Cabotegravir and pregnancy: a winning combination or a risky gamble?

By Ana Espino | Published on December 10, 2025 | 3 min read


HIV remains a major global health crisis, affecting 39 million people in 2022. Pre-exposure prophylaxis (PrEP), primarily administered orally, is highly effective in reducing viral transmission. However, its success largely depends on daily adherence—an obstacle in many high-prevalence regions.  

Among emerging strategies, cabotegravir, a long-acting integrase inhibitor administered as an intramuscular injection every eight weeks, stands out for its superior adherence profile. It shows strong potential as a durable alternative to oral PrEP.  

Yet, limited safety data during pregnancy restrict its use among women of reproductive age. Most clinical trials exclude pregnant women, creating a critical evidence gap. In this context, the present study was designed to assess the safety of cabotegravir during pregnancy, examining outcomes for both mother and fetus.    

Cabotegravir with a baby on board: what does the science say?  

This work is based on a systematic review and meta-analysis conducted according to PRISMA guidelines. The authors searched seven databases covering the period from 2016 to 2023. Inclusion criteria focused on studies involving pregnant women exposed to cabotegravir, with or without rilpivirine. In total, six studies were included—five randomized clinical trials and one compassionate-use study.  

Across these studies, 41 pregnancies were identified among women exposed to cabotegravir: 25 resulted in live births, 8 in miscarriages or induced abortions, and 8 lacked follow-up outcome data. Importantly, no congenital malformations or fetal adverse effects were reported. On the maternal side, several adverse events were documented, including cases of pre-eclampsia, hyperemesis gravidarum, and premature rupture of membranes.

The meta-analysis, based on two studies, found no statistically significant difference between cabotegravir and comparator treatments with respect to live birth rates.    

Cabotegravir in pregnancy: green light, yellow light, or red light?  

HIV remains a global health priority, and multiple therapies have emerged to strengthen prevention efforts. Cabotegravir’s long half-life and eight-week injection schedule position it as a promising option for improving adherence to PrEP and reducing infection risk.  

However, its use during pregnancy remains limited due to insufficient safety data. The near-systematic exclusion of pregnant women from clinical trials leads to troubling underrepresentation in available safety analyses, currently preventing clear clinical recommendations for this population.  

This study therefore aimed to better understand the safety profile of cabotegravir in pregnancy to inform future clinical guidance. The findings suggest no major adverse events linked to cabotegravir use during pregnancy. Nonetheless, the data remain too scarce to draw definitive conclusions regarding its safety.  

Further research is required, particularly long-term follow-up of pregnant women exposed to cabotegravir, through registries such as the Antiretroviral Pregnancy Registry. Ongoing trials—including the extension of HPTN084 and studies conducted by the IMPAACT network—will be instrumental. In addition, pregnancy-specific pharmacokinetic data will be essential to optimize dosing in this population.   

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