Combo Drug for HCV GT-4, 5 Meets Primary Endpoint in Study

Ledipasvir in combination with sofosbuvir achieved sustained virologic response rates 12 weeks after treatment (SVR12) in 93% and 95% patients with chronic hepatitis C virus (HCV) genotype 4 or 5 infections, respectively, a study presented at the 50th International Liver Congress in Vienna, Austria has shown.

The study evaluated ledipasvir/sofosbuvir 90mg/400mg as a once-daily, fixed-dose combination tablet for 12 weeks in treatment-naive and treatment-experienced patients with or without cirrhosis across five sites in France. Of the 85 patients enrolled in the study, 44 patients had GT-4 and 41 patients had GT-5 chronic HCV infection. Sustained virologic response rates four weeks after treatment (SVR4), a secondary endpoint, in treatment naive patients were 95% and 90% for GT-4 and GT-5 HCV infections, respectively. In treatment-experienced patients with cirrhosis, all of the GT-4 infected patients and 89% of GT-5 infected patients achieved SVR4; in patients without cirrhosis, 91% of GT-4 and 94% of GT-5 infected patients achieved SVR4. Findings showed that SVR12 rates were similar across all patient types.

Researchers concluded that a ribavirin- and interferon-free regimen of ledipasvir/sofosbuvir led to high SVR4 rates of 93% in GT-4 and GT-5 HCV-infected treatment-naive and treatment-experienced patients with or without cirrhosis. This fixed-dose combination oral treatment may be an effective option to treat more patients.

Ledipasvir/sofosbuvir is currently indicated for the treatment of chronic hepatitis C virus genotype 1 infection.

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