High rates of virologic suppression with DTG/3TC in newly diagnosed adults with HIV-1 infection and baseline viral load >500,000 c/mL: 48-week subgroup analysis of the STAT study.

배경 The primary analysis of the STAT study demonstrated the feasibility, efficacy, and safety of using DTG/3TC as a first-line regimen in a test-and-treat setting through 24 weeks, with therapy adjustments for baseline resistance or hepatitis B virus (HBV) co-infection. Here we present secondary analyses through Week 48 of virologic outcomes in participants by baseline viral load (VL). 방법 STAT is a single-arm study of treatment-naive adults with HIV-1 infection who initiated DTG/3TC ≤14 days after HIV-1 diagnosis without availability of screening/baseline laboratory results. If baseline testing indicated DTG or 3TC resistance, HBV co-infection, or creatinine clearance <30 mL/min/1.73 m 2, then antiretroviral therapy (ART) was potentially adjusted and participants remained on study. Efficacy analyses included proportion of participants with HIV-1 RNA <50 c/mL regardless of ART regimen at Week 48, among all participants (ITT-E missing = failure analysis) and among participants with available HIV-1 RNA data at Week 48 (observed analysis). 결과 Of 131 enrolled, DTG/3TC treatment was adjusted in 10 participants, and of those with available data (n=7), all (100%) achieved HIV-1 RNA <50 c/mL at Week 48. At Week 48, 82% (107/131) of all participants (Figure 1) and 97% (107/110) of those with available data (Figure 2) achieved HIV-1 RNA <50 c/mL. Of participants with baseline VL ≥500,000 c/mL, 89% (17/19) achieved HIV-1 RNA <50 c/mL at Week 48; the remaining 2 withdrew from study. Of participants with baseline VL ≥1,000,000 c/mL, 90% (9/10) achieved HIV-1 RNA <50 c/mL at Week 48 (Table); the remaining participant withdrew consent. Of the 17 participants with baseline VL ≥500,000 c/mL with available data through Week 48, 76% (13/17) achieved virologic suppression by Week 24. One participant with baseline VL ≥500,000 c/mL switched from DTG/3TC before the Week 48 assessment. Of the 9 participants with baseline VL ≥1,000,000 c/mL with available data through Week 48, most participants (8/9; 89%) were suppressed by Week 24. 결론 These data provide evidence for the efficacy and feasibility of using DTG/3TC as a first-line regimen in a test-and-treat setting, including among participants with very high baseline VL. Data included in this abstract have previously been presented in full at IDWeek 2021; September 29-October 3, 2021; Virtual; Slides 75. [ABSTRACT FROM AUTHOR]