First-line HIV Regimen Effective, Safe in Test-and-Treat Setting

Dolutegravir/lamivudine is feasible, effective, and safe as a first-line regimen for the treatment of  newly diagnosed HIV in a test-and-treat setting, according to a study published in AIDS.

“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,” wrote researchers.

The STAT study enrolled 131 patients diagnosed with HIV-1 in a test-and-treat setting and started on DTG/3TC within 15 days of diagnosis, before baseline laboratory results were available. Participants whose baseline testing revealed DTG or 3TC resistance, HBV co-infection, or creatinine clearance less than 30 ml/min per 1.73 m² remained in the study with treatment modification. The analysis looked at efficacy endpoints at week 24.

During the study, 8 participants underwent treatment modification: 5 because of HBV co-infection, one because of a baseline M184V mutation, 1 because of a rash adverse event, and 1because of a personal decision.

At week 24, 92% of participants with available HIV-1 RNA data, and 78% of all study participants, achieved HIV-1 RNA less than 50 copies/ml, according to the study. The incidence of drug-related adverse events was 7%, and no drug-related serious adverse events occurred.

“Despite questions about its utility, primary results from STAT support the feasibility of rapid DTG/3TC initiation,” wrote researchers, “and provide preliminary evidence that antiretroviral therapy modifications can be performed safely via routine clinical care in the presence of baseline resistance or HBV co-infection to achieve virologic efficacy, thus providing the potential advantages of DTG/3TC as soon as the day of diagnosis.”

Reference:
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;35(12):1957-1965. doi: 10.1097/QAD.0000000000002979