PEG-Intron plus ribavirin in non-responders and relapsers
The pegylated interferons have proven superior to standard interferons as monotherapy for chronic hepatitis C and, more recently, in combination with ribavirin (RBV) in treatment-naïve patients.
The goal of the present study is to compare the efficacy of two dose regimens of PEG-Intron plus ribavirin in patients with prior non-response to interferon (IFN) monotherapy or combination therapy, or with relapse after combination therapy.
Patients in the three categories are randomised in this ongoing trial to receive (1) PEG-Intron 1.0 mcg/kg plus RBV 1000-1200 mg/d (Group 1), or (2) PEG-Intron 1.5 mcg/kg plus ribavirin 800 mg/d (Group 2). Prior therapy must have been stopped at least three months prior to entry. Treatment is planned for 48 weeks, with cessation of therapy if PCR for HCV RNA (Roche Amplicor) remains positive at 24 weeks.
Of 330 patients enrolled to date, 131 have completed 48 weeks of therapy with 24 weeks post-treatment follow-up. Of these, the results of follow-up week 24 treatment PCR by intent-to-treat analysis are shown in the Table below.
Overall SR is 21% across all three patient categories. Patients with normal ALT respond as well as those with elevated ALT at onset of therapy. Among the 330 patients in the entire study who have reached 24 wk of therapy, PCR at 24 wk is negative in 19% of group 1 and 32% in group 2.
- Early results indicate that prior treatment failures, even prior non-responders to combination therapy with HCV genotype 1, may respond to PEG-Intron plus RBV. However, sustained response (SR) rates in the genotype 1 non-responders are low thus far, ie 10-12%.
- Combination therapy relapsers and interferon monotherapy non-responders have higher rates of SR than combination therapy non-responders.
- No definitive conclusions can be reached until a larger number of patients have been studied and data on SR become available for the entire cohort.
Quantitative PCR <1000 copies/ml at follow-up week 24:
|Gp 1 (n=70)||Gp 2 (n=61)||Total (n=131)|
|Comb NR genotype 1||5/48 (10%)||4/33 (12%)||9/81 (11%)|
|Comb NR genotype non-1||1/5 (20%)||0/5 (0%)||1/10 (10%)|
|Comb relapsers||3/7 (43%)||9/15 (60%)||12/22 (55%)|
|Interferon NR||4/10 (40%)||2/8 (25%)||6/18 (33%)|
I Jacobson et al. Pegylated interferon alfa-2B plus ribavirin in patients with chronic hepatitis C: a trial in prior nonresponders to interferon monotherapy or combination therapy and in combination therapy relapsers. Abstract 782 (poster). 53rd AASLD. November 1-5, 2002. Boston, MA. Hepatology 2002: Vol 36 No 4, Pt 2 of 2.
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