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Background: Health benefits of postpartum antiretroviral therapy (ART) for women with high CD4 counts have not been assessed in randomized trials.
Methods: Asymptomatic, HIV+, non-breastfeeding women with pre-ART CD4 cell counts ≥ 400 cells/mm3 started on ART during pregnancy were randomized up to 42 days after delivery to continue or discontinue ART. LPV/RTV+TDF/FTC was the preferred ART regimen. The primary composite endpoint included death, AIDS-defining illness, and serious non-AIDS events. 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 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%), Thai (16%) and White (15%). Median entry CD4 count was 696 cells/mm3, 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 0.34%, significantly lower than expected and not significantly different between arms. WHO Stage 2 and 3 events were reduced with continued ART (Table). Toxicity rates were higher in the continue arm but the difference was not statistically significant. Among women randomized to continue ART, 189/827 (23%) had virologic failure. Of the 155 with resistance testing, 134 (86%) failed without resistance to their current regimen, suggesting non-adherence.


Study Endpoint Table
[Study Endpoint Table]


Conclusions: In the largest randomized trial to date evaluating postpartum ART, serious clinical events were rare among young women with high CD4 cell counts. Continued ART was safe and was associated with reductions in WHO 2/3 conditions. Virologic failure rates were high, underscoring the need to improve adherence in this population.