International Congress of Drug Therapy in HIV Infection 23-26 October 2016, Glasgow, UK

Abstract

Introduction: High prices of direct-acting antivirals (DAAs) can prevent access to treatment. Generic versions of sofosbuvir (SOF) are being mass produced for prices under 1% of the current U.S. retail price. Under UK and Australian law, individual patients have the legal right to import 3 months of treatment for hepatitis C virus (HCV), for their personal use. This analysis assessed the efficacy and safety of generic DAAs legally imported into countries where treatment access is limited. Methods: SOF, ledipasvir (LDV) and daclatasvir (DCV) were imported from generic companies into Europe, Australia and North America. Selection of DAAs and treatment duration depended on baseline HCV genotype and fibrosis stage. Initial generic supplies were evaluated using high precision liquid chromatography (HPLC) and nuclear magnetic resonance (NMR) to evaluate presence of active drug. Patients taking generic DAAs were evaluated pretreatment, and at weeks 2, 4, 12 and then for SVR4 and 12. Adverse events were recorded. This analysis includes data from 448 patients, whose imported treatment was organized from the FixHepC website. Results: Of the 448 patients treated, 237 received SOF/LDV, 208 SOF/ DCV and 3 SOF/RBV. By HPLC and NMR, all imported drugs passed quality control standards for active DAA drugs. Overall, the patients were 57% male with a mean age of 55 years; 66% were genotype 1, 25% genotype 3 and mean baseline HCV RNA was 6.5 log10 IU/mL. Based on currently available data, the percentage with HCV RNA