GSK Launches Dovato®, China's First Complete, Once-Daily, Single-Tablet Two-Drug Regimen for HIV Treatment

ShanghaiJuly 1, 2021/PR Newswire/ -- GlaxoSmithKline (hereinafter referred to as "GSK") is used forDovato® (generic name: lamivudine and dolutegravir tablets), an innovative two-drug regimen for HIV treatment,On June 26, 2021Officially launched in China. Dovato® was approved by China's National Medical Products Administration in March 2021. Compared with traditional triple-drug regimens, it reduces the number of antiretroviral medications required for individuals infected with the human immunodeficiency virus (hereinafter referred to as "HIV") while achieving scientifically proven virological suppression. As China's first complete, once-daily, single-tablet two-drug regimen for HIV, the launch of Dovato® provides a novel treatment option for people living with HIV in China.

Group Photo at the Product Launch Meeting

Dovato^®Composed of a fixed dose of dolutegravir (50 mg) and lamivudine (300 mg). Dolutegravir 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.^[2]。

GSKMs. Qi Xin, General Manager, China Prescription Medicines and Vaccinesstated: “Dovato^®I am deeply delighted and proud to see its official launch in China. This two-drug regimen pioneers the 'simplified treatment' concept for HIV/AIDS, providing people living with HIV with more innovative and simpler treatment options. As a major public health challenge faced globally, HIV/AIDS has consistently been one of the strategic priorities in GSK's product portfolio planning and global R&D.‘‘Not leaving a single HIV patient behind’ is our shared mission in the fight against HIV/AIDS. Today, we introduce Dovato^®Its introduction to China is the best testament to this mission.”

HIV/AIDS is one of the major challenges threatening global public health. In 2019, there were approximately 1.7 million new HIV infections globally, and 690,000 people died from AIDS-related illnesses.^[3]。In China, despite the overall prevalence consistently remaining at a low level, HIV/AIDS remains the infectious disease with the highest number of reported deaths. Between January and October 2020 alone, the number of newly reported HIV infections in China reached 112,000, with the cumulative total of people living with HIV standing at 1.045 million, underscoring that prevention and control efforts still have a long and arduous path ahead.^[4]。

With the implementation of the "Four Frees and One Care" policy and the widespread adoption of antiretroviral therapy (ART), HIV/AIDS, once regarded as a "terminal illness," is gradually transitioning from a fatal disease into a preventable and controllable chronic infectious disease. As the life expectancy of patients living with HIV/AIDS continues to extend, age-related chronic diseases are becoming increasingly prevalent, posing significant challenges to their health status and quality of life. Minimizing the adverse effects and drug interactions associated with long-term medication, improving treatment adherence, and thereby enhancing overall quality of life has emerged as a new therapeutic need for HIV/AIDS patients.

Prof. Lu Hongzhou, Shanghai Public Health Clinical Centerstated: “People living with HIV require lifelong medication; therefore, HIV antiretroviral therapy must comprehensively consider factors such as drug accessibility, drug toxicity and adverse effects, and long-term complications. Among antiretroviral treatment regimens, ‘simplified therapy’ represents a new trend in current HIV/AIDS management, with dual-drug regimens gradually demonstrating their advantages in HIV treatment. Results from large-scale Phase 3 clinical trials indicate that Dovato^®With a high barrier to resistance and a favorable safety profile, it demonstrates long-term virologic suppression non-inferior to that of a three-drug regimen, while significantly reducing drug exposure, drug-related adverse effects, and drug-drug interactions.^[5]. Dovato^®The successful market launch provides us with more options for addressing the complex medical challenge of HIV antiretroviral therapy. I believe that, with Dovato^®“The 'simplified therapy' represented by it, while improving patient adherence, can help patients live with a higher 'quality' of life and embrace a simpler lifestyle.”

As a leading global healthcare company, GSK has been deeply committed to HIV prevention and treatment in China for over two decades, successfully registering nine HIV treatment drugs with the National Medical Products Administration (NMPA). Looking ahead, GSK will continue to introduce industry-leading innovative HIV solutions for Chinese patients, consistently providing people living with HIV and the Chinese public with more innovative, safer, and more cost-effective HIV prevention and treatment options, thereby helping to advance the overall standard of HIV/AIDS prevention and control in China.

【References】

1.  CahnP, MaderoJS, ArribasJR, et al. Dolutegravir plus lamivudine versus dolutegravir plus tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naive adults with HIV-1 infection (GEMINI-1 and GEMINI-2): week 48 results from two multicentre, double-blind, randomised, non-inferiority, phase 3 trials. Lancet. 2019 Jan 12;393(10167):143–155.

2. Lamivudine and Dolutegravir Tablets Package Insert

3. UNAIDS. Global AIDS Update 2020http://www.unaids.org.cn/page122?article_id=1200 

4. CCTV.com: China reports 1.045 million people living with HIVhttps://news.cctv.com/2020/12/01/ARTI6S5jWUXIIirhNklF5I2c201201.shtml

5.  /2020/unaids-data Cahn P.,Sierro Madera J., Arribas J, et al. Durable efficacy of dolutegravir (DTG) plus lamivudine (3TC) in antiretroviral treatment-naïve adults with HIV-1 infection – 3-year results from the GEMINI studies. Presented at HIV Glasgow 2020.

AboutGSK：

GSK is a science-led global healthcare company dedicated to helping people do more, feel better, and live longer. For more information, please visitwww.gsk.com。