High incidence of Hepatitis C virus infection observed in the PROUD study of HIV pre-exposure prophylaxis.

HIV negative men who have sex with men (MSM) who access pre-exposure prophylaxis (PrEP) report sexual behaviours that could place them at high risk of hepatitis C virus infection (HCV). We report HCV prevalence and incidence from the PROUD trial of PrEP.PROUD was an open-label, wait-list design randomised trial of HIV PrEP for MSM.Participants were recruited between November 2012 and April 2014, and follow-up continued to October 2016. Initial HCV testing followed national guidelines, with screening "on indication", but was replaced by routine quarterly screening in the latter part of the study.We estimated HCV seroprevalence at enrolment and incidence overall and according to calendar year.544 participants were recruited to PROUD. 133 (24.4%) were screened for HCV at enrolment, and 490 (90.1%) were tested at least once during follow-up. Seroprevalence at enrolment was 2.1% (11/530; 95% CI: 1.0-3.7%). Median follow-up time was 2.6 (IQR: 2.1-3.0) years and total follow-up of 1188.8 person years (PY). Twenty-five participants had a new HCV infection during the trial, yielding an incidence rate of 2.1 per 100 PY (25/1188.8; 95% CI: 1.4-3.1), of which three were re-infections. There was some evidence that HCV incidence increased over calendar time (P-value for trend=0.09), reaching an estimated 4.0 per 100 PY (95% CI: 2.0-8.1)in 2016. In conclusion, participants in PROUD had a high, and possibly increasing, incidence of HCV infection. This high incidence of HCV supports the 2018 BHIVA/BASHH recommendation for quarterly HCV testing among HIV-negative MSM using PrEP in the UK.