Sustained Virologic Suppression With Dolutegravir/Lamivudine in a Test-and-Treat Setting Through 48 Weeks

作者：Charlotte-Paige Rolle, Mezgebe Berhe, Tulika Singh, Roberto Ortiz, Anson K Wurapa, Moti Ramgopal, Dushyantha Jayaweera, Peter A. Leone, Jessica Matthews, Michael Cupo, Mark Underwood, Konstantinos Angelis, Brian Wynne, Deanna Merrill, Christopher Nguyen, Jean van Wyk, Andrew Zolopa · 发表于：Open Forum Infectious Diseases · 年份：2023 · DOI：10.1093/ofid/ofad101 · 被引用次数：24 · 研究领域：Hepatitis B Virus Studies、HIV/AIDS drug development and treatment、Hepatitis C virus research

Abstract Background We assessed the efficacy and safety of dolutegravir/lamivudine (DTG/3TC) in a US test-and-treat setting at a secondary 48-week time point of the multicenter, single-arm, phase IIIb STAT study. Methods Participants were eligible adults newly diagnosed with human immunodeficiency virus (HIV)-1 and had started once-daily DTG/3TC within 14 days of diagnosis, before laboratory results were available. Antiretroviral therapy (ART) was modified if baseline testing indicated DTG or 3TC resistance, hepatitis B virus (HBV) coinfection, or creatinine clearance <30 mL/min per 1.73 m2, and these participants remained in the study. A proportion with HIV-1 ribonucleic acid (RNA) <50 copies/mL at Week 48 was calculated among all participants (intention-to-treat-exposed [ITT-E] missing = failure analysis) and those with available data (observed analysis). Results At Week 48, 82% of all participants regardless of ART (107 of 131; ITT-E missing = failure) and 97% with available data (107 of 110; observed analysis) achieved HIV-1 RNA <50 copies/mL. High proportions of virologic response were seen overall, including in participants with high viral load (≥500 000 copies/mL; 89%) or low CD4+ cell count (<200 cells/mm3; 78%) at baseline. Ten participants had treatment modification (baseline HBV coinfection, n = 5; participant/proxy decision, n = 2; baseline M184V resistance mutation, adverse event [AE; rash], and pregnancy, n = 1 each) before Week 48. T...