Maternal health outcomes among HIV-infected breastfeeding women with high CD4 counts: results of a treatment strategy trial

Risa M Hoffman, Konstantia Nadia Angelidou, Sean S Brummel, Friday Saidi, Avy Violari, Dingase Dula, Vidya Mave, Lee Fairlie, Gerhard Theron, Moreen Kamateeka, Tsungai Chipato, Benjamin H Chi, Lynda Stranix-Chibanda, Teacler Nematadzira, Dhayendre Moodley, Debika Bhattacharya, Amita Gupta, Anne Coletti, James A McIntyre, Karin L Klingman, Nahida Chakhtoura, David E Shapiro, Mary Glenn Fowler, Judith S Currier, IMPAACT PROMISE 1077BF/FF team, Risa M Hoffman, Konstantia Nadia Angelidou, Sean S Brummel, Friday Saidi, Avy Violari, Dingase Dula, Vidya Mave, Lee Fairlie, Gerhard Theron, Moreen Kamateeka, Tsungai Chipato, Benjamin H Chi, Lynda Stranix-Chibanda, Teacler Nematadzira, Dhayendre Moodley, Debika Bhattacharya, Amita Gupta, Anne Coletti, James A McIntyre, Karin L Klingman, Nahida Chakhtoura, David E Shapiro, Mary Glenn Fowler, Judith S Currier, IMPAACT PROMISE 1077BF/FF team

Abstract

Background: IMPAACT PROMISE 1077BF/FF was a randomized study of antiretroviral therapy (ART) strategies for pregnant and postpartum women with high CD4+ T-cell counts. We describe postpartum outcomes for women in the study who were randomized to continue or discontinue ART after delivery.

Methods: Women with pre-ART CD4+ cell counts ≥350 cells/mm3 who started ART during pregnancy were randomized postpartum to continue or discontinue treatment. Women were enrolled from India, Malawi, South Africa, Tanzania, Uganda, Zambia, and Zimbabwe. The primary outcome was a composite of progression to AIDS-defining illness or death. Log-rank tests and Cox regression models assessed treatment effects. Incidence rates were calculated per 100 person-years. A post hoc analysis evaluated WHO Stage 2/3 events. All analyses were intent-to-treat.

Findings: 1611 women were enrolled (June 2011-October 2014) and 95% were breastfeeding. Median age at entry was 27 years, CD4+ count 728 cells/mm3 and the majority of women were Black African (97%). After a median follow-up of 1.6 years, progression to AIDS-defining illness or death was rare and there was no significant difference between arms (HR: 0·55; 95%CI 0·14, 2·08, p = 0.37). WHO Stage 2/3 events were reduced with continued ART (HR: 0·60; 95%CI 0·39, 0·90, p = 0.01). The arms did not differ with respect to the rate of grade 2, 3, or 4 safety events (p = 0.61).

Interpretation: Serious clinical events were rare among predominately breastfeeding women with high CD4+ cell counts over 18 months after delivery. ART had significant benefit in reducing WHO 2/3 events in this population.

Trial registration: ClinicalTrials.gov NCT01061151.

Keywords: HIV and breastfeeding; HIV/AIDS; antiretroviral therapy (ART); postpartum maternal health.

Conflict of interest statement

Disclosure statement

No potential conflict of interest was reported by the authors.

Figures

Figure 1:
Figure 1:
Description of the PROMISE 1077 BF/FF women included in the analysis. This analysis includes all women on three-drug ART during pregnancy who were randomized postpartum to continue or discontinue, as well as all women randomized to continue ART at cessation of breastfeeding (black boxes).
Figure 2:
Figure 2:
CONSORT flow diagram for women included in the analysis*
Figure 3:
Figure 3:
CD4 T-cell counts over time (median, 10th and 90th percentile, and proportion <350 cells/mm3). The median CD4 T-cell counts in the continue (blue) and discontinue (red) arms are shown at each follow-up visit. The proportion with CD4 T-cells below 350 cells/mm3 are shown across the top of the figure at each time point.
Figure 4:
Figure 4:
Survival curves for key study findings (A) Primary Composite Endpoint; (B) WHO 2 and 3 events; (C) Safety Endpoint

Source: PubMed

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