Infectious Diseases Division, Hospital Universitario Clínico de Valladolid, 47003 Valladolid, Spain.
Infectious Diseases Division, Hospital Universitario de Burgos, 09006 Burgos, Spain.
Viruses. 2023 Apr 10;15(4):936. doi: 10.3390/v15040936.
BACKGROUND: The high effectiveness and safety of the two-drug (2DRs) strategy using dolutegravir (DTG) plus lamivudine (3TC) have led to international guidelines recommending their use for treatment-naive HIV patients. In virologically suppressed patients, de-escalating from 3DRs to DTG plus either rilpivirine (RPV) or 3TC has shown high rates of virological suppression. OBJECTIVES: This study aimed to compare the real-life data of two multicenter Spanish cohorts of PLWHIV treated with DTG plus 3TC (SPADE-3) or RPV (DORIPEX) as a switch strategy, not only in terms of virological suppression, safety, and durability but also in terms of immune restoration. The primary endpoint was the percentage of patients with virological suppression on DTG plus 3TC and DTG plus RPV at weeks 24 and 48. The secondary outcomes included the proportion of patients who experienced the protocol-defined loss of virological control by week 48; changes in immune status in terms of CD4+ and CD8+ T lymphocyte counts and the CD4+/CD8+ ratio; the rate, incidence, and reasons for discontinuation of treatment over the 48-week study period; and safety profiles at weeks 24 and 48. METHODS: We conducted a retrospective, observational, multicenter study of 638 and 943 virologically suppressed HIV-1-infected patients in two cohorts who switched to 2DRs with DTG plus RPV or DTG plus 3TC. RESULTS: The most frequent reasons for starting DTG-based 2DRs were treatment simplification/pill burden or drug decrease. The virological suppression rates were 96.9%, 97.4%, and 99.1% at weeks 24, 48, and 96, respectively. The proportion of patients with virological failure over the 48-week study period was 0.01%. Adverse drug reactions were uncommon. Patients treated with DTG+3TC increased CD4, CD8, and CD4/CD8 parameters at 24 and 48 weeks. CONCLUSIONS: We conclude that DTG-based 2DRs (combined with 3TC or RPV) in clinical practice were effective and safe as a switching strategy, with a low VF and high viral suppression rates. Both regimens were well tolerated, and ADR rates were low, including neurotoxicity and induced treatment discontinuations.
背景：二联疗法（2DRs）使用多替拉韦（DTG）加拉米夫定（3TC）的高有效性和安全性，导致国际指南建议将其用于初治 HIV 患者。在病毒学抑制的患者中，从 3DRs 降级为 DTG 加利匹韦林（RPV）或 3TC，已显示出高病毒学抑制率。
目的：本研究旨在比较使用 DTG 加 3TC（SPADE-3）或 RPV（DORIPEX）作为转换策略的两个西班牙多中心 PLWHIV 队列的真实数据，不仅在病毒学抑制、安全性和持久性方面，而且在免疫恢复方面。主要终点是在第 24 周和第 48 周时，接受 DTG 加 3TC 和 DTG 加 RPV 的患者中病毒学抑制的百分比。次要结局包括第 48 周时符合方案定义的病毒学控制失败的患者比例；CD4+和 CD8+T 淋巴细胞计数和 CD4+/CD8+比值的免疫状态变化；48 周研究期间治疗中断的发生率、发生率和原因；以及第 24 周和第 48 周的安全性特征。
方法：我们进行了一项回顾性、观察性、多中心研究，纳入了两个队列中的 638 名和 943 名病毒学抑制的 HIV-1 感染患者，他们分别换用 DTG 加 RPV 或 DTG 加 3TC 的二联疗法。
结果：开始 DTG 为基础的二联疗法的最常见原因是治疗简化/负担或药物减少。第 24 周、48 周和 96 周时的病毒学抑制率分别为 96.9%、97.4%和 99.1%。48 周研究期间，病毒学失败的患者比例为 0.01%。药物不良反应不常见。接受 DTG+3TC 治疗的患者在第 24 周和第 48 周时 CD4、CD8 和 CD4/CD8 参数增加。
结论：我们的结论是，DTG 为基础的二联疗法（与 3TC 或 RPV 联合使用）作为一种转换策略，在临床实践中是有效和安全的，病毒失败率低，病毒学抑制率高。两种方案均耐受良好，不良反应发生率低，包括神经毒性和导致治疗中断。
Medicine (Baltimore). 2022-6-17
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