Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. (1st October 2021)

• Record Type: Journal Article
• Authors: Rolle, Charlotte-Paige; Berhe, Mezgebe; Singh, Tulika; Ortiz, Roberto; Wurapa, Anson; Ramgopal, Moti; Leone, Peter A.; Matthews, Jessica E.; Dalessandro, Marybeth; Underwood, Mark R.; Angelis, Konstantinos; Wynne, Brian R.; Merrill, Deanna; Nguyen, Christopher; van Wyk, Jean; Zolopa, Andrew R.
• Is Part Of: AIDS. Volume 35:Number 12(2021)
• Publication Date: 2021-10-01
• Subjects: dolutegravir -- dolutegravir/lamivudine -- rapid initiation -- test-and-treat -- two-drug regimen; AIDS (Disease) -- Periodicals; Acquired Immunodeficiency Syndrome; AIDS (Disease); Periodicals; Periodicals; 616.9792005
• DOI: 10.1097/QAD.0000000000002979
• Languages: English
• ISSNs: 0269-9370

Abstract

Abstract : Objectives: Dolutegravir/lamivudine (DTG/3TC) is indicated for treatment-naive and experienced people with HIV; 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. We present feasibility and efficacy of DTG/3TC in newly diagnosed individuals in a test-and-treat setting. Design: The single-arm STAT study evaluated DTG/3TC in a US test-and-treat setting. Methods: Eligible adults initiated DTG/3TC 14 days or less after HIV-1 diagnosis without availability of baseline laboratory results. If baseline testing indicated DTG or 3TC resistance, HBV co-infection, or creatinine clearance less than 30 ml/min per 1.73 m 2, participants remained on study with treatment modification. Efficacy endpoints included proportions of participants with HIV-1 RNA less than 50 copies/ml at Week 24, regardless of antiretroviral regimen, among all participants (intention-to-treat exposed) and those with available HIV-1 RNA data (observed). Results: Of 131 participants enrolled, 8% were female and 50% were non-white. Through Week 24, treatment was modified in eight participants [five with HBV co-infection, one with baseline M184V, one for adverse event (rash), one participant decision]. At Week 24, 78% (102/131) of all participants and 92% (102/111) of those with available data achieved HIV-1 RNA less than 50 copies/ml. Incidence of drug-related adverse events was low (7%); no drug-related serious adverse events occurred. Conclusion: These data demonstrate the feasibility, efficacy, and safety of using DTG/3TC as a first-line regimen in a test-and-treat setting, with therapy adjustments for baseline resistance or HBV co-infection occurring safely via routine clinical care as needed [ClinicalTrials.gov, NCT03945981; see Supplemental Digital Content 1, video abstract (Video abstract summarizing the STAT study design and results), http://links.lww.com/QAD/C189 ]. Abstract : Supplemental Digital Content is available in the text