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The challenge

The NSW HIV Strategy, released on 1 December 2015, aimed for the virtual elimination of HIV transmission in NSW by 2020. HIV treatment as prevention has been ramped up over the 3 years to 2015, but despite this, and substantial ongoing investment in community-wide promotion of safe sexual behaviour, new HIV diagnoses in NSW had declined only slightly. EPIC-NSW was a large-scale, targeted implementation study which aimed for the rapid roll-out of HIV pre-exposure prophylaxis (PrEP), to at least 3,700 individuals at high risk of HIV, in order to rapidly decrease HIV transmission.

The project

The project aimed to enrol mostly gay and bisexual men at high risk of HIV. Study participants commenced on daily oral PrEP according to the NSW PrEP Guidelines. By rapidly rolling out PrEP and following participants for 2 years, the study researchers expected a reduction of about 50% in new HIV diagnoses in NSW due to decreased infection in the cohort, and by a larger percentage due to the interruption of chains of transmission. The rapid and large-scale roll-out of PrEP was expected to aid the NSW HIV Strategy in achieving the goal of the virtual elimination of HIV transmission by 2020.

The method

The project was an implementation research project to mimic the conditions that would occur when PrEP was rolled out at the population level. There was no control arm. The project was conducted within the Clinical Trials Notification framework. All follow-up information were electronically extracted from clinical records by linking to the ACCESS study database. The project was expanded so that all eligible NSW and ACT participants could obtain PrEP and was extended until publicly-subsidised PrEP became available in Australia. TDF/FTC as PrEP were prescribed according to the NSW guidelines.

The results

The project enrolled 9,709 study participants of whom 9,596 were dispensed PrEP, between March 1 2016 and April 30 2018. Participants were followed until March 31 2019. HIV incidence remained less than 2 per 1,000 person-years over up to three-years of follow-up, including during a transition from study-provided to publicly-subsidised PrEP.

The impact

To our knowledge, EPIC-NSW is the first large-scale study to demonstrate efficacy of PrEP over a follow up period of up to three years. The final follow-up of the EPIC-NSW project provides reassuring data that extended provision of PrEP for a period of up to 3 years, associated with a transition to off-study PrEP provision with a moderate drug co-payment, was associated with a continuing very low HIV incidence. PrEP failures in our large cohort only occurred in association with non-adherence, suggesting a real-world efficacy in adherent individuals that is close to 100%. There was a decrease of about 40% in early stage HIV infections state-wide in NSW.

Project collaborators

New South Wales Health; Australian Capital Territory Health Directorate; ACON – New South Wales; Australasian Society for HIV, Viral Hepatitis & Sexual Health Medicine (ASHM); Positive Life NSW; General practitioners who specialise in HIV and NSW publicly funded sexual health clinics and private practices; Local Health Districts – New South Wales

Project funding

The project was funded by the New South Wales Ministry of Health and the ACT Health Directorate. The first 24,000 bottles of TDF/FTC were provided by Gilead Sciences and the remaining medications were supplied by Mylan Laboratories Ltd funded by the New South Wales Ministry of Health.