Virological Response rates using Generic Direct Acting Antiviral Treatment for Hepatitis C, Legally Imported into Russia
AASLD LiverLearning®. Dragunova J. Nov 14, 2016; 144913
Topic: Clinical Trials and Therapeutic Developments
Ms. Julia Dragunova
Ms. Julia Dragunova

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TITLE: Virological Response rates using Generic Direct Acting Antiviral Treatment for Hepatitis C, Legally Imported into Russia

This project was not sponsored

Introduction: An estimated 5 million people in Russia are infected with hepatitis C (4.4% of the adult population). Russia and Eastern Europe are not included in voluntary license agreements, and prices of Direct Acting Antivirals in Eastern Europe are very high. Under Russian law, individual citizens can import non-registered medicines for their personal use. An increasing number of Russians are treating their Hepatitis C infection with generic drugs produced in India, China or Egypt. This analysis assessed the efficacy of generic Direct Acting Antivirals (DAAs) imported into Russia.
Methods: Generic versions of sofosbuvir (SOF), ledipasvir (LDV) and daclatasvir (DCV) were sourced from generic suppliers in India, China and Egypt and sent to Russian patients living with Hepatitis C. The choice of DAAs and the length of treatment were determined based on baseline HCV Genotype and stage of fibrosis. Patients taking generic DAAs were evaluated pre-treatment, and at Weeks 4, 12 during treatment (EOT) and then for SVR 4, 12, and 24. This analysis includes available data from 134 patients being monitored in infectious disease and state university hospitals throughout throughout Russia, Belarus, Ukraine and Estonia.
Results: Of the 134 patients treated, 34 received SOF/LDV and 100 received SOF/DCV. Overall, the patients were 52 % male with a mean age of 36 years; 42 % were Genotype 1 and mean baseline HCV RNA was 6.23 log10 IU/mL. A rapid virological response (RVR) was observed in 72 % (23/32) of the patients treated with SOF/DCV and 82 % (9/11) of the patients treated with SOF/LDV. Based on currently available data, the percentage with HCV RNA Conclusions: In this analysis, treatment with legally imported generic DAAs achieved high rates of HCV RNA undetectability at the end of treatment, and SVR in all patients evaluated so far. The efficacy observed is similar to Phase 3 trials of the branded medicines. Mass treatment with the current generic DAAs is a feasible and economical alternative route of accessing curative DAA’s, where the high-prices for branded DAA’s currently prevent access to treatment.
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