Randomized trials of pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM) have reported efficacy of more than 85%. Modelling predicts PrEP will have greatest population-level efficacy if rapidly targeted, with high coverage, to those at high risk. In New South Wales (NSW), more than 80% of HIV diagnoses occur in MSM. Despite substantial increases in testing and treatment since 2012, and the state approaching the UNAIDS 90/90/90 targets, annual HIV diagnoses varied little over the decade to 2016.
The expanded PrEP Implementation in Communities in NSW study (EPIC-NSW) is an open-label implementation study of the use of co-formulated TDF/FTC to prevent HIV. Commencing March 1 2016, we aimed to recruit all estimated 3700 MSM at high-risk of HIV in NSW by end 2016, in over 20 clinics across the state. High-risk eligibility criteria were based on local epidemiologic data. Co-primary outcomes of the study are (a) HIV incidence among study participants, collected by electronic data capture from clinic data management systems and (b) state-wide HIV diagnoses in MSM, utilizing NSW Ministry of Health HIV surveillance data. HIV surveillance data were reported as (a) all diagnoses and (b) early infection, defined as likely HIV infection in the last 12 months, based on HIV testing history and/or clinical and/or laboratory diagnosis of recent infection.
The initial target of 3700 high-risk MSM was reached in October 2016, with an average monthly recruitment of 499 (range: 442-555). Recruitment is continuing (currently 7293). By September 2017 only one HIV seroconversion in a study participant was documented. In the first half-year of 2017 there were 101 HIV diagnoses in MSM in NSW, 35% lower than the 156 diagnoses in the half-year immediately prior to commencement of recruitment (June-Dec 2015). This was the lowest half-yearly number of HIV diagnoses in MSM since HIV surveillance commenced in NSW in 1985. Early HIV infections in MSM declined from 82 to 46, a 44% decrease.
The high-level, targeted and rapid roll-out of PrEP in NSW led to a 35% decline in state-wide HIV diagnoses in MSM, and a 44% decline in early HIV infections in MSM, to levels unprecedented since the beginning of the HIV epidemic. This was achieved less than one year after the target recruitment was reached. In a concentrated epidemic with high testing and treatment coverage, PrEP scale up led to a rapid decline in HIV transmission at the population level.