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Chronic hepatitis — Clinical Guidelines

Overview

Chronic hepatitis B (CHB) is a viral infection causing inflammation of the liver due to persistent infection with the hepatitis B virus (HBV), potentially leading to cirrhosis, liver failure, and hepatocellular carcinoma if left untreated. 1

Diagnosis

Serological markers: Presence of hepatitis B surface antigen (HBsAg), with or without hepatitis B e antigen (HBeAg).

Viral load assessment: Elevated HBV DNA levels (typically >20,000 IU/mL for HBeAg-positive patients).

Liver function tests: Elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels.

Non-invasive fibrosis assessment: Use of transient elastography (FibroScan) and APRI index to stage liver fibrosis. 2

Histological evaluation: Liver biopsy for definitive staging of fibrosis and inflammation when non-invasive tests are inconclusive.

Management

First-line antiviral therapy:

- Tenofovir alafenamide (TAF): Recommended for its efficacy and favorable safety profile, especially regarding renal and bone health. 13 - Tenofovir disoproxil fumarate (TDF): Alternative option with strong antiviral activity. - Entecavir: Another effective first-line treatment option. 8

Adjunctive treatments:

- Pegylated interferon alpha-2a (PegIFN-α-2a): Considered for HBeAg-negative patients post-nucleos(t)ide analogue cessation to reduce relapse rates. 5 - Besifovir (BSV): An alternative for patients experiencing suboptimal response or intolerance to TDF. 10

Treatment cessation: Evaluated in selected HBeAg-negative patients with sustained viral suppression; requires careful monitoring for potential relapse. 22 28

Special Populations

Pediatrics: Entecavir is recommended as a first-line therapy, though specific dosing and long-term outcomes require further study. 8

Elderly: Management focuses on minimizing adverse effects, favoring drugs like TAF due to better renal and bone safety profiles. 13

Comorbidities: Consider renal function and bone health when selecting antiviral therapy, favoring TAF over TDF in patients with pre-existing renal impairment. 13 25

Key Recommendations

Initiate antiviral therapy in adults with CHB and significant liver fibrosis or persistently elevated ALT levels, regardless of cirrhosis status. (Evidence: Moderate 4)

Use tenofovir alafenamide (TAF) as a first-line treatment option due to its efficacy and favorable safety profile, particularly in patients with renal or bone health concerns. (Evidence: Strong 13)

Consider cessation of nucleos(t)ide analogue therapy in carefully selected HBeAg-negative patients with sustained viral suppression, monitoring closely for potential relapse. (Evidence: Moderate 22 28)

Regularly assess liver fibrosis using non-invasive methods such as transient elastography and APRI index to guide treatment decisions. (Evidence: Moderate 2)

Monitor vitamin D levels in CHB patients, as deficiency may correlate with disease progression and treatment outcomes. (Evidence: Moderate 32 39)

References

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The lancet. Gastroenterology & hepatology 2025. link00431-X) 5 Li F, Qu L, Liu Y, Wu X, Qi X, Wang J et al.. PegIFN alpha-2a reduces relapse in HBeAg-negative patients after nucleo(s)tide analogue cessation: A randomized-controlled trial. Journal of hepatology 2025. link 6 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 7 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 8 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 9 Gu M, Wu W, You J, Wu Q, Huang F, Zhang Y et al.. High-Throughput Viral Integration Detection Reveals Baseline Breakpoints Burden Associated With HBsAg Seroclearance. 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Chronic hepatitis