LIVER MEETING 2013

WASHINGTON – Treatment with the hepatitis C antiviral drug sofosbuvir plus ribavirin resulted in high response rates in a study of 182 treatment-naive patients co-infected with hepatitis C and HIV, who were being treated with a variety of antiretroviral regimens, Dr. Mark Sulkowski said at the annual meeting of the American Association for the Study of Liver Disease.

The sustained virologic response rates 12 weeks after treatment (SVR12), the primary endpoint, were similar to the SVR12 rates in studies of patients infected with hepatitis C virus (HCV) only, who were treated with an interferon-free regimen of sofosbuvir plus ribavirin for 12-24 weeks, said Dr. Sulkowski, medical director of the viral hepatitis center in the divisions of infectious diseases and gastroenterology/hepatology at Johns Hopkins University, Baltimore.

"More importantly, sofosbuvir-ribavirin was effectively coadministered with multiple antiretroviral regimens, and there was no evidence of an adverse effect on the HIV disease," he said. The antiretroviral therapy (ART) regimens included HIV-1 protease inhibitors, reverse transcriptase (non-nucleoside and nucleoside) inhibitors, and integrase inhibitors.

The population of patients coinfected with HIV and HCV "has a high medical need" for an effective, interferon-free oral regimen that can be safely administered with ART, and drug interaction studies have shown that sofosbuvir can be administered with many antiretroviral drugs, Dr. Sulkowski said.

Sofosbuvir is an orally administered HCV-specific nucleotide polymerase inhibitor, with potent antiviral activity against HCV genotypes 1 through 6; it is taken once a day at a dose of 400 mg. A Food and Drug Administration advisory panel recently recommended that it be approved for treatment-naive adults with genotype 1 and 4 infections (in combination with pegylated interferon and ribavirin) and for treatment of adults with genotype 2 and 3 infections (in combination with ribavirin); approval is expected in December.

The study evaluated treatment with sofosbuvir,with 1,000-1,200 mg ribavirin a day, in HIV-positive patients coinfected with HCV: 114 patients with HCV genotype 1 infections treated for 24 weeks and 68 patients with genotypes 2 or 3 treated for 12 weeks. The study had broad inclusion criteria, and included patients with cirrhosis, with no platelet level cut off, treated with a wide range of antiretroviral therapy regimens (85%-98% were on ART). Their mean age was 48-49 years, 81%-82% were male, and most were white.

The SVR12 rates were 76% among patients with HCV genotype 1, 88% among genotype 2 patients, and 67% among genotype 3 patients, which were similar to the rates observed for patients infected with hepatitis C only, Dr. Sulkowski said. The two patients with HCV viral breakthrough were documented to be noncompliant with treatment, and there was no evidence of sofosbuvir resistance in the cases of virologic failures. In other studies of patients with HCV infection only, who were treated with sofosbuvir plus ribavirin without interferon, SVR12 rates have ranged from 68% among genotype 1 patients treated for 24 weeks to 97% among genotype 2 patients and 56% among genotype 3 patients treated for 12 weeks, Dr. Sulkowski said.

Overall, treatment was well tolerated, with a low rate of discontinuations from adverse events. Fatigue, headache, and insomnia were the most common adverse effects, and were similar in frequency and severity to that observed in studies of patients with HCV infection only. The rate of serious adverse events was 7%. There was one death, a suicide, in a patient treated for 12 weeks, who had a history of mental illness. There was no evidence of sofosbuvir resistance in the virologic failures.

About 21% of the patients treated for 24 weeks developed anemia, a known adverse effect of ribavirin, and 25% of those patients required a reduction in ribavirin dose.

As for HIV safety, there was no evidence of HIV breakthrough, Dr. Sulkowski said. Two patients with transient HIV viral breakthrough were not adhering to ART. There was no drop in the CD4 T-cell percentage values; there was a drop in absolute CD4 T cells, which he said is consistent with a known ribavirin-mediated decrease in lymphocytes.

Dr. Sulkowski disclosed that the study was funded by Gilead Sciences, the manufacturer of sofosbuvir.

[email protected]

WASHINGTON – Treatment with the hepatitis C antiviral drug sofosbuvir plus ribavirin resulted in high response rates in a study of 182 treatment-naive patients co-infected with hepatitis C and HIV, who were being treated with a variety of antiretroviral regimens, Dr. Mark Sulkowski said at the annual meeting of the American Association for the Study of Liver Disease.

The sustained virologic response rates 12 weeks after treatment (SVR12), the primary endpoint, were similar to the SVR12 rates in studies of patients infected with hepatitis C virus (HCV) only, who were treated with an interferon-free regimen of sofosbuvir plus ribavirin for 12-24 weeks, said Dr. Sulkowski, medical director of the viral hepatitis center in the divisions of infectious diseases and gastroenterology/hepatology at Johns Hopkins University, Baltimore.

"More importantly, sofosbuvir-ribavirin was effectively coadministered with multiple antiretroviral regimens, and there was no evidence of an adverse effect on the HIV disease," he said. The antiretroviral therapy (ART) regimens included HIV-1 protease inhibitors, reverse transcriptase (non-nucleoside and nucleoside) inhibitors, and integrase inhibitors.

The population of patients coinfected with HIV and HCV "has a high medical need" for an effective, interferon-free oral regimen that can be safely administered with ART, and drug interaction studies have shown that sofosbuvir can be administered with many antiretroviral drugs, Dr. Sulkowski said.

Sofosbuvir is an orally administered HCV-specific nucleotide polymerase inhibitor, with potent antiviral activity against HCV genotypes 1 through 6; it is taken once a day at a dose of 400 mg. A Food and Drug Administration advisory panel recently recommended that it be approved for treatment-naive adults with genotype 1 and 4 infections (in combination with pegylated interferon and ribavirin) and for treatment of adults with genotype 2 and 3 infections (in combination with ribavirin); approval is expected in December.

The study evaluated treatment with sofosbuvir,with 1,000-1,200 mg ribavirin a day, in HIV-positive patients coinfected with HCV: 114 patients with HCV genotype 1 infections treated for 24 weeks and 68 patients with genotypes 2 or 3 treated for 12 weeks. The study had broad inclusion criteria, and included patients with cirrhosis, with no platelet level cut off, treated with a wide range of antiretroviral therapy regimens (85%-98% were on ART). Their mean age was 48-49 years, 81%-82% were male, and most were white.

The SVR12 rates were 76% among patients with HCV genotype 1, 88% among genotype 2 patients, and 67% among genotype 3 patients, which were similar to the rates observed for patients infected with hepatitis C only, Dr. Sulkowski said. The two patients with HCV viral breakthrough were documented to be noncompliant with treatment, and there was no evidence of sofosbuvir resistance in the cases of virologic failures. In other studies of patients with HCV infection only, who were treated with sofosbuvir plus ribavirin without interferon, SVR12 rates have ranged from 68% among genotype 1 patients treated for 24 weeks to 97% among genotype 2 patients and 56% among genotype 3 patients treated for 12 weeks, Dr. Sulkowski said.

Overall, treatment was well tolerated, with a low rate of discontinuations from adverse events. Fatigue, headache, and insomnia were the most common adverse effects, and were similar in frequency and severity to that observed in studies of patients with HCV infection only. The rate of serious adverse events was 7%. There was one death, a suicide, in a patient treated for 12 weeks, who had a history of mental illness. There was no evidence of sofosbuvir resistance in the virologic failures.

About 21% of the patients treated for 24 weeks developed anemia, a known adverse effect of ribavirin, and 25% of those patients required a reduction in ribavirin dose.

As for HIV safety, there was no evidence of HIV breakthrough, Dr. Sulkowski said. Two patients with transient HIV viral breakthrough were not adhering to ART. There was no drop in the CD4 T-cell percentage values; there was a drop in absolute CD4 T cells, which he said is consistent with a known ribavirin-mediated decrease in lymphocytes.

Dr. Sulkowski disclosed that the study was funded by Gilead Sciences, the manufacturer of sofosbuvir.

[email protected]

WASHINGTON – Treatment with the hepatitis C antiviral drug sofosbuvir plus ribavirin resulted in high response rates in a study of 182 treatment-naive patients co-infected with hepatitis C and HIV, who were being treated with a variety of antiretroviral regimens, Dr. Mark Sulkowski said at the annual meeting of the American Association for the Study of Liver Disease.

The sustained virologic response rates 12 weeks after treatment (SVR12), the primary endpoint, were similar to the SVR12 rates in studies of patients infected with hepatitis C virus (HCV) only, who were treated with an interferon-free regimen of sofosbuvir plus ribavirin for 12-24 weeks, said Dr. Sulkowski, medical director of the viral hepatitis center in the divisions of infectious diseases and gastroenterology/hepatology at Johns Hopkins University, Baltimore.

"More importantly, sofosbuvir-ribavirin was effectively coadministered with multiple antiretroviral regimens, and there was no evidence of an adverse effect on the HIV disease," he said. The antiretroviral therapy (ART) regimens included HIV-1 protease inhibitors, reverse transcriptase (non-nucleoside and nucleoside) inhibitors, and integrase inhibitors.

The population of patients coinfected with HIV and HCV "has a high medical need" for an effective, interferon-free oral regimen that can be safely administered with ART, and drug interaction studies have shown that sofosbuvir can be administered with many antiretroviral drugs, Dr. Sulkowski said.

Sofosbuvir is an orally administered HCV-specific nucleotide polymerase inhibitor, with potent antiviral activity against HCV genotypes 1 through 6; it is taken once a day at a dose of 400 mg. A Food and Drug Administration advisory panel recently recommended that it be approved for treatment-naive adults with genotype 1 and 4 infections (in combination with pegylated interferon and ribavirin) and for treatment of adults with genotype 2 and 3 infections (in combination with ribavirin); approval is expected in December.

The study evaluated treatment with sofosbuvir,with 1,000-1,200 mg ribavirin a day, in HIV-positive patients coinfected with HCV: 114 patients with HCV genotype 1 infections treated for 24 weeks and 68 patients with genotypes 2 or 3 treated for 12 weeks. The study had broad inclusion criteria, and included patients with cirrhosis, with no platelet level cut off, treated with a wide range of antiretroviral therapy regimens (85%-98% were on ART). Their mean age was 48-49 years, 81%-82% were male, and most were white.

The SVR12 rates were 76% among patients with HCV genotype 1, 88% among genotype 2 patients, and 67% among genotype 3 patients, which were similar to the rates observed for patients infected with hepatitis C only, Dr. Sulkowski said. The two patients with HCV viral breakthrough were documented to be noncompliant with treatment, and there was no evidence of sofosbuvir resistance in the cases of virologic failures. In other studies of patients with HCV infection only, who were treated with sofosbuvir plus ribavirin without interferon, SVR12 rates have ranged from 68% among genotype 1 patients treated for 24 weeks to 97% among genotype 2 patients and 56% among genotype 3 patients treated for 12 weeks, Dr. Sulkowski said.

Overall, treatment was well tolerated, with a low rate of discontinuations from adverse events. Fatigue, headache, and insomnia were the most common adverse effects, and were similar in frequency and severity to that observed in studies of patients with HCV infection only. The rate of serious adverse events was 7%. There was one death, a suicide, in a patient treated for 12 weeks, who had a history of mental illness. There was no evidence of sofosbuvir resistance in the virologic failures.

About 21% of the patients treated for 24 weeks developed anemia, a known adverse effect of ribavirin, and 25% of those patients required a reduction in ribavirin dose.

As for HIV safety, there was no evidence of HIV breakthrough, Dr. Sulkowski said. Two patients with transient HIV viral breakthrough were not adhering to ART. There was no drop in the CD4 T-cell percentage values; there was a drop in absolute CD4 T cells, which he said is consistent with a known ribavirin-mediated decrease in lymphocytes.

Dr. Sulkowski disclosed that the study was funded by Gilead Sciences, the manufacturer of sofosbuvir.

[email protected]

WASHINGTON – Hepatoxicity from herbal and dietary supplements is on the rise in the United States, with body-building supplements being implicated as the most common cause of liver injury, according to the results of a recent study.

Between September 2004 and March 2013, 845 cases of liver injury were thought to be "definitely, highly likely, or probably" from an herbal or dietary supplement, or from prescription drugs. Of these cases, 136 (16%) were attributed to a product in the herbal and dietary supplement category. Patients reported consuming a total of 262 different herbal and dietary supplements; 30% were body-building products. Cases of liver injury from all herbal and dietary supplements increased from 7% in 2004-2005 to 20% in 2010-2012, reported Dr. Victor J. Navarro at the annual meeting of the American Association for the Study of Liver Diseases.

The prospective study used data from the Drug-Induced Liver Injury Network (DILIN). The network was established in 2003 by the National Institute of Diabetes and Digestive and Kidney Diseases to collect and analyze cases of severe liver injury caused by prescription and over-the-counter drugs, as well as alternative medications, including herbal products and supplements.

Of the hepatotoxicity cases due to supplements, 7 were excluded because they involved both body-building and other herbal and dietary supplements. Of the remaining 129 cases, 44 were attributed to body-building supplements and 85 cases were attributed to other types of herbal and dietary supplements. These cases were compared with 709 cases of drug-induced liver injury, noted Dr. Navarro, chair of the division of hepatology, Einstein Healthcare Network, Philadelphia.

Clinical features and demographic characteristics differed between the groups. The 44 patients with injury induced by body-building supplements were younger (mean age 33 years, vs. 48-50 years in the other two groups), and all were men. In the other two groups, 35%-37% of cases occurred in men.

As for clinical presentation, "the body-building supplement injury cases stood apart," as there was a "distinct presentation of prolonged jaundice," Dr. Navarro noted. "These patients tended to have fewer comorbid conditions," were heavier, and were "uniformly symptomatic." They all had jaundice, and 84% had pruritus. Of patients in the other herbal and dietary supplement group, 78% presented with jaundice and 48% presented with pruritus, compared with and 68% and 53%, respectively, of those with drug-induced liver injury.

Body-building liver injury cases required hospitalization more often, but no patients in this group died or had a liver transplant. There were deaths from all causes in the two other groups, but the differences were not significant. However, 13% of the cases of liver injury from other supplements resulted in a liver transplant, compared with 3% among the drug-induced liver injury group, a significant difference.

The higher transplant rate indicates that the hepatoxicity induced by non-body-building supplements "may be more severe" than injury induced by prescription drugs, Dr. Navarro observed.

Other marked differences between the groups included a serum total bilirubin that was significantly higher and persisted significantly longer in patients with liver injury from body-building supplements.

Although the study results indicate that hepatotoxicity due to herbal and dietary supplements is increasing, this was not a population-based study, and so "additional efforts to characterize the true burden of disease in the U.S. population are needed," and are being addressed by DILIN, Dr. Navarro said.

The National Institutes of Health sponsored the study. Dr. Navarro had no relevant disclosures. Information about DILIN is available here.

[email protected]

WASHINGTON – Hepatoxicity from herbal and dietary supplements is on the rise in the United States, with body-building supplements being implicated as the most common cause of liver injury, according to the results of a recent study.

Between September 2004 and March 2013, 845 cases of liver injury were thought to be "definitely, highly likely, or probably" from an herbal or dietary supplement, or from prescription drugs. Of these cases, 136 (16%) were attributed to a product in the herbal and dietary supplement category. Patients reported consuming a total of 262 different herbal and dietary supplements; 30% were body-building products. Cases of liver injury from all herbal and dietary supplements increased from 7% in 2004-2005 to 20% in 2010-2012, reported Dr. Victor J. Navarro at the annual meeting of the American Association for the Study of Liver Diseases.

The prospective study used data from the Drug-Induced Liver Injury Network (DILIN). The network was established in 2003 by the National Institute of Diabetes and Digestive and Kidney Diseases to collect and analyze cases of severe liver injury caused by prescription and over-the-counter drugs, as well as alternative medications, including herbal products and supplements.

Of the hepatotoxicity cases due to supplements, 7 were excluded because they involved both body-building and other herbal and dietary supplements. Of the remaining 129 cases, 44 were attributed to body-building supplements and 85 cases were attributed to other types of herbal and dietary supplements. These cases were compared with 709 cases of drug-induced liver injury, noted Dr. Navarro, chair of the division of hepatology, Einstein Healthcare Network, Philadelphia.

Clinical features and demographic characteristics differed between the groups. The 44 patients with injury induced by body-building supplements were younger (mean age 33 years, vs. 48-50 years in the other two groups), and all were men. In the other two groups, 35%-37% of cases occurred in men.

As for clinical presentation, "the body-building supplement injury cases stood apart," as there was a "distinct presentation of prolonged jaundice," Dr. Navarro noted. "These patients tended to have fewer comorbid conditions," were heavier, and were "uniformly symptomatic." They all had jaundice, and 84% had pruritus. Of patients in the other herbal and dietary supplement group, 78% presented with jaundice and 48% presented with pruritus, compared with and 68% and 53%, respectively, of those with drug-induced liver injury.

Body-building liver injury cases required hospitalization more often, but no patients in this group died or had a liver transplant. There were deaths from all causes in the two other groups, but the differences were not significant. However, 13% of the cases of liver injury from other supplements resulted in a liver transplant, compared with 3% among the drug-induced liver injury group, a significant difference.

The higher transplant rate indicates that the hepatoxicity induced by non-body-building supplements "may be more severe" than injury induced by prescription drugs, Dr. Navarro observed.

Other marked differences between the groups included a serum total bilirubin that was significantly higher and persisted significantly longer in patients with liver injury from body-building supplements.

Although the study results indicate that hepatotoxicity due to herbal and dietary supplements is increasing, this was not a population-based study, and so "additional efforts to characterize the true burden of disease in the U.S. population are needed," and are being addressed by DILIN, Dr. Navarro said.

The National Institutes of Health sponsored the study. Dr. Navarro had no relevant disclosures. Information about DILIN is available here.

[email protected]

WASHINGTON – Hepatoxicity from herbal and dietary supplements is on the rise in the United States, with body-building supplements being implicated as the most common cause of liver injury, according to the results of a recent study.

Between September 2004 and March 2013, 845 cases of liver injury were thought to be "definitely, highly likely, or probably" from an herbal or dietary supplement, or from prescription drugs. Of these cases, 136 (16%) were attributed to a product in the herbal and dietary supplement category. Patients reported consuming a total of 262 different herbal and dietary supplements; 30% were body-building products. Cases of liver injury from all herbal and dietary supplements increased from 7% in 2004-2005 to 20% in 2010-2012, reported Dr. Victor J. Navarro at the annual meeting of the American Association for the Study of Liver Diseases.

The prospective study used data from the Drug-Induced Liver Injury Network (DILIN). The network was established in 2003 by the National Institute of Diabetes and Digestive and Kidney Diseases to collect and analyze cases of severe liver injury caused by prescription and over-the-counter drugs, as well as alternative medications, including herbal products and supplements.

Of the hepatotoxicity cases due to supplements, 7 were excluded because they involved both body-building and other herbal and dietary supplements. Of the remaining 129 cases, 44 were attributed to body-building supplements and 85 cases were attributed to other types of herbal and dietary supplements. These cases were compared with 709 cases of drug-induced liver injury, noted Dr. Navarro, chair of the division of hepatology, Einstein Healthcare Network, Philadelphia.

Clinical features and demographic characteristics differed between the groups. The 44 patients with injury induced by body-building supplements were younger (mean age 33 years, vs. 48-50 years in the other two groups), and all were men. In the other two groups, 35%-37% of cases occurred in men.

As for clinical presentation, "the body-building supplement injury cases stood apart," as there was a "distinct presentation of prolonged jaundice," Dr. Navarro noted. "These patients tended to have fewer comorbid conditions," were heavier, and were "uniformly symptomatic." They all had jaundice, and 84% had pruritus. Of patients in the other herbal and dietary supplement group, 78% presented with jaundice and 48% presented with pruritus, compared with and 68% and 53%, respectively, of those with drug-induced liver injury.

Body-building liver injury cases required hospitalization more often, but no patients in this group died or had a liver transplant. There were deaths from all causes in the two other groups, but the differences were not significant. However, 13% of the cases of liver injury from other supplements resulted in a liver transplant, compared with 3% among the drug-induced liver injury group, a significant difference.

The higher transplant rate indicates that the hepatoxicity induced by non-body-building supplements "may be more severe" than injury induced by prescription drugs, Dr. Navarro observed.

Other marked differences between the groups included a serum total bilirubin that was significantly higher and persisted significantly longer in patients with liver injury from body-building supplements.

Although the study results indicate that hepatotoxicity due to herbal and dietary supplements is increasing, this was not a population-based study, and so "additional efforts to characterize the true burden of disease in the U.S. population are needed," and are being addressed by DILIN, Dr. Navarro said.

The National Institutes of Health sponsored the study. Dr. Navarro had no relevant disclosures. Information about DILIN is available here.

[email protected]

WASHINGTON – A pilot study screening for hepatitis C in the emergency department found that at least 12% of baby boomers who were previously unaware of their HCV status were positive for the virus.

Infection was confirmed in almost 9% of HCV-positive patients, lead author Dr. James W. Galbraith reported at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Galbraith, an associate professor of emergency medicine at the University of Alabama, Birmingham, reported on initial results of a screening program funded by the Centers for Disease Control and Prevention that began in September. Results are currently tabulated through Oct. 17. During that time, there were 2,363 unique ED visits by patients born in the years 1945 to 1965. Seventy-three percent (1,721) agreed to answer two questions given by a triage nurse: Have you ever been tested for HCV, and if yes, are you aware of that result? Seventy-five percent, or 1,287 patients, did not know their status and were offered testing.

Alicia Ault/IMNG Medical Media

Of those, 90% (1,148) accepted the antibody test. Patients were excluded from testing if they were medically or surgically unstable, had known HCV infection, or if they chose to opt out.

Antibody tests were performed on 984 of those patients, with results returned to ED physicians within 30-60 minutes. Eighty-eight percent had negative results, but 12%, or 118 patients, were HCV positive.

Researchers attempt to verify positive test results with polymerase chain reaction testing, but it is not always easy to do so, said Dr. Galbraith. Patients must be kept for a new blood draw, and many have already left the ED. Testing is also expensive, he noted.

Overall, men were significantly more likely than were women to test positive (17% compared with 8%). There was no significant difference in HCV positivity rates between whites and African Americans (11% vs. 13%). Patients without insurance or those on Medicaid or other public insurance plans were significantly more likely to be positive, with 17% in each of those groups exhibiting reactivity on the antibody assay, compared with 5% of insured patients.

When patients are determined to be HCV positive, ED physicians counsel and direct them to resources in the community, including specialists. Dr. Galbraith said that the numbers of baby boomers being found to be HCV positive are likely to overwhelm the available specialists.

By September 2014, Dr. Galbraith said, his ED is likely to screen 8,000 baby boomers. If the prevalence rate remains stable, that would mean 864 who are HCV positive and more than 600 with confirmed infection, he said.

Still, it’s important to screen, said Dr. Galbraith, adding that given the study results, "the implication is that the ED may be an important venue for HCV screening."

Two federal entities have called for increased screening. In May, the CDC urged HCV testing for all Americans born between 1945 and 1965.

The U.S. Preventive Services Task Force followed in June, recommending routine HCV screening for high risk Americans, and one-time screening for adults born between 1945 and 1965.

The study was funded by the Centers for Disease Control and Prevention. Dr. Galbraith reported no disclosures.

[email protected]

On Twitter @aliciaault

WASHINGTON – A pilot study screening for hepatitis C in the emergency department found that at least 12% of baby boomers who were previously unaware of their HCV status were positive for the virus.

Infection was confirmed in almost 9% of HCV-positive patients, lead author Dr. James W. Galbraith reported at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Galbraith, an associate professor of emergency medicine at the University of Alabama, Birmingham, reported on initial results of a screening program funded by the Centers for Disease Control and Prevention that began in September. Results are currently tabulated through Oct. 17. During that time, there were 2,363 unique ED visits by patients born in the years 1945 to 1965. Seventy-three percent (1,721) agreed to answer two questions given by a triage nurse: Have you ever been tested for HCV, and if yes, are you aware of that result? Seventy-five percent, or 1,287 patients, did not know their status and were offered testing.

Alicia Ault/IMNG Medical Media

Of those, 90% (1,148) accepted the antibody test. Patients were excluded from testing if they were medically or surgically unstable, had known HCV infection, or if they chose to opt out.

Antibody tests were performed on 984 of those patients, with results returned to ED physicians within 30-60 minutes. Eighty-eight percent had negative results, but 12%, or 118 patients, were HCV positive.

Researchers attempt to verify positive test results with polymerase chain reaction testing, but it is not always easy to do so, said Dr. Galbraith. Patients must be kept for a new blood draw, and many have already left the ED. Testing is also expensive, he noted.

Overall, men were significantly more likely than were women to test positive (17% compared with 8%). There was no significant difference in HCV positivity rates between whites and African Americans (11% vs. 13%). Patients without insurance or those on Medicaid or other public insurance plans were significantly more likely to be positive, with 17% in each of those groups exhibiting reactivity on the antibody assay, compared with 5% of insured patients.

When patients are determined to be HCV positive, ED physicians counsel and direct them to resources in the community, including specialists. Dr. Galbraith said that the numbers of baby boomers being found to be HCV positive are likely to overwhelm the available specialists.

By September 2014, Dr. Galbraith said, his ED is likely to screen 8,000 baby boomers. If the prevalence rate remains stable, that would mean 864 who are HCV positive and more than 600 with confirmed infection, he said.

Still, it’s important to screen, said Dr. Galbraith, adding that given the study results, "the implication is that the ED may be an important venue for HCV screening."

Two federal entities have called for increased screening. In May, the CDC urged HCV testing for all Americans born between 1945 and 1965.

The U.S. Preventive Services Task Force followed in June, recommending routine HCV screening for high risk Americans, and one-time screening for adults born between 1945 and 1965.

The study was funded by the Centers for Disease Control and Prevention. Dr. Galbraith reported no disclosures.

[email protected]

On Twitter @aliciaault

WASHINGTON – A pilot study screening for hepatitis C in the emergency department found that at least 12% of baby boomers who were previously unaware of their HCV status were positive for the virus.

Infection was confirmed in almost 9% of HCV-positive patients, lead author Dr. James W. Galbraith reported at the annual meeting of the American Association for the Study of Liver Diseases.

Dr. Galbraith, an associate professor of emergency medicine at the University of Alabama, Birmingham, reported on initial results of a screening program funded by the Centers for Disease Control and Prevention that began in September. Results are currently tabulated through Oct. 17. During that time, there were 2,363 unique ED visits by patients born in the years 1945 to 1965. Seventy-three percent (1,721) agreed to answer two questions given by a triage nurse: Have you ever been tested for HCV, and if yes, are you aware of that result? Seventy-five percent, or 1,287 patients, did not know their status and were offered testing.

Alicia Ault/IMNG Medical Media

Of those, 90% (1,148) accepted the antibody test. Patients were excluded from testing if they were medically or surgically unstable, had known HCV infection, or if they chose to opt out.

Antibody tests were performed on 984 of those patients, with results returned to ED physicians within 30-60 minutes. Eighty-eight percent had negative results, but 12%, or 118 patients, were HCV positive.

Researchers attempt to verify positive test results with polymerase chain reaction testing, but it is not always easy to do so, said Dr. Galbraith. Patients must be kept for a new blood draw, and many have already left the ED. Testing is also expensive, he noted.

Overall, men were significantly more likely than were women to test positive (17% compared with 8%). There was no significant difference in HCV positivity rates between whites and African Americans (11% vs. 13%). Patients without insurance or those on Medicaid or other public insurance plans were significantly more likely to be positive, with 17% in each of those groups exhibiting reactivity on the antibody assay, compared with 5% of insured patients.

When patients are determined to be HCV positive, ED physicians counsel and direct them to resources in the community, including specialists. Dr. Galbraith said that the numbers of baby boomers being found to be HCV positive are likely to overwhelm the available specialists.

By September 2014, Dr. Galbraith said, his ED is likely to screen 8,000 baby boomers. If the prevalence rate remains stable, that would mean 864 who are HCV positive and more than 600 with confirmed infection, he said.

Still, it’s important to screen, said Dr. Galbraith, adding that given the study results, "the implication is that the ED may be an important venue for HCV screening."

Two federal entities have called for increased screening. In May, the CDC urged HCV testing for all Americans born between 1945 and 1965.

The U.S. Preventive Services Task Force followed in June, recommending routine HCV screening for high risk Americans, and one-time screening for adults born between 1945 and 1965.

The study was funded by the Centers for Disease Control and Prevention. Dr. Galbraith reported no disclosures.

[email protected]

On Twitter @aliciaault

For patients with chronic hepatitis C infection, achieving an undetectable viral load cut the risk of death by 45% and the risk of liver-related adverse events by 27%, a large study demonstrated.

But only 16% of patients who took antivirals reached undetectable viral levels, according to the first cohort study to quantify the impact of viral load–suppression on real-world patients at all levels of disease progression.

Bristol-Myers Squibb sponsored the trial, and its findings were simultaneously presented at the annual meeting of the American Association for the Study of Liver Diseases and published online Nov. 5 in JAMA Internal Medicine.

Unfortunately, very few patients achieve an undetectable viral load without taking antiviral agents – only 39 of 97,485 untreated participants in the study. And because of the drugs’ adverse effects and expense, only one-fourth of patients in real-world clinical conditions are willing to initiate antiviral therapy – and only a fraction of those treated patients (16.4% in the study) achieved viral suppression to undetectable levels, said Jeffrey McCombs, Ph.D., of the department of clinical pharmacy and pharmaceutical economics and policy, University of Southern California, Los Angeles, and his associates.

To obtain a cohort large enough to quantify the effects of viral load suppression, Dr. McCombs and his colleagues used information from the Veterans Affairs clinical case registry of HCV-infected patients. They identified and examined the clinical records of 128,769 patients enrolled in the database in 1999-2010. The mean follow-up period was 6 years.

Those study subjects were predominantly men, and the mean age was 52 years. Approximately 51% were white, and 31% were black.

Only 24.3% of the total study population received antiviral therapy at any time after diagnosis, and only 16.4% achieved an undetectable viral load after treatment.

The study’s coprimary endpoints were all-cause mortality and a composite of newly diagnosed cirrhosis (either compensated or decompensated), hepatocellular carcinoma, or a liver-related hospitalization. There were 15,458 deaths and 35,253 composite events in the sample of 734,829 person-years of data.

Compared with the majority of patients who carried a detectable viral load throughout the study period, patients who achieved an undetectable viral load showed a 45% lower risk of death and a 27% lower risk of the composite endpoint, the investigators said (JAMA Intern. Med. 2013 Nov. 5 [doi:10.1001/jamainternmed.2013.12505]).

Achieving an undetectable viral load also reduced the risk of each component of the composite endpoint, individually.

The results remained very robust in a sensitivity analysis restricted only to the 54,420 patients who had significant liver fibrosis at baseline.

"Clearly, new therapeutic options might offer significant benefits ... if their introduction improves the willingness of patients to initiate therapy and the likelihood that the patient will achieve viral suppression leading to a sustained viral response," Dr. McCombs and his associates said.

Understanding the challenges patients face with those treatments, as well as patient expectations, "are essential to help both providers and patients make informed decisions about when to initiate antiviral therapy and to motivate patient adherence," the researchers added.

Bristol-Myers Squibb supported the study. Dr. McCombs and his associates also reported other ties to Bristol-Myers Squibb.

For patients with chronic hepatitis C infection, achieving an undetectable viral load cut the risk of death by 45% and the risk of liver-related adverse events by 27%, a large study demonstrated.

But only 16% of patients who took antivirals reached undetectable viral levels, according to the first cohort study to quantify the impact of viral load–suppression on real-world patients at all levels of disease progression.

Bristol-Myers Squibb sponsored the trial, and its findings were simultaneously presented at the annual meeting of the American Association for the Study of Liver Diseases and published online Nov. 5 in JAMA Internal Medicine.

Unfortunately, very few patients achieve an undetectable viral load without taking antiviral agents – only 39 of 97,485 untreated participants in the study. And because of the drugs’ adverse effects and expense, only one-fourth of patients in real-world clinical conditions are willing to initiate antiviral therapy – and only a fraction of those treated patients (16.4% in the study) achieved viral suppression to undetectable levels, said Jeffrey McCombs, Ph.D., of the department of clinical pharmacy and pharmaceutical economics and policy, University of Southern California, Los Angeles, and his associates.

To obtain a cohort large enough to quantify the effects of viral load suppression, Dr. McCombs and his colleagues used information from the Veterans Affairs clinical case registry of HCV-infected patients. They identified and examined the clinical records of 128,769 patients enrolled in the database in 1999-2010. The mean follow-up period was 6 years.

Those study subjects were predominantly men, and the mean age was 52 years. Approximately 51% were white, and 31% were black.

Only 24.3% of the total study population received antiviral therapy at any time after diagnosis, and only 16.4% achieved an undetectable viral load after treatment.

The study’s coprimary endpoints were all-cause mortality and a composite of newly diagnosed cirrhosis (either compensated or decompensated), hepatocellular carcinoma, or a liver-related hospitalization. There were 15,458 deaths and 35,253 composite events in the sample of 734,829 person-years of data.

Compared with the majority of patients who carried a detectable viral load throughout the study period, patients who achieved an undetectable viral load showed a 45% lower risk of death and a 27% lower risk of the composite endpoint, the investigators said (JAMA Intern. Med. 2013 Nov. 5 [doi:10.1001/jamainternmed.2013.12505]).

Achieving an undetectable viral load also reduced the risk of each component of the composite endpoint, individually.

The results remained very robust in a sensitivity analysis restricted only to the 54,420 patients who had significant liver fibrosis at baseline.

"Clearly, new therapeutic options might offer significant benefits ... if their introduction improves the willingness of patients to initiate therapy and the likelihood that the patient will achieve viral suppression leading to a sustained viral response," Dr. McCombs and his associates said.

Understanding the challenges patients face with those treatments, as well as patient expectations, "are essential to help both providers and patients make informed decisions about when to initiate antiviral therapy and to motivate patient adherence," the researchers added.

Bristol-Myers Squibb supported the study. Dr. McCombs and his associates also reported other ties to Bristol-Myers Squibb.

For patients with chronic hepatitis C infection, achieving an undetectable viral load cut the risk of death by 45% and the risk of liver-related adverse events by 27%, a large study demonstrated.

But only 16% of patients who took antivirals reached undetectable viral levels, according to the first cohort study to quantify the impact of viral load–suppression on real-world patients at all levels of disease progression.

Bristol-Myers Squibb sponsored the trial, and its findings were simultaneously presented at the annual meeting of the American Association for the Study of Liver Diseases and published online Nov. 5 in JAMA Internal Medicine.

Unfortunately, very few patients achieve an undetectable viral load without taking antiviral agents – only 39 of 97,485 untreated participants in the study. And because of the drugs’ adverse effects and expense, only one-fourth of patients in real-world clinical conditions are willing to initiate antiviral therapy – and only a fraction of those treated patients (16.4% in the study) achieved viral suppression to undetectable levels, said Jeffrey McCombs, Ph.D., of the department of clinical pharmacy and pharmaceutical economics and policy, University of Southern California, Los Angeles, and his associates.

To obtain a cohort large enough to quantify the effects of viral load suppression, Dr. McCombs and his colleagues used information from the Veterans Affairs clinical case registry of HCV-infected patients. They identified and examined the clinical records of 128,769 patients enrolled in the database in 1999-2010. The mean follow-up period was 6 years.

Those study subjects were predominantly men, and the mean age was 52 years. Approximately 51% were white, and 31% were black.

Only 24.3% of the total study population received antiviral therapy at any time after diagnosis, and only 16.4% achieved an undetectable viral load after treatment.

The study’s coprimary endpoints were all-cause mortality and a composite of newly diagnosed cirrhosis (either compensated or decompensated), hepatocellular carcinoma, or a liver-related hospitalization. There were 15,458 deaths and 35,253 composite events in the sample of 734,829 person-years of data.

Compared with the majority of patients who carried a detectable viral load throughout the study period, patients who achieved an undetectable viral load showed a 45% lower risk of death and a 27% lower risk of the composite endpoint, the investigators said (JAMA Intern. Med. 2013 Nov. 5 [doi:10.1001/jamainternmed.2013.12505]).

Achieving an undetectable viral load also reduced the risk of each component of the composite endpoint, individually.

The results remained very robust in a sensitivity analysis restricted only to the 54,420 patients who had significant liver fibrosis at baseline.

"Clearly, new therapeutic options might offer significant benefits ... if their introduction improves the willingness of patients to initiate therapy and the likelihood that the patient will achieve viral suppression leading to a sustained viral response," Dr. McCombs and his associates said.

Understanding the challenges patients face with those treatments, as well as patient expectations, "are essential to help both providers and patients make informed decisions about when to initiate antiviral therapy and to motivate patient adherence," the researchers added.

Bristol-Myers Squibb supported the study. Dr. McCombs and his associates also reported other ties to Bristol-Myers Squibb.

WASHINGTON – The addition of ribavirin to a fixed-dose combination of sofosbuvir and ledipasvir, two potent direct-acting hepatitis C antiviral drugs, increased the response rate from 70% to 100% in previously-treated patients with chronic hepatitis C infection and fibrosis or cirrhosis.

That finding emerged from a phase II study presented by Dr. Edward Gane at the annual meeting of the American Association for the Study of Liver Diseases.

Sofosbuvir, a nucleotide polymerase inhibitor, has potent antiviral activity against HCV genotypes 1-6, and ledipasvir, an NS5A inhibitor, has potency against genotypes 1a and 1b1. Both are taken once a day orally. To date, more than 2,000 people have been treated with the fixed-dose combination of sofosbuvir (400 mg) and ledipasvir (90 mg), which is now in phase III trials, said Dr. Gane, chief hepatologist and deputy director of the New Zealand Liver Transplant Unit at Auckland City Hospital.

The study evaluated the efficacy and safety of the sofosbuvir-ledipasvir fixed-dose combination for 12 weeks in treatment-experienced patients with HCV genotype 1 and advanced fibrosis or cirrhosis. The investigators also looked at the shortest duration of the combination required in treatment-naive patients with genotype 1 who did not have cirrhosis. The primary endpoint was the sustained virologic response rate (undetectable HCV) 12 weeks after active treatment was stopped (SVR12).

Most of the patients were white, and most were male. Their mean age was 51-61 years, and most had genotype 1a (60%-85%).

Patients were divided into three different groups:

• Treatment-experienced patients with HCV genotype 1 and cirrhosis, treated with the fixed dose combination without ribavirin (10 patients) or with ribavirin (9 patients) for 12 weeks.

Among those on the fixed-dose combination only, 70% reached SVR12. When ribavirin was added, SVR12 was reached by all patients.

• Treatment-naive patients with HCV genotypes 2 and 3, treated with the fixed-dose combination and ribavirin (10 patients) for 12 weeks. Again, 100% of these patients reached SVR12.

• An exploratory cohort of 25 treatment-naive noncirrhotic patients with HCV genotype 1 treated with the fixed-dose combination plus ribavirin for 6 weeks. Fewer of these patients (68%) reached SVR 12.

Sofosbuvir-ledipasvir, with or without ribavirin, "was generally safe and well-tolerated," with no serious adverse events reported or treatment discontinuations, Dr. Gane said. In general, adverse events were mild, and grade 3/4 laboratory abnormalities were infrequent and consistent with the safety profile of ribavirin, he added.

"In the historically difficult to treat treatment-experienced patients with cirrhosis, the addition of ribavirin ... enhances the efficacy of sofosbuvir plus ledipasvir when given for 12 weeks," Dr. Gane said.

The optimal duration of this combination in genotype 1 patients appears to be more than 6 weeks, he added, "with unacceptable relapse rates" when treatment is reduced to 6 weeks.

Importantly, the study also found that the efficacy of the combination was not reduced in patients with resistance-associated variants at baseline, Dr. Gane said.

Patients in the studies were enrolled in the ELECTRON or ELECTRON 2 studies.

Neither sofosbuvir or ledipasvir is approved by the Food and Drug Administration, but at an Oct. 25 meeting, an FDA advisory panel unanimously recommended the approval of sofosbuvir for two groups of patients with chronic hepatitis C infection: treatment-naive adults with genotype 1 and 4 infections, in combination with pegylated interferon and ribavirin; and for adults with genotype 2 and 3 infections, in combination with ribavirin. An approval decision is expected by Dec. 8.

Dr. Gane disclosed that he served on the advisory board committees for Gilead, Roche, AbbVie, Achillion, Janssen, Novartis, and Vertex within the previous 12 months. The study was funded by Gilead Sciences, maker of the fixed-dose combination. Several of the authors of the study are Gilead employees.

[email protected]

WASHINGTON – The addition of ribavirin to a fixed-dose combination of sofosbuvir and ledipasvir, two potent direct-acting hepatitis C antiviral drugs, increased the response rate from 70% to 100% in previously-treated patients with chronic hepatitis C infection and fibrosis or cirrhosis.

That finding emerged from a phase II study presented by Dr. Edward Gane at the annual meeting of the American Association for the Study of Liver Diseases.

Sofosbuvir, a nucleotide polymerase inhibitor, has potent antiviral activity against HCV genotypes 1-6, and ledipasvir, an NS5A inhibitor, has potency against genotypes 1a and 1b1. Both are taken once a day orally. To date, more than 2,000 people have been treated with the fixed-dose combination of sofosbuvir (400 mg) and ledipasvir (90 mg), which is now in phase III trials, said Dr. Gane, chief hepatologist and deputy director of the New Zealand Liver Transplant Unit at Auckland City Hospital.

The study evaluated the efficacy and safety of the sofosbuvir-ledipasvir fixed-dose combination for 12 weeks in treatment-experienced patients with HCV genotype 1 and advanced fibrosis or cirrhosis. The investigators also looked at the shortest duration of the combination required in treatment-naive patients with genotype 1 who did not have cirrhosis. The primary endpoint was the sustained virologic response rate (undetectable HCV) 12 weeks after active treatment was stopped (SVR12).

Most of the patients were white, and most were male. Their mean age was 51-61 years, and most had genotype 1a (60%-85%).

Patients were divided into three different groups:

• Treatment-experienced patients with HCV genotype 1 and cirrhosis, treated with the fixed dose combination without ribavirin (10 patients) or with ribavirin (9 patients) for 12 weeks.

Among those on the fixed-dose combination only, 70% reached SVR12. When ribavirin was added, SVR12 was reached by all patients.

• Treatment-naive patients with HCV genotypes 2 and 3, treated with the fixed-dose combination and ribavirin (10 patients) for 12 weeks. Again, 100% of these patients reached SVR12.

• An exploratory cohort of 25 treatment-naive noncirrhotic patients with HCV genotype 1 treated with the fixed-dose combination plus ribavirin for 6 weeks. Fewer of these patients (68%) reached SVR 12.

Sofosbuvir-ledipasvir, with or without ribavirin, "was generally safe and well-tolerated," with no serious adverse events reported or treatment discontinuations, Dr. Gane said. In general, adverse events were mild, and grade 3/4 laboratory abnormalities were infrequent and consistent with the safety profile of ribavirin, he added.

"In the historically difficult to treat treatment-experienced patients with cirrhosis, the addition of ribavirin ... enhances the efficacy of sofosbuvir plus ledipasvir when given for 12 weeks," Dr. Gane said.

The optimal duration of this combination in genotype 1 patients appears to be more than 6 weeks, he added, "with unacceptable relapse rates" when treatment is reduced to 6 weeks.

Importantly, the study also found that the efficacy of the combination was not reduced in patients with resistance-associated variants at baseline, Dr. Gane said.

Patients in the studies were enrolled in the ELECTRON or ELECTRON 2 studies.

Neither sofosbuvir or ledipasvir is approved by the Food and Drug Administration, but at an Oct. 25 meeting, an FDA advisory panel unanimously recommended the approval of sofosbuvir for two groups of patients with chronic hepatitis C infection: treatment-naive adults with genotype 1 and 4 infections, in combination with pegylated interferon and ribavirin; and for adults with genotype 2 and 3 infections, in combination with ribavirin. An approval decision is expected by Dec. 8.

Dr. Gane disclosed that he served on the advisory board committees for Gilead, Roche, AbbVie, Achillion, Janssen, Novartis, and Vertex within the previous 12 months. The study was funded by Gilead Sciences, maker of the fixed-dose combination. Several of the authors of the study are Gilead employees.

[email protected]

WASHINGTON – The addition of ribavirin to a fixed-dose combination of sofosbuvir and ledipasvir, two potent direct-acting hepatitis C antiviral drugs, increased the response rate from 70% to 100% in previously-treated patients with chronic hepatitis C infection and fibrosis or cirrhosis.

That finding emerged from a phase II study presented by Dr. Edward Gane at the annual meeting of the American Association for the Study of Liver Diseases.

Sofosbuvir, a nucleotide polymerase inhibitor, has potent antiviral activity against HCV genotypes 1-6, and ledipasvir, an NS5A inhibitor, has potency against genotypes 1a and 1b1. Both are taken once a day orally. To date, more than 2,000 people have been treated with the fixed-dose combination of sofosbuvir (400 mg) and ledipasvir (90 mg), which is now in phase III trials, said Dr. Gane, chief hepatologist and deputy director of the New Zealand Liver Transplant Unit at Auckland City Hospital.

The study evaluated the efficacy and safety of the sofosbuvir-ledipasvir fixed-dose combination for 12 weeks in treatment-experienced patients with HCV genotype 1 and advanced fibrosis or cirrhosis. The investigators also looked at the shortest duration of the combination required in treatment-naive patients with genotype 1 who did not have cirrhosis. The primary endpoint was the sustained virologic response rate (undetectable HCV) 12 weeks after active treatment was stopped (SVR12).

Most of the patients were white, and most were male. Their mean age was 51-61 years, and most had genotype 1a (60%-85%).

Patients were divided into three different groups:

• Treatment-experienced patients with HCV genotype 1 and cirrhosis, treated with the fixed dose combination without ribavirin (10 patients) or with ribavirin (9 patients) for 12 weeks.

Among those on the fixed-dose combination only, 70% reached SVR12. When ribavirin was added, SVR12 was reached by all patients.

• Treatment-naive patients with HCV genotypes 2 and 3, treated with the fixed-dose combination and ribavirin (10 patients) for 12 weeks. Again, 100% of these patients reached SVR12.

• An exploratory cohort of 25 treatment-naive noncirrhotic patients with HCV genotype 1 treated with the fixed-dose combination plus ribavirin for 6 weeks. Fewer of these patients (68%) reached SVR 12.

Sofosbuvir-ledipasvir, with or without ribavirin, "was generally safe and well-tolerated," with no serious adverse events reported or treatment discontinuations, Dr. Gane said. In general, adverse events were mild, and grade 3/4 laboratory abnormalities were infrequent and consistent with the safety profile of ribavirin, he added.

"In the historically difficult to treat treatment-experienced patients with cirrhosis, the addition of ribavirin ... enhances the efficacy of sofosbuvir plus ledipasvir when given for 12 weeks," Dr. Gane said.

The optimal duration of this combination in genotype 1 patients appears to be more than 6 weeks, he added, "with unacceptable relapse rates" when treatment is reduced to 6 weeks.

Importantly, the study also found that the efficacy of the combination was not reduced in patients with resistance-associated variants at baseline, Dr. Gane said.

Patients in the studies were enrolled in the ELECTRON or ELECTRON 2 studies.

Neither sofosbuvir or ledipasvir is approved by the Food and Drug Administration, but at an Oct. 25 meeting, an FDA advisory panel unanimously recommended the approval of sofosbuvir for two groups of patients with chronic hepatitis C infection: treatment-naive adults with genotype 1 and 4 infections, in combination with pegylated interferon and ribavirin; and for adults with genotype 2 and 3 infections, in combination with ribavirin. An approval decision is expected by Dec. 8.

Dr. Gane disclosed that he served on the advisory board committees for Gilead, Roche, AbbVie, Achillion, Janssen, Novartis, and Vertex within the previous 12 months. The study was funded by Gilead Sciences, maker of the fixed-dose combination. Several of the authors of the study are Gilead employees.

[email protected]

WASHINGTON – Programs to screen pregnant women for hepatitis C infection could go far to reduce a host of adverse outcomes, according to an analysis of a large national sample.

"Targeted HCV screening may overlook many pregnant women with chronic HCV infections, and that may contribute to the underdiagnosis of pediatric hepatitis C in the United States," study investigator Dr. Po-Hung Chen said at the annual meeting of the American Association for the Study of Liver Diseases.

Denise Fulton/IMNG Medical Media

"Chronic hepatitis C is associated with adverse maternal/fetal consequences. In light of these findings, there seems to be a need to further evaluate universal hepatitis C screening as a part of antepartum care," he added.

Dr. Chen of the division of gastroenterology at Johns Hopkins University, Baltimore, and colleagues collected data on all births and spontaneous abortions recorded in the National Inpatient Sample between 2003 and 2010.

More than 28,000 of the 32 million deliveries or miscarriages recorded in the National Inpatient Sample were to mothers infected with HCV, he reported.

Of HCV-positive mothers, 72% had no traditional risk factors for the disease.

HCV-positive mothers were significantly more likely to experience obstetric pulmonary embolism (adjusted OR, 3.05) and thyroid dysfunction (aOR, 1.37), and more likely to experience maternal death, but not significantly so (aOR, 2.49). They also were significantly more likely to be white, less affluent, on Medicaid, substance abusers, and have more comorbidities.

Women who were HCV positive were significantly more likely to have labor before 37 weeks’ gestation (aOR, 1.36), antepartum hemorrhage (aOR, 1.44), and poor fetal growth (aOR, 1.61).

Cost of care and length of stay were significantly greater for mothers who were HCV positive, Dr. Chen said.

Previous analysis using data from the National Health and Nutrition Examination Survey (NHANES) showed that the prevalence of hepatitis C virus infection in women aged 20-39 years was 1%-1.6% in the period between 1999 and 2002. Dr. Chen noted that this could be an underestimation because NHANES is based on home health surveys and therefore does not include prison populations and homeless women, who are at high risk for HCV infection.

Currently, no definitive guidelines exist on how to manage chronic HCV in pregnant women, likely because of a dearth of suitable proven management options, Dr. Chen said, adding that ribavirin is contraindicated in pregnancy, interferon is generally not recommended, and the currently approved protease inhibitors are not options for single-drug management.

The American College of Obstetricians and Gynecologists does not recommend routine prenatal screening for HCV; instead, the college recommends screening only in women who are at high risk based on Centers for Disease Control and Prevention criteria.

Dr. Chen did not report financial conflicts of interest.

[email protected]

WASHINGTON – Programs to screen pregnant women for hepatitis C infection could go far to reduce a host of adverse outcomes, according to an analysis of a large national sample.

"Targeted HCV screening may overlook many pregnant women with chronic HCV infections, and that may contribute to the underdiagnosis of pediatric hepatitis C in the United States," study investigator Dr. Po-Hung Chen said at the annual meeting of the American Association for the Study of Liver Diseases.

Denise Fulton/IMNG Medical Media

"Chronic hepatitis C is associated with adverse maternal/fetal consequences. In light of these findings, there seems to be a need to further evaluate universal hepatitis C screening as a part of antepartum care," he added.

Dr. Chen of the division of gastroenterology at Johns Hopkins University, Baltimore, and colleagues collected data on all births and spontaneous abortions recorded in the National Inpatient Sample between 2003 and 2010.

More than 28,000 of the 32 million deliveries or miscarriages recorded in the National Inpatient Sample were to mothers infected with HCV, he reported.

Of HCV-positive mothers, 72% had no traditional risk factors for the disease.

HCV-positive mothers were significantly more likely to experience obstetric pulmonary embolism (adjusted OR, 3.05) and thyroid dysfunction (aOR, 1.37), and more likely to experience maternal death, but not significantly so (aOR, 2.49). They also were significantly more likely to be white, less affluent, on Medicaid, substance abusers, and have more comorbidities.

Women who were HCV positive were significantly more likely to have labor before 37 weeks’ gestation (aOR, 1.36), antepartum hemorrhage (aOR, 1.44), and poor fetal growth (aOR, 1.61).

Cost of care and length of stay were significantly greater for mothers who were HCV positive, Dr. Chen said.

Previous analysis using data from the National Health and Nutrition Examination Survey (NHANES) showed that the prevalence of hepatitis C virus infection in women aged 20-39 years was 1%-1.6% in the period between 1999 and 2002. Dr. Chen noted that this could be an underestimation because NHANES is based on home health surveys and therefore does not include prison populations and homeless women, who are at high risk for HCV infection.

Currently, no definitive guidelines exist on how to manage chronic HCV in pregnant women, likely because of a dearth of suitable proven management options, Dr. Chen said, adding that ribavirin is contraindicated in pregnancy, interferon is generally not recommended, and the currently approved protease inhibitors are not options for single-drug management.

The American College of Obstetricians and Gynecologists does not recommend routine prenatal screening for HCV; instead, the college recommends screening only in women who are at high risk based on Centers for Disease Control and Prevention criteria.

Dr. Chen did not report financial conflicts of interest.

[email protected]

WASHINGTON – Programs to screen pregnant women for hepatitis C infection could go far to reduce a host of adverse outcomes, according to an analysis of a large national sample.

"Targeted HCV screening may overlook many pregnant women with chronic HCV infections, and that may contribute to the underdiagnosis of pediatric hepatitis C in the United States," study investigator Dr. Po-Hung Chen said at the annual meeting of the American Association for the Study of Liver Diseases.

Denise Fulton/IMNG Medical Media

"Chronic hepatitis C is associated with adverse maternal/fetal consequences. In light of these findings, there seems to be a need to further evaluate universal hepatitis C screening as a part of antepartum care," he added.

Dr. Chen of the division of gastroenterology at Johns Hopkins University, Baltimore, and colleagues collected data on all births and spontaneous abortions recorded in the National Inpatient Sample between 2003 and 2010.

More than 28,000 of the 32 million deliveries or miscarriages recorded in the National Inpatient Sample were to mothers infected with HCV, he reported.

Of HCV-positive mothers, 72% had no traditional risk factors for the disease.

HCV-positive mothers were significantly more likely to experience obstetric pulmonary embolism (adjusted OR, 3.05) and thyroid dysfunction (aOR, 1.37), and more likely to experience maternal death, but not significantly so (aOR, 2.49). They also were significantly more likely to be white, less affluent, on Medicaid, substance abusers, and have more comorbidities.

Women who were HCV positive were significantly more likely to have labor before 37 weeks’ gestation (aOR, 1.36), antepartum hemorrhage (aOR, 1.44), and poor fetal growth (aOR, 1.61).

Cost of care and length of stay were significantly greater for mothers who were HCV positive, Dr. Chen said.

Previous analysis using data from the National Health and Nutrition Examination Survey (NHANES) showed that the prevalence of hepatitis C virus infection in women aged 20-39 years was 1%-1.6% in the period between 1999 and 2002. Dr. Chen noted that this could be an underestimation because NHANES is based on home health surveys and therefore does not include prison populations and homeless women, who are at high risk for HCV infection.

Currently, no definitive guidelines exist on how to manage chronic HCV in pregnant women, likely because of a dearth of suitable proven management options, Dr. Chen said, adding that ribavirin is contraindicated in pregnancy, interferon is generally not recommended, and the currently approved protease inhibitors are not options for single-drug management.

The American College of Obstetricians and Gynecologists does not recommend routine prenatal screening for HCV; instead, the college recommends screening only in women who are at high risk based on Centers for Disease Control and Prevention criteria.

Dr. Chen did not report financial conflicts of interest.

[email protected]

WASHINGTON – Implementation of recommended one-time screening of Baby Boomers would identify an additional 51,000 veterans infected with the hepatitis C virus, according to researchers with the Department of Veterans Affairs.

Investigators looked at records for all veterans in the VA health care system from 1999 to 2012 who had a VA outpatient visit in 2012.

Denise Fulton/IMNG Medical Media

Broken down by birth cohort, of the 5.5 million vets who were seen, hepatitis C virus (HCV) screening was performed for 42% of those born before 1945, 64% of those born in 1945-1965 (Baby Boomers), and 58% of those born after 1965, Dr. Lisa I. Backus of the VA Palo Alto (Calif.) Health Care System reported at the annual meeting of the annual meeting of the American Association for the Study of Liver Diseases.

In the Baby Boomer cohort, 13% of veterans screened had HCV antibodies and 10% were infected with HCV, compared with 3% and 1.7%, respectively, for veterans born before 1945 and 2% and 1% of those born after 1965. Dr. Backus noted that in excess of 95% of veterans who screen positive for HCV antibodies are subsequently tested for HCV viral load and/or genotyping.

Dr. Backus noted that the VA population in general has a higher HCV infection rate than the general public – 6.1% for veterans vs. 2.5% for all Americans.

When HCV infection prevalence rates were extrapolated to veterans in the Baby Boom cohort who were not yet screened – approximately 900,000 – the data suggest that as many as 51,000 additional veterans would be identified with HCV infection with full birth cohort screening, Dr. Backus reported.

This study underlines the need for one-time screening for individuals born during the Baby Boom years, she said.

The Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommend one-time screening for this birth cohort.

"Without care and treatment, 1.7 million Americans with HCV will develop cirrhosis, 400,000 will develop hepatocellular carcinoma, and more than 1 million will go on to die of HCV-related disease. And obviously, they can’t get into care if they don’t know they have hepatitis C," Dr. Backus said, citing CDC data.

"Our work should also serve as an example to other health care organizations to prompt them to assess their own HCV screening rates and HCV prevalence rates and to make such rates public," she said.

The study was funded by the Department of Veterans Affairs. Dr. Backus had no relevant conflicts of interest.

[email protected]

WASHINGTON – Implementation of recommended one-time screening of Baby Boomers would identify an additional 51,000 veterans infected with the hepatitis C virus, according to researchers with the Department of Veterans Affairs.

Investigators looked at records for all veterans in the VA health care system from 1999 to 2012 who had a VA outpatient visit in 2012.

Denise Fulton/IMNG Medical Media

Broken down by birth cohort, of the 5.5 million vets who were seen, hepatitis C virus (HCV) screening was performed for 42% of those born before 1945, 64% of those born in 1945-1965 (Baby Boomers), and 58% of those born after 1965, Dr. Lisa I. Backus of the VA Palo Alto (Calif.) Health Care System reported at the annual meeting of the annual meeting of the American Association for the Study of Liver Diseases.

In the Baby Boomer cohort, 13% of veterans screened had HCV antibodies and 10% were infected with HCV, compared with 3% and 1.7%, respectively, for veterans born before 1945 and 2% and 1% of those born after 1965. Dr. Backus noted that in excess of 95% of veterans who screen positive for HCV antibodies are subsequently tested for HCV viral load and/or genotyping.

Dr. Backus noted that the VA population in general has a higher HCV infection rate than the general public – 6.1% for veterans vs. 2.5% for all Americans.

When HCV infection prevalence rates were extrapolated to veterans in the Baby Boom cohort who were not yet screened – approximately 900,000 – the data suggest that as many as 51,000 additional veterans would be identified with HCV infection with full birth cohort screening, Dr. Backus reported.

This study underlines the need for one-time screening for individuals born during the Baby Boom years, she said.

The Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommend one-time screening for this birth cohort.

"Without care and treatment, 1.7 million Americans with HCV will develop cirrhosis, 400,000 will develop hepatocellular carcinoma, and more than 1 million will go on to die of HCV-related disease. And obviously, they can’t get into care if they don’t know they have hepatitis C," Dr. Backus said, citing CDC data.

"Our work should also serve as an example to other health care organizations to prompt them to assess their own HCV screening rates and HCV prevalence rates and to make such rates public," she said.

The study was funded by the Department of Veterans Affairs. Dr. Backus had no relevant conflicts of interest.

[email protected]

WASHINGTON – Implementation of recommended one-time screening of Baby Boomers would identify an additional 51,000 veterans infected with the hepatitis C virus, according to researchers with the Department of Veterans Affairs.

Investigators looked at records for all veterans in the VA health care system from 1999 to 2012 who had a VA outpatient visit in 2012.

Denise Fulton/IMNG Medical Media

Broken down by birth cohort, of the 5.5 million vets who were seen, hepatitis C virus (HCV) screening was performed for 42% of those born before 1945, 64% of those born in 1945-1965 (Baby Boomers), and 58% of those born after 1965, Dr. Lisa I. Backus of the VA Palo Alto (Calif.) Health Care System reported at the annual meeting of the annual meeting of the American Association for the Study of Liver Diseases.

In the Baby Boomer cohort, 13% of veterans screened had HCV antibodies and 10% were infected with HCV, compared with 3% and 1.7%, respectively, for veterans born before 1945 and 2% and 1% of those born after 1965. Dr. Backus noted that in excess of 95% of veterans who screen positive for HCV antibodies are subsequently tested for HCV viral load and/or genotyping.

Dr. Backus noted that the VA population in general has a higher HCV infection rate than the general public – 6.1% for veterans vs. 2.5% for all Americans.

When HCV infection prevalence rates were extrapolated to veterans in the Baby Boom cohort who were not yet screened – approximately 900,000 – the data suggest that as many as 51,000 additional veterans would be identified with HCV infection with full birth cohort screening, Dr. Backus reported.

This study underlines the need for one-time screening for individuals born during the Baby Boom years, she said.

The Centers for Disease Control and Prevention and the U.S. Preventive Services Task Force both recommend one-time screening for this birth cohort.

"Without care and treatment, 1.7 million Americans with HCV will develop cirrhosis, 400,000 will develop hepatocellular carcinoma, and more than 1 million will go on to die of HCV-related disease. And obviously, they can’t get into care if they don’t know they have hepatitis C," Dr. Backus said, citing CDC data.

"Our work should also serve as an example to other health care organizations to prompt them to assess their own HCV screening rates and HCV prevalence rates and to make such rates public," she said.

The study was funded by the Department of Veterans Affairs. Dr. Backus had no relevant conflicts of interest.

[email protected]

Liver disease patients, advocates and government leaders in health joined together before the Liver Meeting 2013 for the 1st International Rally for Liver Disease Awareness, in Washington.

Dr. T. Jake Liang, chief of the Liver Disease Branch at the National Institutes of Health, discussed the important role physicians play in liver disease education and screening. Dr. Melanie B. Thomas, clinical oncologist and founder of the CanLiv foundation, spoke about the importance of interdiscplinary care for patients with liver disease. During the rally, Dr. Howard Koh, assistant secretary for health at the U.S. Department of Health and Human Services, outlined 10 areas in which the government has stepped up efforts to support education, outreach, and research about liver disease.

The Liver Meeting 2013 is the annual meeting of the American Association for the Study of Liver Diseases.

Liver disease patients, advocates and government leaders in health joined together before the Liver Meeting 2013 for the 1st International Rally for Liver Disease Awareness, in Washington.

Dr. T. Jake Liang, chief of the Liver Disease Branch at the National Institutes of Health, discussed the important role physicians play in liver disease education and screening. Dr. Melanie B. Thomas, clinical oncologist and founder of the CanLiv foundation, spoke about the importance of interdiscplinary care for patients with liver disease. During the rally, Dr. Howard Koh, assistant secretary for health at the U.S. Department of Health and Human Services, outlined 10 areas in which the government has stepped up efforts to support education, outreach, and research about liver disease.

The Liver Meeting 2013 is the annual meeting of the American Association for the Study of Liver Diseases.

Liver disease patients, advocates and government leaders in health joined together before the Liver Meeting 2013 for the 1st International Rally for Liver Disease Awareness, in Washington.

Dr. T. Jake Liang, chief of the Liver Disease Branch at the National Institutes of Health, discussed the important role physicians play in liver disease education and screening. Dr. Melanie B. Thomas, clinical oncologist and founder of the CanLiv foundation, spoke about the importance of interdiscplinary care for patients with liver disease. During the rally, Dr. Howard Koh, assistant secretary for health at the U.S. Department of Health and Human Services, outlined 10 areas in which the government has stepped up efforts to support education, outreach, and research about liver disease.

The Liver Meeting 2013 is the annual meeting of the American Association for the Study of Liver Diseases.