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BACKGROUND: High prices of direct acting antivirals (DAAs) for hepatitis C virus (HCV) can lead to restrictions on access to treatment in high- and middle-income countries. An increasing number of people in these countries are treating their HCV infection with generic drugs produced in India, China, Bangladesh or Egypt. This analysis assessed the efficacy of generic imported DAAs. METHODS: Patients sourced generic versions of sofosbuvir (SOF), ledipasvir (LDV) and daclatasvir (DCV) from suppliers in India, Bangladesh, China and Egypt via three buyers' clubs. The choice of DAAs and the length of treatment were determined 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 then for sustained virological response (SVR) at 4, 12, and 24 weeks, normally by a treating clinician. RESULTS: Overall 616 patients submitted results: 199 from an Australian buyers' club, 205 from a South-east Asian buyers' clubs, and 212 from an Eastern European buyers' club. Of the 616 patients treated, 276 received SOF/LDV (35 with ribavirin [RBV]) and 340 received SOF/DCV (61 with RBV). At baseline, 61% were male, 52% had HCV genotype 1 and 11% had liver cirrhosis. The mean age was 44.3 years and the mean baseline HCV RNA was 6.9 log10 IU/mL. A rapid virological response (RVR) was observed in 314/375 (84%) of the patients treated. Based on currently available data, the percentage of patients with HCV RNA below the lower limit of quantification (LLoQ) was 99% (234/237) at EOT, 99% (299/303) at SVR4 and 99% (247/250) at SVR12. CONCLUSIONS: In this analysis, treatment with imported generic DAAs achieved high rates of HCV RNA undetectability at the end of treatment, and SVR12 in 99% of patients evaluated to date. Mass treatment with generic DAAs is a feasible and economical alternative route of accessing curative DAAs, where the high prices for branded alternatives prevent access to treatment.
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INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is not available on the National Health Service (NHS) in England. People are buying generic versions of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) on the internet, which is legal under UK import laws. METHODS: HIV-negative individuals attending our clinic who reported purchasing generic PrEP online were provided with risk-reduction advice and were evaluated for HIV, hepatitis B and C, renal function and sexually transmitted infections (STIs)on their first visit. They were offered regular follow-up visits every 3 months and given risk-reduction advice. Plasma therapeutic drug monitoring (TDM) for tenofovir and FTC was also offered. RESULTS: 641 individuals accessed the service during 2016-2017. Median time on generic PrEP was 202 days. All were MSM, 81% were white, 75% used PrEP daily and 14% on an event-driven basis, and 67% were on generic TDF/FTC manufactured by Cipla Ltd. There were no serious adverse events. Thirty-nine percent of individuals (191/494) reported using recreational drugs in the 12 months before starting PrEP, and 29% (127/443) reported this while taking PrEP. During follow-up, 26% (142/552) of individuals were diagnosed with an STI at one or more follow-up visits. In 336 person-years of follow-up, there were no cases of HIV infection (0%, 95% CI 0%-1.1%). There were no new cases of hepatitis B and two new cases of hepatitis C. DISCUSSION: There were no new cases of HIV in 641 individuals using generic PrEP. At the same centre, new HIV diagnoses fell from 69 per month in October 2015 to 15 per month in June 2017. We believe that our support for individuals taking generic PrEP has contributed to this fall. There was a 10% increase in STI diagnoses during PrEP compared to baseline. Strategies to reduce STIs remain crucial.