The safety of cabotegravir in pregnancy: a systematic review and meta-analysis.

BACKGROUND

HIV remains an important global public health crisis. Antiretroviral treatment has been essential to suppress viral replication, and in at-risk individuals, antiretroviral pre-exposure prophylaxis drugs (PrEP) lower transmission rates. Unfortunately, current oral regimens require stringent daily adherence to be effective. Long-acting intra-muscular cabotegravir potentially averts the issue of poor patient adherence. This formulation has the potential to cause a breakthrough in mitigating the spread of HIV; however, safety in pregnancy is still to be established. This systematic review aimed to assess the data relating to the safety and prevalence of adverse effects of cabotegravir in pregnancy.

METHODS AND ANALYSIS: The research followed the PRISMA guidelines and Cochrane Handbook. Keyword and MeSH term combinations were utilised. Studies matching the inclusion criteria published between 2016 and 2023 through EMBASE, PubMed, Scopus, Science Direct, Cochrane Library, Medline, and Web of Science were reviewed. Studies were screened by title and abstract, followed by full-text screening by two independent investigators. Duplicate studies were removed. Relevant data was extracted from the selected studies. Critical appraisal and the risk of bias were evaluated using the Joanna Briggs Institute (JBI) SUMARI program. The I2 test was used to assess statistical heterogeneity.

RESULTS AND OUTCOMES: Of the 12,357 studies identified, 6 articles were included in the review. This review investigated 41 known pregnancies in females on cabotegravir, of which 25 live babies were born, 8 were not born due to spontaneous/elective abortion, and 8 were lost to follow-up. No congenital abnormalities, birth defects, or foetal adverse effects were reported.

CONCLUSION

The small sample size currently precludes a definitive conclusion on the safety profile of cabotegravir use during pregnancy. More research in this area is required to assess this drug's role in utero.

SYSTEMATIC REVIEW REGISTRATION: This systematic review and meta-analysis protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) with the registration number CRD42023449146.