Postpartum ART Safe, Beneficial in HIV-Positive Women
A study recently published in PLoS One found continued antiretroviral therapy (ART) to be safe and beneficial in HIV-positive postpartum women with high CD4+ T cell counts.
“This is the first large multicenter randomized clinical trial to compare the strategy of stopping or continuing ART in postpartum women with early stage HIV infection,” the study investigators wrote in their paper.
The open-label trial (ClinicalTrials.gov identifier: NCT00955968) enrolled 1652 HIV-positive women between January 2010 and November 2014 from 52 centers in Argentina, Brazil, Botswana, China, Peru, Haiti, Thailand, and the United States. The median age of the participants was 28. All women were treatment-naïve except for prior ART exposure during pregnancy (median 19 weeks); the median CD4+ T cell count upon enrollment was 696 cells/mm3.
Study participants were randomly assigned in a 1:1 ratio to one of two groups based upon continuation or discontinuation of ART within 42 days after delivery. A combination of lopinavir/ritonavir and fixed-dose tenofovir/emtricitabine was selected as the preferred ART regimen.
A low rate of serious clinical events was observed over a 2.3-year follow-up period in both study groups. Overall, only 10 study participants (0.26%) experienced a primary composite end point event, defined either as death from any cause; AIDS-defining illness; or a non-AIDS-related cardiovascular, renal, or hepatic event. Furthermore, women who received continued ART experienced a 50% decrease in the rates of World Health Organization (WHO) clinical stage 2 and 3 events compared with women who discontinued ART.
“These findings demonstrate a very low rate of serious non-AIDS events among young women as compared to rates previously reported among studies that included populations who were older,” the investigators noted.
The study results further pointed to relatively high rates of virologic failure (23%) in women receiving continued ART. The investigators postulated that this finding is associated, at least in part, with poor long-term adherence to treatment. Namely, 15% of women in the ART group discontinued treatment prematurely.
Therefore, the researchers emphasized the need to “remove the barriers to long-term adherence during the postpartum period.”
Antiretroviral drug resistance was identified as another possible cause of virologic failure - antiretroviral drug resistance testing confirmed that 12% of women failed due to resistance to their current ART.
The investigators concluded that these findings stress “the importance of evaluating newer and potentially more durable antiretroviral agents such as integrase inhibitors” that might circumvent the drug resistance barrier in pregnant and postpartum women.