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Current treatment of chronic hepatitis C in China: Dilemma and potential problems
1Qun-Ying Han, Zheng-Wen Liu, Department of Infectious Diseases, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an 710061, Shaanxi Province, China.
Insights
Direct-acting antiviral agents (DAAs) offer advanced hepatitis C virus (HCV) treatment, but China lacks approved options. Patients illegally obtain DAAs, raising ethical and legal concerns, necessitating urgent policy changes for patient access.
Area of Science:
- Hepatology
- Virology
- Pharmacology
Background:
- Hepatitis C virus (HCV) infection remains a significant global health challenge, particularly in China, which has the highest number of cases worldwide.
- Despite major advances in treatment with direct-acting antiviral agents (DAAs), these life-saving medications are not yet approved in mainland China.
- Current standard care in China relies on interferon (IFN)-α-based therapy, leaving patients unresponsive or intolerant with no viable treatment alternatives.
Discussion:
- Many Chinese patients resort to illegally obtaining DAAs, including generic sofosbuvir, from abroad to manage their HCV infection.
- This practice introduces considerable ethical, legal, and medical challenges, including issues related to drug quality, safety, and patient management.
- The lack of legal access to effective DAAs creates a critical unmet medical need for a large patient population.
Key Insights:
- The absence of approved DAAs in China creates a treatment gap, forcing patients into risky acquisition methods.
- The illegal procurement and use of DAAs raise significant concerns regarding patient safety, regulatory oversight, and medical ethics.
- Urgent policy interventions are required to address the accessibility of DAAs for HCV patients in China.
Outlook:
- Early approval and launching of DAAs in China are crucial to provide legal and safe treatment options.
- Legalizing the purchase of DAAs from outside China for use within the country could offer an interim solution.
- Addressing these issues promptly is essential to improve patient outcomes and mitigate the public health impact of HCV in China.
Abstract:
Major advances have been made in the treatment of chronic hepatitis C virus (HCV) infection with the advent of direct-acting antiviral agents (DAAs). China has the most cases of HCV infection worldwide, but none of the DAAs has been approved in mainland China so far, and interferon (IFN)-α-based treatment remains the standard of care. HCV patients without response or with contraindications to IFN-based therapy have no alternative options. However, many patients buy DAAs, especially the generic forms of sofosbuvir, from other countries or areas. Under these circumstances, the use of these drugs may cause many predictable and unpredictable problems in ethics, law and medical practice. Given the obstacles of legal accessibility to DAAs and the potential problems of obtaining and using DAAs in China, the early launching of the DAAs in China or the legalization of buying drugs from areas outside China and using these drugs in China is an urgent issue and needs to be dealt with as soon as possible, in the interest of the patients.
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