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Background <p>Ainuovirine (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&#xa0;weeks.</p> Methods <p>In the base study (weeks 0–48), eligible virologically suppressed PLWH (<i>n</i> = 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.</p> Results <p>The 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&#xa0;kg), in contrast to ISG with a minimal weight loss (− 0.03&#xa0;kg; DSG versus ISG, − 0.56&#xa0;kg, [− 1.07 to − 0.05]). Fasting serum low-density lipoprotein cholesterol remained generally unchanged in ISG (0.01&#xa0;mmol/L) but improved greatly in DSG at week 96 from week 48 (− 0.30&#xa0;mmol/L; − 0.31&#xa0;mmol/L [− 0.47 to − 0.16]).</p> Conclusions <p>Both ISG and DSG maintained high viral Suppression in PLWH through 96&#xa0;weeks. DSG could offset weight gain and dyslipidemia associated with previous exposure to E/C/F/TAF.</p> Trial registration <p>Chinese Clinical Trial Register number, ChiCTR2100051605.</p>

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Immediate and delayed switches to tenofovir DF-containing, ainuovirine-based antiretroviral regimen: the SPRINT extensional study

  • 期刊论文

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  • 发表日期：

    2025年9月30日

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  • Fujie Zhang,
  • Weiping Cai,
  • Hao Wu,
  • Ping Ma,
  • Qingxia Zhao,
  • Hongxia Wei,
  • Hongzhou Lu,
  • Hui Wang,
  • Shenghua He,
  • Zhu Chen,
  • Yaokai Chen,
  • Min Wang,
  • Xinming Yun,
  • Ziyue Zhou,
  • Heliang Fu,
  • Hong Qin

摘要

Background

Ainuovirine (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.

Methods

In 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.

Results

The 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]).

Conclusions

Both 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 registration

Chinese Clinical Trial Register number, ChiCTR2100051605.