Wide-scale implementation of oral tenofovir-based pre-exposure prophylaxis (PrEP) for HIV prevention is now policy in many settings. However, the optimal frequency for monitoring kidney function remains uncertain. We investigated the impact of 6-monthly compared with 3-monthly creatinine clearance (CrCl) monitoring on the identification of moderate kidney dysfunction, defined as CrCl <60 mL/min.
Data were from 2 prospective daily oral PrEP studies in Kenya and Uganda: the Partners PrEP Study, a randomized safety, and efficacy trial of PrEP that conducted 3-monthly CrCl monitoring (n = 4404) and the Partners Demonstration Project (n = 954), an open-label delivery study of PrEP that used 6-monthly monitoring. CrCl ≥60 mL/min was required for enrollment in both studies. Abnormal results were followed with confirmatory testing within approximately 1 week. Follow-up was for up to 24 months.
Of 5358 participants included in the analysis, 87% were younger than 45 years, a third were female, and 21% had a baseline CrCl between 60 and 90 mL/min. Confirmed CrCl <60 mL/min events were rare, occurring in 52 individuals (<1%) in 24 months. The 12-month cumulative proportion of persons with CrCl <60 mL/min was 0.2% with 3-monthly screening and 0.5% with 6-monthly screening. Older age (>45 years), lower weight (<55 kg), elevated blood pressure (>140 mm Hg), and baseline CrCl between 60 and 90 mL/min were independently associated with CrCl decline <60 mL/min during follow-up.
In these 2 PrEP studies, with generally young participants, the occurrence and pattern of clinically relevant decline in CrCl were not qualitatively different based on 3- or 6-monthly CrCl monitoring schedule. These data suggest that for most persons receiving PrEP for up to 24 months, less frequent CrCl monitoring would be safe and reduce required expenditures for repeat confirmatory testing.
*Department of Global Health, University of Washington, Seattle, WA;
†Division of Disease Control, School of Public Health, Makerere University, Kampala, Uganda;
Departments of ‡Epidemiology;
§Medicine, University of Washington, Seattle, WA;
‖Department of Medicine, Division of Nephrology, Icahn School of Medicine at Mount Sinai, New York, NY;
¶Kenya Medical Research Institute, Nairobi, Kenya;
#Department of Medicine, University of Manitoba, Winnipeg, Canada;
**Department of Obstetrics and Gynecology, University of Nairobi, Nairobi, Kenya; and
††Department of Medicine, Makerere University, Kampala, Kenya.
Correspondence to: Kenneth K. Mugwanya, MBChB, MS, PhD, University of Washington, 325 Ninth Avenue, UW Box 359927 Seattle, WA 98104 (e-mail: email@example.com).
The Partners Demonstration Project was funded by the National Institute of Mental Health of the US National Institutes of Health (Grant R01 MH095507), the Bill & Melinda Gates Foundation (Grant OPP1056051), and through the generous support of the American people through the US Agency for International Development (cooperative agreement AID-OAA-A-12-00023). The Partners PrEP Study was funded by the Bill & Melinda Gates Foundation (Grant OPP47674). Gilead Sciences donated the PrEP medication for both studies but had no role in data collection or analysis. The results and interpretation presented here do not necessarily reflect the views of the study funders.
Abstract presented at the International AIDS Conference; July 18–22, 2016; Durban, South Africa.
The authors have no funding or conflicts of interest to disclose.
K.K.M., J.M.B, and R.H. conceived the study and wrote the first draft of the manuscript. K.K.M. performed the statistical analysis. C.W., C.L.C., A.R., J.K., and E.K. contributed critical revisions to the analysis and interpretation. All authors contributed to the writing of the final draft.
Members of the Partners PrEP Study Team and Partners Demonstration Project Team listed in Appendix 1.
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Received June 30, 2017
Accepted October 12, 2017