ArticleBMC medicine2025
Immediate and delayed switches to tenofovir DF-containing, ainuovirine-based antiretroviral regimen: the SPRINT extensional study.
Article in BMC medicine, 2025. 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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Abstract
backgroundAinuovirine (ANV) is a new-generation nonnucleoside reverse transcriptase inhibitor with potent antiviral activity and favorable neuropsychiatric and cardiometabolic safety. The SPRINT study showed that switching to fixed-dose ANV combined with lamivudine and tenofovir DF (ANV/3TC/TDF) provided non-inferior virologic efficacy and improved cardiometabolic conditions in virologically suppressed people living with HIV (PLWH) compared to that to cobicistat-boosted elvitegravir plus emtricitabine and tenofovir alafenamide (E/C/F/TAF) at 48 weeks.
methodsIn the base study (weeks 0-48), eligible virologically suppressed PLWH (n = 762) were randomized to receive ANV/3TC/TDF or E/C/F/TAF in a double-blind manner. In the extensional study (weeks 48-96), eligible participants on ANV/3TC/TDF continued the assigned regimen (immediate switch group, ISG), while those on E/C/F/TAF re-switched to ANV/3TC/TDF (delayed switch group, DSG). The original E/C/F/TAF group (weeks 0-48) was used as comparator for efficacy analysis. The primary efficacy endpoint was the proportion of PLWH with HIV RNA titer ≥ 50 copies/mL at week 96. Safety outcomes of primary interest included Changes in body weight and fasting serum lipids from weeks 48 to 96.
resultsThe primary efficacy endpoints were both 3.4% with ISG and DSG at week 96, non-inferior to 1.6% for comparator at week 48. Estimated treatment differences were 1.8% (95% confidence interval [CI] - 0.5 to 4.3%) with ISG versus comparator and 1.9% (95%CI - 0.4 to 4.4%) with DSG versus comparator, respectively. Non-inferiority was established for both ISG and DSG as the upper limits of 95%CI were both below the prespecified margin of 5%. The treatment-emergent adverse events were generally similar between the two switch groups. DSG showed modest reduction in body weight (mean, - 0.59 kg), in contrast to ISG with a minimal weight loss (- 0.03 kg; DSG versus ISG, - 0.56 kg, [- 1.07 to - 0.05]). Fasting serum low-density lipoprotein cholesterol remained generally unchanged in ISG (0.01 mmol/L) but improved greatly in DSG at week 96 from week 48 (- 0.30 mmol/L; - 0.31 mmol/L [- 0.47 to - 0.16]).
conclusionsBoth ISG and DSG maintained high viral Suppression in PLWH through 96 weeks. DSG could offset weight gain and dyslipidemia associated with previous exposure to E/C/F/TAF.
trial registrationChinese Clinical Trial Register number, ChiCTR2100051605.
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