2010 - Daily emtricitabine plus tenofovir disoproxil fumarate reduced risk for HIV infection in men who have sex with men

Kalil, Andre C.; Sandkovsky, Uriel S.
April 2011
ACP Journal Club;4/17/2011, Vol. 154 Issue 4, p1
Academic Journal
Question Does daily emtricitabine (FTC) plus tenofovir disoproxil fumarate (TDF) prevent HIV infection in men and transgender women who have sex with men? Methods Design Randomized placebo-controlled trial (Preexposure Prophylaxis Initiative [iPrEx] trial). ClinicalTrials.gov NCT00458393. Allocation Unclear allocation concealment.* Blinding Blinded (participants and endpoint monitoring committee).* Follow-up period >2.8 years (median 1.2 y). Setting 11 centers in Brazil, Ecuador, Peru, South Africa, Thailand, and the USA. Participants 2499 persons >18 years of age (mean age 27 y) who were male at birth; having sex with men; HIV-seronegative and at high-risk for HIV infection in the past 6 months (had anal sex with >4 or >6 male partners, depending on study site, or unprotected anal sex with a partner who had HIV or unknown infection status; current sexually transmitted infection; or past transactional sex activity); scored >80 on the Karnofsky scale; and had creatinine clearance >60 mg/dL. Exclusion criteria included serious, active illnesses (e.g., tuberculosis, cancer requiring treatment, and diabetes needing hypoglycemic agents); use of nephrotoxic agents; past nontraumatic pathologic bone fracture; and possible past use of antiretroviral drugs or anti-HIV vaccines in a blinded clinical trial. Intervention Daily oral FTC, {200 mg}†, plus TDF, {300 mg}† (n =>1251), or placebo (n =>1248). Outcomes HIV infection (positive antibody test or detectable HIV-RNA). Other outcomes included adverse events. Patient follow-up 82% (intention-to-treat analysis). Main results Daily FTC-TDF reduced emergent HIV infection more than placebo (Table). More participants receiving FTC-TDF had grade 2 nausea and >5% unintentional weight loss than those receiving placebo (2% vs 1%, P =>0.04 for both events); groups did not differ for other adverse events or serious adverse events (5% in each group, P =>0.57). Conclusion Daily emtricitabine plus tenofovir disoproxil fumarate reduced risk for HIV infection in high-risk men and transgender women who have sex with men.


Related Articles

  • Combination emtricitabine/tenofovir disoproxil fumarate provided partial protection against HIV in MSM. DeNyse, Ashley // Infectious Disease News;Dec2010, Vol. 23 Issue 12, p26 

    The article reports on a study which found that treatment with oral emtricitabine plus tenofovir disoproxil fumarate provided partial protection against HIV in men who have sex with men.

  • Check interim guidance for PrEP in men, women.  // Contraceptive Technology Update;Oct2012, Vol. 33 Issue 10, p113 

    The Centers for Disease Control and Prevention has issued new interim guidance for use of pre-exposure prophylaxis (PrEP) for in heterosexual men and women at high risk for HIV. • The daily drug regimen may be used by HIV-uninfected individuals to reduce their risk of HIV infection....

  • Emtricitabine/tenofovir disoproxil fumarate in HIV-1 pre-exposure prophylaxis: a guide to its once-daily use in the EU. Deeks, Emma; Lyseng-Williamson, Katherine; Plosker, Greg // Drugs & Therapy Perspectives;Jan2017, Vol. 33 Issue 1, p8 

    The fixed-dose combination of emtricitabine/tenofovir disoproxil fumarate (tenofovir DF) [Truvada] is approved in the EU for pre-exposure prophylaxis, in conjunction with safer sex practices, to reduce the risk of sexually-acquired HIV-1 infection in adults at high risk. Once-daily...

  • Daily PrEP prevents HIV in high risk gay men.  // BMJ: British Medical Journal;9/19/2015, Vol. 351 Issue 8025, ph4860 

    The article discusses research published in the journal "Lancet" on the effectiveness of daily HIV pre-exposure prophylaxis (PrEP) with combined tenofovir disoproxil fumarate and emtricitabine in preventing HIV infections in high risk gay men.

  • PrEP combo provided protection in MSM, transgender women.  // Infectious Disease News;Sep2011, Vol. 24 Issue 9, p44 

    The article discusses a research study which found the safety and effectiveness of pre-exposure prophylaxis with daily oral emtricitabine and tenofovir disoproxil fumarate in preventing human immunodeficiency virus (HIV) acquisition in men who have sex with men (MSM) and transgender women.

  • Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Single-Tablet Regimen: A Guide to Its Use in HIV-1 Infection. Lyseng-Williamson, Katherine A.; Scott, Lesley J. // Clinical Drug Investigation;2012, Vol. 32 Issue 10, p715 

    The once-daily, single-tablet regimen of emtricitabine/rilpivirine/tenofovir disoproxil fumarate (Evipleraâ„¢ [EU]; Compleraâ„¢ [US]) provides a convenient option for antiretroviral therapy in treatment-naive patients with HIV-1 infection. In well designed trials in this patient...

  • Challenges for HIV Pre-Exposure Prophylaxis among Men Who Have Sex with Men in the United States. Mansergh, Gordon; Koblin, Beryl A.; Sullivan, Patrick S. // PLoS Medicine;Aug2012, Vol. 9 Issue 8, p1 

    An essay is presented on challenges for HIV Pre-Exposure prophylaxis (PrEP) among men involved in same sex intercourse in the U.S. The authors mention that such prevention of viral infection with anti-retroviral (ARV) medication was discovered to be effective among men who have sex with men...

  • Final data confirm PrEP reduced risk for HIV in heterosexual couples. Henry, Jennifer; Shafer, Emily // Infectious Disease News;Apr2012, Vol. 25 Issue 4, p17 

    The article reports on the findings by researchers from the University of Washington that once-daily tenofovir and combination emtricitabine/tenofovir reduced the risk for HIV infection in heterosexual men and women with a partner who is HIV-positive.

  • Tenofovir diphosphate concentrations and prophylactic effect in a macaque model of rectal simian HIV transmission. Anderson, Peter L.; Glidden, David V.; Bushman, Lane R.; Heneine, Walid; García-Lerma, J. Gerardo // Journal of Antimicrobial Chemotherapy (JAC);Sep2014, Vol. 69 Issue 9, p2470 

    Objectives This study evaluated the relationship between intracellular tenofovir diphosphate concentrations in peripheral blood mononuclear cells and prophylactic efficacy in a macaque model for HIV pre-exposure prophylaxis (PrEP). Methods Macaques were challenged with simian HIV (SHIV) via...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics