ViiV Healthcare has announced data from the DOLCE study, demonstrating that Dovato (dolutegravir/lamivudine, DTG/3TC) is highly effective in treatment-naive individuals with advanced HIV. The study assessed the efficacy and safety of Dovato in antiretroviral treatment (ART)-naive individuals with low CD4 counts (≤200 cells/mL). The results indicate that Dovato, a two-drug regimen, shows comparable efficacy to a three-drug regimen in this population.
The DOLCE study was a randomised, open-label, multicentre trial involving 230 participants. Participants were randomised in a 2:1 ratio to receive either Dovato (n=152) or a three-drug regimen of dolutegravir plus tenofovir disoproxil fumarate/emtricitabine (DTG+TDF/XTC) (n=77). The baseline characteristics of the participants were similar between the two treatment groups, representing a population with severe immunosuppression. Specifically, 43% of participants had baseline CD4 counts less than 100 cells/mL, 69% had baseline viral load (VL) greater than 100,000 copies/mL, and 23% had a very high baseline VL, greater than 500,000 copies/mL.
The primary endpoint of the study was the proportion of subjects with VL <50 copies/ml at week 48. At week 48, comparable efficacy was observed, with 82% of individuals in the Dovato group and 80% in the three-drug regimen group achieving a VL<50. Furthermore, a post-hoc analysis showed that Dovato was non-inferior to the three-drug regimen in achieving a VL<50.
Expert Commentary
"We know taking fewer medicines is an important consideration for many in the HIV community, and these new data continue to reinforce the efficacy and safety of Dovato, a 2-drug regimen," said Harmony P. Garges, M.D., Chief Medical Officer at ViiV Healthcare. "The findings from the DOLCE study build on the robust body of evidence supporting its use in treatment-naive adults living with HIV and shows comparable efficacy to a 3-drug regimen, even in people with low CD4 counts and high viral loads."
Implications for HIV Treatment
The findings from the DOLCE study suggest that Dovato can be a highly effective treatment option for treatment-naive individuals with advanced HIV, even those with low CD4 counts and high viral loads. This is clinically significant because it offers a two-drug regimen as a viable alternative to traditional three-drug regimens, potentially reducing the pill burden and associated side effects for patients. The non-inferiority of Dovato compared to the three-drug regimen provides healthcare professionals with another effective tool in managing HIV, particularly in patients who may benefit from a simpler treatment approach.
