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Meta-Analysis
. 2023 Dec 8;39Suppl 1(Suppl 1):e00089522.
doi: 10.1590/0102-311XEN089522. eCollection 2023.

Adverse effects of daily oral pre-exposure prophylaxis in men who have sex with men and transgender women: a systematic review and meta-analysis

Marcos Pereira  1 , Caroline Tianeze de Castro  1 , Laio Magno  1   2 , Tarcio de Almeida Oliveira  1 , Fabiane Soares Gomes  1 , Fabiane Maria Fernandes Neves  3 , Pedro Rafael Dos Santos do Nascimento  1 , Ines Dourado  1
Affiliations
Meta-Analysis

Adverse effects of daily oral pre-exposure prophylaxis in men who have sex with men and transgender women: a systematic review and meta-analysis

Marcos Pereira et al. Cad Saude Publica. .

Abstract
in English, Portuguese, Spanish

The adverse effects of oral pre-exposure prophylaxis (PrEP) using tenofovir disoproxil fumarate are barriers to PrEP initiation and continuation. Although serious effects are rare and predictable, evidence for this assessment among men who have sex with men (MSM) and transgender women (TGW) is still limited. This study assesses the adverse effects of daily oral PrEP in MSM and TGW. This is a systematic review and meta-analysis of clinical trials and cohort studies on the use of daily oral PrEP selected from the PubMed/MEDLINE, Embase, LILACS, and Cochrane CENTRAL databases. Data extraction included adverse effects and changes in renal and hepatic markers. Random effects models were used to summarize the risk of adverse effects throughout the study. Heterogeneity was assessed using the Cochran's Q test and the inconsistency test (I2). The risk of bias and the certainty of the evidence were assessed using the Cochrane Collaboration recommendations. The search identified 653 references. Of these, 10 were selected. All studies assessed the eligibility of renal and hepatic markers. The use of daily oral PrEP was not associated with grade 3 or 4 adverse events (RR = 0.99; 95%CI: 0.83-1.18; I2 = 26.1%), any serious adverse event (RR = 1.04; 95%CI: 0.58-1.87; I2 = 88.4%), grade 3+4 creatinine level (RR = 0.66; 95%CI: 0.24-1.84; I2 = 79.9%), and grade 3 or 4 hypophosphatemia (RR = 0.56; 95%CI: 0.15-2.10). The certainty of the evidence ranged from high to moderate for the outcomes analyzed. Daily oral PrEP is safe and well tolerated by MSM and TGW. Adverse effects were minimal and evenly distributed between intervention and control.

Os efeitos adversos da profilaxia pré-exposição (PrEP) oral com fumarato de tenofovir desoproxila são barreiras para o início e a continuidade da PrEP. Embora os efeitos graves sejam raros e previsíveis, as evidências dessa avaliação entre homens que fazem sexo com homens (HSH) e mulheres transgênero (MTG) ainda são limitadas. Este estudo avalia os efeitos adversos da PrEP oral diária em HSH e MTG. Trata-se de uma revisão sistemática e metanálise de ensaios clínicos e coortes que demonstram o uso de PrEP oral diária selecionados nas bases de dados PubMed/MEDLINE, Embase, LILACS e Cochrane CENTRAL. A extração de dados incluiu os efeitos adversos e alterações nos marcadores renais e hepáticos. Modelos de efeitos aleatórios foram usados para resumir o risco de efeitos adversos ao longo do estudo. A heterogeneidade foi avaliada pelo teste Q de Cochran e inconsistência (I2). O risco de viés e a certeza da evidência foram avaliados por meio das recomendações da Colaboração Cochrane. Foram identificadas 653 referências. Destes, dez foram selecionadas. Todos os estudos avaliaram marcadores renais de elegibilidade e marcadores hepáticos. O uso diário de PrEP oral não foi associado a eventos de grau 3 ou 4 (RR = 0,99; IC95%: 0,83-1,18; I2 = 26,1%), a qualquer evento adverso grave (RR = 1,04; IC95%: 0,58-1,87; I2 =88,4%), à creatinina grau 3 ou 4 (RR = 0,66; IC95%: 0,24-1,84; I2 = 79,9%) e à hipofosfatemia grau 3 ou 4 (RR = 0,56; IC95%: 0,15-2,10). A certeza das evidências variou de alta a moderada para os desfechos analisados. A PrEP oral diária é segura e bem tolerada por HSH e MTG. Os efeitos adversos foram mínimos e distribuídos uniformemente entre a intervenção e o controle.

Los efectos adversos de la profilaxis preexposición (PrEP) oral con fumarato de disoproxilo de tenofovir son barreras para el inicio y la continuación de la PrEP. Aunque los efectos graves son raros y predecibles, la evidencia de esta evaluación entre hombres que tienen sexo con hombres (HSH) y mujeres transgénero (MTG) sigue siendo limitada. Este estudio evalúa los efectos adversos de la PrEP oral diaria en HSH y MTG. Se trata de una revisión sistemática y un metaanálisis de ensayos clínicos y cohortes que demuestran el uso de la PrEP oral diaria seleccionada de las bases de datos PubMed/MEDLINE, Embase, LILACS y Cochrane CENTRAL. La recolección de datos incluyó efectos adversos y cambios en los marcadores renales y hepáticos. Se utilizaron modelos de efectos aleatorios para resumir el riesgo de efectos adversos a lo largo del estudio. La heterogeneidad se evaluó mediante la prueba Q de Cochran y la inconsistencia (I2). El riesgo de sesgo y la certeza de la evidencia se evaluaron utilizando las recomendaciones de la Colaboración Cochrane. Se identificaron 653 referencias. De estas, se seleccionaron diez. Todos los estudios evaluaron los marcadores renales de elegibilidad y los marcadores hepáticos. El uso diario de la PrEP oral no se asoció con eventos de grado 3 o 4 (RR = 0,99; IC95%: 0,83-1,18; I2 = 26,1%), con ningún evento adverso grave (RR = 1,04; IC95%: 0,58-1,87; I2 = 88,4%), con creatinina de grado 3 o 4 (RR = 0,66; IC95%: 0,24-1,84; I2 = 79,9%) y con hipofosfatemia de grado 3 o 4 (RR = 0,56, IC95%: 0,15-2,10). La certeza de la evidencia varió de alta a moderada para los resultados analizados. La PrEP oral diaria es segura y bien tolerada por HSH y MTG. Los efectos adversos fueron mínimos y se distribuyeron uniformemente entre la intervención y el control.

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Figures

Figure 1
Figure 1. Flowchart of study selection.
Figure 2
Figure 2. Assessment of risk of bias in non-randomized studies (ROBINS-I - Risk of Bias in Non-randomized Studies of Interventions).
Figure 3
Figure 3. Forest plots for adverse effects of the use of daily oral pre-exposure prophylaxis (PrEP) in men who have sex with men (MSM) and transgender women (TGW).
See this image and copyright information in PMC

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