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.