The safety and tolerability of long-acting injectable cabotegravir (CAB-LA) as HIV pre-exposure prophylaxis (PrEP) for cisgender women during pregnancy was confirmed in a global study. Results from over 300 pregnancies and infants were shared at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
CAB-LA, sold under the brand name Apretude in some regions, is an effective method for preventing HIV, delivered through an intramuscular injection every two months. In fact, a previous trial had demonstrated it’s superior protection over oral TDF/FTC. Nonetheless, there has been limited information available about its safety during pregnancy up until this point.
The study, HPTN 084, was conducted to evaluate the effectiveness of CAB-LA in cisgender women across several countries in East and Southern Africa. The participants were HIV-negative women who had to the potential to become pregnant during the study.
They had the option to choose between CAB-LA or oral PrEP (TDF/FTC) and could use contraception if they wished. The study included thorough safety monitoring throughout its duration. Pregnant participants were carefully observed for complications related to pregnancy, such as gestational hypertension, pre-eclampsia, and weight gain, as well as infant outcomes, including miscarriage, stillbirth, premature birth, and low birth weight.
The study recorded a total of 367 pregnancies during this phase. Looking at adverse events the study recorded:
Maternal adverse events:
- 45.7 per 100 person years for those who used CAB-LA during pregnancy
- 47.1 per 100 person years for those who used CAB-LA before pregnancy
- 37.5 per 100 person years who did not use CAB-LA at all
Adverse outcomes for infants:
- 33% for pregnancies involving CAB-LA use
- 38% for pregnancies where there had been prior CAB-LA use
- 27% where there had been no CAB-LA use at all.
There was one significant congenital anomaly reported in a participant who was receiving CAB-LA. Fortunately, there were no maternal fatalities. Overall, the pregnancy and infant outcomes observed in this study were similar to those expected in the general population.
In general, CAB-LA proved to be safe and well accepted. These results highlight the safety of administering CAB-LA before and throughout pregnancy.
Kimberly Smith, MD, MPH, Head of Research & Development at ViiV Healthcare, said:
“Today’s late-breaking pregnancy safety data from the HPTN 084 open label extension add to the body of evidence for Apretude (cabotegravir LA) as a prevention option for women, including those who conceive while on this long-acting regimen. Women continue to tell us they need more options for HIV prevention, which is why we have been focused on studying cabotegravir LA for PrEP in women from the very beginning. We will continue to prioritise their needs, and those of others disproportionately affected by HIV, as part of our ongoing commitment to ending the epidemic.”
The study was conducted and implemented by the NIH-funded HIV Prevention Trials Network (HPTN). NIAID sponsored and co-funded the trial with ViiV Healthcare and the Bill & Melinda Gates Foundation.
