Long‐term titrated recombinant interferon‐α2a in chronic hepatitis C: a randomized controlled trial

Abstract

The efficacy and tolerability of 12-month treatment with titrated doses of recombinant interferon-alpha 2a (IFN-alpha 2a) in chronic hepatitis C were studied in 67 consecutively recruited patients randomly assigned either to a starting dose of IFN-alpha 2a 6 MU, subsequently adjusted to the serum alanine aminotransferase (ALT) response (n = 35), or to no therapy (n = 32; controls). End-of-treatment ALT levels were normal and hepatitis C virus (HCV) RNA was negative by nested polymerase chain reaction (PCR) in 17 (49%) treated patients compared to none of the controls (P < 0.001). During the 12 months after stopping treatment the number of patients who remained in remission was eight (23%) and one respectively (4%) (P = 0.031). Follow-up liver biopsy showed reduced hepatic inflammation in 80% of treated patients and in 29% of controls (P < 0.001). The eight sustained responders and 27 non-responders or relapsers received similar mean total doses of IFN (565 MU vs 545 MU) and had a similar incidence of anti-IFN neutralizing antibodys (13% vs 19%). Absence of cirrhosis was the only independent pretreatment parameter that predicted a sustained response. In conclusion, a mean cumulative dose of IFN 549 MU, titrated over 12 months, was well tolerated, and resulted in the long-term clearance of HCV RNA and normal ALT levels in 23% of patients.

Meta‐analysis of interferon randomized trials in the treatment of viral hepatitis C in naive patients: 1999 Update

“…In addition to the previous meta‐analysis performed, nine new RCTs, which had been published as full papers and fulfilled the criteria of inclusion, were identified. Therefore the core group of the meta‐analysis of IFN vs. control [7–32] now include 26 RCTs. Clinical characteristics are described in Table 1.…”

Sustained suppression of hepatitis C virus by high doses of interferon and ribavirin in adult hemophilic patients

“…HCV was typed by a hybridization assay (Inno‐Lipa II, Innogenetics, Zwijndrecht, Belgium). Se‐rum HCV‐RNA was assessed by nested RT‐PCR, using specific primers from the 5′ noncoding region with a sensitivity limit of 50 IU per mL 12 …”

Sustained suppression of hepatitis C virus by interferon and ribavirin in hemophilic patients not responding to interferon monotherapy

“…Serum HCV-RNA was assessed by nested RT-PCR, using specific primers from the 5Ј noncoding region with a limit sensitivity of 50 copies/mL. 16 Continuous variables were expressed as mean or median values and ranges. Categorical variables were expressed as frequency and percent values and compared by the Fisher exact test.…”