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


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.