Observational studyThe Lancet. Global health2018
Comparative safety of dolutegravir-based or efavirenz-based antiretroviral treatment started during pregnancy in Botswana: an observational study.
Observational study in The Lancet. Global health, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 84 papers, 5 of them syntheses that pooled 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.
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
84 citing papers in PubMed, 5 syntheses or guidelines pooled it, 151 citations in OpenAlex.
- Incidence of neonatal sepsis among HIV exposed neonates of mothers on integrase strand transfer inhibitors in sub-Saharan Africa: a systematic review and meta-analysis.BMC infectious diseases · 2026Pooled it
- Risk of Congenital Anomalies with Dolutegravir-Based Anti-retroviral Regimens: A Systematic Review and Meta-analysis.Clinical drug investigation · 2024Pooled it
- Comparative risk of adverse perinatal outcomes associated with classes of antiretroviral therapy in pregnant women living with HIV: systematic review and meta-analysis.Frontiers in medicine · 2024Pooled it
- Pooled it
- Adverse perinatal outcomes associated with antiretroviral therapy in women living with HIV: A systematic review and meta-analysis.Frontiers in medicine · 2022Pooled it
- Efficacy and safety of three antiretroviral therapy regimens started in pregnancy up to 50 weeks post partum: a multicentre, open-label, randomised, controlled, phase 3 trial.The lancet. HIV · 2023Trial
- A randomized comparison of health-related quality of life outcomes of dolutegravir versus efavirenz-based antiretroviral treatment initiated in the third trimester of pregnancy.AIDS research and therapy · 2022Trial
- Pregnancy Outcomes of Women Conceiving on Antiretroviral Therapy (ART) Compared to Those Commenced on ART During Pregnancy.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021Trial
- Trial
- Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial.The lancet. HIV · 2020Trial
- Safety and pharmacokinetics of dolutegravir in pregnant mothers with HIV infection and their neonates: A randomised trial (DolPHIN-1 study).PLoS medicine · 2019Trial
- High rates of transmitted NNRTI resistance among persons with acute HIV infection in Malawi: implications for first-line dolutegravir scale-up.AIDS research and therapy · 2019Trial
- Autism outcomes and neurobehavioural markers in young children born to mothers with HIV in Kenya: a protocol for the Alama project.BMJ open · 2026Article
- Safety of Antihypertensive Medication for the Management of Non-Severe Gestational Hypertension Among Pregnant Individuals in Botswana-Emulating a Series of Target Trials.Paediatric and perinatal epidemiology · 2026Article
- Article
- Inflammation at the maternal-fetal interface: a perspective on interacting risk factors for preterm birth in sub-Saharan African women living with HIV.Frontiers in immunology · 2026Review
- Target trials of preconception switch from nevirapine or efavirenz-based antiretroviral therapy to dolutegravir-based antiretroviral therapy on adverse birth and maternal outcomes.AIDS (London, England) · 2025Article
- Antiretroviral drug exposure in pregnancy and risk of congenital anomalies: a European case/non-case malformed study.European journal of clinical pharmacology · 2025Article
- Association between Maternal HIV and Adverse Birth Outcomes in the Era of Universal Antiretroviral Therapy in Malawi.Journal of acquired immune deficiency syndromes (1999) · 2025Article
- A programmatic assessment of dolutegravir adverse events and discontinuations in Uganda.HIV medicine · 2025Article
24 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
12 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundGlobal rollout of dolutegravir-based antiretroviral therapy (ART) has been hampered in part by insufficient safety data in pregnancy. We compared birth outcomes among women initiating dolutegravir-based ART with those among women initiating efavirenz-based ART in pregnancy in Botswana.
methodsIn this observational study, we captured birth outcome data at eight government hospitals throughout Botswana (~45% of all deliveries in the country) in an ongoing study that started on Aug 15, 2014. In 2016, Botswana changed first-line ART from efavirenz-tenofovir-emtricitabine to dolutegravir-tenofovir-emtricitabine, including for pregnant women. This analysis includes women starting either efavirenz-based ART or dolutegravir-based ART during singleton pregnancy (regimen started and delivery occurring between Aug 15, 2014, and Aug 15, 2016, for efavirenz-based ART and between Nov 1, 2016, and Sept 30, 2017, for dolutegravir-based ART). We excluded births to mothers who had switched regimen or stopped ART. The primary outcomes were the combined endpoints of any adverse outcome (stillbirth, preterm birth [<37 weeks' gestation], small for gestational age [SGA; less than the tenth percentile of birthweight by gestational age], or neonatal death [within 28 days of age]) and severe adverse outcomes (stillbirth, neonatal death, very preterm birth [<32 weeks' gestation], and very SGA [less than the third percentile of birthweight by gestational age]). We fitted log-binomial regression models, controlling for maternal age, gravidity, and education, to estimate adjusted risk ratios (aRRs).
findingsOur analysis included 1729 pregnant women who initiated dolutegravir-based ART and 4593 who initiated efavirenz-based ART. The risk for any adverse birth outcome among women on dolutegravir versus efavirenz was similar (33·2% vs 35·0%; aRR 0·95, 95% CI 0·88-1·03), as was the risk of any severe birth outcome (10·7% vs 11·3%; 0·94, 0·81-1·11). We found no significant differences by regimen in the individual outcomes of stillbirth, neonatal death, preterm birth, very preterm birth, SGA, or very SGA.
interpretationAdverse birth outcomes were similar among pregnant women who initiated dolutegravir-based and efavirenz-based ART. Dolutegravir-based ART can be safely initiated in pregnancy.
fundingNational Institutes of Health.
Indexed as
Identifiers
What 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.