The two-drug regimen dolutegravir plus lamivudine demonstrated durable efficacy for up to 3 years in phase III studies and a high barrier to resistance in treatment-naive and virologically suppressed people with HIV (PWH). This systematic literature review summarizes real-world evidence evaluating effectiveness and safety of dolutegravir plus lamivudine. We searched Ovid MEDLINE®, Embase®, PubMed, Cochrane library, and relevant international conference proceedings from 2013 to 2020. Qualitative synthesis of virologic suppression at Week 48, treatment-emergent resistance, discontinuation rates, and comorbidities was undertaken, with no statistical analyses conducted. Linked publications and potential for duplication in reporting of outcomes for cohorts and populations were identified, and the publication reporting the highest number of PWH receiving dolutegravir plus lamivudine was included in the analysis. Thirty-four studies reporting on cohorts of PWH not suspected to be linked or to include duplicate data receiving dolutegravir plus lamivudine were identified (N = 5017). Of 3744 virologically suppressed PWH who switched to dolutegravir plus lamivudine, 603 (16%) reported history of virologic failure. Nineteen studies included effectiveness data (n = 3558), four of which included data from treatment-naive PWH (n = 69). In studies with > 100 PWH, high rates of virologic suppression (Week 48, 97-100%) were maintained with dolutegravir plus lamivudine, with low rates of virologic failure (0-3.3 per 100 person-years of follow-up); one instance of emergent integrase strand transfer inhibitor resistance was reported in a complex treatment-experienced individual. Rates of discontinuation due to adverse events were low and consistent with previously observed trial data. Dolutegravir plus lamivudine minimally impacted renal function and had minimal impact on or improved lipid profiles and bone mineral density. This systematic review demonstrates that effectiveness and safety of dolutegravir plus lamivudine in clinical practice support data from randomized controlled trials with regard to high rates of virologic response, low rates of discontinuation, and a high barrier to resistance.

中文翻译：

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现实世界临床实践中使用双药方案 Dolutegravir 加拉米夫定治疗 HIV：系统文献综述。

多替拉韦加拉米夫定的两种药物方案在 III 期研究中显示出长达 3 年的持久疗效，并且在未经治疗和病毒学抑制的 HIV 感染者 (PWH) 中具有很高的耐药屏障。这篇系统的文献综述总结了评估多替拉韦加拉米夫定有效性和安全性的真实世界证据。我们检索了 2013 年至 2020 年的 Ovid MEDLINE®、Embase®、PubMed、Cochrane 图书馆和相关国际会议论文集。对第 48 周的病毒学抑制、治疗出现的耐药性、停药率和合并症进行了定性综合，没有进行统计分析实施。确定了相关出版物和重复报告队列和人群结果的可能性，分析中包括了报告接受多替拉韦加拉米夫定治疗的 PWH 数量最多的出版物。确定了 34 项关于 PWH 队列的研究，这些研究报告的 PWH 队列没有被怀疑有关联或包含接受多替拉韦加拉米夫定的重复数据（N = 5017）。在转为多替拉韦加拉米夫定的 3744 名病毒学抑制的 PWH 中，603 名 (16%) 报告了病毒学失败的病史。19 项研究包括有效性数据 (n = 3558)，其中四项包括来自未治疗 PWH 的数据 (n = 69)。在 > 100 PWH 的研究中，多替拉韦加拉米夫定维持高病毒学抑制率（第 48 周，97-100%），病毒学失败率低（每 100 人年随访 0-3.3）；在经历过复杂治疗的个体中报告了一个紧急整合酶链转移抑制剂耐药性的实例。由于不良事件导致的停药率很低，并且与之前观察到的试验数据一致。多替拉韦加拉米夫定对肾功能的影响最小，对血脂和骨矿物质密度的影响或改善也很小。该系统评价表明，多替拉韦加拉米夫定在临床实践中的有效性和安全性支持来自随机对照试验的数据，这些数据涉及病毒学应答率高、停药率低和耐药屏障高。多替拉韦加拉米夫定对肾功能的影响最小，对血脂和骨矿物质密度的影响或改善也很小。该系统评价表明，多替拉韦加拉米夫定在临床实践中的有效性和安全性支持来自随机对照试验的数据，这些数据涉及病毒学应答率高、停药率低和耐药屏障高。多替拉韦加拉米夫定对肾功能的影响最小，对血脂和骨矿物质密度的影响或改善也很小。该系统评价表明，多替拉韦加拉米夫定在临床实践中的有效性和安全性支持来自随机对照试验的数据，这些数据涉及病毒学应答率高、停药率低和耐药屏障高。