The findings come from the HIV Prevention Trials Network (HPTN) 084 open label extension (OLE) study, which evaluated cis-gender women in sub-Saharan Africa who became pregnant while using Apretude for HIV pre-exposure prophylaxis (PrEP). According to ViiV Healthcare, the data showed that Apretude was generally well tolerated among pregnant women and maintained cabotegravir levels above those associated with HIV protection throughout pregnancy.
Kimberly Smith, head of research and development at ViiV Healthcare, commented on the findings: “Today’s late-breaking pregnancy safety data from the HPTN 084 open label extension add to the body of evidence for Apretude 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 prioritize their needs, and those of others disproportionately affected by HIV, as part of our ongoing commitment to ending the epidemic.”
The new data will be presented at the 25th International AIDS Conference in Munich, Germany, that started on July 22nd finishing on the 26th.
Study findings
The HPTN 084 OLE included 2,472 participants who were given the option to use either cabotegravir LA for PrEP or daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets. Participants who became pregnant could choose to continue their Apretude regimen throughout pregnancy. Among the 367 confirmed pregnancies in 348 participants, maternal and pregnancy outcomes for those using cabotegravir LA for PrEP were consistent with those using FTC/TDF and aligned with expected background rates.
The incidence of pregnancy-related maternal adverse events was reported as 45.7 per 100 person-years for those using Apretude during pregnancy, 47.1 per 100 person-years for those using Apretude prior to pregnancy, and 37.5 per 100 person-years for those with no exposure to Apretude. Adverse pregnancy outcomes were similar across all groups, with 33% of women using Apretude during pregnancy reporting negative outcomes compared to 38% of those with prior Apretude use and 27% of those with no exposure. Importantly, no maternal deaths were recorded, and none of the women who became pregnant acquired HIV during pregnancy.
Pharmacokinetic analysis
A sub-study within the HPTN 084 OLE evaluated the pharmacokinetics of cabotegravir in 50 participants who continued using Apretude during pregnancy. The analysis found that cabotegravir concentrations remained above the protective threshold throughout pregnancy. Median concentrations were 2.1 µg/mL before pregnancy, 1.9 µg/mL during pregnancy, and 2.5 µg/mL postpartum. Although cabotegravir levels decreased slightly from the first to the third trimester, they remained within the protective range.
Sinead Delany-Moretlwe, MBBCh, Ph.D., DTM&H, HPTN 084 Protocol Chair, and Research Director at Wits RHI, University of the Witwatersrand in Johannesburg, South Africa, emphasized the significance of these findings: “Women of childbearing age in sub-Saharan Africa experience disproportionately higher rates of HIV incidence, making it essential that we study how HIV medicines impact their health and wellbeing during pregnancy. The findings of the HPTN 084 open label extension provide further evidence on the safety and tolerability of cabotegravir LA for PrEP in expectant mothers and their unborn infants while maintaining protective levels against HIV throughout pregnancy. These findings build upon the well-established efficacy of cabotegravir LA for PrEP and provide reassurance for its usage in this particularly vulnerable population.”
Broader implications
Apretude (cabotegravir LA for PrEP) is approved in several countries, including the US, EU, UK, Canada, Australia, and South Africa, with ongoing submissions to other regulatory agencies. The HPTN 084 trial, funded by the U.S. National Institutes of Health, the Bill & Melinda Gates Foundation, and ViiV Healthcare, highlights the superior efficacy of cabotegravir LA for PrEP over daily oral FTC/TDF in preventing HIV acquisition.
The positive data on Apretude use during pregnancy underscores its potential as a safe and effective HIV prevention method for women, including those who become pregnant. ViiV Healthcare's ongoing commitment to addressing the needs of women at risk of HIV is evident through their dedicated research and development efforts.
