AI Article Synopsis
- The study aims to evaluate the risk of congenital anomalies in newborns exposed to dolutegravir during pregnancy compared to those on other antiretroviral regimens, following some concerns about birth defects associated with dolutegravir use.
- A systematic review and meta-analysis were conducted involving 26 studies, with 12 included in the final analysis, which showed no significant difference in congenital anomaly risks between the two groups of newborns (risk ratio of 1.10, p = 0.59).
- Moderate heterogeneity was found among the studies (I = 47%), indicating some variation in the results, but overall, the findings suggest dolutegravir does not pose a significantly higher risk
Article Abstract
Background And Objectives: Dolutegravir has been used as a first-line anti-human immunodeficiency virus drug because of its better efficacy compared with other counterpart medicines. However, making a unanimous decision on its use during pregnancy has become difficult for stakeholders following congenital anomalies reported with its use. The objective of this systematic review and meta-analysis was to study the risk of congenital anomalies in newborns exposed to dolutegravir-based-regimens compared with those exposed to non-dolutegravir-based regimens during the antenatal period.
Methods: An extensive literature search was performed in MEDLINE (through PubMed), EMBASE, Cochrane Database of Systematic Reviews, Google Scholar, and ClinicalTrials.gov until 30 November, 2023. Studies reporting data on congenital anomalies following antenatal use of dolutegravir were included. Risk of bias for randomized controlled trials, non-randomized controlled trials, and observational studies was assessed using RoB2, ROBINS-I, and ROBINS-E tools, respectively. A meta-analysis was performed in 'RevMan 5.4.1' using a random-effects model. Heterogeneity was assessed by the 'Q' statistic and I value. A sensitivity analysis was performed for higher heterogeneity/high-risk studies. The study protocol was registered in PROSPERO [CRD42023446374] a priori.
Results: Of 26 eligible studies, 12 (six randomized controlled trials and six observational studies with a pooled sample of 32,617) were included in a meta-analysis and 14 in a qualitative synthesis only. The meta-analysis does not show a statistically significant difference in the risk of congenital anomalies between newborns exposed antenatally to dolutegravir-based regimen(s) and those exposed to non-dolutegravir-based regimens [risk ratio 1.10; 95% confidence interval 0.79-1.53; p = 0.59]. Heterogeneity was moderate (I = 47%). Pooled results for randomized controlled trials and observational studies separately and the sensitivity analysis for heterogeneity provided similar results.
Conclusions: The risk of congenital anomalies was not significantly different between dolutegravir-based regimens and non-dolutegravir-based-regimens in newborns exposed during their antenatal period.
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| http://dx.doi.org/10.1007/s40261-024-01390-y | DOI Listing |
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