Lamivudine and alpha-interferon in combination long term for precore mutant chronic hepatitis B

Isabella Tatulli, Ruggiero Francavilla, Giovanni Luca Rizzo, Vincenzo Vinciguerra, Enzo Ierardi, Annacinzia Amoruso, Carmine Panella, Antonio Francavilla

Research output: Contribution to journalArticle

Abstract

Background/Aims: Alpha-interferon (α-IFN) and lamivudine are the two licensed drugs for patients with chronic hepatitis B, however, their efficacy in precore mutant chronic hepatitis B is limited. The aim of this study was to investigate the efficacy of 1 year α-IFN-lamivudine combination therapy for anti-HBe/hepatitis B virus-(HBV)-DNA positive patients. Methods: Between 1997 and 1999, 29 consecutive anti-HBe/HBV-DNA positive patients entered this prospective pilot study. Patients received 100 mg lamivudine orally daily and α-IFN 6 million units (MU) three times weekly for 52 weeks. All patients were followed-up for 12 months after stopping therapy. Primary end points were loss of serum HBV-DNA and alanine transaminase normalization at week 52. Results: Overall, the end-treatment biochemical and virological response was 93% while the sustained response at week 104 was 14%. HBV-DNA negative patients did not experience a viral breakthrough during treatment; no tyrosine-methionine-aspartate-aspartate amino acid motif of HBV polymerase (YMDD) variant emerged. At week 52, 46% of patients with paired liver biopsies slides available, showed an histological improvement (histological activity index ≥2). Conclusions: Combination of lamivudine and interferon for I year is followed by high end-treatment virological and biochemical response rates, by improvement of liver histology and by the prevention of the emergence of YMDD mutation; however, the sustained response rate remains low.

Original languageEnglish
Pages (from-to)805-810
Number of pages6
JournalJournal of Hepatology
Volume35
Issue number6
DOIs
Publication statusPublished - 2001

Fingerprint

Lamivudine
Chronic Hepatitis B
Interferon-alpha
DNA
Aspartic Acid
Therapeutics
Amino Acid Motifs
Liver
Alanine Transaminase
Hepatitis B virus
Methionine
Interferons
Tyrosine
Histology
Prospective Studies
Biopsy
Mutation
Serum
Pharmaceutical Preparations

Keywords

  • Anti-HBe positive chronic hepatitis B
  • Antiviral therapy
  • Combination therapy
  • Lamivudine-resistant mutants
  • Nucleoside analogue

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Tatulli, I., Francavilla, R., Rizzo, G. L., Vinciguerra, V., Ierardi, E., Amoruso, A., ... Francavilla, A. (2001). Lamivudine and alpha-interferon in combination long term for precore mutant chronic hepatitis B. Journal of Hepatology, 35(6), 805-810. https://doi.org/10.1016/S0168-8278(01)00201-X

Lamivudine and alpha-interferon in combination long term for precore mutant chronic hepatitis B. / Tatulli, Isabella; Francavilla, Ruggiero; Rizzo, Giovanni Luca; Vinciguerra, Vincenzo; Ierardi, Enzo; Amoruso, Annacinzia; Panella, Carmine; Francavilla, Antonio.

In: Journal of Hepatology, Vol. 35, No. 6, 2001, p. 805-810.

Research output: Contribution to journalArticle

Tatulli, I, Francavilla, R, Rizzo, GL, Vinciguerra, V, Ierardi, E, Amoruso, A, Panella, C & Francavilla, A 2001, 'Lamivudine and alpha-interferon in combination long term for precore mutant chronic hepatitis B', Journal of Hepatology, vol. 35, no. 6, pp. 805-810. https://doi.org/10.1016/S0168-8278(01)00201-X
Tatulli, Isabella ; Francavilla, Ruggiero ; Rizzo, Giovanni Luca ; Vinciguerra, Vincenzo ; Ierardi, Enzo ; Amoruso, Annacinzia ; Panella, Carmine ; Francavilla, Antonio. / Lamivudine and alpha-interferon in combination long term for precore mutant chronic hepatitis B. In: Journal of Hepatology. 2001 ; Vol. 35, No. 6. pp. 805-810.
@article{0ab831bd501b402a86b2d8c31d94a95c,
title = "Lamivudine and alpha-interferon in combination long term for precore mutant chronic hepatitis B",
abstract = "Background/Aims: Alpha-interferon (α-IFN) and lamivudine are the two licensed drugs for patients with chronic hepatitis B, however, their efficacy in precore mutant chronic hepatitis B is limited. The aim of this study was to investigate the efficacy of 1 year α-IFN-lamivudine combination therapy for anti-HBe/hepatitis B virus-(HBV)-DNA positive patients. Methods: Between 1997 and 1999, 29 consecutive anti-HBe/HBV-DNA positive patients entered this prospective pilot study. Patients received 100 mg lamivudine orally daily and α-IFN 6 million units (MU) three times weekly for 52 weeks. All patients were followed-up for 12 months after stopping therapy. Primary end points were loss of serum HBV-DNA and alanine transaminase normalization at week 52. Results: Overall, the end-treatment biochemical and virological response was 93{\%} while the sustained response at week 104 was 14{\%}. HBV-DNA negative patients did not experience a viral breakthrough during treatment; no tyrosine-methionine-aspartate-aspartate amino acid motif of HBV polymerase (YMDD) variant emerged. At week 52, 46{\%} of patients with paired liver biopsies slides available, showed an histological improvement (histological activity index ≥2). Conclusions: Combination of lamivudine and interferon for I year is followed by high end-treatment virological and biochemical response rates, by improvement of liver histology and by the prevention of the emergence of YMDD mutation; however, the sustained response rate remains low.",
keywords = "Anti-HBe positive chronic hepatitis B, Antiviral therapy, Combination therapy, Lamivudine-resistant mutants, Nucleoside analogue",
author = "Isabella Tatulli and Ruggiero Francavilla and Rizzo, {Giovanni Luca} and Vincenzo Vinciguerra and Enzo Ierardi and Annacinzia Amoruso and Carmine Panella and Antonio Francavilla",
year = "2001",
doi = "10.1016/S0168-8278(01)00201-X",
language = "English",
volume = "35",
pages = "805--810",
journal = "Journal of Hepatology",
issn = "0168-8278",
publisher = "Elsevier B.V.",
number = "6",

}

TY - JOUR

T1 - Lamivudine and alpha-interferon in combination long term for precore mutant chronic hepatitis B

AU - Tatulli, Isabella

AU - Francavilla, Ruggiero

AU - Rizzo, Giovanni Luca

AU - Vinciguerra, Vincenzo

AU - Ierardi, Enzo

AU - Amoruso, Annacinzia

AU - Panella, Carmine

AU - Francavilla, Antonio

PY - 2001

Y1 - 2001

N2 - Background/Aims: Alpha-interferon (α-IFN) and lamivudine are the two licensed drugs for patients with chronic hepatitis B, however, their efficacy in precore mutant chronic hepatitis B is limited. The aim of this study was to investigate the efficacy of 1 year α-IFN-lamivudine combination therapy for anti-HBe/hepatitis B virus-(HBV)-DNA positive patients. Methods: Between 1997 and 1999, 29 consecutive anti-HBe/HBV-DNA positive patients entered this prospective pilot study. Patients received 100 mg lamivudine orally daily and α-IFN 6 million units (MU) three times weekly for 52 weeks. All patients were followed-up for 12 months after stopping therapy. Primary end points were loss of serum HBV-DNA and alanine transaminase normalization at week 52. Results: Overall, the end-treatment biochemical and virological response was 93% while the sustained response at week 104 was 14%. HBV-DNA negative patients did not experience a viral breakthrough during treatment; no tyrosine-methionine-aspartate-aspartate amino acid motif of HBV polymerase (YMDD) variant emerged. At week 52, 46% of patients with paired liver biopsies slides available, showed an histological improvement (histological activity index ≥2). Conclusions: Combination of lamivudine and interferon for I year is followed by high end-treatment virological and biochemical response rates, by improvement of liver histology and by the prevention of the emergence of YMDD mutation; however, the sustained response rate remains low.

AB - Background/Aims: Alpha-interferon (α-IFN) and lamivudine are the two licensed drugs for patients with chronic hepatitis B, however, their efficacy in precore mutant chronic hepatitis B is limited. The aim of this study was to investigate the efficacy of 1 year α-IFN-lamivudine combination therapy for anti-HBe/hepatitis B virus-(HBV)-DNA positive patients. Methods: Between 1997 and 1999, 29 consecutive anti-HBe/HBV-DNA positive patients entered this prospective pilot study. Patients received 100 mg lamivudine orally daily and α-IFN 6 million units (MU) three times weekly for 52 weeks. All patients were followed-up for 12 months after stopping therapy. Primary end points were loss of serum HBV-DNA and alanine transaminase normalization at week 52. Results: Overall, the end-treatment biochemical and virological response was 93% while the sustained response at week 104 was 14%. HBV-DNA negative patients did not experience a viral breakthrough during treatment; no tyrosine-methionine-aspartate-aspartate amino acid motif of HBV polymerase (YMDD) variant emerged. At week 52, 46% of patients with paired liver biopsies slides available, showed an histological improvement (histological activity index ≥2). Conclusions: Combination of lamivudine and interferon for I year is followed by high end-treatment virological and biochemical response rates, by improvement of liver histology and by the prevention of the emergence of YMDD mutation; however, the sustained response rate remains low.

KW - Anti-HBe positive chronic hepatitis B

KW - Antiviral therapy

KW - Combination therapy

KW - Lamivudine-resistant mutants

KW - Nucleoside analogue

UR - http://www.scopus.com/inward/record.url?scp=0035742578&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0035742578&partnerID=8YFLogxK

U2 - 10.1016/S0168-8278(01)00201-X

DO - 10.1016/S0168-8278(01)00201-X

M3 - Article

C2 - 11738109

AN - SCOPUS:0035742578

VL - 35

SP - 805

EP - 810

JO - Journal of Hepatology

JF - Journal of Hepatology

SN - 0168-8278

IS - 6

ER -