ViiV Healthcare, the HIV specialist owned by GlaxoSmithKline plc. (GSK), presented Dovato’s 48-week data of the phase 3 SALSA and 144-week data of TANGO at the 2021 International AIDS Society.

The 2021 International AIDS Society was held online from July 18-21. Dovato, HIV treatment, is a two-drug regimen (2DR).

SALSA is a phase 3 trial randomized, multi-center, open-label, and non-inferiority study. On the 493 HIV-1 infected adults that used the Current Regimen Therapy (CRT), transition to two-drug regimen Davato (50mg of dolutegravir and 300mg of lamivudine) was made.

Also, its safety, effects, and drug tolerance were analyzed. The CRT is an anti-retroviral therapy of three or more drug regimen, including at least two of Nucleoside Reverse Transcriptase Inhibitors (NRTI), which virologically suppresses patients. More than 120 research organizations from North America, Europe, Asia-Pacific, South America, and Africa participated in the SALSA study. The treatment of 246 participants was switched to using Dovato while the rest 247 maintained CRT.

According to the 48-week data of the SALSA study, the group that had made the transition to Dovato showed treatment effects sustained and the safety profile also consistent. On the 48th week of the research, 99.6 percent of the Dovato transition group sustained below 50c/mL of HIV-1 RNA. Thus, similar to 98.8 percent of the 3-drug regimen CRT group, Dovato’s effectiveness was proven.

In the two groups, no patients with Confirmed Virologic Withdrawal or resistant variants were found.

The percentages of overall Adverse Event (AE) were similar among the two groups. There were low chances of AE that led to the suspension of the research. Also, there were no serious deviant cases concerning the drugs in both of the groups. Both biomarkers of renal and bone changes showed a statistically significant and advantageous number in the Dovato group.

The SALSA study includes a variety of HIV-infected participants treated with various regimens using more than three drugs. More than 120 research sites in North America, Europe, Asia-Pacific, South America, and Africa participated. Thirty-nine percent of them were older than fifty, and it was of diverse ethnic groups.

“It is exciting to have more data re-affirming Dovato’s efficacy and positive barrier against resistance development,” said Professor Josep Llibre, the principal investigator of the SALSA study. “These findings show that can maintain virologically suppressed status with a two-drug regimen, lesser use of drugs.”

Also, ViiV Healthcare presented 144 weeks of phase 3 TANGO study, testing the efficacy of transition to Dovato from a three-drug regimen that contains tenofovir alafenamide (TAF)

After around three years of treatment, Dovato proved its non-inferiority to the TAF-based three-drug regimen in virological suppression. In the Dovato group, there were no cases of virological failure or resistance found. The overall adverse event rates of both groups were similar. In lipid changes, the Dovato group showed superiority.

“SALSA is the second switch study to demonstrate Dovato’s non-inferior efficacy and high barrier to resistance, with no participants experiencing virologic failure in the Dovato arm of the study,” said Kimberly Smith, the head of research & development at Viiv Healthcare. “These findings demonstrate its versatility for participants who had previously been on a broad range of different regimens, cementing its place in the HIV treatment paradigm.”