STAT trial: Feasibility of two-drug DTG/3TC as first-line treatment
In further findings presented at the meeting on the STAT trial, researchers evaluated the feasibility not of switching to, but of initiating patients on, the two-drug DTG treatment as a first-line therapy, within 14 days of HIV-1 diagnosis.
The “test-and-treat” approach counters common belief that the regimen should be started only after the traditional three-drug regimens, because of the potential of transmitted resistance and baseline hepatitis B virus coinfection.
In the study of 131 patients, at week 48, 82% (107/131) of all participants and 97% (107/110) of those with available data achieved HIV-1 RNA levels of < 50 c/mL.
While two participants had confirmed virologic failure in the study, there were no treatment-emergent resistance-associated mutations, and neither patient discontinued the two-drug DTG treatment. There were low rates of drug-related adverse events (8%) and they were not serious.
“The STAT data is important as it shows us, for the first time, that in patients where potentially very little is known prior to treatment initiation, DTG/3TC can be very effectively used as a first-line regimen in a ‘test-and-treat’ approach without compromising on patient safety,” first author, MD, director of research operations, Orlando (Fla.) Immunology Center, said in an interview.
Dr. Rolle added that “with careful monitoring of test results in the first weeks of therapy, we can appropriately and safely adjust therapy from DTG/3TC to a three-drug regimen if needed for patients that have transmitted drug resistance to DTG or 3TC, or hepatitis B coinfection, with both of these occurring at very low rates regardless.”
The SALSA and STAT studies received funding from ViiV Healthcare. Dr. Llibre has received honoraria or consultation fees from ViiV Healthcare, Gilead Sciences and Janssen-Cilag. Dr. Rolle has received grants from and served on advisory boards/speakers bureaus for ViiV Healthcare, Gilead, and Janssen. Dr. Calmy had no disclosures to report.