Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells-mm3Report as inadecuate




Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ≥ 400 cells-mm3 - Download this document for free, or read online. Document in PDF available to download.

Background

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.

Methods

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.

Results

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.

Conclusions

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



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

Source: http://plos.srce.hr/



DOWNLOAD PDF




Related documents