High prices for Direct Acting Antivirals (DAAs) are a barrier to treatment access. High-income countries such as Russia, China, Southeast Asia and Eastern Europe are not included in voluntary license agreements, and prices of DAAs in these countries are very high. In most of these countries, individual citizens can legally import non-registered medicines for their personal use. An increasing number of individuals are treating their Hepatitis C infection with generic drugs produced in India, China or Egypt. This analysis assessed the effectiveness of generic DAAs imported into 40 countries.
568 patients sourced generic versions of sofosbuvir (SOF), ledipasvir (LDV) and daclatasvir (DCV) from suppliers in India, Bangladesh, China and Egypt via established Buyers Clubs and personal connections. The choice of DAAs and the length of treatment were determined based on baseline RNA levels, HCV Genotype and stage of fibrosis. Patient HCV RNA levels were evaluated pre-treatment, during treatment, at end of treatment (EOT) and for SVR 4, 12, and 24 weeks.
Overall, 568 patients submitted results (146 from an Australian Buyers Club, 154 from a Chinese Buyers Club, 200 from a Russian Buyers Club, 68 from a Southeast Asian Buyers Club). Of these, 121 received SOF (59 with RBV), 169 received SOF/LDV (18 with RBV), 279 received SOF/DCV (15 with RBV) and 1 received SOF/LDV/DCV. Overall, the patients were 64% male with a mean age of 43.2 years; 47% were Genotype 1, and 11% cirrhotic. Mean baseline HCV RNA was 6.9 log10 IU/mL. A rapid virological response (RVR) was observed in 94% (29/31) of patients treated with SOF/RBV, 84% (137/163) of the patients treated with SOF/DCV and 80% (75/94) of the patients treated with SOF/LDV. Based on currently available data, the percentage of patients with HCV RNA
Treatment with legally imported generic DAAs achieved high rates of HCV RNA undetectability at the end of treatment and SVR in the majority of patients evaluated to date. The efficacy observed was similar to Phase 3 trials of the branded medicines. Mass treatment with the current generic DAAs is an alternative and feasible route of accessing economical DAAs, where the high-prices for branded DAAs prevent access to treatment.