GSK's HIV Two-Drug Combination Therapy Dovato Approved in China

On March 3, the National Medical Products Administration (NMPA) of China issued an announcement approving the new drug application for GSK’s dolutegravir and lamivudine tablets, with the approval number: Guo Yao Zhun Zi HJ20210013. According to the priority review public notice from the NMPA’s Center for Drug Evaluation (CDE), the approved indication is for the treatment of human immunodeficiency virus type 1 (HIV-1) in adults and adolescents aged 12 years and older (weighing at least 40 kg) who have no known or suspected resistance to integrase inhibitors or lamivudine.

Source of screenshot: Reference [1]

Dolutegravir/Lamivudine Tablets (brand name: Dovato) are a fixed-dose combination tablet developed by ViiV Healthcare, a subsidiary of GSK. Dolutegravir is a next-generation HIV integrase inhibitor that offers potent antiviral efficacy, favorable safety and tolerability profiles, and a low potential for drug-drug interactions. Lamivudine is a nucleoside reverse transcriptase inhibitor that acts by blocking HIV reverse transcriptase and hepatitis B virus polymerase.

In April 2019, the U.S. FDA approved this two-drug antiretroviral therapy as a complete regimen for the treatment of HIV-infected patients who had never previously received antiretroviral therapy. Notably, this marks the first FDA-approved complete treatment regimen consisting of a fixed-dose combination of two drugs for antiretroviral-naïve adult patients with HIV.

In China, companies such as GSK and ViiV Healthcare jointly submitted a New Drug Application (NDA) for dolutegravir/lamivudine tablets in November 2019. Each tablet contains 50 mg of dolutegravir sodium (equivalent to 50 mg of dolutegravir) and 300 mg of lamivudine. Subsequently, in February 2020, the application was included in the priority review program due to its significant therapeutic advantages. The proposed indication is for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older.

Screenshot source: CDE official website

In two randomized, double-blind, controlled clinical trials involving 1,433 antiretroviral-naïve adult patients with HIV infection, researchers compared the efficacy of dolutegravir/lamivudine dual therapy with that of dolutegravir/tenofovir/emtricitabine triple therapy. The results demonstrated that dolutegravir/lamivudine tablets were effective and safe, with the dual therapy achieving a reduction in blood HIV viral load comparable to that of the triple therapy.

Furthermore, according to data presented by ViiV Healthcare at the 10th International AIDS Society Conference on HIV Science (IAS 2019), the dolutegravir/lamivudine dual therapy met the non-inferiority criteria compared with the dolutegravir/tenofovir/emtricitabine triple therapy. After 96 weeks of treatment, 86% of patients in the dual antiretroviral therapy group achieved viral suppression, compared with 90% in the triple antiretroviral therapy group.

The FDA noted in a press release that the emergence of the dual therapy of dolutegravir and lamivudine tablets is an effective complement to triple therapy, providing patients with the option of using a combination tablet composed of two drugs. Reducing the use of one drug can help eliminate toxic side effects and potential drug interactions associated with the third drug, benefiting certain patients who have concerns about long-term use of multiple medications.

AIDS is a severe disease caused by HIV infection, once considered an untreatable and fatal condition. However, with the establishment of combination antiretroviral therapy (commonly known as "cocktail therapy") in the late 20th century, AIDS has become a manageable chronic disease. Although current treatments cannot completely cure HIV infection, they can significantly reduce viral load in patients, maintain immune function, and prevent the transmission of HIV. Through antiretroviral therapy, people living with AIDS can achieve life expectancies comparable to those of the general population.

We congratulate GSK on the official approval and market launch of its dolutegravir/lamivudine tablets in China, and we hope that this product will benefit more patients living with HIV.

▽Follow [WuXi AppTecGermany】WeChat Official Account