在多替替韦时代重新审视依非韦伦:低剂量依非韦伦是一种可行的替代方案,能够与多替替韦相抗衡

Anirudh Anilkumar, Sumit Arora, KuldeepK Ashta, Nishant Raman
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Methods: A phase-IV comparative study of consecutive cases who switched their first-line NNRTI-based ART to either EFV-400 or DTG with a dual NRTI backbone between October 2020 to December 2021 and underwent at least 48 weeks of follow-up. The study is a non-randomised trial, wherein ART regimens were based on physician choice, patient preference and drug availability. Results: A total of 102 [DTG arm: 52; EFV-400 arm: 50; intention-to-treat (ITT) population] participants met the inclusion criteria. At 48-week follow-up, virological failure was not observed in either arm. Virological suppression to < 200 cp/mL was attained in 97.9% (n = 48/49; 95% confidence interval [CI]: 89.1–99.9) and 95.9% (n = 47/49; 95% CI: 86.02–99.5) of patients, respectively, in the DTG and-EFV-400 arm (ITT-populations). There was no significant difference in mean change from baseline in body weight and body mass index between DTG and-EFV-400 arms. The proportion of patients who gained ≥ 10% of their baseline body weight at 24 weeks of exposure to DTG was 16% (n = 8, 95% CI: 5.8 to 26.2) and that to EFV-400 was 10% (n = 5, 95% CI: 1.7 to 18.3) with a difference in proportions: 6.0% (95% CI: −7.1–19.1)]. There was a significant decrease at 24 weeks in mean fasting levels of lipid fractions in the DTG arm as compared to EFV-400 [total cholesterol: − 24.3 mg/dL, 95% CI: −35.2 to − 13.3 vs. −6.9 mg/dL, 95% CI: −17.9–4.1 (P = 0.029) and triglycerides:−35.9 mg/dL, 95% CI: −60.9 to − 10.9 vs. 8.6 mg/dL, 95% CI: −16.6 to 33.8 (P = 0.014)]. Adverse events (AEs) of any grade including laboratory derangements to DTG were experienced by 6% (n = 3, 95% CI: −0.6 to 12.6) and that to EFV-400 by 8% (n = 4, 95% CI: 0.5 to 15.5) with a difference in proportions: 2.0% (95% CI: −7.9 to 11.9). Grades 3–4-AE occurred in two patients, both in the EFV-400 arm. 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引用次数: 0

摘要

背景:一线双NRTI +基于nnrti的ART已显示出良好的病毒学效果;然而,毒性是常见的,并且往往是修改一线抗逆转录病毒治疗的最常见原因。目的:本研究的目的是通过研究抗逆转录病毒治疗(ART)转换策略,对病毒学抑制的印度HIV感染者(PLH)使用一线双核苷逆转录酶抑制剂(NRTI) +非NRTI (NNRTI)为基础的ART治疗的病毒学有效性和安全性的结果,重新审视dolutegravir (DTG)时代的低剂量依非韦伦(EFV)。方法:在2020年10月至2021年12月期间,将一线基于nnrti的ART转换为EFV-400或双NRTI骨干DTG的连续病例进行iv期比较研究,并进行至少48周的随访。这项研究是一项非随机试验,其中抗逆转录病毒治疗方案是基于医生的选择、患者的偏好和药物的可获得性。结果:共102例[DTG组:52例;EFV-400臂:50;意向治疗(ITT)人群]名受试者符合纳入标准。在48周的随访中,两组均未观察到病毒学失败。97.9%的患者病毒学抑制< 200 cp/mL (n = 48/49;95%置信区间[CI]: 89.1-99.9)和95.9% (n = 47/49;95% CI: 86.02-99.5),分别为DTG组和efv -400组(itt -人群)患者。DTG组和efv -400组的体重和体重指数相对基线的平均变化无显著差异。暴露于DTG 24周时体重增加≥10%的患者比例为16% (n = 8, 95% CI: 5.8 ~ 26.2), EFV-400为10% (n = 5, 95% CI: 1.7 ~ 18.3),比例差异为6.0% (95% CI:−7.1 ~ 19.1)。与EFV-400相比,在24周时,DTG组的平均空腹脂质含量显著降低[总胆固醇:- 24.3 mg/dL, 95% CI: - 35.2至- 13.3 vs. - 6.9 mg/dL, 95% CI: - 17.9至4.1 (P = 0.029),甘油三酯:- 35.9 mg/dL, 95% CI: - 60.9至- 10.9 vs. 8.6 mg/dL, 95% CI: - 16.6至33.8 (P = 0.014)]。包括实验室紊乱在内的任何级别的不良事件(ae)对DTG的发生率为6% (n = 3, 95% CI: - 0.6至12.6),对EFV-400的发生率为8% (n = 4, 95% CI: 0.5至15.5),比例差异为2.0% (95% CI: - 7.9至11.9)。3 -4级ae发生在2例患者中,均在EFV-400组。DTG组未观察到中枢神经系统ae, EFV-400组中有2例患者发生ae。EFV-400组中有2例患者因不良反应而停止治疗。结论:DTG和efv -400为基础的一线ART在双重NRTI + nnrti为基础的一线ART病毒学抑制患者中表现出良好的病毒学有效性和安全性。
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Revisiting efavirenz in the era of dolutegravir: Low-dose efavirenz, a viable alternative capable of holding its own against dolutegravir-based regimens
Background: First-line dual NRTI + NNRTI-based ART has shown good virological effectiveness; however, toxicity is common and is often the most common reason for modification of first-line ART. Aims: The purpose of this study is to revisit low-dose efavirenz (EFV) in the era of dolutegravir (DTG) by investigating anti-retroviral therapy (ART) switch strategies for outcomes of virological effectiveness and safety in virologically suppressed Indian persons living with HIV (PLH) on first-line dual nucleoside reverse transcriptase inhibitors (NRTI) + non-NRTI (NNRTI)-based ART. Methods: A phase-IV comparative study of consecutive cases who switched their first-line NNRTI-based ART to either EFV-400 or DTG with a dual NRTI backbone between October 2020 to December 2021 and underwent at least 48 weeks of follow-up. The study is a non-randomised trial, wherein ART regimens were based on physician choice, patient preference and drug availability. Results: A total of 102 [DTG arm: 52; EFV-400 arm: 50; intention-to-treat (ITT) population] participants met the inclusion criteria. At 48-week follow-up, virological failure was not observed in either arm. Virological suppression to < 200 cp/mL was attained in 97.9% (n = 48/49; 95% confidence interval [CI]: 89.1–99.9) and 95.9% (n = 47/49; 95% CI: 86.02–99.5) of patients, respectively, in the DTG and-EFV-400 arm (ITT-populations). There was no significant difference in mean change from baseline in body weight and body mass index between DTG and-EFV-400 arms. The proportion of patients who gained ≥ 10% of their baseline body weight at 24 weeks of exposure to DTG was 16% (n = 8, 95% CI: 5.8 to 26.2) and that to EFV-400 was 10% (n = 5, 95% CI: 1.7 to 18.3) with a difference in proportions: 6.0% (95% CI: −7.1–19.1)]. There was a significant decrease at 24 weeks in mean fasting levels of lipid fractions in the DTG arm as compared to EFV-400 [total cholesterol: − 24.3 mg/dL, 95% CI: −35.2 to − 13.3 vs. −6.9 mg/dL, 95% CI: −17.9–4.1 (P = 0.029) and triglycerides:−35.9 mg/dL, 95% CI: −60.9 to − 10.9 vs. 8.6 mg/dL, 95% CI: −16.6 to 33.8 (P = 0.014)]. Adverse events (AEs) of any grade including laboratory derangements to DTG were experienced by 6% (n = 3, 95% CI: −0.6 to 12.6) and that to EFV-400 by 8% (n = 4, 95% CI: 0.5 to 15.5) with a difference in proportions: 2.0% (95% CI: −7.9 to 11.9). Grades 3–4-AE occurred in two patients, both in the EFV-400 arm. Central nervous system AEs were not observed in the DTG arm and occurred in two patients in the EFV-400 arm. Two patients in the EFV-400 arm discontinued the regimen due to AEs. Conclusion: Both DTG and EFV-400-based first-line ART show good virological effectiveness and safety profiles in patients who are virologically suppressed on dual NRTI + NNRTI-based first-line ART.
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