Background Tenofovir/lamivudine/dolutegravir (TLD) is the preferred first-line antiretroviral therapy (ART) regimen for people with HIV (PWH), including those who were previously virologically suppressed on non-nucleoside reverse transcriptase inhibitors (NNRTIs). We sought to estimate the real-world effectiveness of the TLD transition in Ugandan public-sector clinics. Methods We conducted a prospective cohort study of PWH ≥18 years who were transitioned from NNRTI-based ART to TLD. Study visits were conducted on the day of TLD transition and 24- and 48- weeks later. The primary endpoint was viral suppression (<200 copies/mL) at 48-weeks. We collected blood for retrospective viral load (VL) assessment and conducted genotypic resistance tests for specimens with VL >500 copies/mL. Results We enrolled 500 participants (median age of 47 years; 41% women). At 48-weeks after TLD transition, 94% of participants were in care with a VL <200 copies/mL (n = 469/500); 2% (n = 11/500) were lost from care or died; and only 2% (n = 9/500) had a VL >500 copies/mL. No incident resistance to DTG was identified. Few participants (2%, n = 9/500) discontinued TLD due to adverse events. Conclusions High rates of viral suppression, high tolerability, and lack of emergent drug resistance support use of TLD as the preferred first-line regimen in the region.

中文翻译：

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乌干达多替拉韦实施的人群有效性 - 前瞻性观察队列研究 (DISCO)：48 周结果


背景 替诺福韦/拉米夫定/多替拉韦 (TLD) 是 HIV 感染者 (PWH) 的首选一线抗逆转录病毒治疗 (ART) 方案，包括那些先前接受非核苷逆转录酶抑制剂 (NNRTI) 病毒学抑制的患者。我们试图评估乌干达公共部门诊所 TLD 过渡的实际有效性。方法 我们对从基于 NNRTI 的 ART 过渡到 TLD 的 18 岁以上 PWH 进行了前瞻性队列研究。研究访问在 TLD 过渡当天以及 24 周和 48 周后进行。主要终点是 48 周时的病毒抑制（<200 拷贝/mL）。我们收集血液进行回顾性病毒载量 (VL) 评估，并对 VL > 500 拷贝/mL 的样本进行基因型耐药性测试。结果 我们招募了 500 名参与者（中位年龄 47 岁；41% 为女性）。 TLD 转换后 48 周时，94% 的参与者接受 VL <200 拷贝/mL 的护理 (n = 469/500)； 2% (n = 11/500) 失去护理或死亡；只有 2% (n = 9/500) 的 VL >500 拷贝/mL。未发现对 DTG 产生耐药性的事件。少数参与者 (2%, n = 9/500) 由于不良事件而终止 TLD。结论 病毒抑制率高、耐受性高且没有出现耐药性，支持 TLD 作为该地区首选的一线治疗方案。