Systematic Literature Review and Meta-Analysis of INSTI-Based Antiretroviral Therapy Single- Versus Multiple-Tablet Regimens for the Treatment of HIV.

INTRODUCTION

Antiretroviral single-tablet regimens (STRs) have several advantages over multiple-tablet regimens (MTRs), including increased adherence and improved treatment satisfaction for people with HIV (PWH). This analysis has systematically reviewed and compared STRs and MTRs in adult PWH receiving integrase strand transfer inhibitor (INSTI)-based regimens.

METHODS

MEDLINE and Embase databases were searched on November 28, 2023, to identify studies published from 2013 to 2023 that evaluated INSTI-based STRs compared with ≥ 1 INSTI-based MTRs. Study quality was assessed based on the University of York Centre for Reviews and Dissemination guidelines. Pairwise meta-analyses were conducted to provide pooled relative estimates for key clinical outcomes.

RESULTS

Twenty-five publications were included in the quantitative syntheses. STRs were associated with improved adherence based on 3 retrospective studies [rate ratio (RR) = 1.64 (95% confidence interval: 1.46-1.83)] but there was no difference in adherence in the 1 randomized controlled trial (RCT) that assessed adherence [RR = 1.02 (0.77-1.35)], though, due to blinding, both STR and MTR groups took multiple pills. STRs were associated with higher persistence than MTRs based on 7 retrospective studies [RR = 1.33 (1.17-1.52)]. PWH treated with MTRs versus STRs were more likely to discontinue therapy in retrospective studies [hazard ratio = 1.62 (1.52-1.72), 6 studies] and prospective cohort studies [RR = 4.43 (1.62-12.09), 3 studies], but not within RCTs where there was no difference in discontinuation [RR = 0.83 (0.55-1.26), 4 trials]. Risk of virologic failure was comparable between STRs and MTRs in RCTs [RR = 1.00 (0.35-2.84), 5 trials] and retrospective studies [odds ratio = 1.30 (0.30-5.53), 5 studies].

CONCLUSION

INSTI-based STRs were associated with improved adherence and persistence, and lower discontinuation rates compared with INSTI-based MTRs in observational, real-world studies, whereas no differences in adherence or discontinuation were seen in RCTs. Neither RCTs nor real-world studies showed any difference in virologic failure for STRs and MTRs. STRs are a potential tool for supporting adherence and persistence in real-world settings.

REGISTRATION: PROSPERO number CRD42024525515.