ViiV Healthcare Reports Dovato's High Efficacy in Treatment-Naïve Advanced HIV Patients

ViiV Healthcare, a prominent company specializing in HIV treatment and owned mainly by GSK, with Pfizer and Shionogi as shareholders, recently unveiled findings from the 48-week DOLCE study. This research, coordinated by Fundación Huésped and the Bahiana Foundation of Infectiology, demonstrated that the two-drug regimen, Dovato (dolutegravir/lamivudine), achieved comparable viral suppression results to the traditional three-drug therapy among adults with advanced HIV. These results were presented at the HIV Glasgow 2024 conference in Scotland, held from 10 to 13 November.

Dr. Harmony P. Garges, Chief Medical Officer at ViiV Healthcare, commented on the importance of these findings, emphasizing that taking fewer medications is a significant concern for many in the HIV community. The study findings support the effectiveness and safety of Dovato, providing evidence that this two-drug regimen is as efficacious as a three-drug regimen, even in patients with low CD4 counts and high viral loads.

The DOLCE study was designed as a randomized, open-label, multicenter trial to evaluate the efficacy and safety of the DTG/3TC combination in 230 antiretroviral treatment (ART)-naïve individuals with advanced HIV, characterized by low CD4 counts (≤200 cells/mL). Participants were divided in a 2:1 ratio to receive either DTG/3TC or a combination of DTG+TDF/XTC. The baseline characteristics of the participants were similar across both treatment groups, representing a severely immunosuppressed population. Notably, 43% of participants had baseline CD4 counts of less than 100 cells/mL, 69% had a baseline viral load (VL) exceeding 100,000 copies/mL, and 23% had a baseline viral load greater than 500,000 copies/mL.

The primary endpoint of the study was the proportion of participants with a VL of less than 50 copies/mL after 48 weeks. The study observed comparable efficacy, with 82% of the DTG/3TC group and 80% of the three-drug regimen group achieving this target. A post-hoc analysis further confirmed that Dovato was non-inferior to the three-drug therapy.

Professor Pedro Cahn, Scientific Director of Fundación Huésped and an investigator in the DOLCE study, expressed optimism about the findings, noting that they provide additional support for the efficacy and safety of two-drug regimens. These results bolster the confidence of healthcare providers in prescribing DTG/3TC, offering a reliable alternative to traditional three-drug treatments for patients with HIV.

Additional analysis revealed that DTG/3TC was non-inferior to the three-drug regimen, with an adjusted risk difference of 2.0%. The study also found similar results in secondary efficacy measures such as viral load decline, time to viral suppression, and CD4 recovery between the two groups. Among participants with a baseline viral load greater than 500,000 copies, 74% in the DTG/3TC group and 67% in the DTG+TDF/XTC group achieved virologic success. The median CD4 count increased by 200 cells/mL in the DTG/3TC arm and by 177 cells/mL in the triple therapy arm.

Safety profiles through Week 48 were consistent across both groups, with similar rates of serious adverse events and immune reconstitution inflammatory syndrome. The discontinuation rates were also comparable between the two groups.

The DOLCE study (NCT04880395) is a phase IV, open-label, multicenter trial assessing the efficacy of DTG/3TC in treatment-naïve adults with advanced HIV, conducted across 11 sites in Argentina and Brazil. The primary outcome was the proportion of participants with plasma HIV-1 RNA levels below 50 copies/mL at Week 48, with secondary outcomes including efficacy, resistance, safety, and tolerability.

Dovato is approved as a complete regimen for treating HIV-1 infection in adults without prior antiretroviral treatment history or to replace current antiretroviral regimens in virologically suppressed individuals. It is available in the US, Europe, Japan, Australia, and other countries worldwide.