SynthesisEuropean journal of clinical pharmacology2026
Efficacy and safety of doravirine/islatravir for the treatment of HIV-1: a systematic review and meta-analysis of randomized controlled trials with GRADE assessment.
Synthesis in European journal of clinical pharmacology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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3 authors.
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Abstract
purposeTwo-drug antiretroviral regimens are being investigated as alternatives to standard three-drug therapy for HIV-1. Doravirine/islatravir is a once-daily oral combination with promising efficacy and safety, but its overall clinical performance has not been systematically quantified. This study evaluated the efficacy and safety of doravirine/islatravir compared with standard triple option therapy in adults living with HIV-1.
methodsPubMed, Scopus, Web of Science, and the Cochrane Library were systematically searched for phase III randomized controlled trials comparing doravirine/islatravir with standard triple option therapy. Eligible studies were independently screened, and data were extracted and pooled using R software.
resultsSix phase III trials involving 3,518 adults were included. At 48 weeks, doravirine/islatravir was associated with a significantly lower risk of virological failure (HIV-1 RNA ≥ 50 copies/mL) compared with standard triple option therapy (RR: 0.51, 95% CI [0.30-0.88]; P = 0.015). Rates of virological suppression (< 50 and < 200 copies/mL) were comparable between groups. No significant differences were observed in overall, serious, or grade 3-4 adverse events, or treatment discontinuation due to adverse events. Dose-stratified analyses showed that the 100/0.75 mg formulation was associated with significant declines in CD4 cell count and total lymphocyte count at 48 weeks, whereas the optimized 100/0.25 mg dose showed no significant immunological differences compared with standard triple option therapy.
conclusionsDoravirine/islatravir is an effective and generally well-tolerated two-drug regimen for HIV-1. The optimized 100/0.25 mg formulation maintained virological efficacy without significant short-term immunological differences versus standard triple option therapy; however, longer follow-up is needed to confirm its long-term immunological safety.
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