Efficacy of raltegravir in achieving virological suppression at delivery in HIV-positive pregnant women: a systematic review and meta-analysis.

BACKGROUND: The world's first HIV integrase inhibitor, raltegravir (RAL), has been widely used for the treatment of HIV infection over the past 15 years, and continues benefiting people living with HIV (PLWH) today due to its efficient virological suppression and favourable safety profile. However, to date, there have not been any published systematic analyses evaluating the efficacy of RAL in HIV-positive pregnant women. Herein, our study aimed to evaluate the efficacy of raltegravir (RAL) regarding virological suppression at delivery in Human immunodeficiency virus (HIV)-positive pregnant women by systematic review and meta-analysis. METHODS: In this study, we searched PubMed, EMBASE, the Cochrane Library, and Web of Science from inception until January 17th, 2023. Clinical trials and observational studies (cohort studies, case series, case reports) were included. All analyses were performed using R 4.1.1 statistical software with random effects modelling. RESULTS: Twenty-two studies with 806 HIV-positive pregnant women were included. Pooled analysis indicated that the overall effectiveness rate for achieving virological suppression at delivery is 85% (95% confidence interval [CI]: 79% - 90%). Analysis of secondary outcomes revealed an overall efficacy of 78% (95% CI: 72% - 84%) for those with an HIV RNA load of < 1000 RNA copies/mL at delivery when RAL was initiated from the second trimester onward. Additionally, subgroup analysis showed an overall effectiveness rate of 75% (95% CI: 58% - 87%) for treatment-naïve (n = 29) and 76% (95% CI: 60%-86%) for treatment-experienced patients (n = 38). CONCLUSION: It concluded that RAL is effective for achieving virological suppression at delivery in HIV-positive pregnant women, and possibly contribute to the prevention of mother-to-child HIV transmission. TRIAL REGISTRATION: This study was registered in PROSPERO, with registration number: CRD42023428508.