Kidney function in tenofovir disoproxil fumarate-based oral pre-exposure prophylaxis users: a systematic review and meta-analysis of published literature and a multi-country meta-analysis of individual participant data

作者：Robin Schaefer, Pedro Henrique Amparo da Costa Leite, Ronaldo Silva, Quarraisha Abdool Karim, Christopher Akolo, Carlos F. Cáceres, Inês Dourado, Kimberly Green, Anita Hettema, Elske Hoornenborg, Smarajit Jana, Bernhard Kerschberger, Hally Mahler, Sindy Matse, Hamish McManus, Jean‐Michel Molina, Sushena Reza‐Paul, Iskandar Azwa, Maryam Shahmanesh, Doug Taylor, Hamid Vega-Ramírez, Valdiléa G. Veloso, Rachel Baggaley, Shona Dalal · 发表于：UCL Discovery (University College London) · 年份：2022 · DOI：10.60692/3q801-n6x68 · 被引用次数：20 · 研究领域：HIV/AIDS Research and Interventions、HIV, Drug Use, Sexual Risk、HIV/AIDS drug development and treatment

Previous WHO guidance on tenofovir disoproxil fumarate-based oral pre-exposure prophylaxis (PrEP) suggests measuring creatinine levels at PrEP initiation and regularly afterwards, which might represent barriers to PrEP implementation and uptake. We aimed to systematically review published literature on kidney toxicity among tenofovir disoproxil fumarate-based oral PrEP users and conducted an individual participant data meta-analysis (IPDMA) on kidney function among PrEP users in a global implementation project dataset.In this systematic review and meta-analysis we searched PubMed up to June 30, 2021, for randomised controlled trials (RCTs) or cohort studies that reported on graded kidney-related adverse events among oral PrEP users (tenofovir disoproxil fumarate-based PrEP alone or in combination with emtricitabine or lamivudine). We extracted summary data and conducted meta-analyses with random-effects models to estimate relative risks of grade 1 and higher and grade 2 and higher kidney-related adverse events, measured by elevated serum creatinine or decline in estimated creatinine clearance or estimated glomerular filtration rate. The IPDMA included (largely unpublished) individual participant data from 17 PrEP implementation projects and two RCTs. Estimated baseline creatinine clearance and creatinine clearance change after initiation were described by age, gender, and comorbidities. We used random-effects regressions to estimate the risk in decline of creatinine clearance...