Overview of systematic reviews on the risks and benefits of HIV pre-exposure prophylaxis available in the Brazilian Unified Health System
DOI:
https://doi.org/10.5712/rbmfc21(48)3695Keywords:
Pre-exposure prophylaxis, Emtricitabine, tenofovir disoproxil fumarate drug combination, Disease preventionAbstract
This is an overview of systematic reviews aimed at assessing the risks and benefits of HIV PrEP available through SUS. The clinical outcomes of interest were reduction in HIV incidence, sexual behavior and risk compensation, ARV medications, incidence of other STIs, and ARV resistance in cases of seroconversion. For this purpose, a search was conducted in the databases Medline via PubMed, Virtual Health Library (VHL), Epistemonikos, and Cochrane Library up to January 2022, without language restrictions. The reviews were required to include PrEP available through the SUS (TDF/FTC), with placebo as the comparator. Four systematic reviews published between 2016 and 2021 were included. All reviews analyzed different adverse effects of PrEP, identifying a positive association with changes in renal function, reduced BMD, gastrointestinal alterations (nausea and vomiting), and >5% body weight loss. The efficacy of PrEP was confirmed in cases of moderate and high adherence. No increase in STI rates, risk compensation, or ARV resistance in cases of seroconversion was identified. Therefore, TDF/FTC-based PrEP available through the Brazilian SUS is effective in reducing HIV incidence among individuals at higher risk who maintain moderate to high adherence. However, it is an additive prevention measure offered to asymptomatic individuals. In this context, shared decision-making regarding its indication is important, as not everyone will benefit equally and there is a risk of adverse events
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Brasil. Ministério da Saúde. Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde. Secretaria de Vigilância em Saúde. Protocolo clínico e diretrizes terapêuticas para profilaxia pré-exposição (PrEP) de risco à infecção pelo HIV [Internet]. Ministério da Saúde; 2022 [acessado em 21 jun. 2026]. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/protocolo_clinico_profilaxia_prep.pdf
Alencar TMD. Protocolo clínico e diretrizes terapêuticas para profilaxia pré-exposição (PrEP) de risco à infecção pelo HIV [Internet]. Ministério da Saúde; 2018 [acessado em 21 jun. 2026]. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/protocolo_clinico_diretrizes_terapeuticas_profilaxia_pre_exposicao_risco_infeccao_hiv.pdf
United States. Public Health Service. Centers for Disease Control and Prevention (U.S.). National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (U.S.). Division of HIV/AIDS Prevention. Preexposure Prophylaxis Work Group. Preexposure prophylaxis for the prevention of HIV infection in the United States – a clinical practice guideline. US Public Health Service; 2021.
Capeletti NM. Rastreamento, check-up e prevenção quaternária. Universidade Aberta do SUS (UNA-SUS); 2017.
Norman AH. Estratégias da medicina preventiva de Geoffrey Rose. Rev Bras Med Fam Comunidade. 2015;10(34):1-3. https://doi.org/10.5712/rbmfc10(34)1092 DOI: https://doi.org/10.5712/rbmfc10(34)1092
Heath I. Combating disease mongering: daunting but nonetheless essential. PLoS Med. 2006;3(4):e146. https://doi.org/10.1371/journal.pmed.0030146 DOI: https://doi.org/10.1371/journal.pmed.0030146
Norman AH, Tesser CD. Prevenção quaternária na atenção primária à saúde: uma necessidade do Sistema Único de Saúde. Cad Saúde Pública. 2009;25(9):2012-20. https://doi.org/10.1590/S0102-311X2009000900015 DOI: https://doi.org/10.1590/S0102-311X2009000900015
Brasil. Ministério da Saúde. Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde. Departamento de Gestão e Incorporação de Tecnologias e Inovação em Saúde. Diretrizes metodológicas: elaboração de pareceres técnico-científicos [Internet]. Brasília: Ministério da Saúde; 2021 [acessado em 21 jun. 2026]. Disponível em: https://bvsms.saude.gov.br/bvs/publicacoes/diretrizes_metodologicas_elaboracao_parecer_tecnico_1ed.pdf
Gates M, Gates A, Pieper D, Fernandes RM, Tricco AC, Moher D, et al. Reporting guideline for overviews of reviews of healthcare interventions: development of the PRIOR statement. BMJ. 2022;378:e070849. https://doi.org/10.1136/bmj-2022-070849 DOI: https://doi.org/10.1136/bmj-2022-070849
Shah S, Pilkington V, Hill A. Is tenofovir disoproxil fumarate associated with weight loss? AIDS. 2021;35(Suppl 2):S189-95. https://doi.org/10.1097/QAD.0000000000003083 DOI: https://doi.org/10.1097/QAD.0000000000003083
Baranek B, Wang S, Cheung AM, Mishra S, Tan DH. The effect of tenofovir disoproxil fumarate on bone mineral density: a systematic review and meta-analysis. Antivir Ther. 2020;25(1):21-32. https://doi.org/10.3851/IMP3346 DOI: https://doi.org/10.3851/IMP3346
Chou R, Evans C, Hoverman A, Sun C, Dana T, Bougatsos C, et al. Preexposure Prophylaxis for the Prevention of HIV Infection: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2019;321(22):2214-30. https://doi.org/10.1001/jama.2019.2591 DOI: https://doi.org/10.1001/jama.2019.2591
Fonner VA, Dalglish SL, Kennedy CE, Baggaley R, O’Reilly KR, Koechlin FM, et al. Effectiveness and safety of oral HIV preexposure prophylaxis for all populations. AIDS. 2016;30(12):1973-83. https://doi.org/10.1097/QAD.0000000000001145 DOI: https://doi.org/10.1097/QAD.0000000000001145
Ministério da Saúde. Departamento de Gestão e Incorporação de Tecnologias em Saúde. Coordenação-Geral de Gestão de Protocolos Clínicos e Diretrizes Terapêuticas. Protocolo Clínico e Diretrizes Terapêuticas da Osteoporose. Ministério da Saúde; 2022.
Hosek SG, Landovitz RJ, Kapogiannis B, Siberry GK, Rudy B, Rutledge B, et al. Safety and Feasibility of Antiretroviral Preexposure Prophylaxis for Adolescent Men Who Have Sex With Men Aged 15 to 17 Years in the United States. JAMA Pediatr. 2017;171(11):1063-71. https://doi.org/10.1001/jamapediatrics.2017.2007 DOI: https://doi.org/10.1001/jamapediatrics.2017.2007
Havens PL, Perumean-Chaney SE, Patki A, Cofield SS, Wilson CM, Liu N, et al. Changes in Bone Mass After Discontinuation of Preexposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine in Young Men Who Have Sex With Men: Extension Phase Results of Adolescent Trials Network Protocols 110 and 113. Clin Infect Dis. 2020;70(4):687-91. https://doi.org/10.1093/cid/ciz486 DOI: https://doi.org/10.1093/cid/ciz486
Traeger MW, Schroeder SE, Wright EJ, Hellard ME, Cornelisse VJ, Doyle JS, et al. Effects of Pre-exposure Prophylaxis for the Prevention of Human Immunodeficiency Virus Infection on Sexual Risk Behavior in Men Who Have Sex With Men: A Systematic Review and Meta-analysis. Clin Infect Dis. 2018;67(5):676-86. https://doi.org/10.1093/cid/ciy182 DOI: https://doi.org/10.1093/cid/ciy182
Heath I. In defence of a National Sickness Service. BMJ. 2007;334(7583):19. https://doi.org/10.1136/bmj.39066.541678.B7 DOI: https://doi.org/10.1136/bmj.39066.541678.B7
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