Clinical outcomes after the introduction of dolutegravir for second-line antiretroviral therapy in South Africa: a retrospective cohort study.
Clinical outcomes after the introduction of dolutegravir for second-line antiretroviral therapy in South Africa: a retrospective cohort study.
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南非引入多替拉韦作为二线抗逆转录病毒治疗后的临床结果：一项回顾性队列研究。
DOI：
10.1101/2023.07.07.23292347
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发表时间：
2023
期刊：
影响因子：
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通讯作者：
Dorward,Jienchi
中科院分区：
文献类型：
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作者：
Asare,Kwabena;Sookrajh,Yukteshwar;vanderMolen,Johan;Khubone,Thokozani;Lewis,Lara;Lessells,RichardJ;Naidoo,Kogieleum;Sosibo,Phelelani;vanHeerden,Rosemary;Garrett,Nigel;Dorward,Jienchi
背景：dolutegravir现在被推荐用于低收入和中等收入国家的二线抗逆转录病毒治疗（ART）。在南非，我们比较了dolutegravir （DTG）与之前洛匹那韦/利托那韦（LPV/r）方案的结果。方法我们使用从南非59家诊所常规收集的去识别数据。我们纳入了年龄≥15岁且病毒学失败（连续两次病毒载量≥1000拷贝/mL）的艾滋病毒感染者，他们接受了一线富马酸替诺福韦二氧吡酯（TDF）为基础的抗逆转录病毒治疗，并切换到二线抗逆转录病毒治疗。我们使用改良泊松回归模型来比较切换到二线方案齐多夫定（AZT）、恩曲他滨/拉米夫定（XTC）、DTG和TDF/XTC/DTG和AZT/XTC/LPV/r后12个月的护理保留和病毒抑制（<50拷贝/ml）的结果。在1214名参与者中，729名（60.0%）为女性，中位年龄为36岁（四分位数范围为30 ~ 42岁），689名（56.8%）转为AZT/XTC/LPV/r， 217名（17.9%）转为AZT/XTC/DTG， 308名（25.4%）转为TDF/XTC/DTG。AZT/XTC/DTG组留置率较高（85.7%），调整风险比（aRR） 1.14, 95%可信区间（CI） 1.03 ~ 1.27；调整风险差（aRD）为10.89%,95%CI 2.01 ~ 19.78)，但与AZT/XTC/LPV/r（75.2%）相比，TDF/XTC/DTG （76.9%, aRR 1.01, 95%CI 0.94 ~ 1.10; aRD 1.04%, 95%CI - 5.03 ~ 7.12）无差异。与AZT/XTC/DTG相比，TDF/XTC/DTG的护理保留率无统计学差异（aRR 0.89, 95%CI 0.78 ~ 1.01; aRR - 9.85%, 95%CI - 20.33 ~ 0.63）。在病毒载量为12个月的799名患者中，AZT/XTC/DTG组的病毒抑制率（59.3%,aRR 1.25, 95%CI 1.06至1.47;aRD 11.57%, 95%CI 2.37至20.76）和TDF/XTC/DTG组（60.7%,aRR 1.30, 95%CI 1.14至1.48;aRD 14.16%, 95%CI 7.14至21.18）高于AZT/XTC/LPV/r组（46.7%）。基于dtg的二线方案与基于LPV/r的方案相比具有相似或更好的护理保留和更好的病毒抑制。与AZT/XTC/DTG相比，TDF/XTC/DTG对病毒的抑制作用相似。资金。比尔和梅林达·盖茨基金会，非洲牛津倡议。
BackgroundDolutegravir is now recommended for second-line anti-retroviral therapy (ART) in low- and middle-income countries. We compared outcomes with dolutegravir (DTG) versus the previous lopinavir/ritonavir (LPV/r) regimen in South Africa.MethodsWe used routinely collected, de-identified data from 59 South African clinics. We included people living with HIV aged ≥ 15 years with virologic failure (two consecutive viral loads ≥1000 copies/mL) on first-line tenofovir disoproxil fumarate (TDF)-based ART and switched to second-line ART. We used modified Poisson regression models to compare outcomes of 12-month retention-in-care and viral suppression (<50 copies/ml) after switching to second-line regimens of zidovudine (AZT), emtricitabine/lamivudine (XTC), DTG and TDF/XTC/DTG and AZT/XTC/LPV/r.FindingsOf 1214 participants, 729 (60.0%) were female, median age was 36 years (interquartile range 30 to 42), 689 (56.8%) were switched to AZT/XTC/LPV/r, 217 (17.9%) to AZT/XTC/DTG and 308 (25.4%) to TDF/XTC/DTG. Retention-in-care was higher with AZT/XTC/DTG (85.7%, adjusted risk ratio (aRR) 1.14, 95% confidence interval (CI) 1.03 to 1.27; adjusted risk difference (aRD) 10.89%, 95%CI 2.01 to 19.78) but not different with TDF/XTC/DTG (76.9%, aRR 1.01, 95%CI 0.94 to 1.10; aRD 1.04%, 95%CI −5.03 to 7.12) compared to AZT/XTC/LPV/r (75.2%). Retention-in-care with TDF/XTC/DTG was not statistically significantly different from AZT/XTC/DTG (aRR 0.89, 95%CI 0.78 to 1.01; aRD −9.85%, 95%CI −20.33 to 0.63). Of 799 participants who were retained-in-care with a 12-month viral load, viral suppression was higher with AZT/XTC/DTG (59.3%, aRR 1.25, 95%CI 1.06 to 1.47; aRD 11.57%, 95%CI 2.37 to 20.76) and TDF/XTC/DTG (60.7%, aRR 1.30, 95%CI 1.14 to 1.48; aRD 14.16%, 95%CI 7.14 to 21.18) than with the AZT/XTC/LPV/r regimen (46.7%).InterpretationDTG-based second-line regimens were associated with similar or better retention-in-care and better viral suppression than the LPV/r-based regimen. TDF/XTC/DTG had similar viral suppression compared to AZT/XTC/DTG. Funding. Bill & Melinda Gates Foundation, Africa Oxford Initiative.