Maternal Disease Progression in the First Year after Delivery among HIV+ African Women: HPTN 046 Clinical Trial
Mary Glenn Fowler1, E Brown2, Y Maldonado3, T Chipato4, K Manjii5, K George6, S Eshleman1, S Zwerski7, H Coovadia8, H Watts9, for the HPTN 046 Study Team
1Johns Hopkins Univ Sch of Med, Baltimore, MD, US; 2Fred Hutchinson Cancer Res Ctr, Seattle, WA, US; 3Stanford Univ Sch of Med, CA, US; 4Univ of Zimbabwe Med Sch, Harare; 5Muhimbili Univ of Hlth and Allied Sci, Dar es Salaam, Tanzania; 6FHI 360, Research Triangle Park, NC, US; 7NIAID, NIH, Bethesda, MD, US; 8Univ of the Witwatersrand, Johannesburg, South Africa; and 9Natl Inst of Child Hlth and Human Devt, NIH, Rockville, MD, US
Background: The majority of pregnant HIV+ women in Africa are healthy, with CD4 counts ≥350 and do not meet current criteria for HIV therapy. Recent research indicates the benefits of early treatment initiation among non-pregnant adults with CD4 counts between 350 and 550 to reduce the risk of progression to AIDS. However, rates of disease progression among HIV-infected post-partum African women are not well described. The purpose of this analysis was to assess rates of disease progression over 1 year post partum among African HIV+ women followed in a multi-site randomized placebo-controlled PMTCT trial of infant nevirapine, HPTN 046.
Methods: We analyzed data from 2025 HIV+ women in HPTN 046 vs 2.0 (Zimbabwe and Uganda, n = 347) and vs 3.0 (Tanzania, South Africa, Uganda, Zimbabwe, n = 1678). We used the Kaplan Meier method to assess declines in CD4 to <200 among HIV+ women; and WHO clinical stage-3 to -4 events over 12 months post-partum. In separate Kaplan Meier analyses, we excluded women with CD4 <200, or who were on ART either at or within 6 weeks of delivery.
Results: At delivery, 1430 (71%) women had CD4 ≥350 (29% with CD4 350 to 549; 41% with CD4 ≥550) and 574 (28%) were on ART. At 6 weeks post partum 1855 of 1945 (95%) were WHO clinical stage I-II. By 12 months post-partum, including 6 women who died, 4.3% of HIV+ women with baseline CD4 ≥350 and 1% with CD4>550 within 6 weeks of delivery had a decline in CD4 to <200; and 4.3% had developed AIDS (clinical stage IV or CD4 <200).
Conclusions: Among breast-feeding HIV+ African women with CD4 counts ≥350 at delivery, progression to AIDS (clinical or immunologic) or death was uncommon during the first year post delivery. Decisions on whether to continue newly delivered mothers who do not meet current treatment criteria on triple ARV needs careful long-term follow-up of adherence, resistance, and treatment complications.