by Carolyn Chu, MD, MSc, AAHIVS, AAHIVM Chief Medical Officer
September 21, 2021
Rolle CP, Berhe M, Singh T, et al. Dolutegravir/lamivudine as a first-line regimen in a test-and-treat setting for newly diagnosed people living with HIV. AIDS. 2021 Oct 1; 35(12): 1957-1965. doi: 10.1097/QAD.0000000000002979. PMID: 34115650.
The STAT study was a single-arm trial examining use of DTG/3TC in a U.S. test-and-treat setting. 131 adults were enrolled to “rapid” DTG/3TC initiation within 14 days of diagnosis. 15 (11%) participants discontinued the study by week 24, and 8 participants (6%) had therapy modifications after enrollment: 5 HBV co-infections were identified, 1 participant had M184V on baseline plasma genotype, and 2 changed for other reasons (rash and participant decision). At 24 weeks, 102/131 (78%, which includes 5 people with ART modification) achieved HIV-1 RNA < 50 copies/mL. Among participants with available data under any ART at week 24, 102/111 (92%) had HIV-1 RNA < 50 copies/mL. Overall, 97/131 (74%) were still on DTG/3TC at week 24 with HIV viral load < 50 copies/mL. Median time to suppression was 35 days. No treatment-emergent HIV or HBV resistance associated mutations were detected. Of 9 evaluable participants with VL ≥ 50 copies/mL at week 24, 4 had baseline RNA > 500,000 copies/mL. A 7% incidence of drug-related adverse events was observed, mostly grade 1. Baseline median weight was 74.2kg, and a median 5.2% increase was observed for participants on DTG/3TC.
Many providers have been understandably cautious about the utility of DTG/3TC for rapid ART initiation given concerns related to transmitted drug resistance, hepatitis B co-infection, and high initial viral load among newly diagnosed persons. In this STAT cohort, <10% of study participants who initially started DTG/3TG subsequently needed therapy modification, and no treatment-emergent HIV drug resistance was observed. Drug-related adverse events occurred in <10%, and overall approximately three-quarters of participants remained on DTG/3TC through 24 weeks with achievement of HIV-1 RNA < 50 copies/mL. Larger and longer-term studies with a comparison arm as well as “real world” clinical experience are needed to help assess whether this option might be a safe and sufficiently effective alternative to more established “rapid ART” regimens.
The author has no conflicts of interest to disclose.
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