A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B

Paola Piccolo; Ilaria Lenci; Luigi Demelia; Franco Bandiera; Maria R. Piras; Giorgio Antonucci; Lorenzo Nosotti; Terenzio Mari; Adriano De Santis; Maria L. Ponti; Orazio Sorbello; Fabio Iacomi; Mario Angelico

doi:10.3851/IMP1466

A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B

Paola Piccolo, Ilaria Lenci, Luigi Demelia, Franco Bandiera, Maria R. Piras, Giorgio Antonucci, Lorenzo Nosotti, Terenzio Mari, Adriano De Santis, Maria L. Ponti, Orazio Sorbello, Fabio Iacomi, Mario Angelico

Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani

Research output: Contribution to journal › Article › peer-review

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	https://doi.org/10.3851/IMP1466
Publication status	Published - 2009

ASJC Scopus subject areas

Pharmacology
Pharmacology (medical)
Infectious Diseases

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Piccolo, P., Lenci, I., Demelia, L., Bandiera, F., Piras, M. R., Antonucci, G., Nosotti, L., Mari, T., De Santis, A., Ponti, M. L., Sorbello, O., Iacomi, F., & Angelico, M. (2009). A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B. Antiviral Therapy, 14(8), 1165-1174. https://doi.org/10.3851/IMP1466

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 › peer-review

Piccolo, P, Lenci, I, Demelia, L, Bandiera, F, Piras, MR, Antonucci, G, Nosotti, L, Mari, T, De Santis, A, Ponti, ML, Sorbello, O, Iacomi, F & Angelico, M 2009, 'A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B', Antiviral Therapy, vol. 14, no. 8, pp. 1165-1174. https://doi.org/10.3851/IMP1466

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. / A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B. In: Antiviral Therapy. 2009 ; Vol. 14, No. 8. pp. 1165-1174.

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title = "A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B",

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",

author = "Paola Piccolo and Ilaria Lenci and Luigi Demelia and Franco Bandiera and Piras, {Maria R.} and Giorgio Antonucci and Lorenzo Nosotti and Terenzio Mari and {De Santis}, Adriano and Ponti, {Maria L.} and Orazio Sorbello and Fabio Iacomi and Mario Angelico",

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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

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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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A randomized controlled trial of pegylated interferon-α2a plus adefovir dipivoxil for hepatitis B e antigen-negative chronic hepatitis B

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