Results at 24 weeks in a recent phase 3b study indicate the two-drug regimen dolutegravir/lamivudine (Dovato) may be feasible to use as part of a test-and-treat strategy for patients newly diagnosed with HIV-1, according to recent research from the STAT study presented at the American Conference for the Treatment of HIV (ACTHIV) 2020.

“As physicians, we know the potential benefits of starting treatment as quickly as possible to reduce viral load, both to support the individual’s health as well as reduce the likelihood of HIV transmission,” Charlotte-Paige Rolle MD, MPH, director of research operations at Orlando Immunology Center, and principal investigator for the STAT study, said in a press release. “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 HBV [hepatitis B virus] co-infection or baseline resistance and underwent rapid therapy adjustment, did not adversely impact efficacy or safety outcomes.”

Dr. Rolle and colleagues enrolled 111 participants with HIV-1 in the phase 3b STAT study, which evaluated the safety and efficacy of Dovato for up to 48 weeks. Participants were tested for hepatitis B co-infection within 14 days of starting treatment. 

Data from the first 24 weeks were available, which showed 102 of 111 participants (92%) achieved viral suppression, defined as HIV RNA < 50 copies per mL. Follow-up data at 24 weeks was not available for 5 participants. In 97 of 111 participants (87%) who stayed on Dovato, viral suppression was maintained at 24 weeks. Among 10 participants (8%) with an HIV-1 RNA of > 1,000,000 copies per mL, 80% had achieved viral suppression of RNA < 50 copies per mL. Regarding safety, 2 participants (1=2%) had grade 2-5 drug-related adverse events, and 2 participants (2%) had serious adverse events.

There were 8 participants who switched from Dovato to another antiretroviral therapy (ART) due to a positive hepatitis B infection (5 participants), resistance to lamivudine at baseline (1 participants), or another reason. However, viral suppression was achieved in 5 of the 8 participants with 24-week data available.

“The results from the STAT study reinforce the proven efficacy of Dovato and provide further evidence supporting its use in settings where rapid treatment initiation is the standard. The STAT study also shows us that this treatment can be initiated when the baseline HBV co-infection or resistance status is unknown, as appropriate therapy adjustments can be made once results become available without compromising patient safety,” Kimberly Smith, MD, MPH, head of research and development at ViiV Healthcare, said in a press release. “These findings represent an important step forward in our understanding of current treatment options that can be rapidly initiated after an HIV diagnosis and confirm the validity of this approach with Dovato.”