Rabie Helena, Yin Dwight E, Ward Shawn, Rani Yasha, Ziemba Lauren, Brooks Kristina M, Cressey Tim R, Masheto Gaerolwe R, Cassim Haseena, Deville Jaime G, Ponatshego Ponego L, Patel Faeezah, Aurpibul Linda, Barnabas Shaun L, Mustich Iris, Coletti Anne, Heckman Barbara, Krotje Chelsea, Townley Ellen, Moye Jack, Majji Sai, Acosta Edward P, Ryan Kevin, Chandasana Hardik, Brothers Cynthia H, Buchanan Ann M, Flynn Patricia M
From the Department of Paediatrics and Child Health, Faculty of Medicine and Health Science, University of Stellenbosch, Cape Town, South Africa.
Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, Maryland.
Pediatr Infect Dis J. 2025 May 29;44(8):777-84. doi: 10.1097/INF.0000000000004859.
BACKGROUND: Dispersible and immediate-release fixed-dose combinations (FDC) of abacavir, dolutegravir, and lamivudine are priority first-line antiretroviral therapy (ART) in children with HIV-1 (CWHIV). We report safety, efficacy and tolerability of these regimens through 48 weeks of treatment. METHODS: IMPAACT 2019 was a phase I/II, international, multisite, open-label, noncomparative study of dispersible and immediate-release FDC abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in participants with HIV-1 <12 years of age weighing 6 to <40 kg. At entry, participants were ART-naive or ART-experienced and virally suppressed on stable ART for ≥6 months. Participants received weight-banded dosing and enrolled across 5 weight bands in parallel. Follow-up visits were completed at weeks 1, 4, 12, 24, 36 and 48. RESULTS: Fifty-seven participants were enrolled; 2 participants withdrew due to poor drug tolerability. Fifty-four of 55 participants on the study at week 48 remained on the study drug. All 54 participants who remained on study drug through week 48 had viral loads of <200 copies/mL. CD4-lymphocyte counts remained stable with age over 48 weeks. Mean change (95% confidence interval) in body mass index Z-scores was 0.4 (0.2-0.6). Nine study drug-related adverse events were reported. One drug-induced liver injury attributed to abacavir and dolutegravir led to the permanent discontinuation of the study drug. CONCLUSIONS: Dispersible FDC ABC/DTG/3TC is the first dispersible dolutegravir-containing single tablet regimen for CWHIV. Dispersible- and immediate-release ABC/DTG/3TC was observed to be generally safe, effective and well-tolerated in CWHIV through 48 weeks.
背景：阿巴卡韦、多替拉韦和拉米夫定的可分散速释固定剂量复方制剂（FDC）是1型HIV感染儿童（CWHIV）优先选用的一线抗逆转录病毒疗法（ART）。我们报告了这些治疗方案在48周治疗期内的安全性、有效性和耐受性。 方法：IMPAACT 2019是一项I/II期国际多中心开放标签非对照研究，研究对象为年龄小于12岁、体重6至小于40千克的1型HIV感染者，给予可分散速释FDC阿巴卡韦/多替拉韦/拉米夫定（ABC/DTG/3TC）治疗。入组时，参与者既往未接受过ART治疗或有ART治疗史且在稳定的ART治疗下病毒得到抑制≥6个月。参与者接受按体重分组给药，并平行纳入5个体重组。在第1、4、12、24、36和48周完成随访。 结果：共纳入57名参与者；2名参与者因药物耐受性差而退出。在第48周时，55名参与研究的参与者中有54名仍在使用研究药物。在第48周仍继续使用研究药物的所有54名参与者的病毒载量均<200拷贝/毫升。48周内CD4淋巴细胞计数随年龄保持稳定。体重指数Z评分的平均变化（95%置信区间）为0.4（0.2 - 0.6）。报告了9例与研究药物相关的不良事件。1例由阿巴卡韦和多替拉韦引起的药物性肝损伤导致研究药物永久停用。 结论：可分散FDC ABC/DTG/3TC是首个用于CWHIV的含多替拉韦的可分散单片制剂。观察到可分散速释ABC/DTG/3TC在CWHIV中48周内总体安全、有效且耐受性良好。
Cochrane Database Syst Rev. 2013-6-5
J Int AIDS Soc. 2022-4
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