ArticleJournal of virus eradication2018
Safety and pharmacokinetics of dolutegravir in HIV-positive pregnant women: a systematic review.
Article in Journal of virus eradication, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
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Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Risk of Congenital Anomalies with Dolutegravir-Based Anti-retroviral Regimens: A Systematic Review and Meta-analysis.Clinical drug investigation · 2024Pooled it
- Unexpected interactions between dolutegravir and folate: randomized trial evidence from South Africa.AIDS (London, England) · 2021Trial
- Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: A randomised trial (DolPHIN-1 study).PLoS medicine · 2019Trial
- Placenta models for HIV-1-ART-nicotine comorbidity research: advances and remaining challenges.Cell death discovery · 2026Review
- CEST MRI assessment of HIV-1-associated neurometabolic impairments in a humanized mouse model.NeuroImmune pharmacology and therapeutics · 2025Article
- CombinedActa biochimica et biophysica Sinica · 2025Article
- Article
- CEST MRI detects antiretroviral drug toxicities in the developing mouse brain.Frontiers in pharmacology · 2025Article
- Role of Dolutegravir/Lamivudine in the Management of Pregnant People Living with HIV-1: A Narrative Review.Infectious diseases and therapy · 2025Review
- Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review.Drug safety · 2024Article
- Integrase inhibitor drugs during pregnancy and congenital anomalies: A case/non-case study from the global pharmacovigilance database VigiBase®.Pharmacology research & perspectives · 2024Article
- Metabolic implications and safety of dolutegravir use in pregnancy.The lancet. HIV · 2023Review
- Long-acting dolutegravir formulations prevent neurodevelopmental impairments in a mouse model.Frontiers in pharmacology · 2023Article
- Inhibition of matrix metalloproteinases by HIV-1 integrase strand transfer inhibitors.Frontiers in toxicology · 2023Article
- HIV-1 Integrase Strand Transfer Inhibitors and Neurodevelopment.Pharmaceuticals (Basel, Switzerland) · 2022Review
- Second-Generation Human Immunodeficiency Virus Integrase Inhibitors Induce Differentiation Dysregulation and Exert Toxic Effects in Human Embryonic Stem Cell and Mouse Models.The Journal of infectious diseases · 2022Article
- Dolutegravir Inhibition of Matrix Metalloproteinases Affects Mouse Neurodevelopment.Molecular neurobiology · 2021Article
- Dolutegravir and pregnancy outcomes in women on antiretroviral therapy in Brazil: a retrospective national cohort study.The lancet. HIV · 2021Article
- The Prevalence and Associated Factors of Hypertension among HIV Patients.International journal of hypertension · 2021Article
- Mother-to-Child HIV Transmission With In Utero Dolutegravir vs. Efavirenz in Botswana.Journal of acquired immune deficiency syndromes (1999) · 2020Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
backgroundThe integrase strand transfer inhibitor dolutegravir (DTG) is being introduced into low- and middle-income countries (LMICs) as an alternative to first-line treatment with non-nucleoside reverse transcriptase inhibitors. However, DTG is not yet widely recommended for use in pregnant women. The aim of this systematic review was to analyse all available data on birth outcomes and congenital anomalies in the infants of pregnant women treated with DTG.
methodsA PubMed and Embase search was conducted using the terms "dolutegravir" or "DTG" and "pregnancy" or "pregnant" from the earliest available date on the database to 26 July 2017. Any reports involving women who were pregnant, HIV positive and taking DTG were included. The percentage of pregnant women with adverse birth outcomes or congenital anomalies in their infants after taking dolutegravir was compared with five historical control databases.
resultsThere were six databases included in the main analysis of birth outcomes and congenital anomalies, with a total of 1200 pregnant women. The percentage of pregnant women taking DTG with adverse birth outcomes and congenital abnormalities was similar to results from historical control studies of HIV-positive women. However, there was significant heterogeneity among the six databases - the percentage of infants with congenital anomalies ranged from 0.0% in Botswana (0/116 infants) to 13.3% in IMPAACT P1026S (2/15 infants).
conclusionsUp to 15 million people could be on treatment with DTG in LMICs within the next 5 years, of whom a substantial percentage is likely to be women of child-bearing potential. In many countries with large HIV epidemics, unplanned pregnancies are common and access to antenatal clinic facilities may be limited. Continued pharmacovigilance is essential, but it is reassuring that no clear safety signals have been detected, to date, for pregnant women treated with DTG in terms of birth outcomes or congenital anomalies.
Identifiers
29682297PMC5892677What OpenQuestion holds
Registered trials
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.