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Chronic persistent type B viral hepatitis — Clinical Guidelines

Overview

Chronic hepatitis B (CHB) is a significant global health issue affecting millions worldwide 2. It is defined by persistent hepatitis B surface antigen (HBsAg) positivity for more than six months 15. CHB can lead to severe complications, including advanced liver disease, liver cancer, and liver transplantation 13 15.

Diagnosis

Diagnosis is based on persistent HBsAg positivity for >6 months 15.

The immune-tolerant (IT) phase is characterized by HBsAg positivity, detectable HBV DNA, and normal alanine aminotransferase (ALT) levels 10.

Significant liver fibrosis and inflammatory activity rates in the IT phase are approximately 10% and 16%, respectively 10.

Precore (PC) and/or basal core promoter (BCP) mutations are prevalent, especially in HBeAg-negative patients, and can enhance viral replication 6.

Management

Current guidelines recommend antiviral therapy for non-cirrhotic CHB with significant liver fibrosis or elevated ALT 1.

Nucleos(t)ide analogues (NAs) are a first-line treatment option 4 12. Entecavir is recommended as a first-line drug in many guidelines 4.

Tenofovir disoproxil fumarate (TDF) significantly reduces intrahepatic HBV DNA and HBV core+ hepatocytes, but does not affect HBsAg+ hepatocytes 3.

Early antiviral treatment with tenofovir alafenamide in adults with non-cirrhotic CHB and moderate or high viremia but normal or mildly elevated ALT reduced the incidence of serious liver-related adverse events 1.

Functional cure, defined as loss of HBsAg, is the optimal goal and can be achieved through NA induction, pegylated interferon alpha (PegIFNα), or spontaneous clearance 2.

Newer agents targeting HBsAg reduction, such as JNJ-73763989 and bersacapavir, are under investigation for achieving functional cure 5. RNAi therapeutics like RG6346 and bepirovirsen are also being studied 8 11.

Toll-like receptor 8 agonists like selgantolimod are being evaluated for their potential to induce serologic changes associated with durable cure 7.

Special Populations

Most children with CHB are asymptomatic and do not require treatment but are at increased risk for severe complications later in life 15. Recommendations exist for screening, monitoring, and referral of pediatric CHB 15.

Key Recommendations

Antiviral therapy is recommended for individuals with non-cirrhotic chronic hepatitis B who have significant liver fibrosis or elevated alanine aminotransferase concentrations 1. (Evidence: Strong)

Early antiviral treatment with tenofovir alafenamide in adults with non-cirrhotic chronic hepatitis B and moderate or high viremia but normal or mildly elevated ALT concentrations may prevent serious liver-related adverse events 1. (Evidence: Moderate)

HBeAg-negative patients with chronic HBV infection should be monitored regularly for HBV mutations and are expected to receive early antiviral treatment to prevent disease progression 6. (Evidence: Moderate)

Cessation of nucleos(t)ide analogue treatment in HBeAg-negative chronic hepatitis B patients with sustained viral suppression may lead to functional cure (HBsAg loss) 9. (Evidence: Moderate)

Nucleos(t)ide analogue therapy is associated with a reduced risk of portal hypertension-related complications, hepatocellular carcinoma, and liver transplantation/death in patients with advanced chronic liver disease 12. (Evidence: Moderate)

References

1 Lim YS, Yu ML, Choi J, Chen CY, Choi WM, Kang W et al.. Early antiviral treatment with tenofovir alafenamide to prevent serious clinical adverse events in adults with chronic hepatitis B and moderate or high viraemia (ATTENTION): interim results from a randomised controlled trial. The lancet. Gastroenterology & hepatology 2025. link00431-X) 2 Zheng J, Wang Z, Huang L, Qiu Z, Xie Y, Jiang S et al.. Achieving chronic hepatitis B functional cure: Factors and potential mechanisms. Virus research 2025. link 3 Pan DZ, Soulette CM, Aggarwal A, Han D, van Buuren N, Wu P et al.. Effects of tenofovir disoproxil fumarate on intrahepatic viral burden and liver immune microenvironment in patients with chronic hepatitis B. Gut 2025. link 4 Wu J, Xie S, Ma Y, He X, Dong X, Shi Q et al.. Entecavir for children and adults with chronic hepatitis B. The Cochrane database of systematic reviews 2025. link 5 Agarwal K, Buti M, van Bömmel F, Lampertico P, Janczewska E, Bourliere M et al.. JNJ-73763989 and bersacapavir treatment in nucleos(t)ide analogue-suppressed patients with chronic hepatitis B: REEF-2. Journal of hepatology 2024. link 6 Li G, Yang D, Liu X, Zhang T, Liu H, Zou J et al.. Precore mutation enhances viral replication to facilitate persistent infection especially in HBeAg-negative patients. Virologica Sinica 2024. link 7 Gane EJ, Dunbar PR, Brooks AE, Zhang F, Chen D, Wallin JJ et al.. Safety and efficacy of the oral TLR8 agonist selgantolimod in individuals with chronic hepatitis B under viral suppression. Journal of hepatology 2023. link 8 Gane EJ, Kim W, Lim TH, Tangkijvanich P, Yoon JH, Sievert W et al.. First-in-human randomized study of RNAi therapeutic RG6346 for chronic hepatitis B virus infection. Journal of hepatology 2023. link 9 van Bömmel F, Stein K, Heyne R, Petersen J, Buggisch P, Berg C et al.. A multicenter randomized-controlled trial of nucleos(t)ide analogue cessation in HBeAg-negative chronic hepatitis B. Journal of hepatology 2023. link 10 Li Z, Yang D, Ge Y, Song S, Lv Q, Ye Y. Histologic changes in immune-tolerant patients with chronic hepatitis B: a systematic review and meta-analysis. Scientific reports 2023. link 11 Yuen MF, Heo J, Kumada H, Suzuki F, Suzuki Y, Xie Q et al.. Phase IIa, randomised, double-blind study of GSK3389404 in patients with chronic hepatitis B on stable nucleos(t)ide therapy. Journal of hepatology 2022. link 12 Kong Y, Lv T, Li M, Zhao L, Meng T, Wu S et al.. Systematic review and meta-analysis: impact of anti-viral therapy on portal hypertensive complications in HBV patients with advanced chronic liver disease. Hepatology international 2022. link 13 Yeo YH, Nguyen MH. Review article: current gaps and opportunities in HBV prevention, testing and linkage to care in the United States-a call for action. Alimentary pharmacology & therapeutics 2021. link 14 Tovo CV, Ahlert M, Panke C, de Mattos ÂZ, de Mattos AA. Treatment of hepatitis B virus infection in chronic infection with HBeAg-positive adult patients (immunotolerant patients): a systematic review. European journal of gastroenterology & hepatology 2021. link 15 Haber BA, Block JM, Jonas MM, Karpen SJ, London WT, McMahon BJ et al.. Recommendations for screening, monitoring, and referral of pediatric chronic hepatitis B. Pediatrics 2009. link

Chronic persistent type B viral hepatitis