GSK’s Dovato (ingredient: dolutegravir/lamivudine), the first two-drug regimen in a single pill for the long-term treatment of HIV, arrived in the Korean market. The tablet targeted improved patient convenience and reduced toxicity.
The Ministry of Food and Drug Safety on Monday granted the nod for Dovato in the treatment of HIV-1 infection in adults and adolescents weighing more than 40 kilograms with no known or suspected substitutions associated with resistance to the individual components of Dovato.
Patients can take one tablet daily. Dovato is the first single tablet combining dolutegravir (DTG) with lamivudine (3TC) to treat HIV-1 infection.
Dolutegravir, an integrase inhibitor (INI), and lamivudine, a nucleoside reverse transcriptase inhibitor (NRTI), prevent viral DNA from being integrated into the genetic material of human immune cells (T cells). At the same time, they block the DNA conversion of the viral RNA, effectively inhibiting viral growth.
As the life expectancy of HIV patients rose, and the disease requires long-term treatment, GSK developed Dovato with a focus on raising patient convenience and lowering drug toxicity. HIV treatment guidelines by the U.S. Department of Health and Human Services (HHS) and the European AIDS Clinical Society recently recommended using Dovato as a first-line treatment.
The local approval was based on the phase-3 GEMINI 1 and 2 trials in around 1,400 adults with HIV infection. In the studies, the Dovato-treated group showed non-inferior efficacy and safety profiles, compared to the group with three-drug-regimen (dolutegravir/tenofovir disoproxil fumarate/emtricitabine).