Editor’s Note: Since the discovery of the first AIDS patient in China in 1985, an enduring battle, devoid of gunfire, has persisted for nearly forty years. Generation after generation of Chinese experts in AIDS prevention and control have tirelessly explored a “Chinese approach” to AIDS diagnosis and treatment that suits the national context. With changing treatment models and philosophies, the connotations of the “Chinese approach” to AIDS diagnosis and treatment have continually been updated and enriched. During the recent “21st National Conference on Viral Hepatitis and Liver Diseases, as well as the 2023 Annual Conference of the Chinese Medical Association Hepatology Branch and the Annual Conference of the Chinese Medical Association Infectious Diseases Branch,” Dr. Taisheng Li, Director of the Infectious Diseases Branch of the Chinese Medical Association, presented an insightful report on “The Establishment and Application of the ‘Chinese Approach’ to AIDS Diagnosis and Treatment.”
The Evolution from HIV/AIDS Treatment 1.0 to 3.0
Dr. Taisheng Li pointed out that research related to global AIDS treatment can be divided into three stages: (1) The 1.0 era, also known as the “pre-cocktail era,” from the report of the first AIDS patient in 1981 to the emergence of the first anti-AIDS drug, zidovudine (AZT), in 1987, and the exploration of the first two-drug regimen AZT+ didanosine (ddI) in 1993. (2) The 2.0 era, also known as the “cocktail era,” during which multiple highly effective antiretroviral therapy (HAART) regimens emerged, and attention was turned to immune function restoration in AIDS patients. (3) The 3.0 era, also known as the “post-cocktail era,” introduced the concept of immune abnormal activation mechanisms, advocated the new strategy of “treat upon discovery,” and provided more comprehensive and integrated treatment services for patients.
AIDS is a chronic and fatal disease with a natural course of about 8-10 years. Some scholars liken this course to a “train approaching a cliff” (J. Coffin, AIDS, 1996), where the end stage or death from AIDS represents the “cliff,” HIV viral load represents the “speed of the train,” and CD4 cell count represents the “distance to the cliff.” While HAART effectively controls the viral load, scientists began to focus on how to enhance patients’ immune systems, extending the “distance to the cliff.” Starting from 1997, Dr. Taisheng Li and other global scholars developed the theory of AIDS immune reconstitution, providing a fresh perspective for the development of AIDS diagnosis and treatment strategies.
Establishment and Refinement of the “Chinese Approach” to Anti-AIDS
With the continuous optimization of HIV/AIDS prevention and treatment models, global confidence in overcoming AIDS is growing. The Joint United Nations Programme on HIV/AIDS (UNAIDS) has committed to “ending the AIDS epidemic by 2030” and achieving the “4 95s targets”: 95% of people living with HIV knowing their status, 95% of diagnosed individuals receiving antiretroviral therapy (ART), 95% of those on ART achieving viral suppression, and 95% of HIV key populations receiving appropriate and effective comprehensive prevention.
In 1985, Peking Union Medical College Hospital reported the first AIDS patient in China, marking the beginning of AIDS prevention and control in the country. Currently, there are over 1.2 million surviving AIDS patients in China, with treatment coverage and viral suppression rates exceeding 90%. Behind this hard-earned “anti-AIDS report card” is the arduous process of gradually establishing and refining the “Chinese approach” to AIDS diagnosis and treatment.
China initiated free AIDS treatment nationwide in 2003. Before this, AIDS prevention and control faced challenges such as high mortality rates, strong infectivity, and treatment difficulties, requiring research into treatment plans that could be widely implemented nationwide. While the country urgently invested in the production of generic drugs, Chinese AIDS prevention and control experts continued to explore optimized treatment plans that suited the national context. Dr. Taisheng Li’s team, in collaboration with 13 hospitals nationwide, studied a combination regimen of zidovudine and stavudine, which achieved the equivalent level of similar foreign drugs and received recognition from the World Health Organization (WHO). This research achievement was mentioned in the 2010 Global Report on AIDS Treatment. Building upon this, Dr. Li’s team further explored an optimized regimen involving a six-month switch from stavudine to zidovudine, offering advantages of low toxicity, equivalence, and affordability. The incidence of adverse reactions, particularly bone marrow suppression and fat atrophy, significantly decreased. This research was included in the 2017 Second CAS Outstanding Scientific Paper Selection. Currently, China’s AIDS treatment strategies have formed a pattern of “three horses advancing together,” including providing nationally free drugs as a “bottom line” treatment, various new treatment plans covered by medical insurance, and the introduction of internationally advanced treatment plans as self-paid drugs.
Dr. Taisheng Li emphasized that overall, they adhere to an anti-AIDS treatment “Chinese approach” that is suitable for the national context. Around 2006, they initially established the “Chinese approach” using mainly effective regimens with domestically produced generic drugs to reduce large-scale patient deaths. By 2010, they improved the “Chinese approach,” exploring more cost-effective, less toxic regimens to further reduce mortality and infectivity. In 2018, they developed and perfected the “Chinese approach,” creating a comprehensive diagnosis and treatment system for AIDS and proposing a new strategy for immune reconstitution.
The updating and release of the “Chinese Guidelines for the Diagnosis and Treatment of AIDS” witnessed the establishment and improvement of the “Chinese approach.” From the first edition of the guidelines in 2006 to the fifth edition in 2021, the recommended regimens in the guidelines consistently combined evidence-based medicine with China’s national conditions, continually optimizing China’s AIDS diagnosis and treatment strategies and experiences. The guidelines were widely promoted and used across the country through guideline lectures. In 2016, the journal “Science” highly praised Dr. Taisheng Li’s team’s scientific research for significantly advancing China’s AIDS diagnosis and treatment processes. The written “Chinese Guidelines for the Diagnosis and Treatment of AIDS” promoted the standardization of AIDS treatment nationwide and effectively controlled new infections. As early as the 2018 version of the guidelines, the concept of HIV/AIDS comprehensive management was proposed, and the 2021 version further improved the content of comprehensive management. This concept has also been adopted in the 2021 WHO guidelines.
Challenges and Research Hotspots in the Diagnosis and Treatment of AIDS in China
Despite the establishment of the “Chinese approach,” which has significantly improved the level of AIDS diagnosis and treatment in China and effectively controlled the spread of the disease, there are still numerous challenges in AIDS diagnosis and treatment in the country. These challenges span various levels, including epidemiology, antiviral treatment, immune activation, and the promotion of prevention strategies. One prominent issue is the late discovery of HIV/AIDS patients in China. Research based on CD4 count levels in 2014 showed that over half (55.2%) of newly reported patients had been infected for five or more years (Hao Yang, et al., Chinese Journal of Epidemiology, 2014). Surveillance data from the Chinese Center for Disease Control and Prevention (China CDC) indicates that the proportion of late-discovered patients (initial CD4 < 200/mm3) in China increased from around 35% in 2015 to approximately 40% in 2021, with the late-discovery rate exceeding 45% for patients aged 50 and above. Besides the high proportion of late discovery, issues such as the aging of AIDS patients and long-term drug side effects are increasingly attracting attention. These issues include cardiovascular diseases, lipid metabolism abnormalities, osteoporosis, renal insufficiency, neurocognitive disorders caused by both AIDS itself and antiretroviral therapy (ART).
Whether it’s the adverse outcomes of late-discovered patients or the acceleration of the aging process, chronic immune activation and chronic inflammation have played important roles. They can impact immune reconstruction in patients and the clearance of viral reservoirs, becoming one of the recent hotspots in AIDS treatment research. In recent years, Dr. Taisheng Li’s team has innovatively applied the strategy of immune activation inhibition using the Chinese herbal medicine Thunder God Vine to improve immune reconstruction in AIDS patients. Triptolide, an extract from Thunder God Vine, is a chemically modified Class 1.1 new drug. In a randomized controlled Phase II study applied to AIDS patients with immune reconstruction deficiency, it was found to increase CD4 cell counts and improve inflammatory indicators. The related research findings have been published in The Lancet. With the deepening of clinical research and the accumulation of clinical experience, Dr. Taisheng Li led the release of the first “Clinical Diagnosis and Treatment Expert Consensus on AIDS Immune Reconstruction Deficiency (2023 edition),” providing reference for the standardized diagnosis and treatment of immune reconstruction deficiency in AIDS patients.
Dr. Taisheng Li emphasized that the “post-cocktail era” needs to focus on the overall management of AIDS patients, particularly vulnerable groups with immune reconstruction deficiency, complications, concurrent medication, and special sociological factors (age 50 and above, intravenous drug users, anxiety/depression). In clinical treatment, a multidisciplinary team (MDT) should be utilized to cross-integrate resources, compensate for the shortcomings of specialized hospitals and physicians, and achieve patient-centered, individualized diagnosis and treatment, raising the level of management to provide patients with a better quality of life. In AIDS research, large-scale multicenter clinical research, basic research transformation platforms, policy research transformation platforms, and research support systems are required to address new challenges in AIDS diagnosis and treatment continually. As the medical model shifts, the focus of AIDS diagnosis and treatment in China has begun to shift from specialized hospitals to comprehensive hospitals. Overcoming the clinical research difficulties of AIDS requires collaborative, multidisciplinary support from comprehensive hospitals.
Dr. Taisheng Li, MD, PhD
Director of Infectious Diseases Department, Peking Union Medical College Hospital
