Antiretroviral Preexposure Prophylaxis for Heterosexual HIV Transmission in Botswana

Abstract

Daily TDF-FTC prophylaxis prevented HIV infection in sexually active heterosexual adults. The long-term safety of daily TDF-FTC prophylaxis, including the effect on bone mineral density, remains unknown. (Funded by the Centers for Disease Control and Prevention and the National Institutes of Health; TDF2 ClinicalTrials.gov number, NCT00448669.).

Tenofovir-Based Preexposure Prophylaxis for HIV Infection Among African Women

“…Five cases of resistance have been reported in participants in active-product groups in trials of preexposure prophylaxis; all five participants were enrolled while they had acute HIV-1 infection. [1][2][3] In the FEM-PrEP trial, three cases of M184I/V resistance occurred within 12 weeks after enrollment in the TDF-FTC group; the investigators could not exclude the possibility that the participants were infected at the time of enrollment. 6 Acquired resistance was rare in the VOICE trial, a finding that could be explained by consistently low, rather than intermittent, adherence to the study product.…”

“…[1][2][3][4] On the basis of these observations, in July 2012 the Food and Drug Administration approved daily treatment with Truvada for the prevention of HIV-1 acquisition, and the Centers for Disease Control and Prevention has issued guidelines for its use. 5 However, Truvada was found to be ineffective in preventing HIV-1 acquisition among women in the Preexposure Prophylaxis Trial for HIV Prevention among African Women (FEM-PrEP), whose rate of adherence, as assessed on the basis of plasma tenofovir (TFV) levels, was less than 40%.…”

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]''.…”

“…Notwithstanding the dearth of empirical evidence, almost all cost-effectiveness studies of health interventions in the US discount future health benefits and costs at the rate of 3 % as recommended in a widely cited 1996 publication [12]. In the UK, the National Institute for Health and Care Excellence (NICE) provides assistance to the National Health Service and NICE recommends that cost-effectiveness studies of health technologies discount both costs and health benefits at the same rate of 3.5 % and the World Bank urges analysts to discount the number of QALYs gained in cost-effectiveness studies be discounted at 3 % per year.…”

HIV pre-exposure prophylaxis for women and infants prevents vaginal and oral HIV transmission in a preclinical model of HIV infection

“…5 -8 In women, PrEP can reduce vaginal HIV transmission up to 75%. 7,8 Mother-to-child HIV transmission through breastfeeding is also significantly reduced by daily administration of ARVs to infants and/or their mothers. 9 -12 Despite the demonstrated efficacy of PrEP to reduce HIV transmission to women and infants, these strategies often require extended ARV use prompting concerns about potential drug toxicity and the emergence and transmission of drug-resistant HIV strains if PrEP fails; e.g.…”