BOSTON — Viread used by women during pregnancy did not negatively affect bone mineral content in their infants when compared with the use of zidovudine, according to data presented at CROI 2016.
“Our study was focused on understanding if there was an effect on the bones of infants based on drugs that mothers took during pregnancy, and we were specifically interested in understanding if tenofovir [Viread, Gilead Sciences] had an impact,” George K. Siberry, MD, medical officer with the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development, said during a press conference. “When we measured the bone mineral content [BMC] of infants early on, the good news was that there was no difference in the [BMC] between the infants.”
George K. Siberry
The researchers used data from the IMPAACT PROMISE trial, which randomly assigned pregnant women (n = 452) into three treatment groups. Mothers with high CD4 counts were assigned to receive only zidovudine, a triple ARV regimen of ritonavir-boosted lopinavir and zidovudine or a triple ARV regimen of ritonavir-boosted lopinavir combined with tenofovir. The researchers examined 425 infants born to these women, by measuring their BMC within 3 to 4 weeks of birth. DXA scans were conducted to measure BMC at one of eight sites in four African countries.
Study results showed no significant differences in whole-body BMC between the infants born to mothers who received tenofovir and those assigned zidovudine. The researchers found, however, significantly lower mean whole-body BMC in both of these groups when compared with the infants born to mothers who received only zidovudine.
“This gave some reassurance that tenofovir was not having a major adverse impact on infant bones. Tenofovir is part of first-line regimens for pregnant and nonpregnant women throughout the world,” Siberry said. “We did take note of that lower bone mineral content in both of the triple ARV regimens. But, of course, the known and demonstrated strong benefits of triple ARV therapy to the woman and for prevention of HIV to the infant outweigh, at this point, these concerns.” – by David Costill
Siberry GK, et al. Abstract #36. Presented at: Conference on Retroviruses and Opportunistic Infections; Feb. 22-25, 2016; Boston.
Disclosure: Siberry reports no relevant financial disclosures.