The GEMINI trials have showed that the two drugs regimen of dolutegravir+lamivudine (DTG +3TC) was noninferior to a three-drug regimen as a first line regimen for treatment-naive people living with HIV. The aim of our study was to confirm, in a real-life setting, the efficacy of this regimen. We conducted a retrospective, observational study enrolling treatment-naive patients starting a first-line regimen with lamivudine plus dolutegravir. We evaluated the virological efficacy and the immunological and metabolic profiles. Changes from baseline were evaluated through linear-mixed models for repeated measures. Linear regression analyses were performed to explore variables associated to significant changes in laboratory parameters. We analyzed a total of 20 patients: 15 (75%) were men with a median age of 34.5 years. During a cumulative time of 15.4 patients years of follow up (PYFU), we did not observe any adverse event or treatment discontinuation and all patients achieved virological suppression in the first 6 months from treatment initiation. Increase in CD4⁺ cells was significant at both week 24 (p = .003) and week 48 (p = .007) of follow-up. Moreover, CD4/CD8 ratio also significantly improved [median increase of +0.22 (p = .028) after 48 weeks of follow-up]. As to metabolic parameters, we observed no significant changes in total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. In a subgroup of 11 patients, we further investigate HIV-1 DNA variations. Our results are in line with the findings of the GEMINI trials, confirming the efficacy and safety of DTG +3TC in treatment-naive patients.

中文翻译：

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简短交流：多替拉韦加拉米夫定作为一线治疗方案在临床实践中的有效性和安全性

GEMINI 试验表明，多替拉韦 + 拉米夫定 (DTG + 3TC) 两种药物方案作为未接受过治疗的 HIV 感染者的一线方案并不劣于三药方案。我们研究的目的是在现实生活中确认该方案的有效性。我们进行了一项回顾性、观察性研究，招募了开始接受拉米夫定加多替拉韦一线治疗方案的初治患者。我们评估了病毒学功效以及免疫学和代谢特征。通过重复测量的线性混合模型评估基线的变化。进行线性回归分析以探索与实验室参数显着变化相关的变量。我们总共分析了 20 名患者：15 名 (75%) 是男性，中位年龄为 34.5 岁。累计时间为 15 次。4 患者年的随访 (PYFU)，我们没有观察到任何不良事件或治疗中断，并且所有患者在治疗开始后的前 6 个月内都实现了病毒学抑制。CD4 增加⁺细胞在 随访的第24 周 ( p  = .003) 和第 48 周 ( p = .007)均显着。此外，CD4/CD8 比率也显着改善 [  48 周随访后中位数增加 +0.22 ( p = .028 )]。至于代谢参数，我们观察到总胆固醇、低密度脂蛋白胆固醇和高密度脂蛋白胆固醇没有显着变化。在 11 名患者的亚组中，我们进一步调查了 HIV-1 DNA 变异。我们的结果与 GEMINI 试验的结果一致，证实了 DTG +3TC 在初治患者中的有效性和安全性。