Pre-exposure prophylaxis (PrEP) is an antiretroviral therapy-based HIV prevention strategy to prevent HIV infection in people who have not been infected but are at high risk of infection. In the EU, one oral drug has been approved so far (emtricitabine + tenofovir disoproxil fumarate [TDF/FTC], brand name Truvada® as well as generic drugs from various manufacturers). In the USA there is another oral drug (emtricitabine + tenofovir alafenamide [TAF/FTC], brand name Descovy®) as well as an injectable drug (cabotegravir, brand name Apretude®). Several European countries have included PrEP in their national health care system and reimburse its costs. In Austria, the costs are currently not reimbursed; TDF/FTC generics are available on private prescription in a few selected pharmacies. The aim of this review is to provide an update evidence synthesis on the effectiveness and safety of approved oral and parenteral PrEP medicines. The review also addresses potential organisational, economic, social, ethical and legal aspects to support evidence-based decision-making on PrEP in Austria.

Through the updated systematic literature search based on two existing systematic reviews (SR), a total of 4 new randomised controlled trials (RCTs) were identified. The new evidence was described narratively and the strength of the evidence was assessed using GRADE. There are, in total, 17 RCTs on oral PrEP and 2 RCTs on injectable PrEP. Oral PrEP (TDF/FTC) shows high effectiveness, especially among men who have sex with men and serodiscordant couples, with effectiveness increasing with higher adherence. Two RCTs demonstrate the effectiveness and safety of injectable PrEP (cabotegravir).

In addition to assessing effectiveness and safety, potential organisational, economic, patient/social, ethical and legal aspects were researched and summarised, and a questionnaire was sent to relevant patient organisations in Austria to provide a user perspective. Cost-effectiveness analyses show cost-effectiveness or even cost savings of oral PrEP (with TDF/FTC) in several countries of the Global North. PrEP should be offered as part of a comprehensive testing, prevention, counselling and treatment service, which may involve different facilities and health care providers. A comprehensive implementation concept is needed that goes beyond drug prescription and ensures that (regional) inequalities are avoided and the appropriate risk groups are reached. A monitoring system to evaluate the programme should be established.