GSK's HIV Drug Dovato (Lamivudine/Dolutegravir) Granted New Indication in China for Virologically Suppressed Adults

On May 7, the official website of the National Medical Products Administration (NMPA) showed that GSK's new indication application for Lamivudine and Dolutegravir Tablets had been approved. The speculated indication is: treatment of HIV-infected adults who have achieved virological suppression.

Lamivudine and Dolutegravir Tablets (Trade Name: Dovato) consist of a fixed dose of Dolutegravir (DTG, 50mg) and Lamivudine (3TC, 300mg). Its efficacy is non-inferior to the guideline-recommended triple therapy, while it can reduce lifelong cumulative drug exposure and potential long-term toxicity.

Among them, DolutegravirIt is a second-generation HIV integrase strand transfer inhibitor that blocks HIV replication by preventing viral DNA from integrating into the genetic material of human immune cells (T-cells); lamivudine is a nucleoside reverse transcriptase inhibitor, commonly used in combination with other antiretroviral drugs for the treatment of HIV infection.

In April 2019, Dovato was launched in the U.S. for the first time, indicated for adult patients with HIV-1 who have not previously received antiretroviral (ARV) therapy and have no known resistance to DTG or 3TC, becoming the first dual-drug fixed-dose complete regimen approved by the FDA for this indication. In August 2020, Dovato's new indication was expanded for use in adult patients with HIV-1 who have achieved virologic suppression on a stable ARV regimen, have no history of treatment failure, and have no known resistance to each drug component of Dovato.

In March 2021, the product was approved by the pharmaceutical regulatory authority for marketing in China. It is used to treat adults and adolescents aged 12 years and older (weighing at least 40 kg) infected with human immunodeficiency virus type 1 (HIV-1), who have no known or suspected resistance to integrase inhibitors or lamivudine. This is the first complete, once-daily, single-tablet, two-drug treatment regimen for HIV in China.

According to GSK's financial report, Dovato's sales in 2021 were $1.082 billion, a year-on-year increase of 124%, showing excellent performance.