Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection

Area of Science:

• Hepatology and Viral Gastroenterology
• Pharmacology and Drug Development

Background:

• Chronic hepatitis C virus (HCV) infection necessitates effective all-oral combination therapies.
• Daclatasvir (NS5A inhibitor) and sofosbuvir (NS5B polymerase inhibitor) were evaluated for HCV treatment.

Purpose of the Study:

• To assess the efficacy of daclatasvir plus sofosbuvir in patients with HCV genotypes 1, 2, or 3.
• To determine sustained virologic response (SVR) rates at 12 weeks post-therapy.

Main Methods:

• Open-label study involving 211 patients with HCV genotypes 1, 2, or 3.
• Patients received daily oral daclatasvir and sofosbuvir, with or without ribavirin, for 12 or 24 weeks.
• Primary endpoint: SVR (<25 IU/mL HCV RNA) 12 weeks after treatment completion.

Main Results:

• High SVR rates observed: 98% for treatment-naive genotype 1, 92% for genotype 2, and 89% for genotype 3.
• Effective in patients with prior treatment failure (98% SVR) and across various subtypes and IL28B genotypes.
• Common adverse events included fatigue, headache, and nausea.

Conclusions:

• Once-daily oral daclatasvir plus sofosbuvir demonstrates high efficacy for HCV genotypes 1, 2, and 3.
• The combination therapy is effective in treatment-naive patients and those with prior treatment failures.