Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

Abstract

Introduction Antiretroviral pre-exposure prophylaxis (PrEP) reduces the incidence of acquisition of human immunodeficiency virus type 1 (HIV-1) in men who have sex with men and is a promising approach for preventing HIV-1 in heterosexual populations. Methods We conducted a randomized, three-arm trial of oral antiretroviral PrEP among heterosexual couples from Kenya and Uganda in which one member was HIV-1 seronegative and the other HIV-1 seropositive. Seronegative partners were randomly assigned to once-daily tenofovir (TDF), combination emtricitabine/tenofovir (FTC/TDF), or matching placebo and followed monthly for up to 36 months. At enrollment, HIV-1 seropositive partners were not eligible for antiretroviral therapy under national guidelines. All couples received standard HIV-1 treatment and prevention services, including individual and couples risk-reduction counseling and condoms. Results 4758 couples were enrolled; for 62%, the HIV-1 seronegative partner was male. For HIV-1 seropositive participants, the median CD4 count was 495 cells/μL (interquartile range 375–662). Of 82 post-randomization HIV-1 infections, 17 were among those assigned TDF (incidence 0.65 per 100 person-years), 13 among those assigned FTC/TDF (incidence 0.50 per 100 person-years), and 52 among those assigned placebo (incidence 1.99 per 100 person-years), indicating a 67% relative reduction in HIV-1 incidence for TDF (95% CI 44 to 81, p<0.001) and 75% for FTC/TDF (95% CI 55 to 87, p<0.001). HIV-1 protective effects of FTC/TDF and TDF were not significantly different (p=0.23), and both study medications significantly reduced HIV-1 incidence in both men and women. The rate of serious medical events was similar across the study arms. Conclusions Oral TDF and FTC/TDF provided substantial protection against HIV-1 acquisition in heterosexual men and women, with comparable efficacy of TDF and FTC/TDF. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number NCT00557245)

Safety and Efficacy of a Dapivirine Vaginal Ring for HIV Prevention in Women

“…The protection that was observed in this trial among high-risk women is lower than that shown with once-daily tenofovir or combination tenofovir-emtricitabine oral prophylaxis in men who have sex with men 19 and in heterosexual HIV-1-discordant couples. 20 However, in two clinical trials of tenofovir and of tenofovir or tenofovir-emtricitabine oral prophylaxis in participants who are similar to those enrolled in our trial, no protection against HIV-1 infection was observed, because of poor adherence to the daily use of the trial drugs. 11,12 Similarly, in studies that evaluated microbicides, one study of a vaginal gel containing tenofovir showed evidence of protection from HIV-1 infection, 21 but this result was not confirmed in subsequent studies.…”

Racial/Ethnic Differences in Trust in Health Care: HIV Conspiracy Beliefs and Vaccine Research Participation

“…More than 30 years into the HIV/AIDS epidemic, an effective HIV vaccine remains an elusive public health goal. Despite important discoveries about the effectiveness of prevention interventions, such as male circumcision 32,33 and the use of antiretroviral drugs such as microbicides, 34 prophylactic therapy for HIV-uninfected individuals, 35,36 or life-long suppressive therapy for infected individuals, 37 an effective vaccine able to confer long-term immunity is still considered a necessity if we are to eventually end the global AIDS pandemic. 38 Our objectives with this research were to investigate (1) whether trust in research and HIV conspiracy beliefs differed by racial/ ethnic group among community-recruited individuals in a large metropolitan area in the Midwest, and (2) whether trust in research and HIV conspiracy beliefs were associated with willingness to participate in HIV vaccine trials.…”

Measuring the Cost Effectiveness of HIV Prevention Interventions in the US: Pitfalls and Problems

“…A more comprehensive review that included treatmentbased HIV prevention interventions would certainly be valuable because over the past few years several largescale studies have appeared supporting the usefulness of these interventions and some analysts now believe that successful efforts to reduce the incidence of HIV in the US must include a treatment-based HIV prevention initiative [8][9][10][11][12]. A recent CDC publication states that, ''Now that early ART of HIV-infected persons has been shown to be very effective at preventing secondary transmission of HIV among individuals, the current goal is to determine the extent to which ART can be used broadly and effectively to reduce the spread of HIV within a population [13]''.…”