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 |
|---|---|
| Pages (from-to) | 1165-1174 |
| Number of pages | 10 |
| Journal | Antiviral Therapy |
| Volume | 14 |
| Issue number | 8 |
| DOIs | |
| Publication status | Published - 2009 |
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ASJC Scopus subject areas
- Pharmacology
- Pharmacology (medical)
- Infectious Diseases
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A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B. / Piccolo, Paola; Lenci, Ilaria; Demelia, Luigi; Bandiera, Franco; Piras, Maria R.; Antonucci, Giorgio; Nosotti, Lorenzo; Mari, Terenzio; De Santis, Adriano; Ponti, Maria L.; Sorbello, Orazio; Iacomi, Fabio; Angelico, Mario.
In: Antiviral Therapy, Vol. 14, No. 8, 2009, p. 1165-1174.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B
AU - Piccolo, Paola
AU - Lenci, Ilaria
AU - Demelia, Luigi
AU - Bandiera, Franco
AU - Piras, Maria R.
AU - Antonucci, Giorgio
AU - Nosotti, Lorenzo
AU - Mari, Terenzio
AU - De Santis, Adriano
AU - Ponti, Maria L.
AU - Sorbello, Orazio
AU - Iacomi, Fabio
AU - Angelico, Mario
PY - 2009
Y1 - 2009
N2 - 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
AB - 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
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U2 - 10.3851/IMP1466
DO - 10.3851/IMP1466
M3 - Article
VL - 14
SP - 1165
EP - 1174
JO - Antiviral Therapy
JF - Antiviral Therapy
SN - 1359-6535
IS - 8
ER -