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

Charlotte-Paige Rolle; Mezgebe Berhe; Tulika Singh; Roberto Ortiz; Anson Wurapa; Moti Ramgopal; Dushyantha T Jayaweera; Peter A Leone; Jessica E Matthews; Michael Cupo; Mark R Underwood; Konstantinos Angelis; Brian R Wynne; Deanna Merrill; Christopher Nguyen; Jean van Wyk; Andrew R Zolopa

doi:10.1093/ofid/ofad101

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

Open Forum Infect Dis. 2023 Mar 1;10(3):ofad101. doi: 10.1093/ofid/ofad101. eCollection 2023 Mar.

Authors

Charlotte-Paige Rolle¹, Mezgebe Berhe², Tulika Singh³, Roberto Ortiz⁴, Anson Wurapa⁵, Moti Ramgopal⁶, Dushyantha T Jayaweera⁷, Peter A Leone⁸, Jessica E Matthews⁸, Michael Cupo⁹, Mark R Underwood⁸, Konstantinos Angelis¹⁰, Brian R Wynne⁸, Deanna Merrill⁸, Christopher Nguyen⁸, Jean van Wyk¹¹, Andrew R Zolopa^{8

12}

Affiliations

¹ Orlando Immunology Center, Orlando, Florida, USA.
² Baylor University Medical Center, Dallas, Texas, USA.
³ DAP Health, Palm Springs, California, USA.
⁴ Bliss Healthcare Services, Orlando, Florida, USA.
⁵ Infectious Disease Specialists of Atlanta, Decatur, Georgia, USA.
⁶ Midway Immunology and Research Center, Fort Pierce, Florida, USA.
⁷ Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida, USA.
⁸ ViiV Healthcare, Durham, North Carolina, USA.
⁹ GSK, Upper Providence, Pennsylvania, USA.
¹⁰ GSK, Brentford, United Kingdom.
¹¹ ViiV Healthcare, Brentford, United Kingdom.
¹² Stanford University, Palo Alto, California, USA.

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. Two participants met confirmed virologic failure criteria. No treatment-emergent resistance was observed. Ten participants reported drug-related AEs (all grade 1-2); no serious drug-related AEs occurred.

Conclusions: Results demonstrated high proportions of participants with sustained virologic suppression, no treatment-emergent resistance, and good safety over 48 weeks, supporting first-line use of DTG/3TC in a test-and-treat setting.

Keywords: 2-drug regimen; DTG/3TC; first-line regimen; rapid initiation; virologic suppression.