Tolerability and effectiveness of generic direct-acting antiviral drugs in eradication of hepatitis C genotype 4 among Egyptian patients.

BACKGROUND: We investigated tolerability and effectiveness of generic, less expensive direct antiviral drugs in the treatment of hepatitis C virus genotype 4 (HCV GT-4) in an Egyptian cohort.

PATIENTS AND METHODS: Retrospectively, we analysed data from 648 patients with HCV GT4 attending Alexandria Main University Hospital from January 2016 to May 2017 [488 treatment naïve/160 treatment-experienced/288 with chronic hepatitis/360 with cirrhosis]. Patients received generic sofosbuvir/ledipasvir (n = 168, treatment naïve = 136, treatment-experienced = 32) or sofosbuvir/daclatasvir (n = 480, treatment naïve = 352, treatment-experienced = 128) ± ribavirin. We assessed sustained virologic response 12 weeks after treatment, non-response, relapse, treatment discontinuation and drug adverse reactions.

RESULTS: An overall sustained virologic response 12 weeks after treatment was achieved in 97.8%, non-response in 0.6%, relapse in 0.3% and discontinuation of treatment in 1.3% of patients. Sofosbuvir/ledipasvir ± ribavirin regimen attained an overall sustained virologic response 12 weeks after treatment in 96.4% of patients (100% of treatment-experienced vs 95.6% of treatment naïve, P = 0.28), vs 98.3% for sofosbuvir/daclatasvir ± ribavirin regimen (100% of treatment-experienced vs 97.7% of treatment naïve, P = 0.08). No severe drug adverse events or deaths were reported except anaemia due to ribavirin.

CONCLUSION: Generic direct antiviral drugs used in treating Egyptian patients with HCV GT-4 demonstrated equal potency, safety and tolerability compared to original brands, with low cost which would help to provide treatment to a larger scale of patients.