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Medical Forum / Diseases and Disorders / Hepatitis / February 2007

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FYI - Early Predictor

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Suds - 28 Feb 2007 08:23 GMT
Early identification of HCV genotype 1 patients responding to 24 weeks
peginterferon alpha-2a (40 kd)/ribavirin therapy.
 a.. Jensen DM,
 b.. Morgan TR,
 c.. Marcellin P,
 d.. Pockros PJ,
 e.. Reddy KR,
 f.. Hadziyannis SJ,
 g.. Ferenci P,
 h.. Ackrill AM,
 i.. Willems B.
Center for Liver Diseasees, University of Chicago Hospitals, 60637, USA.
djensen@medicine.bsd.uchicago.edu

Approximately one third of hepatitis C virus (HCV) genotype 1 patients
achieved a sustained virological response (SVR) after 24 weeks of treatment
with peginterferon alpha-2a (40 kd) plus ribavirin in a randomized,
multinational trial. We aimed to identify factors associated with a rapid
virological response (RVR) at week 4 (HCV RNA <50 IU/mL) and a SVR (HCV RNA
<50 IU/mL at the end of follow-up) in these patients. Stepwise multiple
logistic regression analysis was used to explore the prognostic factors for
a RVR and SVR in genotype 1 patients treated for 24 weeks. Fifty-one of 216
(24%) genotype 1 patients in the 24-week treatment groups had a RVR. SVR
rates were considerably higher in patients with than without [corrected] a
RVR (89% vs. 19%, respectively). Patients with a baseline HCV RNA of less
than 200,000 IU/mL (OR 9.7, 95% CI 4.2-22.5; P < .0001) or 200,000-600,000
IU/mL (OR 5.6, 95% CI 1.5-9.1; P = .0057) were more likely to achieve a RVR
than those with HCV RNA greater than 600,000 IU/mL. HCV subtype (1b vs. 1a)
was also independently associated with RVR (OR 1.8, 95% CI 0.9-3.7; P =
.0954). RVR (OR 23.7 vs. no RVR, 95% CI 9.1-61.7) and baseline HCV RNA less
than 200,000 IU/mL (OR 2.7 vs. > 600,000 IU/mL, 95% CI 1.1-6.3; P < .026)
were significant and independent predictors of SVR in patients treated for
24 weeks. In conclusion, patients infected with HCV genotype 1 and treated
with peginterferon alpha-2a/ribavirin sustained a RVR 24% of the time. This
portends an 89% probability of a SVR after 24 weeks of treatment.

PMID: 16628671 [PubMed - indexed for MEDLINE]
elmoemerson@webtv.net - 28 Feb 2007 14:32 GMT
I'd like to have seen a control group of people who also had an RVR that
were given 48 weeks of tx instead of 24.  I'll bet that 89% who got SVR
in 24 weeks would have been much closer to 100%, had they gone the full
48 weeks.  The 11% in the study who did not get an SVR after 24 weeks of
tx is still a significant number of folk, and in my opinion, justifies a
48 week course of tx....RVR or not.
elmo  

http://community.webtv.net/elmoemerson/DocElmosHepFile

http://community.webtv.net/elmoemerson/TheFamilyAlbum
greyhackles - 28 Feb 2007 17:16 GMT
>I'd like to have seen a control group of people who also had an RVR that
>were given 48 weeks of tx instead of 24.  I'll bet that 89% who got SVR
[quoted text clipped - 3 lines]
>48 week course of tx....RVR or not.
>elmo  

Hi elmo!

I think what you're looking for is already out there and fairly well
established via retrospective analysis: tx-naive g1 super-responders
(undetectable - using the more sensitive assays - at the end of four weeks on
Peg + Riba) that do the full 48 weeks go on to achieve SVR.

Given that the gold standard for g1s has been 48 weeks for so long - certainly
since the advent of Pegylated interferons - there's not much data available to
retrospectively "see" what would have happened to the same studied cohort had
they gone only 24 weeks. So, over the last two years there have been a few
studies (at least) that are trying to work the number of weeks on tx down, for
good reasons (cost, obviously, along with reducing the wear and tear on the
patient).

So I take these studies as a good thing. Like you I feel it's hard to leave 1
in 10 heppers behind just to shorten therapy (in for a penny, in for a pound,
is how I'd roll). Ideally, these studies will find a way to identify which
super-responder patients can safely cut their tx short at 24 weeks without
fear of relapse, and which ones should continue the full Monty...

Cheers

/greyhackles
 
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