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Randomised study comparing 48 and 96 weeks peginterferon α-2a therapy in genotype D HBeAg-negative chronic hepatitis B.
- Source :
-
Gut [Gut] 2013 Feb; Vol. 62 (2), pp. 290-8. Date of Electronic Publication: 2012 Aug 02. - Publication Year :
- 2013
-
Abstract
- Objective: Treatment with peginterferon α-2a (PegIFN) for 48 weeks is the standard of care for selected HBeAg-negative patients chronically infected with hepatitis B virus (HBV), but with limited treatment efficacy. A study was undertaken to investigate whether treatment extension to 96 weeks improves the outcome in this patient population.<br />Methods: 128 HBeAg-negative patients (120 genotype D) were randomised to weekly 180 μg PegIFN for 48 weeks (group A, n=51), 180 μg PegIFN for 48 weeks followed by 135 μg weekly for an additional 48 weeks (group B, n=52) or 180 μg PegIFN plus lamivudine (100 mg/day) for 48 weeks then 135 μg PegIFN for 48 weeks (group C, n=25). Endpoints were alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (primary), HBV DNA <2000 IU/ml and HBsAg clearance at 48 weeks after treatment.<br />Results: Forty-eight weeks after treatment, six patients in group A and 13 in group B achieved alanine aminotransferase normalisation plus HBV DNA <3400 IU/ml (11.8% vs 25.0%, p=0.08), 6 vs 15 patients had HBV DNA <2000 IU/ml (11.8% vs 28.8%, p=0.03), 0 vs 3 achieved HBsAg clearance (0% vs 5.8%, p=0.24) and 0 vs 5 had HBsAg <10 IU/ml (0% vs 9.6%, p=0.06). While extended PegIFN treatment was the strongest independent predictor of response, the combination with lamivudine did not improve responses. Discontinuation rates were similar among the groups (19.6%, 23.1%, 32.0%, p=0.81) and were mostly due to PegIFN-related adverse events.<br />Conclusions: In HBeAg-negative genotype D patients with chronic hepatitis B, PegIFN treatment for 96 weeks was well tolerated and the post-treatment virological response improved significantly compared with 48 weeks of treatment.<br />Trial Registration Number: http://ClinicalTrials.gov registration number: NCT01095835.
- Subjects :
- Adult
Alanine Transaminase blood
Anti-HIV Agents adverse effects
Anti-HIV Agents therapeutic use
Antiviral Agents adverse effects
DNA, Viral blood
Drug Therapy, Combination
Female
Hepatitis B virus immunology
Hepatitis B, Chronic blood
Hepatitis B, Chronic genetics
Humans
Interferon-alpha adverse effects
Lamivudine adverse effects
Lamivudine therapeutic use
Male
Middle Aged
Polyethylene Glycols adverse effects
Recombinant Proteins adverse effects
Recombinant Proteins therapeutic use
Time Factors
Treatment Outcome
Antiviral Agents therapeutic use
Hepatitis B e Antigens blood
Hepatitis B virus genetics
Hepatitis B, Chronic drug therapy
Interferon-alpha therapeutic use
Polyethylene Glycols therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1468-3288
- Volume :
- 62
- Issue :
- 2
- Database :
- MEDLINE
- Journal :
- Gut
- Publication Type :
- Academic Journal
- Accession number :
- 22859496
- Full Text :
- https://doi.org/10.1136/gutjnl-2011-301430