ViiV Healthcare announces data on Dovato from DOLCE study

ViiV Healthcare announced 48-week findings from the DOLCE study, sponsored by Fundacion Huesped and the Bahiana Foundation of Infectiology, showing the 2-drug regimen Dovato achieved similar results to 3-drug therapy in viral suppression in a population of adults with advanced HIV. A post-hoc analysis of the study showed DTG/3TC was non-inferior to 3-drug therapy regardless of the participant’s baseline viral load. These data were presented at HIV Glasgow 2024, being held in Glasgow, Scotland from 10 – 13 November. DOLCE is a randomised, open-label, multicentre study assessing the efficacy and safety of DTG/3TC in 230 antiretroviral treatment-naive people with advanced HIV. In the clinical trial, participants were randomised in a 2:1 ratio to receive DTG/3TC or DTG+TDF/XTC. The baseline characteristics of the participants were similar between the two treatment groups and represented a population of people with severe immunosuppression – 43% of participants having baseline CD4 counts less than 100 cells/mL, 69% having baseline viral load greater than 100,000 copies (c)/mL, and 23% having a very high baseline VL, greater than 500,000 copies (c)/mL. The primary endpoint of the study was the proportion of subjects with VL less than50 copies/ml at week 48. At week 48 comparable efficacy was observed, with 82% of individuals in the DTG/3TC group and 80% in the 3-drug regimen group achieving a VLless than50. Furthermore, a post-hoc analysis showed that Dovato was non-inferior to the 3-drug regimen in achieving a VLless than50. A post-hoc analysis reported that DTG/3TC was non-inferior to 3-drug therapy. The study also showed that secondary efficacy measures of viral load decline, time to viral suppression, and CD4 recovery were similar between arms. Efficacy by baseline viral load categories was similar across both arms, including those with baseline viral load greater than 500,000 copies with 74% in the DTG/3TC arm, and 67% in the DTG+TDF/XTC arm achieving virologic success. The change in median CD4 count from baseline to Week 48 showed an increase of 200 cells/mL in the DTG/3TC arm and an increase of 177 cells/mL in the triple therapy arm. Safety through Week 48 was comparable across both arms and consistent with known safety profiles and showed similar rates of serious adverse events and immune reconstitution inflammatory syndrome across arms. The rate of discontinuation in both arms was also similar.