GSK is pioneering a new field in the human immunodeficiency virus (HIV) market with Dovato, Korea’s first two-drug regimen in a single pill for the long-term treatment of HIV armed with robust clinical data.

In a news conference Tuesday, GSK said Dovato is the first single tablet combining dolutegravir (DTG) with lamivudine (3TC) to treat HIV-1 infection.

DTG, an integrase strand transfer inhibitor (INSTI), and 3TC, 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.

GSK won approval from the Ministry of Food and Drug Safety in March and received insurance benefits for the drug this month.

“With the rapid development of HIV treatments, the life expectancy of infected people has increased to a point where there is little difference compared to ordinary people,” ViiV Healthcare Medical Director Jean Van Wyk said. ViiV Healthcare is a pharmaceutical firm under the wing of GSK specializing in the development of therapies for HIV infection.

“Looking at the data from Korea, the age group of infected people is recently getting younger,” Van Wyk said. “Accordingly, minimizing the long-term effects of polypharmacy is a trend in the development of HIV treatments.”

In this regard, Dovato paid attention to patients burdened with long-term use of antiretroviral, he noted.

“GSK and Viiv Healthcare have reviewed numerous strategies in clinical trials, such as reducing the number of antiretroviral drugs and the dose, or discontinuing the use of pharmacokinetic (PK) boosters,” Van Wyk said. “Among them, DTV and 3TC had similar PK profiles, while showing complementary treatment effects with different action mechanisms.”

Van Wyk also presented studies showing that the two-drug regimen had no difference in safety and efficacy than the existing three-drug regimen.

“When looking at the GEMINI 1 and GEMINI 2 global phase 3 clinical trials conducted in 1,400 new adult HIV patients, Dovato demonstrated equivalent antiviral efficacy and safety compared to the existing three-drug regimen,” he said. “Notably, none of the patients who showed virological failure in all treatment groups showed resistance due to the treatment.”

Van Wyk stressed that Dovato showed the same effect as a three-drug regimen, including tenofovir alafenamide fumarate (TAF) regimen, in another global phase 3 TANGO clinical trial.

“Based on these clinical results, major HIV treatment guidelines, such as those from the U.S. Department of Health and Human Services and the European AIDS Clinical Society, have also been revised to recommend Dovato as a first-line treatment,” he said.