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

Background: 12-week sofosbuvir/ledipasvir combination is approved for the treatment of hcv genotype 4. objectives: 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. methods: 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). results: 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. conclusions: 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.