Accepted for/Published in: JMIR Public Health and Surveillance
Date Submitted: Jan 20, 2025
Date Accepted: Apr 28, 2025
Tenofovir to prevent HIV infection in western China: a pragmatic randomized controlled trial
ABSTRACT
Background:
The co-formulation of two nucleoside inhibitors shows high efficacy in Pre-exposure prophylaxis(PrEP), yet sole TDF use has not been thoroughly evaluated, and the best regimen remains uncertain.
Objective:
The primary outcomes were the effectiveness and safety of TDF during individuals’ periods of PrEP use. Secondary outcomes were the effectiveness of TDF for participants with good compliance during periods of PrEP use. Tertiary outcomes included the hazard components of HIV infection and behavior change from PrEP initiation to the last visit.
Methods:
We conducted a randomized controlled trial. Participants were randomly assigned (1:1:1) to a time-driven group, event-driven group, or untreated control group. The primary outcomes were the effectiveness and safety of TDF during individuals’ periods of PrEP use. Secondary outcomes were the effectiveness of TDF for participants with good compliance during periods of PrEP use. Tertiary outcomes included the hazard components of HIV infection and behavior change from PrEP initiation to the last visit. For ethical reasons, all participants were provided with condoms and received health education. This study was registered with the Chinese Clinical Trial (ChiCTR-TRC-13003849).
Results:
A total of 1914 participants underwent randomization. During the follow-up of 3513.5 person-years from Jun 2013 to May 2016, HIV seroconversion was observed in 30 persons in time-driven group, 35 in event-driven group and 37 in untreated control group. No severe adverse event was recorded during the trial. For the secondary outcomes, compared with untreated control group, participants with good medication compliance reduced their hazard of HIV infection by 53% (P=.011), and event-driven medication reduced the hazard by 62% (P=.009). For tertiary outcomes, low medication compliance, sex role as 1, no condom use and more sex partners remained significantly associated with HIV risk.
Conclusions:
The efficacy of TDF as PrEP heavily relies on consistent medication adherence. While on-demand usage is advocated as an optimal dosing schedule for PrEP. Clinical Trial: ChiCTR-TRC-13003849
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