Randomized Trial of Clinical Safety of Daily Oral Tenofovir Disoproxil Fumarate Among HIV-Uninfected Men Who Have Sex With Men in the United States

Abstract

Daily oral TDF was well tolerated, with reasonable adherence. No significant renal concerns were identified.

Sexually transmissible infection control programs for men who have sex with men – what will they look like in 2020?

“…Adverse effects caused by FTC-TDF observed in the placebo-controlled pre-exposure prophylaxis initiative (iPrEx) and USA MSM safety trials included nausea, unintentional weight loss, and reduced bone mineral density (~1.5% at 1 year without an increase in fracture risk). 25,26,29 Despite those documented side effects, a recent narrative review concluded that short-and medium-term use of FTC-TDF for PrEP has a safety profile comparable to aspirin. 30 Similar to PrEP for HIV infection, prophylaxis against bacterial STIs has recently shown some promise.…”

“…In 2012, the USA Food and Drug Administration approved Truvada ® (Gilead Sciences, Inc., Foster City, CA, USA) in combination with safer sex practices for use as HIV PrEP in adults following reports of its safety and effectiveness in phase III clinical trials. 25,26 Truvada ® (FTC-TDF) is a fixed-dose combination of two antiviral agents: emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) labelled for once daily oral dosing. Studies have found that adherence to this daily regimen is correlated with its effectiveness in preventing HIV infection, which has been mathematically modelled to be as high as 99% in MSM, with daily oral dosing as prescribed.…”

Preexposure Prophylaxis (PrEP) for HIV Prevention: The Primary Care Perspective

“…In May 2014 the Centers for Disease Control and Prevention (CDC) published updated practice guidelines recommending the use of PrEP with daily oral dosing of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) (Truvada; Gilead Sciences, Foster City, CA) for this indication. 6 This recommendation is based on several randomized controlled trials (RCTs) [7][8][9][10][11] and a Cochrane review 12 supporting the safety and efficacy of PrEP for high-risk individuals, including MSM, injection drug users (IDUs), and heterosexual women who have sex with MSM or IDUs. The Vancouver Consensus, which emerged from the 2015 International AIDS Society Conference, states that PrEP "must be made available to protect those at high risk of acquiring HIV."…”

Stakeholder Engagement in HIV Cure Research: Lessons Learned from Other HIV Interventions and the Way Forward

“…65,66 By that time, research efforts had already advanced considerably. 61,67,68 Subsequent trials were more successful in involving the community, government, and strong oversight of study operations. 59 Illustrating that civil society can influence the implementation of scientific findings, a 2011 letter of US activists to the US Food and Drug Administration was issued to review the PrEP tenofovir/emtricitabine daily regimen.…”