Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells-mm3Reportar como inadecuado

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Health benefits of postpartum antiretroviral therapy ART for human immunodeficiency virus HIV positive women with high CD4+ T-counts have not been assessed in randomized trials.


Asymptomatic, HIV-positive, non-breastfeeding women with pre-ART CD4+ T-cell counts ≥ 400 cells-mm3 started on ART during pregnancy were randomized up to 42 days after delivery to continue or discontinue ART. Lopinavir-ritonavir plus tenofovir-emtricitabine was the preferred ART regimen. The sample size was selected to provide 88% power to detect a 50% reduction from an annualized primary event rate of 2.07%. A post-hoc analysis evaluated HIV-AIDS-related and World Health Organization WHO Stage 2 and 3 events. All analyses were intent to treat.


1652 women from 52 sites in Argentina, Botswana, Brazil, China, Haiti, Peru, Thailand and the US were enrolled 1-2010-11-2014. Median age was 28 years and major racial categories were Black African 28%, Asian 25% White 15%. Median entry CD4 count was 696 cells-mm3 IQR 575–869, median ART exposure prior to delivery was 19 weeks IQR 13–24 and 94% had entry HIV-1 RNA < 1000 copies-ml. After a median follow-up of 2.3 years, the primary composite endpoint rate was significantly lower than expected, and not significantly different between arms continue arm 0.21 -100 person yearspy; discontinue 0.31-100 py, Hazard ratio HR 0.68, 95% CI: 0.19, 2.40. WHO Stage 2 and 3 events were significantly reduced with continued ART 2.08-100 py vs. 4.36-100 py in the discontinue arm; HR 0.48, 95%CI: 0.33, 0.70. Toxicity rates did not differ significantly between arms. Among women randomized to continue ART, 189-827 23% had virologic failure; of the 155 with resistance testing, 103 66% failed without resistance to their current regimen, suggesting non-adherence.


Overall, serious clinical events were rare among young HIV-positive post-partum women with high CD4 cell counts. Continued ART was safe and was associated with a halving of the rate of WHO 2-3 conditions. Virologic failure rates were high, underscoring the urgent need to improve adherence in this population.

Trial registration

ClinicalTrials.gov NCT00955968

Autor: Judith S. Currier , Paula Britto, Risa M. Hoffman, Sean Brummel, Gaerolwe Masheto, Esau Joao, Breno Santos, Linda Aurpibul, Marce

Fuente: http://plos.srce.hr/


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