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

Abstract

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.

EASL recommendations on treatment of hepatitis C: Final update of the series☆

“…Generic drugs and their combinations produced by companies under the license of the Medicines Patent Pool and prequalified by WHO and/or other regulatory authorities have been shown to generate similar results to the original compounds, with similar safety and tolerability. [157][158][159][160][161][162][163][164][165][166][167] The panel recognises the heterogeneity of per capita incomes and health insurance systems across Europe and in other regions, and therefore the constraints that may necessitate continued utilisation of regimens described in previous versions of these recommendations but no longer recommended. In settings where none of the IFN-free, ribavirin-free options proposed in this document are available, options proposed in previous versions of these recommendations remain acceptable for patients likely to respond to these regimens until new DAAs become available and affordable; see prior EASL Recommendations on Treatment of Hepatitis C. 120,[168][169][170][171] In particular, in many lowand middle-income countries where the pangenotypic DAA combinations recommended in the present document are not available and/or not affordable, the combination of generic sofosbuvir and daclatasvir is safe and well tolerated and provides high SVR rates at a very low price.…”

Pharmaceutical policies and regulations of oral antiviral drugs for treatment of hepatitis C in Egypt—case study

“…Several studies showed that the locally produced generic direct-acting antivirals (DAAs) are just as effective and safe as their branded equivalents for the treatment of chronic hepatitis C virus (HCV) infection [ 20 , 21 ]. Key informants’ clinicians indicated that generic DAAs used in treating patients demonstrated equal potency, safety, and tolerability compared to original brands.…”

Evaluation of the Safety and Resistance Associated Variants of Sofosbuvir/Daclatasvir Among Egyptian Patients With Hepatitis C Virus: A Prospective Study

“…Prevalence of HCV in Egypt is one of the highest rate worldwide. The recent introduction of DAA therapy has revolutionized the treatment of chronic HCV infection particularly in Egypt, with very high SVR rates in clinical trials and slightly lower rates in reallife cohorts 7 . The emergence of HCV RAVs could be a cause for this difference.…”