Preexposure chemoprophylaxis for HIV prevention in men who have sex with men

N Engl J Med. 2010 Dec 30;363(27):2587-99. doi: 10.1056/NEJMoa1011205. Epub 2010 Nov 23.

Abstract

Background: Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition.

Methods: We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections.

Results: The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57).

Conclusions: Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenine / adverse effects
  • Adenine / analogs & derivatives*
  • Adenine / blood
  • Adenine / therapeutic use
  • Administration, Oral
  • Adolescent
  • Adult
  • Anti-HIV Agents / adverse effects
  • Anti-HIV Agents / blood
  • Anti-HIV Agents / therapeutic use*
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives*
  • Deoxycytidine / blood
  • Deoxycytidine / therapeutic use
  • Drug Resistance, Viral
  • Drug Therapy, Combination
  • Emtricitabine
  • Follow-Up Studies
  • HIV / genetics
  • HIV / isolation & purification
  • HIV Antibodies / blood
  • HIV Infections / diagnosis
  • HIV Infections / epidemiology
  • HIV Infections / prevention & control*
  • HIV Seropositivity / diagnosis
  • Homosexuality, Male*
  • Humans
  • Incidence
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Organophosphonates / adverse effects
  • Organophosphonates / blood
  • Organophosphonates / therapeutic use*
  • Patient Compliance
  • RNA, Viral / blood
  • Tenofovir
  • Transsexualism
  • Young Adult

Substances

  • Anti-HIV Agents
  • HIV Antibodies
  • Organophosphonates
  • RNA, Viral
  • Deoxycytidine
  • Tenofovir
  • Emtricitabine
  • Adenine

Associated data

  • ClinicalTrials.gov/NCT00458393