A Non-Sofosbuvir–Based, All-Oral Regimen for Genotype 4 HCV Infection

Atif Zaman, MD, MPH reviewing Hézode C et al. Lancet 2015 Mar 30.

Sustained virologic response was 100% with ribavirin added — in both treatment-experienced and treatment-naive patients.

All-oral treatment regimens for hepatitis C virus (HCV) infection are available for genotypes 1 to 3. However, for genotype 4 infection, which accounts for 13% of HCV infections worldwide, recommended treatment regimens still contain interferon. Now, in an industry-funded phase IIb study, investigators have evaluated the efficacy and safety of an interferon-free regimen for these patients.

Eighty-six treatment-naive, HCV genotype 4–infected patients without cirrhosis were randomized to receive a once-daily regimen of ombitasvir (an NS5A inhibitor; 25 mg) plus paritaprevir (an NS3/4A protease inhibitor; 150 mg) plus ritonavir (100 mg) with or without twice-daily ribavirin for 12 weeks. Also, 49 treatment-experienced patients received a 12-week regimen with ribavirin. The primary endpoint was sustained virologic response at 12 weeks after the end of treatment (SVR12).

Among the treatment-naive groups, SVR12 was 100% with the ribavirin-containing regimen and 90.9% with the ribavirin-free regimen (not statistically different). SVR12 was 100% in the treatment-experienced group. Headache was the most frequent adverse event; however, no discontinuation occurred due to the study drug.

CITATION(S):

Hézode C et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): A randomised, open-label trial. Lancet 2015 Mar 30.