Advances in the Diagnosis and Treatment of Viral Hepatitis B and C in China

0
0
0

Advances in the Diagnosis and Treatment of Viral Hepatitis B and C in China

Chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infections affect over 300 million people worldwide, causing liver damage, cirrhosis, and cancer. For decades, China faced a heavy burden of these viruses—but over the past 30 years, the country has made transformative progress in preventing, diagnosing, and treating viral hepatitis, bringing it closer to eliminating these diseases as a public health threat.

Prevention: Vaccination, Blood Safety, and Stopping Transmission

China’s biggest win against HBV has been its universal newborn vaccination program, launched in 1992. This policy cut the prevalence of hepatitis B surface antigen (HBsAg)—a marker of active infection—in the general population from 9.7% in 1992 to 6.2% in 2016. For children under 5, the HBsAg positive rate plummeted even further to just 0.3%—a 97% drop in a generation.

To stop mother-to-child transmission (MTCT)—a major route of HBV spread—China added two key measures: giving hepatitis B immunoglobulin (HBIG) to infants born to HBsAg-positive mothers, and prescribing oral antivirals to pregnant women with high HBV DNA levels during the third trimester. These steps reduced MTCT to nearly zero. Today, the country’s “triple elimination program” (targeting MTCT of HIV, syphilis, and HBV) aims to drive HBsAg prevalence in young people even lower.

For HCV, China tackled transmission through blood safety reforms. A 1998 ban on paid blood donors and strict screening of volunteer donors—paired with safe injection practices and harm reduction programs (like syringe exchange and methadone for people who inject drugs)—cut HCV prevalence from 3.2% in 1992 to 0.7% in 2016.

Diagnosis: From Needles to Non-Invasive Tools

Gone are the days when liver biopsy was the only way to assess liver damage. China has led in validating novel diagnostic tools to make hepatitis care faster, safer, and more accurate:

  • New serum markers: Beyond standard viral load tests, doctors now use quantified HBsAg, anti-HBc (hepatitis B core antibody), hepatitis B core-related antigen, and pre-genomic HBV RNA (pgRNA) to stage disease, monitor progress, and check treatment effectiveness.
  • Non-invasive fibrosis tests: Transient elastography (a painless scan that measures liver stiffness) has been validated in large cohorts of chronic hepatitis B (CHB) patients. Serum fibrosis markers—like APRI or FibroScan—are also widely used after multicenter studies confirmed their reliability in Chinese CHB patients.
  • Beijing Classification: A new system to evaluate liver biopsy samples that identifies whether fibrosis is getting worse (“progressive”), staying the same (“indeterminate”), or improving (“regressive”). This helps doctors track how well treatment works with a single biopsy.

Treatment: More Effective, More Accessible

China’s clinical research on hepatitis has grown exponentially in quality and quantity over the past decade. Key breakthroughs include:

  • First-line antivirals: Nucleo(s)tide analogs (NAs) like entecavir (ETV) and tenofovir disoproxil fumarate (TDF)—the global gold standard for HBV—have proven highly effective in real-world Chinese studies. For patients on NAs with low HBsAg levels (<1500 IU/mL), adding or switching to pegylated interferon (Peg-IFN) boosts the chance of losing HBsAg (a “functional cure” marker) dramatically.
  • Expanded eligibility: The 2019 Chinese guidelines for CHB lowered thresholds for HBV DNA and liver enzyme (ALT) levels, letting more patients start treatment earlier—before liver damage becomes irreversible.
  • Affordability: Thanks to government price negotiations, generic ETV and TDF now cost 90% less than they did a decade ago. Brand-name antivirals (like tenofovir alafenamide) have also gotten cheaper. For HCV, all recommended direct-acting antivirals (DAAs)—both pan-genotypic (works for all HCV types) and genotype-specific—are now covered by China’s basic health insurance. These changes have made life-saving treatment accessible to millions who couldn’t afford it before.

Reimbursement policies have already had a tangible impact. In Beijing, adding HBV antivirals to insurance in 2011 increased diagnosis and treatment rates—and cut liver-related deaths in CHB patients. By 2016, 80% of prescribed HBV antivirals were first-line NAs (up from 13.5% in 2003), meaning fewer patients develop drug resistance.

Challenges Ahead: Diagnosis Gaps and Equity

Despite progress, China still faces hurdles. Only 25% of HBV cases and 30% of HCV cases are diagnosed, and just 17% of eligible CHB patients and 9% of eligible CHC patients receive treatment. Scaling up “test-and-treat” programs—where everyone at risk gets tested and treated immediately—could save millions of lives and is cost-effective (or even cost-saving), studies show.

To meet the WHO’s 2030 goal of eliminating viral hepatitis as a public health threat, China needs to keep raising awareness, expanding screening, and investing in prevention and care.

Conclusion

China’s journey against viral hepatitis is a story of progress: from high prevalence to declining rates, from invasive tests to non-invasive tools, from unaffordable drugs to universal access. But the work isn’t done. By building on these advances—especially by closing diagnosis and treatment gaps—China can lead the way in ending hepatitis B and C for good.

  1. Cui F, Shen L, Li L, et al. Prevention of chronic hepatitis B after 3 decades of escalating vaccination policy, China. Emerg Infect Dis 2017;23:765–772. doi.org/10.3201/eid2305.161477
  2. Polaris Observatory. https://cdafound.org/dashboard/polaris/dashboard.html. [Accessed December 21, 2020]
  3. Shan S, Jia J. Prevention of mother-to-child transmission of hepatitis B virus in the Western Pacific region. Clin Liver Dis (Hoboken) 2021;18:18–21. doi.org/10.1002/cld.1096
  4. Wu Y, Gao J, Qin J, et al. Mother-to-child transmission prevention of human immunodeficiency virus, syphilis and hepatitis B virus. Women Birth 2019;32:570–578. doi.org/10.1016/j.wombi.2018.11.004
  5. Jia J, Hou J, Ding H, et al. Transient elastography compared to serum markers to predict liver fibrosis in a cohort of Chinese patients with chronic hepatitis B. J Gastroenterol Hepatol 2015;30:756–762. doi.org/10.1111/jgh.12840
  6. Duan WJ, Wang XZ, Ma AL, et al. Multicenter prospective study to validate a new transient elastography device for staging liver fibrosis in patients with chronic hepatitis B. J Dig Dis 2020;21:519–525. doi.org/10.1111/1751-2980.12924
  7. Dong XQ, Wu Z, Zhao H, et al. Evaluation and comparison of thirty noninvasive models for diagnosing liver fibrosis in Chinese hepatitis B patients. J Viral Hepat 2019;26:297–307. doi.org/10.1111/jvh.13031
  8. Sun Y, Zhou J, Wang L, et al. New classification of liver biopsy assessment for fibrosis in chronic hepatitis B patients before and after treatment. Hepatology 2017;65:1438–1450. doi.org/10.1002/hep.29009
  9. Zeng N, Zou C, He Z, et al. Systematic review on the reporting quality of randomized controlled trials in patients with hepatitis B or C in China. Int J Infect Dis 2018;67:58–64. doi.org/10.1016/j.ijid.2017.11.011
  10. Jia J, Tang H, Ning Q, et al. Real-world evidence for nucleoside/nucleotide analogues in a 5-year multicentre study of antiviral-naive chronic hepatitis B patients in China: 52-week results. Antivir Ther 2018;23:201–209. doi.org/10.3851/IMP3205
  11. Hou JL, Zhao W, Lee C, et al. Outcomes of long-term treatment of chronic HBV infection with entecavir or other agents from a randomized trial in 24 Countries. Clin Gastroenterol Hepatol 2019;18:457–467. doi.org/10.1016/j.cgh.2019.07.010
  12. Ning Q, Wu D, Wang GQ, et al. Roadmap to functional cure of chronic hepatitis B: an expert consensus. J Viral Hepat 2019;26:1146–1155. doi.org/10.1111/jvh.13126
  13. Cao Z, Liu Y, Ma L, et al. A potent hepatitis B surface antigen response in subjects with inactive hepatitis B surface antigen carrier treated with pegylated-interferon alpha. Hepatology 2017;66:1058–1066. doi.org/10.1002/hep.29213
  14. Zhu S, Zhang H, Dong Y, et al. Antiviral therapy in hepatitis B virus-infected children with immune-tolerant characteristics: a pilot open-label randomized study. J Hepatol 2018;68:1123–1128. doi.org/10.1016/j.jhep.2018.01.037
  15. Chinese Society of Infectious Diseases, Chinese Medical Association; Chinese Society of Hepatology, Chinese Medical Association. The guidelines of prevention and treatment for chronic hepatitis B (2019 version) (in Chinese). Chin J Hepatol 2019;27:938–961. doi.org/10.3760/cma.j.issn.1007-3418.2019.12.007
  16. Li M, Kong YY, Wu SS, et al. Impact of reimbursement program on liver-related mortality in patients with chronic hepatitis B in Beijing. China J Dig Dis 2019;20:467–475. doi.org/10.1111/1751-2980.12794
  17. Li M, Zhao L, Zhou J, et al. Changing clinical care cascade of patients with chronic hepatitis B in Beijing, China. Lancet Reg Health West Pac 2021;16:100249. doi.org/10.1016/j.lanwpc.2021.100249
  18. Shan S, You H, Niu J, et al. Baseline characteristics and treatment patterns of the patients recruited to the China registry of Hepatitis B. J Clin Transl Hepatol 2019;7:322–328. doi.org/10.14218/JCTH.2019.00052
  19. Wang Y, Wang M, Zhang G, et al. Control of chronic hepatitis B in China: perspective of diagnosis and treatment. China CDC Wkly 2020;2:596–600. doi.org/10.46234/ccdcw2020.159

How to cite this article: Jia J. Advances in the diagnosis and treatment of viral hepatitis B and C in China. Chin Med J 2022;135:379–380. doi.org/10.1097/CM9.0000000000001886

Was this helpful?

0 / 0