BOSTON — Co-trimoxazole, used to reduce mortality in HIV-infected infants, did not improve survival rates for infants exposed to HIV in utero but uninfected with the virus, according to data presented at CROI 2016.
“WHO recommends that all infants born to women with HIV be given co-trimoxazole until the child is proven to be HIV uninfected and the period of HIV transmission risk has ended,” Roger L. Shapiro, MD, MPH, associate professor of immunology and infectious diseases at Harvard T.H. Chan School of Public Health, said during a press conference. “In recent years, there has been an increasing awareness that HIV-exposed but uninfected children are also vulnerable to early mortality, although the reasons for this vulnerability are not clear. Therefore, we studied whether co-trimoxazole might improve survival among these children, as it does for HIV-infected children.”
Roger L. Shapiro
The researchers studied 2,866 HIV-exposed uninfected infants from Botswana from May 2011 to April 2015. Study participants were randomly assigned co-trimoxazole or placebo from ages 2 to 4 weeks until age 15 months. The researchers followed-up with children every 1 to 3 months, through age 18 months when mortality was compared between groups. Children who tested positive for HIV during the study were moved to open-label co-trimoxazole.
In March 2015, the Data and Safety Monitoring Board recommended that Shapiro and colleagues stop the study, based on early results. The researchers found that co-trimoxazole was unlikely to benefit HIV-exposed uninfected infants. Results showed that the number of deaths among patients assigned co-trimoxazole (n = 30) and placebo (n = 34) was similar.
Furthermore, hospitalizations, grade 3/4 diagnoses and grade 3/4 anemia cases were not statistically significant between groups. The researchers also found that neutropenia was greater in the co-trimoxazole group (7.9% vs. 5.8%; P = .05).
“In nonmalarial settings with low overall mortality, routine co-trimoxazole prophylaxis may not be required among HIV-exposed uninfected children who have a low ongoing mother-to-child transmission risk,” Shapiro said. – by David Costill
Shapiro RL, et al. Abstract 37. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2016; Boston.
Disclosure: The researchers report no relevant financial disclosures.