Esmat G, et al. - The efficacy and safety of the combination of ravidasvir (an NS5A inhibitor) and sofosbuvir to treat chronic hepatitis C (HCV)-genotype-4 (GT4) infected patients were evaluated in this study. For HCV-GT4 infected patients with and without cirrhosis, treatment with ravidasvir plus sofosbuvir was well-tolerated and correlated with high sustained virologic response rate, with or without ribavirin, regardless of previous interferon-based treatments.

• The researchers recruited 300 patients with HCV-GT4 infection in 3 groups:
  • Treatment-naïve patients with or without compensated Child-A cirrhosis (Group 1)
  • Interferon-experienced patients without cirrhosis (Group 2)
  • Interferon-experienced patients with cirrhosis (Group 3).
• For 12 weeks, Groups 1 and 2 received ravidasvir 200 mg QD plus sofosbuvir 400 mg QD and were randomized 1:1 to treatment with or without weight-based ribavirin.
• Patients in Group 3 received ravidasvir plus sofosbuvir with ribavirin and were randomized 1:1 to a treatment duration of 12 weeks or 16 weeks.
• Sustained virologic response at 12 weeks post treatment (SVR12) was the primary endpoint.

• The researchers enrolled 298 patients: 149 in Group 1, 79 in Group 2 and 70 in Group 3.
• They achieved SVR12 in 95.3% of all patients who started the study, including 98% of patients without cirrhosis and 91% of patients with cirrhosis, whether treatment-naïve or IFN-experienced.
• They found no effects of ribavirin intake and history of previous interferon therapy on SVR12 rates.
• There were no virologic breakthroughs.
• As per the outcomes, study treatment was well-tolerated.