Generic Sofosbuvir/Ledipasvir for Treatment of Naïve, Non-Cirrhotic, Easy to Treat Patients with Chronic Hepatitis C Genotype 4: 8 Vs. 12 Weeks of Treatment

12-week sofosbuvir/ledipasvir combination is approved for the treatment of HCV genotype 4.

The study aimed to evaluate the safety and efficacy of generic sofosbuvir/ledipasvir for 8 and 12 weeks in easy to treat patients infected with the hepatitis C virus (HCV) genotype 4.

In this prospective randomized study, 40 naïve non-cirrhotic easy to treat patients were randomized to receive 8 or 12 weeks (groups 1 and 2, respectively) of generic ledipasvir/sofosbuvir (MPIviropack-Plus provided by Marcyrl Pharmaceutical Industries). A simple randomization was done using computer-generated random numbers by Microsoft Excel. The primary endpoint was the sustained virological response 12 weeks post-treatment (SVR12).

There was no significant difference between the two groups of 8 and 12 weeks of therapy in pre-treatment demographics, laboratory parameters, and viral load. A more significant reduction in liver enzymes was noticed in group 2. No adverse events were recorded. SVR12 was 100% with 8 weeks of generic sofosbuvir/ledipasvir and 95% with 12 weeks of the same regimen.

Generic sofosbuvir/ledipasvir for 8 weeks is highly effective with a high rate of SVR12 among naïve non-cirrhotic easy to treat patients with HCV genotype 4 infection. No additional benefit was associated with the extension of the treatment duration to 12 weeks.