Combo Antiviral Evaluated in Patients with Genotype 4 Hepatitis C Virus
The combination antiviral drug ledipasvir/sofosbuvir appears to be a safe and effective treatment option for genotype 4 hepatitis C virus (HCV), a study in Hepatology reports.
Researchers from France conducted a Phase 2, open-label study (n=44) to evaluate the safety and efficacy of ledipasvir/sofosbuvir in treatment-naive and treatment-experienced patients with HCV genotype 4. Of the enrolled patients, 25 had genotype 4a, 10 had genotype 4d, and 9 had other subtypes. All patients received ledipasvir/sofosbuvir 90mg/400mg once daily for 12 weeks.
The primary endpoint was the percentage of patients with HCV RNA <15 IU/mL 12 weeks after stopping therapy (SVR12). The SVR12 rate was 93% (95% CI: 81–99%) with similar rates between treatment-naive and treatment-experienced patients (95% vs. 91%). Three patients who did not obtain SVR12 relapsed within 4 weeks of the end of treatment; none of these patients had cirrhosis. Study authors reported asthenia, headache, and fatigue as the most common adverse events; there were no serious adverse events.
The combination of ledipasvir, an NS5A inhibitor, and sofosbuvir, an NS5B polymerase inhibitor, proved to be safe and effective for a range of HCV 4 genotypes in patients, including those with compensated cirrhosis.
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