Advancing HIV Simplified Therapy: GSK's Single-Tablet Dual-Regimen Dovato® Paves the Way for Improved Quality of Life
Nov 10, 2021 11:07
CST Updated
11:07
GSK
Pharmaceutical R&D Manufacturer
Since the first case of AIDS was reported in 1981, the fight against HIV/AIDS has lasted for 40 years. To this day, AIDS remains a significant global public health issue. According to relevant reports from UNAIDS, there were approximately 1.5 million new HIV infections globally in 2020, with 680,000 deaths resulting from related illnesses. In recent years, the ongoing spread of the COVID-19 pandemic has brought unprecedented impacts and challenges to global HIV/AIDS prevention and treatment efforts. In China, although the overall prevalence of AIDS remains at a low level, it is still the infectious disease with the highest reported mortality rate. From January to October 2020 alone, the number of newly reported HIV infections in China reached 112,000, with a total of 1,045,000 people living with HIV. The task of prevention and control remains arduous.
As one of the major challenges threatening global public health, the Joint United Nations Programme on HIV/AIDS (UNAIDS) proposed the "three '90'" targets – to ensure 90% of people living with HIV are diagnosed and aware of their infection status in a timely manner; to ensure 90% of those who test positive receive prompt antiretroviral therapy; and to ensure that 90% of those receiving antiretroviral treatment achieve viral suppression.
In this forum,Professor Zhang Renfang, Chief Physician of Shanghai Public Health Clinical Center"One of the challenges in China's HIV/AIDS prevention and control is antiretroviral therapy for AIDS patients. The treatment cycle for AIDS patients can last ten to twenty years. As patients age, they may also suffer from other chronic diseases such as diabetes and hypertension. The use of antiviral drugs can lead to significant organ complications and comorbidities. In recent years, there has been an increase in the number of HIV/AIDS treatment drugs available in China, which can meet the basic needs of patients. However, the diagnosis and treatment of HIV infection have entered an era of chronic disease management. Therefore, we need to quickly improve the patient's immunity to reduce opportunistic infections and the occurrence of tumors. Thus, in addition to monitoring antiviral drugs and following up on adverse reactions, attention should also be given to their chronic diseases and aging issues."
Dr. Pauline Ng, Vice President of GSK and Medical Director of GSK Prescription Drugs ChinaStated: "We are proud that for the three 90 targets set by UNAIDS for HIV treatment, all three indicators have reached 95%. Therefore, people living with HIV currently receiving treatment in China have achieved virological suppression. The question now is whether to propose a fourth 90 target. The fourth 90 target would focus on comorbidities and the well-being of people living with HIV, ensuring that 90% of patients enjoy a good quality of life. As for long-acting treatment options, patients strongly hope to reduce both the dosage and frequency of medication, thereby further improving their quality of life."
In current antiviral treatment regimens, "simplified therapy" is an emerging trend in HIV treatment, with dual-drug therapy gradually demonstrating its advantages in HIV management. Compared to the traditional triple-combination therapy for AIDS, the innovative dual-drug regimen reduces the number of antiretroviral medications that HIV patients need to take while still achieving scientifically validated viral suppression.
Dovato®As China's first complete, once-daily, single-tablet dual-drug treatment regimen for HIV, it officially received approval from the National Medical Products Administration of China in March this year. The currently approved indication is as a complete treatment regimen for adult patients with Human Immunodeficiency Virus type 1 (HIV-1) infection who have no history of antiretroviral therapy and no known resistance-associated mutations to any component of the drug.
This drug consists of a fixed dose of dolutegravir (50mg) and lamivudine (300mg). Dolutegravir is a second-generation 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.
At this CIIE, GSK showcased innovative solutions in the field of HIV treatment. As China's first complete, once-daily, single-tablet HIV dual-drug treatment regimen, the launch of Dovato® pioneered the concept of simplified HIV treatment, providing Chinese HIV patients with a new and groundbreaking treatment option.
During the event, attending journalists exchanged views with Mr. Zhang Yingwei, Vice President of GSK and Head of Corporate Communications and Government Affairs in China, Dr. Pauline Ng, Vice President of GSK and Head of the Medical Department for Prescription Drugs in China, and Ms. Lin Yuping, Head of GSK China's HIV Business Unit.
Q: What are your views and understanding regarding the three 90% targets?
Mr. Zhang Yingwei:I believe everyone can feel the attitude and measures of the country towards the prevention and control of the COVID-19 pandemic. If we could have the same energy, direction, and support towards HIV/AIDS, I believe the three 90% targets for HIV can certainly be achieved by 2030. By successfully achieving these three 90% targets, we can effectively control the source of infection, thereby reducing new infections, ultimately reaching the goal of ending the HIV epidemic. On this basis, GSK China hopes to further assist in advancing the realization of a fourth 90% target — that 90% of HIV patients will reach a state of viral suppression, achieving a high quality of long-term survival.
The road to combating AIDS is long and fraught with challenges. Therefore, not giving up on any person living with HIV is GSK's steadfast mission in the fight against AIDS. In the future, we will continue to collaborate with Chinese experts and the government to provide more innovative, safe, and cost-effective prevention and treatment options for people living with HIV and the public in China, helping AIDS patients achieve a dignified and high-quality "simple life" as soon as possible.
Q: We know that GSK has been striving to provide better treatment options for people living with HIV and also leading the trend in treatment research and development. So, apart from oral medication regimens, what innovative therapies can we expect in the future, and what plans does GSK have?
Dr. Pauline Ng:First, considering the patients' current expectations for treatment, such as ensuring viral suppression and improving quality of life. To meet these treatment needs, we must first consider reducing drug exposure and dose burden while improving the convenience of administration, which means enhancing patient adherence. Beyond that, regarding our overall future R&D plans, the current focus is on long-acting injectables. We hope to improve patients’ quality of life through long-acting injections by reducing their medication burden, dose exposure, and frequency of administration — a revolutionary breakthrough. At the same time, we are actively exploring more mechanisms of action and drug targets, hoping to find targets from various drugs that can achieve both viral suppression and improvement in patients’ quality of life, thereby realizing the development and implementation of our drugs.
Q: Could you please tell me about the progress of the long-acting injectable formulation you just mentioned in China?
Dr. Pauline Ng:Regarding long-acting injectable formulations, we are currently still in the clinical research phase in China. The long-acting injectable is a groundbreaking treatment that has already received FDA approval in the United States for the prevention of HIV infection. In China, we are actively working to advance this project. The registration documents have been submitted, and we are very much looking forward to updates from the regulatory authorities on the latest progress.
Q: It has been half a year since Dovato was launched. What is the current status of its implementation?
Ms. Lin Yuping:Regarding the launch of Dovato, in terms of accessibility, the five major AIDS prevention and treatment centers and hospitals across China have basically started using Dovato. We can also see that an increasing number of patients are already receiving this innovative treatment in clinical settings and benefiting from it. Currently, we are actively participating in this year's national medical insurance negotiations, and we hope that this innovative treatment plan can be included in the medical insurance as soon as possible to benefit more patients.
Question: Nowadays, China's care and support for people living with HIV, as well as related policies, are gradually improving. In your opinion, what positive impacts have these HIV-related policies brought to people living with HIV? How will GSK contribute to the implementation of these policies in the future to enhance HIV prevention and treatment in China?
Mr. Zhang Yingwei:We are delighted to see that after years of continuous promotion of comprehensive prevention and control policies, China's AIDS prevention and control work has achieved remarkable results. At the same time, we can see that the goals and tasks of the "13th Five-Year Plan" have been well realized, specifically表现为: blood transmission is basically blocked, mother-to-child transmission and injection drug use have been effectively controlled. Currently, sexual transmission is the main mode of HIV spread in China, with widespread and complex influencing factors; therefore, continuing comprehensive prevention efforts remains a top priority in the field of AIDS control. The early prevention and expanded treatment measures advocated by these beneficial policies have made HIV and AIDS no longer dreaded as an overwhelming threat, while also setting an example for prevention and control efforts worldwide.
As a global leader in healthcare, GSK will continue to support the Chinese government in the future, focusing on HIV prevention, treatment, and public education. It will help implement more favorable policies, comprehensively improve China's overall HIV prevention and control standards, and work together towards the goal of "ending AIDS as a public health threat by 2030."
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