Pierone Gerald, Brunet Laurence, Fusco Jennifer S, Henegar Cassidy E, Sarkar Supriya, Van Wyk Jean, Vannappagari Vani, Wohlfeiler Michael B, Fusco Gregory P
Department of Adult Primary Care, Whole Family Health Center, Vero Beach, FL, USA.
Department of Epidemiology, Epividian, Raleigh, NC, USA.
HIV AIDS (Auckl). 2024 Apr 16;16:133-140. doi: 10.2147/HIV.S452130. eCollection 2024.
Two-drug regimens (2DR) may address drug-drug interactions and toxicity concerns. Dolutegravir/lamivudine (DTG/3TC) 2DR was approved in the US for both treatment-naïve and treatment-experienced individuals with a viral load <50 copies/mL. This study describes real-world DTG/3TC 2DR treatment outcomes among treatment-experienced individuals, stratified by age, sex, and race.
From the OPERA cohort, people with HIV with a viral load <50 copies/mL who switched from a commonly used three-drug regimen to DTG/3TC 2DR as per the label between April 8, 2019 and April 30, 2021 were included. Incidence rates (Poisson regression) for loss of virologic control (first viral load ≥50 copies/mL), confirmed virologic failure (2 viral loads ≥200 copies/mL or discontinuation after 1 viral load ≥200 copies/mL), and DTG/3TC 2DR discontinuation were estimated overall and stratified by age, sex, and race.
The 787 individuals included were followed for a median of 13.6 months (IQR: 8.2, 22.3). Confirmed virologic failure occurred in ≤5 individuals. Loss of virologic control occurred at a rate of 14.0 per 100 person-years (95% CI: 11.7, 16.8). DTG/3TC 2DR discontinuation occurred at a rate of 17.5 per 100 person-years (95% CI: 15.0, 20.3); 4% discontinued for treatment-related reasons (viremia, adverse diagnosis, side effect, lab abnormality). For all outcomes, incidence rates were comparable across strata of age, sex, and race.
This descriptive study demonstrates that DTG/3TC 2DR is an effective and well-tolerated treatment option for people with HIV with a viral load <50 copies/mL at switch, regardless of their age, sex, or race.
两药方案（2DR）可能解决药物相互作用和毒性问题。度鲁特韦/拉米夫定（DTG/3TC）两药方案在美国已被批准用于初治和经治的病毒载量<50拷贝/毫升的个体。本研究描述了按年龄、性别和种族分层的经治个体中DTG/3TC两药方案的实际治疗效果。
纳入OPERA队列中在2019年4月8日至2021年4月30日期间根据标签从常用的三药方案转换为DTG/3TC两药方案且病毒载量<50拷贝/毫升的HIV感染者。总体以及按年龄、性别和种族分层估计病毒学控制丧失（首次病毒载量≥50拷贝/毫升）、确诊病毒学失败（2次病毒载量≥200拷贝/毫升或在1次病毒载量≥200拷贝/毫升后停药）和DTG/3TC两药方案停药的发生率（泊松回归）。
纳入的787名个体的中位随访时间为13.6个月（四分位间距：8.2，22.3）。确诊病毒学失败的个体≤5例。病毒学控制丧失的发生率为每100人年14.0例（95%置信区间：11.7，16.8）。DTG/3TC两药方案停药的发生率为每100人年17.5例（95%置信区间：15.0，20.3）；4%因治疗相关原因（病毒血症、不良诊断、副作用、实验室异常）停药。对于所有结局，年龄、性别和种族各层的发生率相当。
这项描述性研究表明，对于转换时病毒载量<50拷贝/毫升的HIV感染者，无论其年龄、性别或种族如何，DTG/3TC两药方案都是一种有效且耐受性良好的治疗选择。
