icon-folder.gif   Conference Reports for NATAP  
  DDW Liver Conference
San Francisco, May 19-22, 2002
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Pegylated Interferon (PegIntron) and Ribavirin for Hep C Patients who were Previous Nonresponders
Reported by Jules Levin
  This is the second study reported in an oral presentation on treating previous nonresponders or relapsers to previous therapy with PegIntron and ribavirin. The first study reported here by Ira Jacobson was reported by me yesterday. Eric Lawitz (Alamo Study Group; Brooke Army Medical Center, San Antonio, Tx.) reported these study results.
There have been only preliminary study results on treating nonresponders and relapsers to standard interferon plus ribavirin with Pegylated Interferon and ribavirin. The utility of treating nonresponders and relapsers with peg+RBV has not been well characterized yet. This study and the Jacobson study are showing only preliminary data so far. We should wait for final study results.
This study compared to effectiveness of induction PegIntron and ribavirin to a fixed dose of PegIntron/RBV in previous combination nonresponders and relapsers and IFN monotherapy nonresponders.
The induction regimen: patients received PegIntron 1.5 mcg/kg weekly + ribavirin 1000/1200 mg day for 12 weeks followed by PegIntron 1.0 mcg/kg + 800 mg RBV. The fixed dose regimen was PegIntron 1.0 mcg/kg weekly + RBV 800 mg/day.
680 patients enrolled at 46 sites in this randomized open-label study. There were 473 standard combination nonresponders, 108 monotherapy nonresponders, and 99 standard combination relapsers. 447 have completed 48 weeks. Average age was 46 in both groups; 68% male; 17% African-American; 85% genotype 1; 44% fibrosis stage 3/4.
In the combination nonresponders: after 24 weeks of therapy 32% (n=241) in the induction group and 25% (n=232) in the fixed dose group had HCV viral load clearance. At the end of 48 weeks of treatment, 25% (n=166) in the induction group cleared HCV-RNA and 15% (n=140) cleared HCV in the fixed dose group. Following 24 weeks of follow-up after therapy ends, when we see the SVR (sustained viral response) you expect a lower response rate.
Interim 24 week results were reported on patients who had a partial response during their previous therapy with standard combination therapy (partial response defined as a log or greater reduction in viral load on previous therapy). As expected these patients appear to respond better: after 24 weeks of therapy 46% (n=129) were PCR negative.
Also as expected, nonresponders to prior IFN monotherapy did better: 44% (fixed & induction regimens) cleared HCV after 24 weeks, and 30% (n=44) in the fixed dose regimen & 34% (n=38) in the induction regimen cleared HCV.
Also as expected, relapsers to combination therapy responded the best: after 24 weeks of therapy about 70% in both groups cleared HCV (n=100), and 58% (n=33) in the fixed and 55% (n=29) in the induction regimen cleared HCV.
29% of genotype 1 patients who were combination nonresponders (n=205) & received the induction dose cleared HCV at week 24 compared to 21% (n=197) who received the fixed dose. About 65% of the relapsers with genotype 1 cleared HCV at week 24. About 36% of the genotype 1 nonresponders to IFN monotherapy & cleared HCV at week 24.
Dose reductions to RBV & IFN were about the same in fixed & induction groups: 6% (RBV), 7% (IFN). Discontinuations were also about the same in both groups: 22%.
The authors concluded that neither genotype 1 or advanced liver disease precluded response to therapy.