Unidad Clínica de Enfermedades Infecciosas y Microbiología, Hospital Universitario Virgen Macarena, Sevilla, Spain.
Instituto de Biomedicina de Sevilla / Departamento de Medicina, Universidad de Sevilla / CSIC, Sevilla, Spain.
J Antimicrob Chemother. 2023 Sep 5;78(9):2354-2360. doi: 10.1093/jac/dkad245.
This was a substudy of a Phase IV, randomized clinical trial (ClinicalTrials.gov identifier: NCT04295460) aiming to compare the activity of dolutegravir/lamivudine versus dolutegravir plus tenofovir alafenamide/emtricitabine (DTG + TAF/FTC) in the male genital tract.
Participants were asymptomatic adults without sexually transmitted diseases, treatment-naive people living with HIV (PLWH), with CD4+ T cell counts >200 cells/mm3 and plasma HIV-1-RNA levels >5000 and <500 000 copies/mL, randomized (1:1) to DTG + TAF/FTC or dolutegravir/lamivudine. Blood plasma (BP) and seminal plasma (SP) were collected at baseline and Weeks 4, 8, 12 and 24. HIV-1-RNA was measured in BP and SP using the Cobas 6800 system (Roche Diagnostics) with a lower detection limit of 20 copies/mL. The primary efficacy endpoint was the proportion of subjects with undetectable SP HIV-1-RNA at Week 12 by intention-to-treat analysis.
Fifteen participants in the DTG + TAF/FTC and 16 in the dolutegravir/lamivudine arms were analysed, with basal SP viral load of 4.81 (4.30-5.43) and 4.76 (4.09-5.23), P = 0.469, respectively. At Week 12, only one participant in each treatment arm had a detectable SP HIV-1-RNA (DTG + TAF/FTC, 141 copies/mL; dolutegravir/lamivudine, 61 copies/mL). Based on the estimated means, there was no significant difference in the decay of HIV-1-RNA in both BP and SP over time between the two arms of treatment (F = 0.452, P = 0.662, and F = 1.147, P = 0.185, respectively).
After 12 weeks of treatment, there were no differences in the percentage of undetectable SP HIV-1-RNA in naive PLWH who started dolutegravir/lamivudine compared with DTG + TAF/FTC.
这是一项四期、随机临床试验（ClinicalTrials.gov 标识符：NCT04295460）的子研究，旨在比较多替拉韦/拉米夫定与多替拉韦加替诺福韦艾拉酚胺/恩曲他滨（DTG+TAF/FTC）在男性生殖部位的活性。
参与者为无症状、无性传播疾病、未经治疗的艾滋病毒感染者（PLWH），CD4+T 细胞计数>200 个细胞/mm3，血浆 HIV-1-RNA 水平>5000 且<500000 拷贝/mL，按 1:1 比例随机分为 DTG+TAF/FTC 或多替拉韦/拉米夫定组。在基线和第 4、8、12 和 24 周时采集血血浆（BP）和精液浆（SP）。使用 Cobas 6800 系统（罗氏诊断）测量 BP 和 SP 中的 HIV-1-RNA，检测下限为 20 拷贝/mL。主要疗效终点为意向治疗分析时第 12 周时 SP HIV-1-RNA 不可检测的受试者比例。
在 DTG+TAF/FTC 组和多替拉韦/拉米夫定组中分别分析了 15 名和 16 名受试者，基础 SP 病毒载量分别为 4.81（4.30-5.43）和 4.76（4.09-5.23），P=0.469。在第 12 周时，每个治疗组各有一名受试者的 SP HIV-1-RNA 可检测（DTG+TAF/FTC，141 拷贝/mL；多替拉韦/拉米夫定，61 拷贝/mL）。基于估计均值，在治疗的两个臂之间，BP 和 SP 中的 HIV-1-RNA 随时间的衰减没有显著差异（F=0.452，P=0.662，和 F=1.147，P=0.185）。
在开始多替拉韦/拉米夫定治疗的未经治疗的 PLWH 中，治疗 12 周后，不可检测的 SP HIV-1-RNA 百分比在多替拉韦/拉米夫定组与 DTG+TAF/FTC 组之间没有差异。
