Advances in the Diagnosis and Treatment of Viral Hepatitis B and C in China
Chronic infections caused by the hepatitis B virus (HBV) and hepatitis C virus (HCV) remain significant public health challenges globally. Over the past three decades, China has made substantial progress in the prevention, diagnosis, and treatment of chronic hepatitis B (CHB) and chronic hepatitis C (CHC). These advancements have been driven by a combination of public health initiatives, clinical research, and policy changes, which have collectively reduced the burden of these diseases in the country.
Prevention of Hepatitis B and C
The prevention of HBV and HCV has been a cornerstone of China’s public health strategy. Since the introduction of universal hepatitis B vaccination for newborns in 1992, the prevalence of hepatitis B surface antigen (HBsAg) in the general population has declined significantly. In 1992, the HBsAg prevalence was 9.7%, but by 2016, it had decreased to 6.2%. Notably, the HBsAg positive rate in children under five years old dropped to 0.3%, reflecting the success of the vaccination program. To further reduce mother-to-child transmission (MTCT) of HBV, additional measures have been implemented. These include the administration of hepatitis B immunoglobulin to infants born to HBsAg-positive mothers and the use of oral antiviral therapy during the third trimester of pregnancy for women with high HBV DNA levels. These interventions have reduced the MTCT rate of HBV to nearly zero. The ongoing triple elimination program for the prevention of MTCT of HIV, syphilis, and HBV is expected to further reduce the prevalence of HBsAg in younger age groups.
For HCV, the ban on paid blood donations in 1998 and the implementation of stringent screening for volunteer blood donors have been critical in reducing transmission. Additionally, safe injection practices in healthcare settings and harm reduction programs for people who inject drugs, such as syringe exchange and methadone replacement programs, have contributed to a decline in HCV prevalence. The HCV prevalence in the general population decreased from 3.2% in 1992 to 0.7% in 2016.
Advances in Diagnosis
The diagnosis of HBV and HCV has seen significant advancements in China. Beyond conventional serum markers and viral load quantifications, novel serum markers for HBV infection have been extensively explored and validated. These include the quantification of HBsAg, anti-HBc, hepatitis B core-related antigen, and pre-genomic HBV RNA (pgRNA). These markers have proven useful for better disease staging, progress monitoring, and efficacy assessment.
Non-invasive methods for assessing liver fibrosis have also been validated in large cohorts of CHB patients. Transient elastography, which measures liver stiffness, has been widely adopted as a reliable tool for fibrosis assessment. Serum markers for fibrosis have been validated in multicenter clinical cohorts of CHB patients. To facilitate the evaluation of histological regression of liver fibrosis, a new classification system, known as the Beijing Classification, has been proposed. This classification system identifies the trend of fibrosis changes on a single liver biopsy, categorizing them as predominantly progressive, indeterminate, or predominantly regressive (P-I-R score).
Treatment of Chronic Hepatitis B
The treatment landscape for CHB has evolved significantly in China over the past decade. First-line nucleos(t)ide analogs (NAs), such as entecavir (ETV) and tenofovir disoproxil fumarate (TDF), have demonstrated strong antiviral efficacy in real-world studies. Evidence from several studies in China suggests that adding or switching to pegylated interferon (Peg-IFN) in NA-treated patients with low levels of HBsAg (less than 1500 IU/mL) can achieve higher rates of HBsAg loss. Prospective studies have also shown that Peg-IFN therapy can lead to high rates of HBsAg clearance in patients with inactive HBsAg carrier status and in children under six years old.
Clinical guidelines for the prevention and treatment of CHB have been regularly updated by the Chinese Society of Hepatology and the Chinese Society of Infectious Diseases. The 2019 guidelines expanded the treatment indications by lowering the thresholds for HBV DNA and alanine transaminase levels, allowing more patients to benefit from antiviral therapy. This change is expected to reduce the disease burden at the population level.
The inclusion of antiviral agents for HBV in the reimbursement list of basic medical insurance in Beijing has led to increased diagnosis and treatment rates of CHB. Retrospective analyses of administrative databases indicate that liver-related deaths among CHB patients have decreased since the coverage of antiviral therapy by the reimbursement list in 2011. The proportion of ETV and TDF in prescribed antiviral agents increased from 13.5% in 2003 to 79.7% in 2016, as shown by an analysis of the China Registry of Hepatitis B. In 2019, the prices of generic ETV and TDF were reduced by 90%, and the prices of proprietary ETV, TDF, and tenofovir alafenamide fumarate also saw significant reductions. These price reductions have dramatically increased the availability and affordability of antiviral therapy for HBV.
Treatment of Chronic Hepatitis C
The treatment of CHC has also seen remarkable progress in China. Both pan-genotypic and genotype-specific direct-acting antiviral agents (DAAs) recommended by major international and national guidelines have been proven effective in the Chinese population. Following massive price reductions through governmental negotiations, these highly efficacious DAAs have been included in the reimbursement list of basic social health insurance. This has significantly increased the accessibility of antiviral therapy for HCV.
Challenges and Future Directions
Despite these advancements, challenges remain in the treatment of CHB and CHC. It is estimated that only around 25% of all HBV cases and 30% of all HCV cases in China have been diagnosed. Furthermore, only 17% of CHB patients and 9% of CHC patients eligible for treatment are actually receiving it. Studies suggest that scaling up the test-and-treat strategy could dramatically reduce HBV- or HCV-associated mortality, and this approach is considered cost-effective or even cost-saving.
To eliminate viral hepatitis as a public health threat by 2030, continuous efforts are needed to improve awareness of HBV and HCV, as well as to allocate resources for their prevention, testing, and treatment. These efforts will require a multi-faceted approach, including public health campaigns, healthcare system strengthening, and ongoing research to optimize diagnostic and therapeutic strategies.
In conclusion, China has made significant strides in the prevention, diagnosis, and treatment of viral hepatitis B and C. These achievements have been driven by a combination of vaccination programs, public health initiatives, clinical research, and policy changes. However, challenges remain, and continued efforts are essential to further reduce the burden of these diseases and achieve the goal of eliminating viral hepatitis as a public health threat by 2030.
doi.org/10.1097/CM9.0000000000001886
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