Mothers in the early phases of HIV infection who continued antiretroviral therapy (ART) postpartum experienced a significantly slower rate of disease progression than those who stopped using ART after delivery, according to a study published May 10, 2017, in the open-access journal PLOS ONE by Judith S. Currier of the University of California, Los Angeles, and colleagues from the International Maternal Pediatric and Adolescent and Adult AIDS Clinical Trials Networks.
Previously, it was unclear whether women in the early stages of HIV infection would incur any clinical benefit from continuing ART in the postpartum period due to a lack of clinical data from randomized trials, and concerns about drug toxicity and long-term maternal ART adherence. In this clinical trial, nearly 2000 young, postpartum women who were not breastfeeding their infants, with pre-ART CD4+ T-cell counts greater than 400 cells/mm3 were recruited across 52 sites in eight countries. Those enrolled were randomized to either continue their ART regimen after delivery or discontinue ART after delivery until ART was needed for their own health or by the choice of the study clinician or participant.. The participants' HIV load and CD4+ cell counts were measured after four weeks, 12 weeks, and every 12 weeks thereafter over a 2.3-year period, with study clinicians starting or changing ART regimens for both groups based on patient needs.
Participants who continued ART after delivery experienced half as many mild to moderate clinical events associated with disease progression (WHO Stages 2 and 3) as those who did not, indicating that it may be beneficial for mothers to continue ART after delivery into the postpartum period. However, all participants showed a very low rate of severe non-AIDS clinical events, such as progression to WHO Stage 4 or death, over the median 2.3 years of follow-up.
Although ART continuation in the postpartum period may be optimal, adherence to the prescribed ART regimens was a considerable challenge, with 23 percent of participants having an elevated viral load during the study period.
Continuation of ART in the postpartum period therefore appears to be of clinical benefit to women with early HIV infection and preserved CD4+ cell counts. This study highlights the need to develop better ways to improve adherence to long-term ART in this vulnerable population.
Dr Currier concludes: "The data from this randomized trial provide further evidence of the benefits of continuing antiretroviral therapy after delivery in women with early stage HIV. The study also highlights the challenges of adherence to ART over the long term, an issue we must find ways to address to maximize the benefits of treatment for women living with HIV."
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Citation: Currier JS, Britto P, Hoffman RM, Brummel S, Masheto G, Joao E, et al. (2017) Randomized trial of stopping or continuing ART among postpartum women with pre-ART CD4 ? 400 cells/mm3 . PLoS ONE 12(5): e0176009. https://doi.org/10.1371/journal.pone.0176009
Funding: Overall support for the International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) Network was provided by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) under Award Numbers UM1AI068632 (IMPAACT LOC), UM1AI068616 (IMPAACT SDMC) and UM1AI106716 (IMPAACT LC), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Mental Health (NIMH). Overall support for the AIDS Clinical Trials Group (ACTG) was provided under NIAID Award Number 5UM1AI068636. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. The NIH funders played a role in study design, data collection and analysis, decision to publish, and preparation of the manuscript. Antiretroviral drugs were provided free of charge for this study by AbbVie, BristolMyers Squibb, Gilead Sciences, GlaxoSmithKline/ViiV, and Merck and Company. IMPACCT-http://impaactnetwork.org/. NIAID - https://www.niaid.nih.gov/. NIH - https://www.nih.gov/. NICHD - https://www.nichd.nih.gov/. NIMH - https://www.nimh.nih.gov/. ACTG - https://actgnetwork.org/. AbbVie - http://www.abbvie.com/. BristolMyers Squibb - http://www.bms.com/. Gilead Sciences - http://www.gilead.com/. GlaxoSMithKline/ViiV - http://www.gilead.com/ Merck and Company - http://www.merck.com/.
Competing Interests: I have read the journal's policy and the authors of this manuscript have the following competing interests: LM is a member of PlosMed editorial board. WA receives research grants and contracts from Merck and Glaxo SMithKline; moneys to University of Colorado Denver(UCD). Spouse and UCD receive royalties from Merck for intellectual property. AC owned stock in Bristol-Myers Squibb. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
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