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 language | English |
|---|---|
| Pages (from-to) | 805-810 |
| Number of pages | 6 |
| Journal | Journal of Hepatology |
| Volume | 35 |
| Issue number | 6 |
| DOIs | |
| Publication status | Published - 2001 |
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Keywords
- Anti-HBe positive chronic hepatitis B
- Antiviral therapy
- Combination therapy
- Lamivudine-resistant mutants
- Nucleoside analogue
ASJC Scopus subject areas
- Gastroenterology
Cite this
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 journal › Article
}
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 -