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Feasibility, efficacy, and safety of Dolutegravir/Lamivudine (DTG/3TC) as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV (PLWH): 48-week results of the STAT study

Title
Feasibility, efficacy, and safety of Dolutegravir/Lamivudine (DTG/3TC) as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV (PLWH): 48-week results of the STAT study
Presenter
Charlotte-Paige Rolle
Authors
C.-P. Rolle * (1), M. Berhe (2), T. Singh (3), R. Ortiz (4), A. Wurapa (5), M. Ramgopal (6), D.T. Jayaweera (7), P.A Leone (8), J.E. Matthews (8), M. Cupo (9), M.R. Underwood (8), K. Angelis (10), B.R. Wynne (8), D. Merrill (8), C. Nguyen (8), J. van Wyk (11), A.R. Zolopa (8,12).
Institutions
(1) Orlando Immunology Center, Orlando, United States, (2) Baylor University Medical Center, Dallas, United States, (3) Desert AIDS Project, Palm Springs, United States, (4) Bliss Healthcare Services, Orlando, United States, (5) Infectious Disease Specialists of Atlanta, Decatur, United States, (6) Midway Immunology and Research Center, Fort Pierce, United States, (7) University of Miami Miller School of Medicine, Department of Medicine, Miami, United States, (8) ViiV Healthcare, Research Triangle Park, United States, (9) GlaxoSmithKline, Upper Providence, United States, (10) GlaxoSmithKline, Brentford, United Kingdom, (11) ViiV Healthcare, Brentford, United Kingdom, (12) Stanford University, Palo Alto, United States

BACKGROUND: Dolutegravir/Lamivudine (DTG/3TC) is indicated for treatment-naive and treatment-experienced people living with HIV (PLWH); however, questions remain about its utility in a test-and-treat setting because of potential transmitted resistance and baseline hepatitis B virus (HBV) co-infection. The STAT study evaluated the feasibility of using DTG/3TC as a first-line regimen in a test-and-treat setting in the United States. Here we present the 48-week end-of-study results.
METHODS: STAT is a single-arm study in adults who initiated DTG/3TC 'ยค14 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 m2, participants had their antiretroviral therapy (ART) adjusted and remained on study. Efficacy analyses included proportion of participants with HIV-1 RNA <50 c/mL, regardless of ART received at Week 48, among all participants (ITT-E missing = failure analysis), and among those with available HIV-1 RNA data at Week 48 (observed analysis).
RESULTS: Overall, 131 participants were enrolled in the study. By Week 48, treatment was modified in 10 participants: 5 due to baseline HBV, 1 due to baseline M184V, 1 due to an adverse event (AE; grade 2 rash), 1 due to first-trimester pregnancy, and 2 withdrew consent. After the Week 48 assessment, 1 participant modified ART due to lack of efficacy. At Week 48, 82% (107/131) of all participants and 97% (107/110) of those with available data achieved HIV-1 RNA <50 c/mL (Table). Two participants (2%) met confirmed virologic failure criteria; no treatment-emergent resistance-associated mutations were observed, and both remained on DTG/3TC. Incidence of drug-related AEs was low (8%); no drug-related SAEs occurred.


CONCLUSIONS: These data further support the feasibility of rapid DTG/3TC initiation and demonstrate that appropriate ART adjustments can be performed safely via routine clinical care in the presence of baseline resistance or HBV co-infection.