A double-blind randomized trial of adefovir dipivoxil in Chinese subjects with HBeAg-positive chronic hepatitis B

Area of Science:

• Hepatology
• Virology
• Pharmacology

Background:

• Chronic hepatitis B (CHB) affects millions globally, necessitating effective antiviral therapies.
• Hepatitis B e antigen (HBeAg)-positive CHB is a common and challenging form of the disease.
• Adefovir dipivoxil (ADV) is an antiviral medication used in CHB treatment.

Purpose of the Study:

• To evaluate the efficacy and safety of adefovir dipivoxil (ADV) in Chinese patients with HBeAg-positive chronic hepatitis B (CHB).
• To assess the impact of ADV on viral load (HBV DNA), liver enzyme levels (ALT), and serological markers over 52 weeks.
• To investigate the emergence of drug resistance and adverse events associated with ADV treatment.

Main Methods:

• A multicenter, double-blind, randomized, placebo-controlled study.
• 480 Chinese subjects with HBeAg-positive CHB were enrolled.
• Subjects received either adefovir dipivoxil (ADV) 10 mg daily or a placebo for 52 weeks.

Main Results:

• ADV significantly reduced serum HBV DNA levels compared to placebo after 12 weeks (3.4 vs 0.1 log10 copies/mL reduction).
• At week 52, ADV treatment led to substantial HBV DNA reduction (median 4.5 log10 copies/mL), undetectable HBV DNA in 28% of subjects, and ALT normalization in 79%.
• No significant renal toxicity or adefovir-related HBV mutations were observed; adverse events were similar between groups.

Conclusions:

• Adefovir dipivoxil (ADV) 10 mg daily is safe and effective for Chinese patients with HBeAg-positive CHB over 52 weeks.
• The treatment did not lead to the emergence of drug resistance.
• The study's long-term efficacy and safety are being further evaluated in an ongoing 4-year open-label extension phase.