Authors' objectives: 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.

Authors' results and conclusions: 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). Cost-effectiveness analyses show cost-effectiveness or even cost savings of oral PrEP (with TDF/FTC) in several countries of the Global North.

Authors' recommendations: 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). Cost-effectiveness analyses show cost-effectiveness or even cost savings of oral PrEP (with TDF/FTC) in several countries of the Global North.

Authors' methods: 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. 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.

Project Status: Completed

URL for project: https://aihta.at/page/orale-und-parenterale-praeexpositionsprophylaxe-prep-zur-hiv-praevention-bei-risikopersonen-eine-systematische-uebersichtsarbeit-zur-klinischen-wirksamkeit-und-sicherheit-mit-bewertung-der-organisatorischen-oekonomischen-patient-innenbezogenen-sozialen/en

Year Published: 2023

URL for published report: https://eprints.aihta.at/1436/1/HTA-Projektbericht_Nr.152.pdf

URL for additional information: https://eprints.aihta.at/1436/

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Austria

Organisation Name: Austrian Institute for Health Technology Assessment

Contact Address: Garnisongasse 7/20, A-1090 Vienna, Austria

Contact Name: office@aihta.at

Contact Email: office@aihta.at