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Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial.


ABSTRACT: Worldwide, 50% of human immunodeficiency virus (HIV)-infected people are women. This study was to evaluate whether the safety and efficacy outcomes of three initial antiretroviral regimens (ARVs) differed by sex.Antiretroviral regimen naive participants from nine countries in four continents were assigned to ARVs with efavirenz (EFV) plus lamivudine-zidovudine, atazanavir (ATV) plus didanosine (ddI)-EC/emtricitabine (FTC) or EFV plus FTC-tenofovir-DF. The primary objective was to estimate the sex difference on efficacy outcome of treatment failure defined as one of the following: 1. Time to 1st of confirmed virologic failure, 2. WHO Stage 4 progression or 3. death with hazard ratio (HR) and 95% confidence interval (CI) from adjusted Cox regression models.In all, 739 (47%) women and 832 (53%) men with HIV were evaluated. Women had higher pretreatment CD4+(182 vs 165?cells/mm(3); P?

SUBMITTER: Firnhaber C 

PROVIDER: S-EPMC4604209 | biostudies-literature | 2015 May-Jun

REPOSITORIES: biostudies-literature

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Differences in antiretroviral safety and efficacy by sex in a multinational randomized clinical trial.

Firnhaber Cynthia C   Smeaton Laura M LM   Grinsztejn Beatriz B   Lalloo Umesh U   Faesen Sharla S   Samaneka Wadzanai W   Infante Rosa R   Rana Aadia A   Kumarasamy Nagalingeswaran N   Hakim James J   Campbell Thomas B TB  

HIV clinical trials 20150515 3


<h4>Background and objective</h4>Worldwide, 50% of human immunodeficiency virus (HIV)-infected people are women. This study was to evaluate whether the safety and efficacy outcomes of three initial antiretroviral regimens (ARVs) differed by sex.<h4>Methods</h4>Antiretroviral regimen naive participants from nine countries in four continents were assigned to ARVs with efavirenz (EFV) plus lamivudine-zidovudine, atazanavir (ATV) plus didanosine (ddI)-EC/emtricitabine (FTC) or EFV plus FTC-tenofovir  ...[more]

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