LIVER MEETING 2014

Viral suppression of hepatitis C virus–infected patients improved neural health as measured by magnetic resonance spectroscopy, according to findings from a new study.

Treatment led to an increase in the n-acetyl aspartate/creatine ratio in patients’ basal ganglia, according to Dr. Nezam H. Afdhal of Beth Israel Deaconess Medical Center, Boston.

Dr. Afdhal and his associates studied 14 treatment-naive HCV patients participating in the ION-1 trial. For 12 weeks, seven patients received combination ledipasvir/sofosbuvir; the other seven received the same combination plus ribavirin (RBV). All patients achieved sustained viral response (SVR) to treatment. Researchers used MR spectroscopy to evaluate signals from choline, creatine (Cr), n-acetyl aspartate (NAA), and myoinisitol. “MR spectroscopy showed an increase in the basal ganglia NAA/Cr ratio at week 4 that became significant at SVR (P = .0134) and more apparent in the RBV-free group,” Dr. Afdhal said at the annual meeting of the American Association for the Study of Liver Diseases.

“At week 12 post treatment, the NAA/Cr ratio in left basal ganglia increased in the RBV-free arm (P = .0156) and remained unchanged in the RBV-containing arm (P > .05),” he reported. After 12 weeks post treatment, some changes in the metabolite in the left basal ganglia shown by MR spectroscopy correlated with changes in the emotional function domain of a quality-of-life questionnaire and in the mental health scale of SF-36.

“Changes in the metabolite pattern captured by MR [spectroscopy] also may be associated with changes in patient reported outcomes related to mental health,” the authors said. “The role of HCV on neurocognition is undergoing further study in a double-blind placebo-controlled trial.”

The ION-1 trial was sponsored by Gilead Sciences, manufacturer of ledipasvir/sofosbuvir. Dr. Afdhal reported financial relationships with Gilead, Merck, Vertex, Idenix, GlaxoSmithKline, Springbank, Pharmasett, and Abbott.

Viral suppression of hepatitis C virus–infected patients improved neural health as measured by magnetic resonance spectroscopy, according to findings from a new study.

Treatment led to an increase in the n-acetyl aspartate/creatine ratio in patients’ basal ganglia, according to Dr. Nezam H. Afdhal of Beth Israel Deaconess Medical Center, Boston.

Dr. Afdhal and his associates studied 14 treatment-naive HCV patients participating in the ION-1 trial. For 12 weeks, seven patients received combination ledipasvir/sofosbuvir; the other seven received the same combination plus ribavirin (RBV). All patients achieved sustained viral response (SVR) to treatment. Researchers used MR spectroscopy to evaluate signals from choline, creatine (Cr), n-acetyl aspartate (NAA), and myoinisitol. “MR spectroscopy showed an increase in the basal ganglia NAA/Cr ratio at week 4 that became significant at SVR (P = .0134) and more apparent in the RBV-free group,” Dr. Afdhal said at the annual meeting of the American Association for the Study of Liver Diseases.

“At week 12 post treatment, the NAA/Cr ratio in left basal ganglia increased in the RBV-free arm (P = .0156) and remained unchanged in the RBV-containing arm (P > .05),” he reported. After 12 weeks post treatment, some changes in the metabolite in the left basal ganglia shown by MR spectroscopy correlated with changes in the emotional function domain of a quality-of-life questionnaire and in the mental health scale of SF-36.

“Changes in the metabolite pattern captured by MR [spectroscopy] also may be associated with changes in patient reported outcomes related to mental health,” the authors said. “The role of HCV on neurocognition is undergoing further study in a double-blind placebo-controlled trial.”

The ION-1 trial was sponsored by Gilead Sciences, manufacturer of ledipasvir/sofosbuvir. Dr. Afdhal reported financial relationships with Gilead, Merck, Vertex, Idenix, GlaxoSmithKline, Springbank, Pharmasett, and Abbott.

Viral suppression of hepatitis C virus–infected patients improved neural health as measured by magnetic resonance spectroscopy, according to findings from a new study.

Treatment led to an increase in the n-acetyl aspartate/creatine ratio in patients’ basal ganglia, according to Dr. Nezam H. Afdhal of Beth Israel Deaconess Medical Center, Boston.

Dr. Afdhal and his associates studied 14 treatment-naive HCV patients participating in the ION-1 trial. For 12 weeks, seven patients received combination ledipasvir/sofosbuvir; the other seven received the same combination plus ribavirin (RBV). All patients achieved sustained viral response (SVR) to treatment. Researchers used MR spectroscopy to evaluate signals from choline, creatine (Cr), n-acetyl aspartate (NAA), and myoinisitol. “MR spectroscopy showed an increase in the basal ganglia NAA/Cr ratio at week 4 that became significant at SVR (P = .0134) and more apparent in the RBV-free group,” Dr. Afdhal said at the annual meeting of the American Association for the Study of Liver Diseases.

“At week 12 post treatment, the NAA/Cr ratio in left basal ganglia increased in the RBV-free arm (P = .0156) and remained unchanged in the RBV-containing arm (P > .05),” he reported. After 12 weeks post treatment, some changes in the metabolite in the left basal ganglia shown by MR spectroscopy correlated with changes in the emotional function domain of a quality-of-life questionnaire and in the mental health scale of SF-36.

“Changes in the metabolite pattern captured by MR [spectroscopy] also may be associated with changes in patient reported outcomes related to mental health,” the authors said. “The role of HCV on neurocognition is undergoing further study in a double-blind placebo-controlled trial.”

The ION-1 trial was sponsored by Gilead Sciences, manufacturer of ledipasvir/sofosbuvir. Dr. Afdhal reported financial relationships with Gilead, Merck, Vertex, Idenix, GlaxoSmithKline, Springbank, Pharmasett, and Abbott.

FROM THE LIVER MEETING 2014
A combined formula of ABT-450 with ritonavir, ombitasvir, and dasabuvir, given with ribavirin, yielded high rates of sustained viral response at 12 weeks among patients with hepatitis C virus genotype 1 and cirrhosis, according to work presented at the annual meeting of the American Association for the Study of Liver Diseases.

The regimen worked well in a “broad range of subgroups, including patients with evidence of impaired hepatic synthetic function and/or evidence of portal hypertension,” according to the study, led by Dr. Michael W. Fried, professor of medicine and director of the liver center at the University of North Carolina, Chapel Hill.

Investigators analyzed results from 380 patients randomly assigned to the therapy – coformulated ABT-450/r/ombitasvir+dasabuvir with ribavirin – for either 12 weeks or 24 weeks in the phase III TURQUOISE-II trial. They used sustained viral response to treatment at 12 weeks (SVR12) as the primary outcome measure.

Overall, SVR12 rates were 91.8% for patients taking the drug regimen for 12 weeks, and 96.5% for those taking it for 24 weeks. SVR12 rates did not differ substantially by sex, age, body mass index, or HCV RNA levels. SVR rates ranged from 83.3% at 12 weeks to 96.2% at 24 weeks in patients with platelet counts < 90 × 10⁹/L, and from 84% at 12 weeks to 88.9% at 24 weeks in patients with serum albumin < 35 g/L.
imnews@frontlinemedcom.com

FROM THE LIVER MEETING 2014
A combined formula of ABT-450 with ritonavir, ombitasvir, and dasabuvir, given with ribavirin, yielded high rates of sustained viral response at 12 weeks among patients with hepatitis C virus genotype 1 and cirrhosis, according to work presented at the annual meeting of the American Association for the Study of Liver Diseases.

The regimen worked well in a “broad range of subgroups, including patients with evidence of impaired hepatic synthetic function and/or evidence of portal hypertension,” according to the study, led by Dr. Michael W. Fried, professor of medicine and director of the liver center at the University of North Carolina, Chapel Hill.

Investigators analyzed results from 380 patients randomly assigned to the therapy – coformulated ABT-450/r/ombitasvir+dasabuvir with ribavirin – for either 12 weeks or 24 weeks in the phase III TURQUOISE-II trial. They used sustained viral response to treatment at 12 weeks (SVR12) as the primary outcome measure.

Overall, SVR12 rates were 91.8% for patients taking the drug regimen for 12 weeks, and 96.5% for those taking it for 24 weeks. SVR12 rates did not differ substantially by sex, age, body mass index, or HCV RNA levels. SVR rates ranged from 83.3% at 12 weeks to 96.2% at 24 weeks in patients with platelet counts < 90 × 10⁹/L, and from 84% at 12 weeks to 88.9% at 24 weeks in patients with serum albumin < 35 g/L.
imnews@frontlinemedcom.com

FROM THE LIVER MEETING 2014
A combined formula of ABT-450 with ritonavir, ombitasvir, and dasabuvir, given with ribavirin, yielded high rates of sustained viral response at 12 weeks among patients with hepatitis C virus genotype 1 and cirrhosis, according to work presented at the annual meeting of the American Association for the Study of Liver Diseases.

The regimen worked well in a “broad range of subgroups, including patients with evidence of impaired hepatic synthetic function and/or evidence of portal hypertension,” according to the study, led by Dr. Michael W. Fried, professor of medicine and director of the liver center at the University of North Carolina, Chapel Hill.

Investigators analyzed results from 380 patients randomly assigned to the therapy – coformulated ABT-450/r/ombitasvir+dasabuvir with ribavirin – for either 12 weeks or 24 weeks in the phase III TURQUOISE-II trial. They used sustained viral response to treatment at 12 weeks (SVR12) as the primary outcome measure.

Overall, SVR12 rates were 91.8% for patients taking the drug regimen for 12 weeks, and 96.5% for those taking it for 24 weeks. SVR12 rates did not differ substantially by sex, age, body mass index, or HCV RNA levels. SVR rates ranged from 83.3% at 12 weeks to 96.2% at 24 weeks in patients with platelet counts < 90 × 10⁹/L, and from 84% at 12 weeks to 88.9% at 24 weeks in patients with serum albumin < 35 g/L.
imnews@frontlinemedcom.com

BOSTON – The graying of America will add at least 1 million more patients with chronic hepatitis C virus infection into the Medicare system between 2010 and 2024.

“If all of these patients were treated with an all-oral high efficacy regimen, however, it could save 33,922 lives and increase the number of years lived by an estimated 200,000 years,” study author David Rein, Ph.D., reported at the annual meeting of the American Association for the Study of Liver Diseases.

The study is the first to estimate the number of chronically infected HCV patients in the Medicare system, and the data suggest that as of 2009, there were already 407,786 such patients in the system.

Most patients (68%) were diagnosed with chronic disease only, 24% were diagnosed with some form of end-stage liver disease, and 8% died in 2009.

Co-morbities were commona among the cohort, with 64% having at least one other chronic condition, such as diabetes, renal disease, alcohol/substance abuse, or mental health conditions.

The annual cost of their HCV treatment in 2009 was $2.7 billion in 2014 dollars.

Over the next 10 years, that number could rise to $6.7 billion if these patients aren’t treated, Dr. Rein, a principal research scientist in the Atlanta office of NORC at the University of Chicago, said.

To hear more about this study and whether Medicare can afford this level of care, click here to hear our interview with Dr. Rein.

The study was funded by an unrestricted research grant from Gilead Sciences. Dr. Rein and his co-authors reported having no conflicting interests.

pwendling@frontlinemedcom.com

BOSTON – The graying of America will add at least 1 million more patients with chronic hepatitis C virus infection into the Medicare system between 2010 and 2024.

“If all of these patients were treated with an all-oral high efficacy regimen, however, it could save 33,922 lives and increase the number of years lived by an estimated 200,000 years,” study author David Rein, Ph.D., reported at the annual meeting of the American Association for the Study of Liver Diseases.

The study is the first to estimate the number of chronically infected HCV patients in the Medicare system, and the data suggest that as of 2009, there were already 407,786 such patients in the system.

Most patients (68%) were diagnosed with chronic disease only, 24% were diagnosed with some form of end-stage liver disease, and 8% died in 2009.

Co-morbities were commona among the cohort, with 64% having at least one other chronic condition, such as diabetes, renal disease, alcohol/substance abuse, or mental health conditions.

The annual cost of their HCV treatment in 2009 was $2.7 billion in 2014 dollars.

Over the next 10 years, that number could rise to $6.7 billion if these patients aren’t treated, Dr. Rein, a principal research scientist in the Atlanta office of NORC at the University of Chicago, said.

To hear more about this study and whether Medicare can afford this level of care, click here to hear our interview with Dr. Rein.

The study was funded by an unrestricted research grant from Gilead Sciences. Dr. Rein and his co-authors reported having no conflicting interests.

pwendling@frontlinemedcom.com

BOSTON – The graying of America will add at least 1 million more patients with chronic hepatitis C virus infection into the Medicare system between 2010 and 2024.

“If all of these patients were treated with an all-oral high efficacy regimen, however, it could save 33,922 lives and increase the number of years lived by an estimated 200,000 years,” study author David Rein, Ph.D., reported at the annual meeting of the American Association for the Study of Liver Diseases.

The study is the first to estimate the number of chronically infected HCV patients in the Medicare system, and the data suggest that as of 2009, there were already 407,786 such patients in the system.

Most patients (68%) were diagnosed with chronic disease only, 24% were diagnosed with some form of end-stage liver disease, and 8% died in 2009.

Co-morbities were commona among the cohort, with 64% having at least one other chronic condition, such as diabetes, renal disease, alcohol/substance abuse, or mental health conditions.

The annual cost of their HCV treatment in 2009 was $2.7 billion in 2014 dollars.

Over the next 10 years, that number could rise to $6.7 billion if these patients aren’t treated, Dr. Rein, a principal research scientist in the Atlanta office of NORC at the University of Chicago, said.

To hear more about this study and whether Medicare can afford this level of care, click here to hear our interview with Dr. Rein.

The study was funded by an unrestricted research grant from Gilead Sciences. Dr. Rein and his co-authors reported having no conflicting interests.

pwendling@frontlinemedcom.com