Weight-based dosing regimen of peg-interferon α-2b for chronic hepatitis delta: a multicenter Romanian trial
| Autor: | Liana, Gheorghe, Speranta, Iacob, Iulia, Simionov, Roxana, Vadan, Ileana, Constantinescu, Florin, Caruntu, Ioan, Sporea, Mircea, Grigorescu |
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| Rok vydání: | 2011 |
| Předmět: |
Adult
Male Chi-Square Distribution Time Factors Hepatitis D Chronic Romania Injections Subcutaneous Body Weight Interferon-alpha Interferon alpha-2 Middle Aged Viral Load Antiviral Agents Recombinant Proteins Polyethylene Glycols Young Adult Treatment Outcome Humans RNA Viral Drug Dosage Calculations Female Prospective Studies Hepatitis Delta Virus Biomarkers |
| Zdroj: | Journal of gastrointestinal and liver diseases : JGLD. 20(4) |
| ISSN: | 1842-1121 |
| Popis: | Antiviral therapy for chronic hepatitis D (delta) is not yet satisfactory, although it appears to be the only means to alter the progressive natural course of chronic hepatitis D virus (HDV) infection.To assess safety and efficacy, evaluated by virological, biochemical and histological end-of-treatment (EOT) and end-of-follow-up (EOF) response to peg-interferon α-2b 1.5 µg/kg body weight weekly in a Romanian cohort of naïve patients with chronic hepatitis delta.49 Caucasian patients (55.1% men, 44.9% females) with a mean age of 37.95 years received study medication; per-protocol population consisted of 36 subjects. Virological EOT response was present in 33.3% and EOF response was maintained in 25% of patients. 50% of study population showed normalization of ALT level at EOT and 25% at EOF. A combined biochemical and virological response was observed in 19.4% of patients at EOT and in 16.7% at EOF. At baseline, the necroinflammation quantified by histological activity index (HAI) score was 9.72 and the mean fibrosis score was 2.03; there was a significant decrease of HAI score to 7.44 (p=0.01) at EOT, but not for fibrosis score (1.33, p=0.37). However, only 8.3% of patients at EOT and 19.4% at EOF had progressive histological disease.Treatment with peg-interferon α-2b succeeded in obtaining a negative HVD RNA in 25% of patients after 104 weeks of follow-up, although combined biochemical and virological response was present in only 16.7%. Necroinflammation decreased significantly in treated patients. Longer treatment periods with pegylated interferon or combination regimen peg interferon-nucleotide analogues should be tested in order to increase efficacy. |
| Databáze: | OpenAIRE |
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