Abstract
Background: Pegylated interferon (PEG-IFN)-α monotherapy is the current standard of care for short-term antiviral treatment of hepatitis B e antigen (HBeAg)-negative chronic hepatitis B (CHB). We aimed to assess the safety and efficacy of PEG-IFN-α plus adefovir dipivoxil (ADV) versus PEG-IFN-α monotherapy for compensated HBeAg-negative CHB. Methods: A multicentre randomized controlled trial was performed in eight outpatient hepatology/infectious disease clinics in central Italy. A total of 60 patients (67% male and median age 48 years) with biopsy-proven HBeAg-negative compensated CHB (mean alanine aminotranferase [ALT] levels 3.3 ±3x the upper normal limit and serum hepatitis B virus [HBV] DNA 5.8 ±0.9 log10 IU/ml) were randomized at baseline to receive PEG-IFN-α2a 180 μg/week plus ADV 10 mg/day or PEG-IFN-α2a monotherapy for 48 weeks. Post-treatment follow-up was for 24 additional weeks. The primary end point was sustained HBV DNA suppression defined as serum HBV DNA
Original language | English |
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Pages (from-to) | 1165-1174 |
Number of pages | 10 |
Journal | Antiviral Therapy |
Volume | 14 |
Issue number | 8 |
DOIs | |
Publication status | Published - 2009 |
ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
- Infectious Diseases