ViiV Healthcare announces new data for Apretude use during pregnancy

GSK (GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer (PFE) and Shionogi as shareholders, today shared new maternal safety and pregnancy outcomes and pharmacokinetic findings from the HIV Prevention Trials Network, HPTN, 084 open label extension, OLE, evaluating cis-gender women in sub-Saharan Africa who became pregnant while using Apretude for HIV pre-exposure prophylaxis, PrEP. The findings showed that cabotegravir LA for PrEP was generally well tolerated among pregnant women, and PK findings demonstrated that cabotegravir levels were maintained above those associated with HIV protection throughout the overall pregnancy period. These data will be presented at the 25th International AIDS Conference being held in Munich, Germany. The HPTN 084 OLE findings showed that cabotegravir LA for PrEP maternal and pregnancy outcomes were consistent across cabotegravir LA for PrEP and FTC/TDF exposure groups and with the expected background rates. Pregnancy-related maternal adverse event incidence was 45.7, 47.1, and 37.5 per 100 person years among those using cabotegravir LA for PrEP during pregnancy, prior to pregnancy, or with no cabotegravir LA for PrEP exposure, respectively. Adverse pregnancy outcome rates were similar across groups, with 33% using cabotegravir LA for PrEP during pregnancy, 38% having prior cabotegravir LA for PrEP use, and 27% never using cabotegravir LA for PrEP reporting a negative outcome. One major congenital anomaly was observed, and no maternal deaths were recorded. None of the women who became pregnant acquired HIV during pregnancy. Pharmacokinetic findings demonstrated that target concentrations of cabotegravir were maintained above those associated with protection against HIV acquisition throughout the overall pregnancy period