GSK's Single-Tablet Dual-Drug HIV Treatment Dovato® Approved in China
GSK
Pharmaceutical R&D Manufacturer
Shanghai, March 9, 2021 /PRNewswire/ -- GlaxoSmithKline (hereinafter referred to as "GSK"), a global leading multinational healthcare company, announced today that its innovative two-drug regimen for the treatment of HIV/AIDS, Dovato®Dovato (generic name: lamivudine and dolutegravir tablets) has been officially approved by the China National Medical Products Administration.®It is China's first complete, once-daily, single-tablet two-drug regimen for HIV treatment. Compared with traditional triple-drug regimens, Dovato®It not only reduces the number of antiretroviral drugs taken by individuals infected with the human immunodeficiency virus (hereinafter referred to as “HIV”), but also achieves scientifically validated virologic suppression efficacy.[1]。
GSK's Single-Tablet Dual-Drug HIV Treatment Dovato®
Dovato®Composed of fixed doses of dolutegravir (50 mg) and lamivudine (300 mg). Dolutegravir, a second-generation HIV integrase strand transfer inhibitor, blocks HIV replication by preventing the integration of viral DNA into the genetic material of human immune cells (T cells); lamivudine is a nucleoside reverse transcriptase inhibitor, commonly used in combination with other antiretroviral agents for the treatment of HIV infection.[2]。
GSKMs. Qi Xin, General Manager of Prescription Drugs and Vaccines, Chinastated: “GSK is deeply committed to addressing global healthcare challenges and pledges to continuously provide patients with innovative, differentiated, and affordable high-quality medical products and treatment solutions through scientific technology and top-tier talent, empowering patients to do more, feel better, and live longer. HIV/AIDS is a major public health issue faced by the global community and represents one of GSK’s strategic priorities in global research and development. Dovato®“...approval provides a novel and groundbreaking treatment option for people living with HIV in China, which fills us with great excitement and pride.”
Professor Li Taisheng, Chairman of the Infectious Diseases Branch of the Chinese Medical Associationstated: “Antiretroviral therapy for HIV is a complex medical issue. Since individuals living with HIV require lifelong medication, comprehensive consideration must be given to factors such as drug accessibility, adverse drug reactions, and long-term complications. Antiretroviral regimens have been evolving toward greater safety, simplicity, and efficacy. ‘Simplified therapy’ represents the current new trend in HIV treatment. The GEMINI study showed that, forNo clear contraindications“For patients, innovative single-tablet dual-drug regimens based on integrase inhibitors can achieve efficacy similar to that of traditional three-drug therapies while reducing the number of medications taken.”
April 2019, Dovato®First Approved by the U.S. Food and Drug Administration[3]In the same year, the U.S. Department of Health and Human Services’ “Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents”[4]and the European AIDS Clinical Society Treatment Guidelines[5]Incorporating the dolutegravir/lamivudine two-drug regimen into the preferred recommended regimens. 2020, "Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV" by the Panel on Antiretroviral Guidelines for Adults and Adolescents of the U.S. Department of Health and Human Services[6]Also includes the dolutegravir/lamivudine two-drug regimen as a preferred recommended option.
As of the end of October 2019, China reported more than 100,000 new HIV infections annually.[7], 958,000 people living with HIV[8]With the implementation of China’s “Four Frees and One Care” policy and the widespread adoption of antiretroviral therapy, HIV/AIDS is gradually transitioning from a fatal disease to a preventable and controllable chronic infectious disease. As the life expectancy of people living with HIV/AIDS increases, age-related chronic conditions are becoming more prevalent. Consequently, reducing the side effects and drug interactions associated with long-term medication use, improving adherence among infected individuals, and enhancing their quality of life have emerged as new therapeutic needs.
Currently, dual-drug therapy is gradually demonstrating its advantages in HIV treatment. Data from GEMINI, a large Phase III registration clinical study, show that in treatment-naïve adults with HIV-1 infection, Dovato®The dual-drug regimen demonstrated non-inferior antiviral efficacy compared to the triple-drug regimen, with fewer drug-related adverse events.[1]
Innovation-driven R&D is ingrained in GSK’s DNA. Since the approval of its first antiretroviral therapy for HIV in China in 1999, GSK has been deeply engaged in HIV prevention and treatment in the country for over two decades, successfully registering nine HIV therapeutic drugs with the National Medical Products Administration. Looking ahead, GSK will remain committed to innovative R&D, continuously providing more innovative, safer, and more cost-effective treatment solutions for people living with HIV, thereby meeting the urgent need for antiretroviral therapies.
[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. Product Information for Lamivudine and Dolutegravir Tablets
4. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the Use of Antiretroviral Agents in Adults and Adolescents with HIV. Department of Health and Human Services. December 2019.
5. European AIDS Clinical Society Guideline Ver 10.0.
6. Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults. 2020 Recommendations of the International Antiviral Society–USA Panel
7. China’s Infectious Disease Prevention and Control System, Experience, and Challenges (Liang Xiaofeng, Deputy Director of the Chinese Center for Disease Control and Prevention)http://forum.gxcdc.com/index.php?m=content&c=index&a=show&catid=21&id=74
8. National Health Commission of the People's Republic of China. HIV/AIDS Prevention and Control.http://www.nhc.gov.cn/jkj/s3586/201911/c2388ce70bdd404ea6dfcd886591784d.shtml