Dataset Information

Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men.

ABSTRACT: There is a paucity of data on the effect of antiretroviral medications on male fertility. Couples affected by HIV-1 often have fertility intentions, and antiretroviral medications, as both treatment of HIV-1-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons, are part of peri-conception risk reduction.Within a randomized, placebo-controlled trial of daily oral tenofovir disoproxil fumarate (TDF) and combination emtricitabine (FTC)/TDF PrEP for HIV-1 prevention conducted among heterosexual HIV-1-serodiscordant couples, we assessed the impact of TDF and FTC/TDF use on male fertility, measured as incident pregnancy in female partners of men assigned to PrEP vs. placebo.Of the 2962 HIV-1-uninfected men partners, 986 were randomized to TDF, 1013 to FTC/TDF, and 963 to placebo. The overall pregnancy incidence in their HIV-1-infected female partners was 12.9 per 100 person-years and did not differ significantly across the study arms (13.2 TDF, 12.4 FTC/TDF, 13.2 placebo). The frequency of live births, pregnancy losses, and gestational age at birth or loss was also statistically similar in the three randomization groups.TDF and FTC/TDF, when used as PrEP by HIV-1-uninfected men, did not adversely affect male fertility or pregnancy outcomes.

SUBMITTER: Were EO

PROVIDER: S-EPMC4216472 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men.

Were Edwin O EO Heffron Renee R Mugo Nelly R NR Celum Connie C Mujugira Andrew A Bukusi Elizabeth A EA Baeten Jared M JM

AIDS (London, England) 20140801 13

<h4>Background</h4>There is a paucity of data on the effect of antiretroviral medications on male fertility. Couples affected by HIV-1 often have fertility intentions, and antiretroviral medications, as both treatment of HIV-1-infected persons and pre-exposure prophylaxis (PrEP) for uninfected persons, are part of peri-conception risk reduction.<h4>Methods</h4>Within a randomized, placebo-controlled trial of daily oral tenofovir disoproxil fumarate (TDF) and combination emtricitabine (FTC)/TDF P ...[more]

PMID: 25259704

Similar Datasets

Project description:Pre-exposure prophylaxis (PrEP) has emerged as a promising strategy for preventing the transmission of HIV. Although only one formulation is currently approved for PrEP, research into both new compounds and new delivery systems for PrEP regimens offer intriguing challenges from the perspective of pharmacokinetic and pharmacodynamic modeling. This review aims to provide an overview the current modeling landscape for HIV PrEP, focused on PK/PD and QSP models relating to antiretroviral agents. Both current PrEP treatments and new compounds that show promise as PrEP agents are highlighted, as well as models of uncommon administration routes, predictions based on models of mechanism of action and viral dynamics, and issues related to adherence to therapy. The spread of human immunodeficiency virus (HIV) remains one of the foremost global health concerns. In the absence of a vaccine, other prophylactic strategies have been developed to prevent HIV transmission. One approach, known as pre-exposure prophylaxis (PrEP), allows HIV-negative individuals who are at high risk of exposure to the virus, be it through an HIV-positive sexual partner or through the shared use of drug injection equipment, to substantially reduce the risk of developing an HIV infection. PrEP is a relatively recent approach to combating the HIV epidemic, with the only currently approved treatment being Truvada, a daily oral antiretroviral (ARV) therapy initially indicated in the treatment of active HIV-1 infections, but approved for HIV PrEP in 2012. Although PrEP therapy has consistently demonstrated high efficacy in preventing HIV infection, this efficacy is dependent on patient adherence to the prescribed treatment regimen. This can present a significant problem in low- and middle-income countries, which may lack the infrastructure to provide sufficient access to PrEP medication to maintain daily dosing regimens. Furthermore, while the conventional approach has generally been to advocate for continuous administration akin to regimens used for viral suppression in infected patients, there has been some discussion of whether a better treatment paradigm might be to push for PrEP therapy primarily during those known periods of heightened exposure risk, while relying on post-exposure prophylaxis regimens to prevent infection after unanticipated exposures during low-risk periods. These considerations have led to a push for the development of long-duration and on-demand PrEP formulations, including subdermal and subcutaneous implants, slow-release intramuscular depot injections, vaginal and rectal antimicrobial gels, and intravaginal rings and dissolving films. PrEP therapy is a quickly evolving field, with a variety of antiretroviral compounds and formulations under investigation. This review aims to report on notable drugs and formulations from a pharmacokinetic/pharmacodynamic (PK/PD) modeling perspective. Given the nature of PrEP as a preventive therapy designed for long-term use, clinical trials for PrEP therapies can last for months or even years, particularly in the case of long-duration formulations. Furthermore, in contrast to antiretroviral trials in infected patients, pharmacodynamic endpoints in PrEP therapies are difficult to quantify, as the primary endpoint for efficacy is generally the rate of seroconversion. Computational modeling approaches offer flexible and powerful tools to provide insight into drug behavior in clinical settings, and can ultimately reduce the time, expense, and patient burden incurred in the development of PrEP therapies.

Dataset Information

Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men.

Publications

Pre-exposure prophylaxis does not affect the fertility of HIV-1-uninfected men.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets