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IntroductionHuman immunodeficiency virus (HIV)-exposed infants face elevated risks of neonatal sepsis, influenced by maternal antiretroviral therapy (ART) regimens. Dolutegravir (DTG), a widely used integrase transfer inhibitor (INSTI), and the preferred first line drugs for management of HIV in pregnancy, has shown potential adverse effects such as hyperglycaemia, which may impact neonatal outcomes including risk of neonatal sepsis. We estimated the pooled incidence of neonatal sepsis among neonates exposed to INSTIs in utero compared to non-INSTIs-based ART regimens.Methods and analysisA systematic review and meta-analysis were conducted following written as per the PRISMA guidelines. Databases including PubMed/MEDLINE, Embase, Cochrane Library, CINAHL, Global Health and Global Index Medicus were searched for studies published between January 2013 and September 2025. Eligible studies included clinical trials and cohort studies comparing INSTI-based ART regimens with non-INSTI regimens among pregnant women living with HIV. Data were extracted using Covidence software, Cochrane risk of bias (RoB) and Newcastle-Ottawa Scale (NOS) were used to assessed for quality of randomised clinical trials and observational studies, respectively. The certainty of the evidence was assessed using the Grading, Recommendation, Assessment, Development and Evaluation (GRADE) framework.ResultsA total of 714 studies were identified and screened based on their titles and abstracts, of which 63 articles underwent full-text review. Ultimately, four studies, comprising 7,636 participants, met the predefined eligibility criteria and were included in the analysis. The pooled odds ratio (OR) for neonatal sepsis among infants exposed to INSTIs was 0.44 (95% confidence interval [CI]: 0.15-1.30, p = 0.137). The test for subgroup difference was not significant (p = 0.358): the pooled OR for dolutegravir was 0.27 (95% CI 0.06-1.23, p = 0.090) and for the single raltegravir study was 0.73 (95% CI 0.16-3.30, p = 0.681).ConclusionINSTI-based ART was not associated with a significant difference in neonatal sepsis risk compared with non-INSTI regimens. However, the low number of events limited the precision of the estimates, highlighting the need for further research.RegistrationThis review has been registered with the PROSPERO at https://www.crd.york.ac.uk/PROSPERO/view/CRD420251178411 , registration number CRD420251178411.

Abstract licence: CC BY-NC-ND

BackgroundIntegrase inhibitors (INSTI) and tenofovir alafenamide (TAF) have been associated with greater weight gain compared to nonnucleoside reverse transcriptase inhibitors (NNRTIs) and tenofovir disoproxil fumarate (TDF), but the effects of an antiretroviral regimen switch on weight are unclear.MethodsThis 48-week, 3-parallel group, open-label, multicenter, randomized controlled trial (NCT04636437) in people with HIV and obesity on an INSTI (bictegravir, dolutegravir, or raltegravir) with TAF/emtricitabine (FTC) assessed whether switching to the NNRTI doravirine (DOR) with TAF/FTC or TDF/FTC results in weight loss or stabilization. Treatment effects were estimated using linear regression adjusted for sex, race, and entry weight.ResultsOf the 147 participants randomized, 145 initiated their assigned treatment. At entry, median age was 49 years; body mass index was 34.9 kg/m2, and time on INSTI + TAF/FTC was 3.4 years; 49% were female and 53% Black. After 48 weeks, the estimated mean change in weight was -0.47% (95% CI: -2.09, 1.14) for the DOR + TAF/FTC arm, -2.73% (-4.22, -1.23) for DOR + TDF/FTC, and -1.84% (-3.37, -0.30) for INSTI + TAF/FTC. The estimated mean difference in weight change at 48 weeks for DOR versus INSTI (both with TAF/FTC) was 1.36 percentage points (97.5% CI: -1.20, 3.92) and -0.89 percentage points (-3.34, 1.57) for DOR + TDF/FTC versus INSTI + TAF/FTC. There was no evidence of variation by sex or race, nor of treatment differences for changes in fasting lipids, insulin resistance, fat mass, or bone mineral density.ConclusionsIn people with HIV and obesity, switching from an INSTI + TAF/FTC regimen to DOR/FTC with either TAF or TDF did not produce clinically meaningful differences in weight change or metabolic health after 48 weeks.

Abstract licence: CC BY