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A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia.

Abstract：

BACKGROUND & AIMS:: At least half of patients with chronic hepatitis C virus (HCV) fail to respond to interferon or interferon/ribavirin therapy. Histological improvement is observed in some nonresponders. We conducted a randomized, controlled trial to determine if maintenance interferon therapy could prevent histological progression in this subset of nonresponders. METHODS:Fifty-three patients with chronic HCV were enrolled. All were HCV-RNA positive after 6 months of treatment with interferon alfa-2b but had a histological response. Twenty-seven of the patients were randomly assigned to continue interferon (3 MU 3 times weekly) for 24 months; 26 patients discontinued treatment and were observed prospectively. Alanine aminotransferase (ALT) level and HCV-RNA titer were monitored, and liver biopsy was repeated every 12 months. RESULTS:Before interferon therapy, the 2 groups were well matched for all demographic factors, serum ALT (94.0 +/- 15.6), log HCV-RNA titer (5. 85 +/- 0.15 copies/mL), histology score (9.5 +/- 0.2), and percentage with cirrhosis (25%). After 6 months of treatment, significant reductions (P < 0.05) in serum ALT level (62.6 +/- 9.6), log HCV-RNA titer (4.79 +/- 0.13 copies/mL), and hepatic inflammation (4.0 +/- 0.2) were observed. These improvements were maintained in the patients randomized to continue interferon. Stopping treatment was associated with an increase in serum ALT, log HCV-RNA, and hepatic inflammation back to baseline. After 30 months of treatment, mean fibrosis score declined from 2.5 to 1.7 and 80% of patients had histological improvement (P < 0.03). Discontinuation of interferon was associated with an increase in mean fibrosis score from 2.2 to 2.4 and worsening of hepatic histology in 30% of patients (P < 0.01). CONCLUSIONS:These data support the hypothesis that maintenance interferon may prevent histological progression of chronic HCV in patients who remain viremic.

journal_name

Gastroenterology

journal_title

Gastroenterology

authors

Shiffman ML,Hofmann CM,Contos MJ,Luketic VA,Sanyal AJ,Sterling RK,Ferreira-Gonzalez A,Mills AS,Garret C

doi

10.1016/s0016-5085(99)70402-6

keywords:

subject

Has Abstract

pub_date

1999-11-01 00:00:00

pages

1164-72

issue

eissn

0016-5085

issn

1528-0012

pii

S0016508599004552

journal_volume

117

pub_type

临床试验,杂志文章,随机对照试验

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A randomized, controlled trial of maintenance interferon therapy for patients with chronic hepatitis C virus and persistent viremia.