26 Dec Safety of Tenofovir for HIV Prophylaxis Supported
Medical Research: What is the background for this study? What are the main findings?
Dr. Baeten: The medication tenofovir disoproxil fumarate is used widely for the treatment of HIV-1 infection and, more recently, as pre-exposure prophylaxis (PrEP) to protect against HIV-1 infection for at-risk HIV-1 uninfected persons. Its use has been associated with declines in the estimated glomerular filtration rate (eGFR) when used as part of antiretroviral treatment by HIV-1 infected persons, but limited data are available for risk when used as PrEP for HIV-1 prevention.
Using data from the largest randomized, placebo-controlled trial of PrEP, among heterosexual women and men in Africa, eGFR changes were assessed during prospective follow-up in those receiving pre-exposure prophylaxis and compared to those receiving placebo. PrEP use resulted in a small (-1.59 mL/min/1.73m2, 95% CI -2.44, -0.74) but statistically significant decline in eGFR that was non-progressive over a median of 18 months and a maximum of 36 months of follow-up. PrEP use was not accompanied by a substantial increase in the risk of clinically relevant (≥25%) eGFR decline.
Medical Research: What should clinicians and patients take away from your report?
Dr. Baeten: These data support the safety of TDF-based PrEP in heterosexual populations as part of a comprehensive HIV-1 prevention package.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Baeten: The study required persons with normal renal function at entry, and PrEP effects among subpopulations with co-morbidities or concurrent nephrotoxic medications could not be fully evaluated. In addition, the current study did not evaluate changes in proximal tubular function, another potential consequence of tenofovir disoproxil fumarate exposure, and whether TDF-based PrEP causes early proximal tubular injury in HIV-1 uninfected individuals warrants additional evaluation.