Early Antiviral Therapy in Chronic Hepatitis B Shows Promise in Preventing Liver Complications
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Reviewed by Dat Tien Nguyen, B.A, ScM.
Translated by Nhi Phuong Quynh Le, B.A |
Posted on June 25th, 2025
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Chronic hepatitis B infection is a well-established risk factor for liver cirrhosis and hepatocellular carcinoma. While antiviral medications are effective in managing the disease, current treatment guidelines typically recommend delaying initiation until elevated liver enzymes are detected. However, recent observational data suggest that viremia alone may contribute to increased cancer risk, regardless of enzyme levels. In response, the Government of South Korea, in collaboration with Gilead, funded a study to evaluate the benefits of early antiviral intervention in patients with normal liver enzyme levels.
The study enrolled 734 participants between the ages of 40 and 80 who had been diagnosed with chronic hepatitis B. At baseline, the average HBV DNA level was approximately 5 log₁₀ IU/mL, and 17% of participants tested positive for hepatitis B e-antigen (HBeAg). All participants had alanine aminotransferase (ALT) levels below twice the upper limit defined by the American Association for the Study of Liver Diseases (35 U/L for males and 25 U/L for females). Individuals with hepatitis C, hepatitis D, cirrhosis, or other liver diseases were excluded.
Participants were randomly assigned to receive either a daily 25 mg dose of tenofovir alafenamide or placebo for 12 months. After a median follow-up of 18 months, the results showed that initiating antiviral therapy prior to liver enzyme elevation significantly reduced liver-related complications, including the development of hepatocellular carcinoma. Based on these findings, the authors advocate for a revision of clinical guidelines to support earlier initiation of antiviral treatment in patients with chronic hepatitis B.
The study enrolled 734 participants between the ages of 40 and 80 who had been diagnosed with chronic hepatitis B. At baseline, the average HBV DNA level was approximately 5 log₁₀ IU/mL, and 17% of participants tested positive for hepatitis B e-antigen (HBeAg). All participants had alanine aminotransferase (ALT) levels below twice the upper limit defined by the American Association for the Study of Liver Diseases (35 U/L for males and 25 U/L for females). Individuals with hepatitis C, hepatitis D, cirrhosis, or other liver diseases were excluded.
Participants were randomly assigned to receive either a daily 25 mg dose of tenofovir alafenamide or placebo for 12 months. After a median follow-up of 18 months, the results showed that initiating antiviral therapy prior to liver enzyme elevation significantly reduced liver-related complications, including the development of hepatocellular carcinoma. Based on these findings, the authors advocate for a revision of clinical guidelines to support earlier initiation of antiviral treatment in patients with chronic hepatitis B.