ViiV Healthcare Data Shows Promising Pregnancy Outcomes for Apretude

A recent study conducted by the HIV Prevention Trials Network (HPTN) 084 open label extension (OLE) has provided significant insights into the use of Apretude (cabotegravir LA) for HIV pre-exposure prophylaxis (PrEP) among cis-gender women in sub-Saharan Africa who became pregnant while on the medication. This study, which included 2,472 participants, aimed to evaluate the safety and efficacy of Apretude during pregnancy. The findings, which will be presented at the 25th International AIDS Conference in Munich, Germany, underline the importance of this medication as a viable option for HIV prevention.

The research showed that Apretude was generally well-tolerated among pregnant women and maintained cabotegravir levels above the threshold necessary for HIV protection throughout the duration of pregnancy. Kimberly Smith, the head of research and development at ViiV Healthcare, emphasized the importance of these findings, noting that they add to the growing body of evidence supporting Apretude as a viable prevention option for women, including those who conceive while on this long-acting regimen. Smith highlighted the ongoing need for diverse HIV prevention options and reaffirmed ViiV Healthcare's commitment to addressing the needs of women and other populations disproportionately affected by HIV.

In the HPTN 084 OLE study, participants were given the choice between cabotegravir LA for PrEP and daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets. Of the 367 confirmed pregnancies among 348 participants, the maternal and pregnancy outcomes for those using cabotegravir LA were consistent with those using FTC/TDF, aligning 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 it 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 no maternal deaths recorded, and importantly, none of the women who became pregnant acquired HIV during pregnancy.

A sub-study within the HPTN 084 OLE focused on the pharmacokinetics of cabotegravir in 50 participants who continued using Apretude during pregnancy. This analysis revealed that cabotegravir concentrations remained above the protective threshold throughout pregnancy, with median concentrations measured at 2.1 µg/mL before pregnancy, 1.9 µg/mL during pregnancy, and 2.5 µg/mL postpartum. Although there was a slight decrease in cabotegravir levels 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. Delany-Moretlwe pointed out that women of childbearing age in sub-Saharan Africa experience higher rates of HIV incidence, making it critical to study the impact of HIV medications on their health and wellbeing during pregnancy. The findings provide further evidence of the safety and tolerability of cabotegravir LA for PrEP in expectant mothers and their unborn infants while maintaining protective levels against HIV.

Apretude 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, aimed at ending the HIV epidemic.