka noted.
The findings that LT4 may improve pregnancy outcome in women with SCH are important because SCH has been associated with an increased risk of adverse pregnancy outcomes in some studies and it has been unclear whether LT4 therapy improves outcomes.
However, the association seen in the current study, which involves the largest cohort reporting pregnancy outcomes of women with SCH treated vs. untreated with LT4 therapy, requires confirmation in randomized trials before widespread use of LT4 therapy for SCH can be recommended, she concluded.
Dr. Maraka reported having no disclosures.
AT ITC 2015
Key clinical point: LT4 therapy during pregnancy in women with subclinical hypothyroidism was associated with a decrease in low birth weight and low Apgar scores, but not with a decrease in pregnancy loss in a large retrospective cohort study.
Major finding: The frequency of low birth weight was 1.3% vs. 10%, and the frequency of Apgar scores of 7 or less at 5 minutes was 0% vs. 6.9% in the treated vs. untreated patients.
Data source: A retrospective cohort study of 364 women.
Disclosures: Dr. Maraka reported having no disclosures.
ITC 2015: Review IDs features to aid thyroid lymphoma diagnosis
LAKE BUENA VISTA, FLA. – Rapidly enlarging thyroid masses with compressive symptoms may signal thyroid lymphoma, according to findings from a review of cases at the Mayo Clinic.
Radiologically, these masses tend to present as large, unilateral, thyroid-centered masses that are hypoechoic on ultrasound and that expand into adjacent soft tissue, Dr. Anu Sharma reported at the International Thyroid Congress.
The findings are based on a review of 75 patients with biopsy-proven thyroid lymphoma – a relatively rare disease, accounting for between 1% and 5% of all thyroid malignancies, and less than 1% of all lymphomas – who presented to the Mayo Clinic between 2000 and 2014.
“Thyroid lymphoma can sometimes present very similar to anaplastic carcinoma, and we wanted to see if there are any unique identification factors that you can use to increase your suspicion of thyroid lymphoma,” Dr. Sharma of the Mayo Clinic, Rochester, Minn., said.
Indeed, rapid enlargement and compressive symptoms are also common presenting features of anaplastic carcinoma, she said.
Of the 75 cases included in the review – compromising all cases presenting during the study period – 70.7% involved primary thyroid lymphoma. A neck mass was present in 88% of cases, dysphagia in 45%, and hoarseness in 37%.
The typical presentation included a solid, hypoechoic mass with mildly increased vascularity, no internal calcifications, and edge characteristics that ranged from well-defined (80%) to ill-defined (20%). Median tumor volume was 64 cm3, Dr. Sharma said.
This differs from anaplastic carcinoma in that most patients with anaplastic carcinoma have ill-defined edges, she noted.
Another difference between thyroid lymphoma and anaplastic carcinoma as noted in this study involves necrosis; none of the patients in the current study had areas of necrosis, whereas 78% of anaplastic carcinoma patients in another study had areas of necrosis, she explained.
The patients in the current study had a median age of 67 years, although the ages varied widely. About half (50.7%) were men, and 54.7% had a history of Hashimoto’s thyroiditis. Fifty-seven of the patients had an ultrasound before treatment.
The first diagnostic procedure performed was fine needle aspiration (FNA) in 65 subjects, and the FNA biopsies were abnormal in 69% of those, with 42% suggesting a specific lymphoma subtype. The subtype diagnosis was accurate, based on final tissue analysis, in 89% of those.
“While this is quite impressive, all patients who had FNA ended up having further tissue biopsy for subtype confirmation and for treatment, and this is important, because the subtype of the lymphoma is important in determining the type of treatment uses as well as determining prognosis,” she said.
The diagnosis was confirmed by core biopsy in 46.7% of cases, by incisional biopsy in 9.3%, by partial or total thyroidectomy in 25.3%, and by lymph node biopsy in 13.3%; percentages total 94.6% due to downward rounding. Histologic subtypes included diffuse large B-cell lymphoma (DLBCL) in 73.3% of cases, follicular lymphoma in 5.3%, mucosa-associated lymphoid tissue (MALT) in 10.7%, MALT/DLBCL in 2.6%, T-cell lymphoma in 2.6%, and Hodgkin’s lymphoma in 1.3%; percentages total 95.8% rather than 100% due to downward rounding.
In addition to rapid enlargement of a neck mass with compressive symptoms, findings that should raise suspicion of thyroid lymphoma include a history of Hashimoto’s thyroiditis and the ultrasound findings characterized by this study, Dr. Sharma said.
“Once you have that increased suspicion, you should move toward going to core biopsy rather than FNA to save the patient from having two diagnostic steps rather than one,” she concluded.
Dr. Sharma reported having no disclosures.
LAKE BUENA VISTA, FLA. – Rapidly enlarging thyroid masses with compressive symptoms may signal thyroid lymphoma, according to findings from a review of cases at the Mayo Clinic.
Radiologically, these masses tend to present as large, unilateral, thyroid-centered masses that are hypoechoic on ultrasound and that expand into adjacent soft tissue, Dr. Anu Sharma reported at the International Thyroid Congress.
The findings are based on a review of 75 patients with biopsy-proven thyroid lymphoma – a relatively rare disease, accounting for between 1% and 5% of all thyroid malignancies, and less than 1% of all lymphomas – who presented to the Mayo Clinic between 2000 and 2014.
“Thyroid lymphoma can sometimes present very similar to anaplastic carcinoma, and we wanted to see if there are any unique identification factors that you can use to increase your suspicion of thyroid lymphoma,” Dr. Sharma of the Mayo Clinic, Rochester, Minn., said.
Indeed, rapid enlargement and compressive symptoms are also common presenting features of anaplastic carcinoma, she said.
Of the 75 cases included in the review – compromising all cases presenting during the study period – 70.7% involved primary thyroid lymphoma. A neck mass was present in 88% of cases, dysphagia in 45%, and hoarseness in 37%.
The typical presentation included a solid, hypoechoic mass with mildly increased vascularity, no internal calcifications, and edge characteristics that ranged from well-defined (80%) to ill-defined (20%). Median tumor volume was 64 cm3, Dr. Sharma said.
This differs from anaplastic carcinoma in that most patients with anaplastic carcinoma have ill-defined edges, she noted.
Another difference between thyroid lymphoma and anaplastic carcinoma as noted in this study involves necrosis; none of the patients in the current study had areas of necrosis, whereas 78% of anaplastic carcinoma patients in another study had areas of necrosis, she explained.
The patients in the current study had a median age of 67 years, although the ages varied widely. About half (50.7%) were men, and 54.7% had a history of Hashimoto’s thyroiditis. Fifty-seven of the patients had an ultrasound before treatment.
The first diagnostic procedure performed was fine needle aspiration (FNA) in 65 subjects, and the FNA biopsies were abnormal in 69% of those, with 42% suggesting a specific lymphoma subtype. The subtype diagnosis was accurate, based on final tissue analysis, in 89% of those.
“While this is quite impressive, all patients who had FNA ended up having further tissue biopsy for subtype confirmation and for treatment, and this is important, because the subtype of the lymphoma is important in determining the type of treatment uses as well as determining prognosis,” she said.
The diagnosis was confirmed by core biopsy in 46.7% of cases, by incisional biopsy in 9.3%, by partial or total thyroidectomy in 25.3%, and by lymph node biopsy in 13.3%; percentages total 94.6% due to downward rounding. Histologic subtypes included diffuse large B-cell lymphoma (DLBCL) in 73.3% of cases, follicular lymphoma in 5.3%, mucosa-associated lymphoid tissue (MALT) in 10.7%, MALT/DLBCL in 2.6%, T-cell lymphoma in 2.6%, and Hodgkin’s lymphoma in 1.3%; percentages total 95.8% rather than 100% due to downward rounding.
In addition to rapid enlargement of a neck mass with compressive symptoms, findings that should raise suspicion of thyroid lymphoma include a history of Hashimoto’s thyroiditis and the ultrasound findings characterized by this study, Dr. Sharma said.
“Once you have that increased suspicion, you should move toward going to core biopsy rather than FNA to save the patient from having two diagnostic steps rather than one,” she concluded.
Dr. Sharma reported having no disclosures.
LAKE BUENA VISTA, FLA. – Rapidly enlarging thyroid masses with compressive symptoms may signal thyroid lymphoma, according to findings from a review of cases at the Mayo Clinic.
Radiologically, these masses tend to present as large, unilateral, thyroid-centered masses that are hypoechoic on ultrasound and that expand into adjacent soft tissue, Dr. Anu Sharma reported at the International Thyroid Congress.
The findings are based on a review of 75 patients with biopsy-proven thyroid lymphoma – a relatively rare disease, accounting for between 1% and 5% of all thyroid malignancies, and less than 1% of all lymphomas – who presented to the Mayo Clinic between 2000 and 2014.
“Thyroid lymphoma can sometimes present very similar to anaplastic carcinoma, and we wanted to see if there are any unique identification factors that you can use to increase your suspicion of thyroid lymphoma,” Dr. Sharma of the Mayo Clinic, Rochester, Minn., said.
Indeed, rapid enlargement and compressive symptoms are also common presenting features of anaplastic carcinoma, she said.
Of the 75 cases included in the review – compromising all cases presenting during the study period – 70.7% involved primary thyroid lymphoma. A neck mass was present in 88% of cases, dysphagia in 45%, and hoarseness in 37%.
The typical presentation included a solid, hypoechoic mass with mildly increased vascularity, no internal calcifications, and edge characteristics that ranged from well-defined (80%) to ill-defined (20%). Median tumor volume was 64 cm3, Dr. Sharma said.
This differs from anaplastic carcinoma in that most patients with anaplastic carcinoma have ill-defined edges, she noted.
Another difference between thyroid lymphoma and anaplastic carcinoma as noted in this study involves necrosis; none of the patients in the current study had areas of necrosis, whereas 78% of anaplastic carcinoma patients in another study had areas of necrosis, she explained.
The patients in the current study had a median age of 67 years, although the ages varied widely. About half (50.7%) were men, and 54.7% had a history of Hashimoto’s thyroiditis. Fifty-seven of the patients had an ultrasound before treatment.
The first diagnostic procedure performed was fine needle aspiration (FNA) in 65 subjects, and the FNA biopsies were abnormal in 69% of those, with 42% suggesting a specific lymphoma subtype. The subtype diagnosis was accurate, based on final tissue analysis, in 89% of those.
“While this is quite impressive, all patients who had FNA ended up having further tissue biopsy for subtype confirmation and for treatment, and this is important, because the subtype of the lymphoma is important in determining the type of treatment uses as well as determining prognosis,” she said.
The diagnosis was confirmed by core biopsy in 46.7% of cases, by incisional biopsy in 9.3%, by partial or total thyroidectomy in 25.3%, and by lymph node biopsy in 13.3%; percentages total 94.6% due to downward rounding. Histologic subtypes included diffuse large B-cell lymphoma (DLBCL) in 73.3% of cases, follicular lymphoma in 5.3%, mucosa-associated lymphoid tissue (MALT) in 10.7%, MALT/DLBCL in 2.6%, T-cell lymphoma in 2.6%, and Hodgkin’s lymphoma in 1.3%; percentages total 95.8% rather than 100% due to downward rounding.
In addition to rapid enlargement of a neck mass with compressive symptoms, findings that should raise suspicion of thyroid lymphoma include a history of Hashimoto’s thyroiditis and the ultrasound findings characterized by this study, Dr. Sharma said.
“Once you have that increased suspicion, you should move toward going to core biopsy rather than FNA to save the patient from having two diagnostic steps rather than one,” she concluded.
Dr. Sharma reported having no disclosures.
AT ITC 2015
Key clinical point: Rapidly enlarging thyroid masses with compressive symptoms may signal thyroid lymphoma, according to findings from a review of cases at the Mayo Clinic.
Major finding: Typical presentation included a solid, hypoechoic mass with mildly increased vascularity, no internal calcifications, and edge characteristics that ranged from well-defined (80%) to ill-defined (20%).
Data source: A retrospective review of 75 cases.
Disclosures: Dr. Sharma reported having no disclosures.
Early A-bomb radiation not linked to thyroid function
LAKE BUENA VISTA, FLA. – No link was found between atomic bomb radiation exposure in childhood and autoimmune thyroid disease or thyroid dysfunction in a study of nearly 2,700 Hiroshima and Nagasaki atomic bomb survivors.
Exposure among the 2,668 survivors included in the survey occurred prior to age 10 years, with follow-up more than 60 years later. The prevalence of anti–thyroid peroxidase (anti-TPO) positivity and/or antithyroglobulin (anti-Tg) antibodies, hypothyroidism, and hyperthyroidism was 21.5%, 4.8%, and 1.2%, respectively, when measured between October 2007 and October 2011, Dr. Misa Imaizumi of the Radiation Effects Research Foundation, Nagasaki, Japan, reported at the International Thyroid Congress.
All patients with hyperthyroidism had Graves disease, and the prevalence of anti–thyroid antibody–positive and –negative hypothyroidism was 2.1% and 2.7%, respectively, she said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
An analysis showed no significant dose-response relationship between radiation exposure and any thyroid disease (P greater than .1). This remained true when additional analyses were performed using alternative definitions of hypothyroidism and hyperthyroidism, such as subclinical, antibody-positive, and antibody-negative disease, she noted.
Study subjects included 1,213 men and 1,455 women with known atomic bomb thyroid radiation doses during childhood (mean thyroid dose, 0.182 Gy; median dose, 0.018 Gy).
“As you know, the risk of thyroid cancer increases by radiation exposure, and an increased risk of thyroid cancer has been observed in atomic bomb survivors. It is also well-known that high-dose radiation exposure – several 10s of gray – induces hypothyroidism, but the influence of radiation exposure by low to moderate doses – less than 5 gray – on thyroid dysfunction has been debated, and [studies of] the effects of atomic bomb radiation have been inconclusive,” Dr. Imaizumi said.
Because the radiation sensitivity of the thyroid is believed to be higher in children than in adults, she and her colleagues at the Radiation Effects Research Foundation – a Japan/U.S. collaboration that studies the effects of atomic bomb radiation for peaceful purposes – investigated the effects of childhood exposure on later thyroid dysfunction. Evaluations were conducted between October 2007 and October 2011; patients had a mean age of 68 years at the time of evaluation.
Information about previous thyroid diseases was obtained by questionnaire and by measurement of T4, thyroid-stimulating hormone, anti-TPO antibody, and anti-Tg antibody levels.
“In conclusion, associations between radiation exposure and thyroid dysfunction and other thyroid disease were not found in atomic bomb survivors 60 years after exposure in childhood,” she said.
Dr. Imaizumi reported having no relevant financial disclosures.
LAKE BUENA VISTA, FLA. – No link was found between atomic bomb radiation exposure in childhood and autoimmune thyroid disease or thyroid dysfunction in a study of nearly 2,700 Hiroshima and Nagasaki atomic bomb survivors.
Exposure among the 2,668 survivors included in the survey occurred prior to age 10 years, with follow-up more than 60 years later. The prevalence of anti–thyroid peroxidase (anti-TPO) positivity and/or antithyroglobulin (anti-Tg) antibodies, hypothyroidism, and hyperthyroidism was 21.5%, 4.8%, and 1.2%, respectively, when measured between October 2007 and October 2011, Dr. Misa Imaizumi of the Radiation Effects Research Foundation, Nagasaki, Japan, reported at the International Thyroid Congress.
All patients with hyperthyroidism had Graves disease, and the prevalence of anti–thyroid antibody–positive and –negative hypothyroidism was 2.1% and 2.7%, respectively, she said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
An analysis showed no significant dose-response relationship between radiation exposure and any thyroid disease (P greater than .1). This remained true when additional analyses were performed using alternative definitions of hypothyroidism and hyperthyroidism, such as subclinical, antibody-positive, and antibody-negative disease, she noted.
Study subjects included 1,213 men and 1,455 women with known atomic bomb thyroid radiation doses during childhood (mean thyroid dose, 0.182 Gy; median dose, 0.018 Gy).
“As you know, the risk of thyroid cancer increases by radiation exposure, and an increased risk of thyroid cancer has been observed in atomic bomb survivors. It is also well-known that high-dose radiation exposure – several 10s of gray – induces hypothyroidism, but the influence of radiation exposure by low to moderate doses – less than 5 gray – on thyroid dysfunction has been debated, and [studies of] the effects of atomic bomb radiation have been inconclusive,” Dr. Imaizumi said.
Because the radiation sensitivity of the thyroid is believed to be higher in children than in adults, she and her colleagues at the Radiation Effects Research Foundation – a Japan/U.S. collaboration that studies the effects of atomic bomb radiation for peaceful purposes – investigated the effects of childhood exposure on later thyroid dysfunction. Evaluations were conducted between October 2007 and October 2011; patients had a mean age of 68 years at the time of evaluation.
Information about previous thyroid diseases was obtained by questionnaire and by measurement of T4, thyroid-stimulating hormone, anti-TPO antibody, and anti-Tg antibody levels.
“In conclusion, associations between radiation exposure and thyroid dysfunction and other thyroid disease were not found in atomic bomb survivors 60 years after exposure in childhood,” she said.
Dr. Imaizumi reported having no relevant financial disclosures.
LAKE BUENA VISTA, FLA. – No link was found between atomic bomb radiation exposure in childhood and autoimmune thyroid disease or thyroid dysfunction in a study of nearly 2,700 Hiroshima and Nagasaki atomic bomb survivors.
Exposure among the 2,668 survivors included in the survey occurred prior to age 10 years, with follow-up more than 60 years later. The prevalence of anti–thyroid peroxidase (anti-TPO) positivity and/or antithyroglobulin (anti-Tg) antibodies, hypothyroidism, and hyperthyroidism was 21.5%, 4.8%, and 1.2%, respectively, when measured between October 2007 and October 2011, Dr. Misa Imaizumi of the Radiation Effects Research Foundation, Nagasaki, Japan, reported at the International Thyroid Congress.
All patients with hyperthyroidism had Graves disease, and the prevalence of anti–thyroid antibody–positive and –negative hypothyroidism was 2.1% and 2.7%, respectively, she said at the meeting held by the American Thyroid Association, Asia-Oceania Thyroid Association, European Thyroid Association, and Latin American Thyroid Society.
An analysis showed no significant dose-response relationship between radiation exposure and any thyroid disease (P greater than .1). This remained true when additional analyses were performed using alternative definitions of hypothyroidism and hyperthyroidism, such as subclinical, antibody-positive, and antibody-negative disease, she noted.
Study subjects included 1,213 men and 1,455 women with known atomic bomb thyroid radiation doses during childhood (mean thyroid dose, 0.182 Gy; median dose, 0.018 Gy).
“As you know, the risk of thyroid cancer increases by radiation exposure, and an increased risk of thyroid cancer has been observed in atomic bomb survivors. It is also well-known that high-dose radiation exposure – several 10s of gray – induces hypothyroidism, but the influence of radiation exposure by low to moderate doses – less than 5 gray – on thyroid dysfunction has been debated, and [studies of] the effects of atomic bomb radiation have been inconclusive,” Dr. Imaizumi said.
Because the radiation sensitivity of the thyroid is believed to be higher in children than in adults, she and her colleagues at the Radiation Effects Research Foundation – a Japan/U.S. collaboration that studies the effects of atomic bomb radiation for peaceful purposes – investigated the effects of childhood exposure on later thyroid dysfunction. Evaluations were conducted between October 2007 and October 2011; patients had a mean age of 68 years at the time of evaluation.
Information about previous thyroid diseases was obtained by questionnaire and by measurement of T4, thyroid-stimulating hormone, anti-TPO antibody, and anti-Tg antibody levels.
“In conclusion, associations between radiation exposure and thyroid dysfunction and other thyroid disease were not found in atomic bomb survivors 60 years after exposure in childhood,” she said.
Dr. Imaizumi reported having no relevant financial disclosures.
AT THE INTERNATIONAL THYROID CONGRESS
Key clinical point: No link was found between atomic bomb radiation exposure in childhood and autoimmune thyroid disease or thyroid dysfunction in a study of nearly 2,700 Hiroshima and Nagasaki atomic bomb survivors.
Major finding: A dose-response analysis showed no significant dose-response relationship between radiation exposure and any thyroid disease (P greater than .1).
Data source: A survey and evaluation of 2,668 subjects.
Disclosures: Dr. Imaizumi reported having no relevant financial disclosures.