Evidence map›Paper›PMID 41225339›Full record

SynthesisBMC infectious diseases2025

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

Amber Jasper, Willem Fourie, Sarentha Chetty

Abstract readSystematic ReviewMeta-Analysis
In one paragraph

Synthesis in BMC infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors.

Amber JasperDepartment of Pharmacy and Pharmacology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, 2193, South Africa.
Willem FourieDepartment of Pharmacy and Pharmacology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, 2193, South Africa.
Sarentha ChettyDepartment of Pharmacy and Pharmacology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, 2193, South Africa. chettys4@ukzn.ac.za.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHIV 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 I 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.

conclusionThe 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.

Indexed as

Anti-HIV AgentsHIV InfectionsPregnancy Complications, InfectiousPyridonesDiketopiperazinesFemaleHumansInfectious Disease Transmission, VerticalPre-Exposure ProphylaxisPregnancyAnti-HIV AgentscabotegravirDiketopiperazinesPyridonesCabotegravirHIVPregnancyPrEPPreventionRilpivirineSafety

Identifiers

PMID41225339
PMCPMC12613714

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.