Pregnancy safety and health outcomes for women using Apretude (cabotegravir long-acting for PrEP) have been a focus of recent studies, with positive findings announced by ViiV Healthcare at the 25th International AIDS Conference (AIDS 2024) in Munich, Germany. Findings from the HIV Prevention Trials Network (HPTN) 084 open label extension (OLE) showed that maternal and pregnancy outcomes with Apretude exposure were comparable to those with no cabotegravir exposure. Pharmacokinetic (PK) findings demonstrated that target concentrations of cabotegravir were maintained above those associated with protection against HIV acquisition throughout the overall pregnancy period.
GSK plc, which holds a majority stake in ViiV Healthcare along with Pfizer and Shionogi as shareholders, revealed that the HPTN 084 OLE evaluated cis-gender women in sub-Saharan Africa who became pregnant while using Apretude for HIV pre-exposure prophylaxis (PrEP). The findings indicated that Apretude was generally well tolerated among pregnant women, with cabotegravir levels maintained above those associated with HIV protection throughout the pregnancy period.
Pregnancy Safety: Dr. Kimberly Smith Highlights New Data Supporting Apretude for Women at AIDS 2024
Dr. Kimberly Smith, Head of Research & Development at ViiV Healthcare, commented: “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 initial findings from the HPTN 084 trial showed that cabotegravir LA for PrEP had superior efficacy compared to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) tablets in reducing the risk of HIV acquisition in women. Participants entering the HPTN 084 OLE (n=2472) could choose between cabotegravir LA for PrEP or FTC/TDF tablets as PrEP, with contraceptive requirements removed. Those with prior or current cabotegravir LA for PrEP exposure at the time of pregnancy could consent to continue injections throughout pregnancy. Maternal safety and pregnancy outcomes were assessed across 367 confirmed pregnancies in 348 participants.
The HPTN 084 OLE findings revealed consistent maternal and pregnancy outcomes across cabotegravir LA for PrEP and FTC/TDF exposure groups and with expected background rates. Pregnancy-related maternal adverse event incidence was 45.7 (95% CI 33.1-61.6), 47.1 (95% CI 20.3-92.7), and 37.5 (95% CI 13.8-81.6) 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% (70/212) using cabotegravir LA for PrEP during pregnancy, 38% (26/68) having prior cabotegravir LA for PrEP use, and 27% (12/45) 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.
Pregnancy Findings: Dr. Sinead Delany-Moretlwe Highlights Cabotegravir LA for PrEP’s Safety for Expectant Mothers
Dr. Sinead Delany-Moretlwe, HPTN 084 Protocol Chair and Research Director at Wits RHI, University of the Witwatersrand in Johannesburg, South Africa, highlighted the importance 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.”
A sub-study PK analysis of the HPTN 084 OLE included 50 participants who continued to receive cabotegravir LA for PrEP prior to and during pregnancy. The study found that cabotegravir concentrations were comparable between the pre-pregnant, pregnant, and post-partum periods (median Ctrough concentrations were 2.1 µg/mL [IQR: 1.3, 2.7], 1.9 µg/mL [IQR: 1.5, 2.2], and 2.5 µg/mL [IQR: 2.0, 3.5], respectively). Although cabotegravir LA for PrEP concentrations declined from the first trimester through to the third trimester of pregnancy (median Ctrough concentrations during the first, second, and third trimesters were 2.5 µg/mL [IQR: 2.0, 3.2], 1.8 µg/mL [IQR: 1.5, 2.2], and 1.6 µg/mL [IQR: 1.3, 2.2], respectively), 100% of Ctrough concentrations during the first and second trimesters, and 98% of Ctrough concentrations during the third trimester, remained above target thresholds for the medicine.
These data indicate dose modifications are unlikely to be required for women who become pregnant, although additional analyses are forthcoming to supplement these findings. Apretude (cabotegravir LA for PrEP) is approved for use in multiple countries, including the U.S., EU, UK, Canada, Australia, and South Africa. Submissions to other regulatory agencies are ongoing, further expanding the availability of this preventive treatment option for women at risk of HIV.
In conclusion, the new data presented by ViiV Healthcare at AIDS 2024 provide important insights into the safety and efficacy of Apretude for pregnant women. The findings affirm that Apretude maintains protective levels against HIV throughout pregnancy and is generally well tolerated, offering a valuable prevention option for women, including those who conceive while on this long-acting regimen. These results reinforce ViiV Healthcare’s commitment to addressing the needs of women disproportionately affected by HIV and advancing efforts to end the epidemic.
Resource: Glaxo Smith Kline, July 23, 2024
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