Sunday, May 15, 2016

A Continued Role for Ribavirin in HCV Genotype 3 Infection with Advanced Liver Disease

A Continued Role for Ribavirin in HCV Genotype 3 Infection with Advanced Liver Disease
Atif Zaman, MD, MPH reviewing Leroy V et al. Hepatology 2016 May.

12-week regimen of sofosbuvir, daclatasvir, and ribavirin achieved sustained response in >85% of patients with cirrhosis regardless of treatment experience.

Although current treatment regimens for hepatitis C virus (HCV) infection are effective in most scenarios, sustained virologic response (SVR) rates tend to be lower among HCV genotype 3 patients with advanced liver disease (e.g., SVR rates are approximately 65% in patients with cirrhosis versus >95% in those without cirrhosis).

In the current industry-funded, open-label, randomized, phase III study, investigators evaluated the efficacy of daclatasvir 60 mg daily and sofosbuvir 400 mg daily plus ribavirin 1000–1200 mg daily for 12 or 16 weeks (randomized in a 1:1 fashion) in patients with treatment-naive or treatment-experienced HCV genotype 3 infection and well-compensated stage 3 fibrosis or cirrhosis. The primary endpoint was SVR at 12 weeks after treatment completion (SVR12).

Among 50 study participants, 37 were treatment-experienced and 36 had cirrhosis. The SVR12 rate was 90% (45 of 50) overall, 88% among those treated for 12 weeks, and 92% among those treated for 16 weeks. SVR12 was 100% among patients with stage 3 fibrosis and 86% among those with cirrhosis (83% in the 12-week arm and 89% in the 16-week arm). SVR12 rates for treatment-experienced patients with cirrhosis were similar and ranged from 86% to 88%. Four patients relapsed after treatment. The most common adverse effects were insomnia, fatigue, and headache.

Adding ribavirin to daclatasvir and sofosbuvir in patients with HCV genotype 3 infection and advanced fibrosis or cirrhosis markedly improved SVR rates, even in those who had failed HCV treatment previously. This was accomplished without extending treatment duration beyond 12 weeks, thus being cost-effective as well. It seems that ribavirin use still has a role in HCV treatment.

Editor Disclosures at Time of Publication
Disclosures for Atif Zaman, MD, MPH at time of publication Nothing to disclose

Leroy V et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: A randomized phase III study (ALLY-3+).
( Open Url PubMed abstract (Free)


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