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Next step for relapser to standard IFN/RBV; can non-responders to IFN/RBV respond to Pegylated Interferon plus Ribavirin?
Question for Dr Chung:
My husband initially responded to interferon and ribavarin (he's genotype 1 with insideous fibrosis), (he also took sam-e and milk thistle).
1) is sam-e of any benefit?
There are no clinical data for this that I am aware of, that it helps 6 weeks after finishing treatment his alt level is up and the virus is back.
2) does that make him a relapser?
Yes, assuming his HCV RNA became undetectable at the completion of therapy. he is depleted from 48 weeks of treatment
3) does data show that type 1 relapsers can clear the virus with peglated interferon plus ribavarin?
The data are not back, but we expect that a significant portion will.
answer from Jules Levin--
Preliminary data reported at the DDW conference in May in Atlanta suggest that some some non-responders and relapsers to IFN/RBV will respond nicely to Pegylated Interferon and ribavirin. Since the data is preliminary, as the follow-up is still shortterm, it's hard to predict the response rates. Below is a link to a report of the preliminary data reported at DDW.
Data discussed at DDW reported at week 24 of treatment with PegIntron/RBV about 30% of IFN/RBV previous non-responders had negative PCR and response by patients with genotype 1 occurs but at a lower rate; but there are several caveats. As you know 24 weeks of treatment does not predict outcome, the number of patients analyzed in this dataset were relatively small and doesn't include all the patients in the studies, and I don't think the analysis was what is called intent-to-treat. That is some patients may have withdrawn from treatment and may not have been included as failures as they should have.
In sum, it looks promising that some previous
non-responders to IFN/RBV will respond tp Peg IFN and RBV but it's premature
to say very much about it.
PEG IFN/RBV in Relapsers & Nonresponders
At the June AASLD HCV Conference, preliminary
20 week data was reported on previous non-responders who were now taking Pegasys+RBV.
Although 40% were PCR negative, the data was not brokem down by genotype 1 or
2. To read more details about this report here is a link:
Both The Virus and The Person's Immune System Affect Hepatitis C Clearance and Response To Interferon Therapy
4) is there a relevant statistic on how many type 1 relapsers can clear thevirus with another 48 weeks? there are mixed data on whether sustained responses for extended treatment are better.
answer from Jules Levin--
At this year's EASL conference, data was
reported on 18 month treatment compared to 6 month's treatment. Patients from
hard to treat populations (viral load >3 million; genotype 1 had better response
rates with 18 than 6 months treatment with IFN/RBV. For patients with genotype
1, the response rate for 18 months treatment was 36% vs 23% with 6 months treatment.
as well, the data showed less relapsers with 18 months treatment than 6 months.
However, there are a couple of caveats. Although the data suggests 18 months
treatment may yield better results, this study did not compare it to 12 months
treatment, and the data analysis for genotype 1 was as-treated not intent to
treat. As treated is an less stringent analysis and doesn't include patients
that dropped out of the study. Here is the link to the report of this study:
18 Months of Dual Therapy for Chronic Hepatitis C Decreases Relapse Rate and Suggests New Treatment Approach for Hard to Treat Patients with Cirrhosis, Genotype 1, and High Baseline Viral load
5) how important is it to begin a new round of treatment right away? Is there any alternative?
It depends on the liver biopsy findings, in general if biopsy is more severe yes to starting treatment right away; if biopsy less severe perhaps treatment could be deferred. You should consult with a knowledgeable doctor. RC
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