Dovato (Lamivudine/Dolutegravir) Granted Expanded Indication and Inclusion in China's National Reimbursement Drug List for Stable Switch HIV Treatment

2023Year1Month18Day, GSK (GSK) Innovative Single-pill Dual DrugHIVThe stable conversion indication for the treatment regimen Dovato (generic name: Lamivudine and Dolutegravir Tablets) has been officially included in the "National Basic Medical Insurance, Work-related Injury Insurance, and Maternity Insurance Drug Catalog (2022Year)》 (hereinafter referred to as: National Medical Insurance Catalogue), as a complete solution, for treating those who have achieved virological suppressionHIV-1Adults and12Adolescent infectors aged above。

Dovato is included in the "Chinese AIDS Diagnosis and Treatment Guidelines (2021Year Edition)》First-line Recommended Drugs, consisting of a fixed dose of dolutegravir (50mg) and lamivudine (300mg). As the first complete, once-daily, single-tablet regimen in China,HIVDual-drug regimen, Dovato by GSK2021Year3Approved by the China National Medical Products Administration in [Month] for first-line treatmentHIVAdults infected, included in the national medical insurance catalog in the same year;2022Year4Month, its expanded indication was approved for extension to stable transition.HIVInfected individuals.

Thanks to China“Four Free Ones and One Care”Implementation of the policy,HIVInfections have gradually transformed from fatal diseases into preventable and controllable chronic infectious diseases. WithHIVAs the age of infected individuals increases and underlying diseases emerge, the number of medications they take may gradually rise. Therefore, how to reduce the side effects and drug interactions caused by long-term medication, and improveHIVThe treatment satisfaction of infected individuals has become a new treatment demand. MultipleIIIData from the registered clinical study show that the innovative single-tablet dual-drug treatment regimen Dovato is stable in transition.HIVPatients who achieve efficacy similar to that of traditional triple therapy, by reducing a non-essential drug, the burden of drug treatment is decreased, improving safety andHIVSatisfaction with Treatment Among Infected Individuals.

Professor Taisheng Li, Director of the Department of Infectious Diseases at Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Chairman of the Infectious Diseases Branch of the Chinese Medical Association, and Head of the AIDS Study Group, stated:“For nowHIVFor those infected, the hope for antiviral treatment is no longer just‘Sustain Life’, but also in improving the quality of life and sharing the right to health. The emergence of dual-drug simplified therapy precisely responds to this expectation. Compared with traditional triple-drug therapy, in most cases,HIVIn the infected population, the innovative dual-drug simplified therapy represented by Dovato achieves equivalent efficacy while reducing side effects and drug interactions by eliminating one non-essential drug, which is beneficial for those requiring lifelong medication.HIVFor infected individuals, it is of great significance. The inclusion of this stable conversion indication in the national medical insurance catalog allows more patients at different treatment stages to benefit.HIVInfected individuals have the opportunity to benefit from innovative therapies, building willingness and confidence in long-term treatment.”

Vice President,GSKChina General Manager Qi Xin said:“Self2021The approval of indications for treatment at the beginning of the year and inclusion in medical insurance, to2022The approval and inclusion in medical insurance for the annual stable conversion indication, Dovato's‘Identity’Continuously within two years‘Upgrade’, which has greatly inspired us. Behind this lies the country's high attention to AIDS prevention and treatment, as well as its strong support for innovative drugs and therapies. At the same time, it also reflectsGSKYes‘Never Give Up on AnyoneHIVInfected individuals’A positive practice of the mission. We look forward to bringing better drug options in the new year, continuously accelerating innovation accessibility, and further supporting China's HIV/AIDS prevention and treatment efforts.”

The prevention and treatment of AIDS is also a systematic social work, which requires the joint efforts of the government and all sectors of society.GSKHas reached a cooperation with the China STD/AIDS Prevention and Control Association, and signed the "HIVMemorandum of Strategic Cooperation for the "Continuous Care Advocacy Program." This collaboration will leverage the strengths of both parties by carrying out doctor discussion forums, patient education activities, and public science advocacy programs to enhance HIV prevention awareness across all populations and improve outcomes in China.HIV Improving the quality of life for infected individuals, reducing social discrimination, and better supporting ChinaHIV Relevant prevention and control work, and ultimately bring to an endHIV Epidemic.

References

[1] As a complete treatment regimen for the following two categories of patients without known resistance-related mutations to any component of this product:1Type Human Immunodeficiency Virus (HIV-1) Infection in adults and12Adolescents above the age of (weighing at least40kg) Patient: (1) Patients without antiretroviral treatment history; (2) as an alternative treatment regimen for patients achieving virological suppression under stable antiretroviral therapy (HIV-1 RNA＜50Copy/mL) and no history of treatment failure.

[2] AIDS and Hepatitis C Group of the Infectious Diseases Branch of the Chinese Medical Association, Chinese Center for Disease Control and Prevention, China's AIDS Diagnosis and Treatment Guidelines (2021Year Edition)[J].HIV/AIDS and STDs in China,2021，27（11）：1182-1201.

[3] 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.