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Background: The PROUD and IPERGAY trials demonstrated an 86% reduction in new HIV diagnoses from PrEP. However, PrEP is not available on the National Health Service (NHS) in England. Consequently, people are buying generic versions of TDF/FTC via websites such as www.iwantprepnow, which is legal under UK import laws. In February 2016, we enabled people buying PrEP online to test regularly for HIV, hepatitis B/C and sexually transmitted infections (STIs) and to monitor renal function and antiretroviral drug concentrations. We have recorded a 40% reduction in new HIV diagnoses at the 56 Dean Street Clinic in London, from 2015-2016, in parallel with the introduction of generic PrEP. However, concerns remain about STIs and the quality of PrEP purchased online.
Methods: Notes review of HIV-negative individuals on generic PrEP attending 56 Dean Street from February 2016 - January 2017. Patients were given risk reduction advice and evaluated for HIV, hepatitis B/C, renal function and STIs (gonorrhoea, chlamydia and syphilis) and offered 3-monthly follow-up. Plasma Therapeutic Drug Monitoring for TFV and FTC was also offered. Drug concentrations were measured by ultra-performance liquid chromatography.
Results: Of the 398 individuals on PrEP, 99.7% were Male, 81% White; 87.5% took PrEP daily and 12.5% event-driven; 85% of individuals were on generic TDF/FTC from Cipla Ltd (Tenvir-EM). Adequate drug levels were seen in 96% (335/346). Baseline eGFR (>60ml/min) and/or urinalysis was normal in 99% (318/320) with no deterioration in 100% (150/150) of individuals attending follow-up. 42% of patients reported using “chems” in the 12 months before starting PrEP and 25% reported this whilst taking PrEP. During follow-up, 36% of patients were diagnosed with an STI. There were no new cases of HIV diagnosed on PrEP (0%, 95% C.I.: 0.0 - 4.0%). There were no new cases of hepatitis B and one new case of hepatitis C.
Conclusions: Despite 36% of patients being diagnosed with a new STI while taking generic PrEP, there were no new cases of HIV over the duration of this observational study. Concentrations of TFV and FTC were similar to those in individuals on branded Truvada from Gilead. Strategies to reduce incident STIs remain crucial.

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