The DOLCE study evaluated the efficacy and safety of Dovato in around 230 antiretroviral treatment-naïve individuals with advanced HIV. Credit: New Africa / Shutterstock.

UK-based pharmaceutical company ViiV Healthcare has reported results from a trial of Dovato, a two-drug regimen consisting of dolutegravir/lamivudine (DTG/3TC) designed to treat human immunodeficiency virus (HIV).

A post-hoc analysis of the 48-week findings from the DOLCE study showed that Dovato had similar efficacy to that of a three-drug therapy in viral suppression in adult patients with advanced HIV, as well as being non-inferior in attaining viral suppression.

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DOLCE was a multicentre, randomised, open-label study that evaluated the efficacy and safety of Dovato in around 230 patients with advanced HIV, characterised by a low cluster of differentiation 4 (CD4) counts.

Participants were randomised at a 2:1 ratio to receive either Dovato or the three-drug regimen (DTG+TDF/XTC), with the primary endpoint being the proportion of subjects with a viral load of less than 50 copies/ml at week 48.

Dovato was administered to 152 participants, while the three-drug regimen was given to 77 participants.

After 48 weeks, 82% of individuals in the Dovato arm had achieved viral suppression with a viral load of less than 50 copies/ml, against 80% in the three-drug regimen arm.

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Efficacy based on baseline viral load categories was comparable between both treatment arms, including among those with a baseline viral load greater than 500,000 copies.

Safety profiles through week 48 were comparable between the two arms, with similar rates of serious adverse events and immune reconstitution inflammatory syndrome.

ViiV Healthcare chief medical officer Harmony Garges said: “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 two-drug regimen.

“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 three-drug regimen, even in people with low CD4 counts and high viral loads.”