Infectious Diseases and Hospital Epidemiology, Cantonal Hospital Sankt Gallen, St. Gallen, Switzerland.
Infectious Diseases and Hospital Epidemiology, Children's Hospital of Eastern Switzerland, St. Gallen, Switzerland.
PLoS One. 2020 Sep 23;15(9):e0237770. doi: 10.1371/journal.pone.0237770. eCollection 2020.
The aim of this proof-of-concept study is to test feasibility and efficacy of NVP plus Lamivudine (3TC) as novel simplified HIV maintenance dual therapy (DT) strategy.
Patients under combined antiretroviral treatment (cART) with fully suppressed HIV plasma viral load (pVL) >24 months-whereof >6 months on an NVP- containing regimen-were switched to oral NVP plus 3TC for 24 weeks. Patients could then decide whether to continue DT or return to the previous cART. HIV pVL was monitored monthly until week 144. The primary outcome was confirmed viral failure (RNA >100 copies/ml). Low-level detection of HIV-RNA in plasma was compared in each patient with pre-study viral load measurements.
Twenty patients were included, switched to DT and all completed week 24. One patient decided thereafter to discontinue study participation for personal reasons. After a total of 144 observation weeks, none of the patients failed. The frequency of low- level HIV-RNA detection was not different from the period before randomization.
Our findings are surprising but given the nature of a proof-of-concept study, the results do not support the use of this dual regimen. However, as this dual HIV maintenance strategy was feasible and effective, over a period of 144 weeks, we suggest NVP plus 3TC warrants further evaluation as potential maintenance option in patients tolerating nevirapine. A properly sized multicentre non-inferiority trial is ongoing to further evaluate the value of this DT maintenance strategy.
本概念验证研究旨在检验新型简化 HIV 维持双重治疗（DT）策略奈韦拉平（NVP）加拉米夫定（3TC）的可行性和疗效。
接受联合抗逆转录病毒治疗（cART）、HIV 血浆病毒载量（pVL）完全抑制（>24 个月，其中包含 NVP 方案>6 个月）的患者转换为口服 NVP 加 3TC 治疗 24 周。患者可决定继续接受 DT 或返回之前的 cART。每月监测 HIV pVL 直至第 144 周。主要终点是确认病毒失败（RNA>100 拷贝/ml）。每位患者均将血浆中 HIV-RNA 的低水平检测与研究前的病毒载量测量结果进行比较。
共纳入 20 例患者，转换为 DT，所有患者均完成第 24 周。1 例患者因个人原因决定退出研究。总共 144 周观察后，无一例患者失败。低水平 HIV-RNA 检测的频率与随机分组前无差异。
我们的发现令人惊讶，但鉴于概念验证研究的性质，结果不支持使用这种双重方案。然而，由于这种双重 HIV 维持策略在 144 周的时间内是可行且有效的，我们建议 NVP 加 3TC 值得进一步评估，作为耐受奈韦拉平的患者的潜在维持选择。正在进行一项适当规模的多中心非劣效性试验，以进一步评估这种 DT 维持策略的价值。
