ArticleThe lancet. HIV2021
Dolutegravir and pregnancy outcomes in women on antiretroviral therapy in Brazil: a retrospective national cohort study.
Article in The lancet. HIV, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
42 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.
- Risk of Congenital Anomalies with Dolutegravir-Based Anti-retroviral Regimens: A Systematic Review and Meta-analysis.Clinical drug investigation · 2024Pooled it
- Evaluation of pharmacokinetic interactions between long-acting cabotegravir or emtricitabine/tenofovir disoproxil fumarate and hormonal contraceptive agents: a tertiary analysis of South African participants in HPTN 084.Journal of the International AIDS Society · 2025Trial
- Efficacy and Safety of DRG/3TC for Prophylaxis of HIV Perinatal Transmission: A Pilot Study (PREGNANCY).Open forum infectious diseases · 2024Trial
- Obstetric Pharmacoethics: An ethical framework for obstetric pharmacology.European journal of obstetrics, gynecology, and reproductive biology · 2026Article
- Genetic disorders and congenital anomalies in Nigeria: a scoping review.Journal of community genetics · 2026Review
- Exposure to Frontline Antiretroviral Dolutegravir Disrupts Oligodendrocyte Development Across Differentiation Stages.ASN neuro · 2026Article
- CombinedActa biochimica et biophysica Sinica · 2025Article
- Landscape analysis of pregnancy exposure registries in low- and middle-income countries: a scoping review.BMJ open · 2025Article
- Fetal Defects in Mice Treated With Integrase Strand Transfer Inhibitors: Comparison of Dolutegravir, Raltegravir, Bictegravir, and Cabotegravir.The Journal of infectious diseases · 2025Article
- Maternal HIV Infection and Antiretroviral Therapy in Pregnancy: Implications for Vertical Transmission, Fetal Safety, and Long-Term Infant Outcomes.Pathogens (Basel, Switzerland) · 2025Review
- Persistent sex disparities in access to dolutegravir-based antiretroviral therapy in Latin America and the Caribbean: results from a retrospective observational study using data from 2017 to 2022.Journal of the International AIDS Society · 2025Observational
- Beyond Viral Suppression: Navigating Structural Barriers, Aging and Frailty, Drug Resistance, Therapeutic Innovations, and Reproductive Health Challenges in the Global HIV/AIDS Epidemic.Journal of AIDS and HIV treatment · 2025Article
- Obstetric and newborn outcomes of mothers with and without HIV infection in Anaka general hospital in Northern Uganda.PloS one · 2025Article
- "No One Needs to be Forced": Qualitative Insights on Competing Priorities between Antiretroviral Therapy and Reproductive Health Planning during the Dolutegravir Rollout.AIDS and behavior · 2024Article
- Prenatal syphilis and adverse pregnancy outcomes in women with HIV receiving ART in Brazil: a population-based study.Lancet regional health. Americas · 2024Article
- The safety of a dolutegravir (DTG)-based antiretroviral treatment (ART) regimen for pregnancy and birth outcomes in Ethiopia: evidence from multicenter cohort study.BMC infectious diseases · 2024Article
- Integrase inhibitor drugs during pregnancy and congenital anomalies: A case/non-case study from the global pharmacovigilance database VigiBase®.Pharmacology research & perspectives · 2024Article
- Dolutegravir and Folic Acid Interaction during Neural System Development in Zebrafish Embryos.International journal of molecular sciences · 2024Article
- Challenges, risks, and opportunities of antiretroviral drugs in women of reproductive potential.Expert review of anti-infective therapy · 2024Review
- Dolutegravir induces FOLR1 expression during brain organoid development.Frontiers in molecular neuroscience · 2024Article
Corrections and comments
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Authors and funding
18 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundDolutegravir has been widely available in Brazil since 2017. Following the signal that infants born to women with dolutegravir exposure at conception in Botswana had a higher risk of neural tube defects (NTDs), public health leaders initiated a national investigation to evaluate periconception dolutegravir exposure among all pregnant Brazilian women with HIV and its potential association with risk of NTDs, stillbirth, or miscarriage before 22 weeks (also called spontaneous abortion).
methodsIn this retrospective, observational, national, cohort study, we identified all women with pregnancies and possible dolutegravir exposure within 8 weeks of estimated date of conception between Jan 1, 2017, and May 31, 2018, and approximately 3:1 matched pregnant women exposed to efavirenz between Jan 1, 2015, and May 31, 2018, using the Brazilian antiretroviral therapy database. We did detailed chart reviews for identified women. The primary outcomes were NTD and a composite measure of NTD, stillbirth, or miscarriage. NTD incidences were calculated with 95% CI. The composite outcome was examined with logistic regression using propensity score matching weights to balance confounders.
findingsOf 1427 included women, 382 were exposed to dolutegravir within 8 weeks of estimated date of conception. During pregnancy, 183 (48%) of 382 dolutegravir-exposed and 465 (44%) of 1045 efavirenz-exposed women received folic acid supplementation. There were 1452 birth outcomes. There were no NTDs in either dolutegravir-exposed (0, 95% CI 0-0·0010) or efavirenz-exposed groups (0, 95% CI 0-0·0036). There were 23 (6%) stillbirths or miscarriages in 384 dolutegravir-exposed fetuses and 28 (3%) in the 1068 efavirenz-exposed fetuses (p=0·0037). Logistic regression models did not consistently indicate an association between dolutegravir exposure and risk of stillbirths or miscarriages. After study closure, two confirmed NTD outcomes in fetuses with periconception dolutegravir exposure were reported to public health officials. An updated estimate of NTD incidence incorporating these cases and the estimated number of additional dolutegravir-exposed pregnancies between Jan 1, 2015 and Feb 28, 2019, is 0·0018 (95% CI 0·0005-0·0067).
interpretationNeither dolutegravir nor efavirenz exposure was associated with NTDs in our national cohort; incidence of NTDs is probably well under 1% in dolutegravir-exposed HIV-positive women but still slightly above HIV-uninfected women (0·06%) in Brazil.
fundingThe Brazilian Ministry of Health and the United States' National Institutes of Health.
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What OpenQuestion holds
Registered trials
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