Chronic hepatitis D is the most severe form of chronic viral hepatitis. It results from co-infection or superinfection with hepatitis B virus (HBV) and hepatitis D virus (HDV). The disease may initially go undetected while causing serious liver damage and can progress rapidly to cirrhosis and liver cancer. Before Libevitug’s approval, no drug had been approved in China to treat hepatitis D, and gaps in screening and diagnosis remain.

The Expert consensus on prevention and treatment of hepatitis D in China (the Consensus) provides guidance on hepatitis D screening, diagnosis, treatment, and prevention. Its development was jointly organized by the Promoting Hepatitis Elimination Working Committee of the Chinese Preventive Medicine Association and the Chinese Society of Hepatology, Chinese Medical Association. China’s first hepatitis D expert consensus was recently published jointly in China Preventive Medicine and the Chinese Journal of Hepatology. Drawing on a review of the etiology, natural history, pathogenesis, and epidemiology of hepatitis D, the Consensus sets out 15 recommendations to guide prevention and clinical care in China.

Fifteen Recommendations for Hepatitis D Care

The Consensus provides specific recommendations on screening populations, testing algorithms, follow-up and monitoring, and preventive measures.

Consensus 1:

All HBsAg-positive individuals should receive at least one anti-HDV serological screening test. In settings where laboratory capacity or other resources are limited and universal anti-HDV testing cannot be implemented, anti-HDV screening should be prioritized in the following specific HBsAg-positive populations:

①Patients with chronic hepatitis B who have persistent ALT elevation or disease progression despite standard anti-HBV therapy, after exclusion of other viral infections, including HCV infection, and metabolic liver diseases, including fatty liver disease;

②Patients with acute decompensation of chronic liver disease;

③Patients with advanced liver disease and clinical features suggestive of HDV infection (e.g., low HBV DNA levels with elevated ALT);

④Individuals with a history of residence or travel in regions with high HDV prevalence; or those with documented HDV infection in household members or sexual partners;

⑤Individuals with ongoing high risk of HDV exposure, including hemodialysis patients, individuals with HCV or HIV co-infection, people who inject drugs, men who have sex with men, and sex workers, should undergo annual repeat anti-HDV screening.

Consensus 2:

After the HBsAg test result is positive, anti-HDV (total antibody or anti-HDV IgG) testing should be automatically triggered; if anti-HDV is positive, HDV RNA testing is then reflexively performed. Direct HDV RNA testing following a positive HBsAg result may be considered.

Consensus 3:

HDV RNA is the gold standard for confirming active HDV infection. All individuals with anti-HDV positivity should undergo nucleic acid testing for HDV RNA to determine whether active HDV infection is present.

Consensus 4:

HDV screening should be incorporated into existing national or regional hepatitis B screening programs. A multiplex pathogen testing strategy is recommended to improve screening coverage and efficiency.

Consensus 5:

In patients with acute hepatitis D, anti-HBc IgM testing should be performed to distinguish acute HBV/HDV coinfection from HDV superinfection in HBsAg-positive individuals.

Consensus 6:

Chronic hepatitis D patients with elevated aminotransferase (ALT/AST) and gamma-glutamyl transferase (GGT) levels, advanced liver disease, persistent HDV viremia, high serum HBV DNA levels, coinfection with other viruses, or comorbidities including alcohol abuse, obesity, and diabetes should receive intensified follow-up and monitoring.

Consensus 7:

Patients with a confirmed diagnosis of hepatitis D who test positive for serum/plasma HDV RNA should receive antiviral therapy.

Consensus 8:

Given that chronic HBV coinfects with HDV accelerates liver disease progression, Nucleos(t)ide analogues (NAs) are recommended for the management of HBV infection in HDV-infected patients, in accordance with current guidelines for the prevention and treatment of chronic hepatitis B.

Consensus 9:

For patients with confirmed chronic HDV infection and compensated liver disease, libevitug is recommended as the preferred therapy at a dose of 10 mg/kg (weight) administered intravenously every two weeks. Treatment duration should be individualized according to HDV RNA and ALT responses. A 48-week course is generally recommended.

Consensus 10:

For patients with confirmed chronic HDV infection and compensated liver disease who are unsuitable for libevitug therapy and have no contraindications or intolerance to interferon, PEG-IFNα may be considered as an alternative. The treatment duration should be individualized based on dynamic changes in HDV RNA and ALT levels, as well as treatment tolerability. A 48-week course at a dose of 180 μg once weekly by subcutaneous injection is generally recommended.

Consensus 11:

Patients with chronic HDV infection should undergo routine liver disease assessment every 3 to 6 months. Virologic testing should include quantitative HBsAg, HBV DNA, and HDV RNA.

Consensus 12:

During treatment, quantitative HDV RNA testing is recommended every 3 months to assess virologic response. ALT should be measured at least every 3 to 6 months to determine whether HDV suppression is accompanied by ALT improvement.

Consensus 13:

During treatment, HBV DNA testing is recommended every 6 months for patients with chronic HDV infection who have undetectable HBV DNA and are not receiving nucleos(t)ide analogue therapy. Liver function should be assessed every 3 to 6 months. For patients with cirrhosis or significantly abnormal ALT, more frequent testing may be considered as clinically indicated.

Consensus 14:

After treatment completion, individualized plans for periodic retesting of HDV RNA and HBV DNA should be developed according to the treatment regimen, to monitor possible HBV/HDV reactivation or relapses. If indications for antiviral therapy are met, treatment should be initiated promptly.

Consensus 15:

For newborns of mothers co-infected with HBV and HDV, combined administration of hepatitis B vaccine and hepatitis B immunoglobulin is recommended to prevent mother-to-child transmission. Hepatitis B vaccination is also recommended for other high-risk populations with susceptibility to HDV infection.

Libevitug Recommended as a Preferred Treatment

Under Recommendation 9, Libevitug is a preferred treatment for patients with confirmed chronic HDV infection and compensated liver disease. Treatment duration should be tailored to changes in HDV RNA and ALT levels.

Libevitug (HH-003) is a fully human monoclonal antibody approved in China in 2026. It is the first drug globally to target the PreS1 region of the large HBV surface antigen. By specifically binding to the PreS1 region of the HBV/HDV envelope, libevitug blocks the interaction between virus and the NTCP receptor, thereby inhibiting viral entry into hepatocytes and neutralizing infection. The recommended clinical dose is 10 mg/kg administered intravenously every two weeks. The dose may be increased to 20 mg/kg based on individual patient assessment and evaluation by an experienced physician. The optimal treatment duration remains to be determined. However, a 48-week course of treatment is generally recommended based on the Phase 2b study. In an international, multicenter, randomized, controlled, open-label pivotal Phase 2b study (HH003-204; NCT05861674), 100 patients with chronic HDV infection were enrolled and randomly assigned in a 2:2:1 ratio to receive libevitug 10 mg/kg, libevitug 20 mg/kg, or control, with all groups receiving TAF as background therapy for HBV infection. At week 24, HDV RNA virologic response rates in the libevitug 10 mg/kg and 20 mg/kg groups were 35.5% and 42.5%, respectively, and composite virologic and biochemical (ALT normalization) response rates were 32.4% and 35.0%, respectively. At week 48, HDV RNA virologic response rates increased to 50.0% and 60.0%, respectively, with composite response rates reaching 44.1% and 42.5%, and ALT normalization rates up to 70%. In addition, patients treated with libevitug showed significant improvement in liver stiffness. Libevitug has received Breakthrough Therapy Designation from the National Medical Products Administration (NMPA) of China and the U.S. Food and Drug Administration (FDA) for the treatment of chronic HDV infection.

Over 11 years, Huahui Health has translated original discoveries in viral infection mechanisms into Libevitug through its own drug discovery and development program. Libevitug has received Breakthrough Therapy Designation from both the U.S. FDA and the Center for Drug Evaluation (CDE) of China’s NMPA. As China’s only approved treatment for hepatitis D, it fills a longstanding gap in care. Its efficacy and safety, documented in international multicenter clinical trials, have gained broad recognition within the global hepatology community.

Huahui Health will continue to put patients’ needs first and work with partners to raise awareness of hepatitis D. These efforts aim to promote earlier diagnosis and treatment and help patients benefit sooner. The company is also advancing multiple proprietary drug candidates with first-in-class potential and expanding its viral hepatitis portfolio to address unmet needs worldwide. Huahui Health remains committed to supporting the global goal of eliminating viral hepatitis as a public health threat by 2030.

References

[1] Writing Group for the Expert Consensus on Prevention and Treatment of Hepatitis D. Expert consensus on prevention and treatment of hepatitis D in China. China Preventive Medicine. 2026;27(10):1–14. [In Chinese.]

[2] Chinese Journal of Hepatology WeChat official account. Expert consensus on prevention and treatment of hepatitis D in China. October 15, 2026. Read the original Consensus in Chinese.

About Libevitug (HH-003)

Libevitug is a first-in-class, PreS1-targeting neutralizing monoclonal antibody against HBV/HDV, discovered and developed by Huahui Health. The antibody functions by specifically blocking the interaction between the viral PreS1 domain and the host NTCP receptor, preventing viral entry into hepatocytes and reinfection. The early-stage development of Libevitug received support from the National Major Science and Technology Project for Significant New Drugs Development under China’s 13th Five-Year Plan. On January 20, 2026, Libevitug received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of chronic HDV infection in adults with or without compensated cirrhosis. Previously, it was granted Breakthrough Therapy Designation (BTD) for Hepatitis D by both China’s CDE, NMPA (2023) and the U.S. FDA (2024).

About Huahui Health

Founded in Beijing in 2015, Huahui Health is a patient-centric biopharmaceutical company with profound scientific expertise, developing innovative therapies to address unmet clinical needs worldwide across viral hepatitis, liver diseases, and oncology. Guided by the core principles of Innovation, Integrity, Collaboration, and Mutual Benefit, Huahui Health has established an integrated R&D system spanning the entire drug development process, with a focus on first-in-class and best-in-class breakthrough therapies.