Antiretroviral Shows to be Safe for Newly Diagnosed Adults with HIV

ViiV Healthcare released 24 week data from their single arm Study in Test and Treat (STAT) clinical trial which demonstrated the feasibility of its antiviral, dolutegravir/lamivudine (Dovato) in a rapid Test and Treat model of care in adults with HIV-1.

STAT was a phase 3b, multi-center, open label, single arm, 48-week study conducted in the United States.

“Data from the STAT study showed that the use of Dovato in treatment-naïve patients at the time of or soon after diagnosis, including those who were later found to have [hepatitis B] HBV co-infection or baseline resistance and underwent rapid therapy adjustment, did not adversely impact efficacy or safety outcomes,” Charlotte-Paige Rolle, MD, MPH, director of Research Operations at Orlando Immunology Center and principal investigator for the STAT study, said.

The STAT study followed a model of care increasingly seen in clinical practice, with treatment initiated within 14 days of diagnosis before baseline HBV coinfection status, renal function and resistance test results were available.

All STAT study participants were tested for HBV coinfection prior to receiving Dovato, with results available after initiation of treatment. In the study, 92% (n=102/111) of participants with available data at 24 weeks, achieved a viral load of <50c/mL.

This included participants who stayed on Dovato and those who switched to an alternative antiretroviral (ART). Eight participants switched from Dovato to an alternative ART regimen; 5 of the 8 due to HBV co-infection and one due to base line resistance to lamivudine. Data were available for 5 of these participants and showed that they all achieved a viral load of <50c/mL at 24 weeks. They did not develop HBV or HIV resistance-associated mutations, and 1 indicating that rapid initiation of use in Test and Treat strategies.

Like a dolutegravir-based three-drug regimen, Dovato uses two drugs to inhibit the viral cycle at two different sites. INIs, like dolutegravir, inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic infection. Lamivudine is an NRTI that works by interfering with the conversion of viral ribonucleic acid (RNA) into deoxyribonucleic acid (DNA) which in turn stops the virus from multiplying.

Earlier this month, Dovato received an FDA approval for expanding its indication to be used as a complete regimen for treatment of HIV infection to replace an existing ART regimen in adults who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.

This indication was based off the TANGO study results, which was a phase 3 trial, which was a randomized, open-label, noninferiority study evaluating the efficacy and safety of switching to Dovato (dolutegravir and lamivudine) vs remaining on a 3-/4-drug tenofovir alafenamide fumarate (TAF)-based regimen in virologically suppressed adults living with HIV-1.