To clarify since it got jammed together:
HCV-RNA detectable at > or = 10 IU/ml but < or = 30000 IU/ml at week 12 but UND by week 24: extend therapy to 72 weeks.

I think JmJm mentioned it, but wasn't this study based on fix dose riba, 800mg? With these studies, I'm beginning to believe one can find studies to support any opinion (G)..I to am trying to decided on treatment length (my doc wants to do 54, 36 past clearing). I can't help thinking that 72 weeks was an arbitrary number chosen for study purposes..Why not 71? Now studies should be refining that number (G)..I did find this study posted on your earlier thread, suggesting 32 weeks and 36 weeks past clearing
http://www.journals.uchicago.edu/JID/journal/issues/v189n6/31190/31190.web.pdf
I figure I have 34 weeks to decide to extend further than the suggested 54, so hopefully newer data will come out. One would think these greedy drug companies would be sponsoring extended treatment studies to sell more drugs. I guess, push comes to shove, I probably am leaning to the more is better is better theory. Hopefully you have some time to decide, never know, new data may come out and say 60 weeks, an you can stop earlier (got to be an optimist!)

Berg refers to 3 studies on the benefit of extended treatment, 2 of them with fixed riba dosage (Sanchez-Tapias; Berg), 1 with weightbased riba dosage(Pearlman).

I too have read about the Drusano model of adding 36 weeks from UND, but come to the conclusion that this is a mathematic model rather than a study, and not worth basing my decision upon. My doctors here have so far approved 56 weeks, so I still have to push for 72. I figure better safe than sorry. Sure 72 weeks is a set number, but as we do not have the exact duration necessary, one has to go by something. What Berg states is that to slow responders, 48 weeks for sure is undertreatment.

I have also heard of a study where they tried to individualize duration of treatment even more, depending on when one was UND before 12 weeks. It was not succesful, so they returned to 48 weeks for all who were UND between week 5 and 12. (The idea was that the earlier you got UND before week 12, the fewer weeks you had to go.)

As Proactive suggests, hard to really match up these studies exactly and you have to  read them quite carefully. Pearlman's study includes 48% Afro Americans (very hard to treat group); around a quarter were F3/F4 and 31% bmi of 30 or above. I mean, C'mon this group is not representative of most of us!

http://www.hivandhepatitis.com/2006icr/aasld/docs/110306_f.html


Zazza, do you have a link to the Berg article cited. Thanks.

-- Jim

My understading is that Berg used "<50", not "<10" in his study, as you cite. Perhaps your differentiating from a Berg article versus his own study. Again, a link or more information would be great if you have it. Thanks.

-- Jim

www.hepatitis-bw.de/HepatitisCBergIndividualisierung2006.pdf

This is the link to a pdf-file of the article, but unfortunately the article is in German. I did okay with my highschool German though, understood all of it. Look at the last page where Berg has made a chart of a possible new consensus for treatment duration. (You should be able to understand it even if you don't understand German. Just ask me otherwise.)

And yes, Berg did have 50 IU/ml as the detection limit of his study, but in the article he uses 10 IU/ml and he also explains why one should use as sensitive tests as possible.

I did read about the participants in the Pearlman study, but I figured that if such a difficult-to-treat group also showed a higher rate of SVR (from 18% for 48 weeks to 39% for 72 weeks), this supports the other studies.

I have also read an abstract from a Berg study about low baseline viral load, where the relapse rate for those < 400000 IU/ml (including rapid, early and slow responders) decreases from 15% to 6% by extending treatment to 72 weeks. Know anything about if low baseline viral load is helpful even for slow responders, Jim?

Referring to another Berg study ("Reliable early prediction of viral relapse by detection of minimal residual hepatitis C viremia at treatment week 12") Mark Sulkowski, MD, writes:

"Using a highly sensitive real-time PCR (TaqMan) to reanalyze serum samples of early virologic responders, Berg and colleagues[18] found that residual viremia could be detected in 84 (38%) of 222 patients and that the detection of minimal residual HCV viremia at treatment Week 12 was associated with viral relapse after the end of therapy in 78% of these patients. This suggests that the most sensitive assay available is therefore a valuable prognostic tool for the prediction of individual treatment outcome. The authors suggested that treatment of patients with detectable viremia at Week 12 should be individually intensified by either prolonging treatment duration or preventing dose reductions by the application of erythropoietin or granulocyte-macrophage colony-stimulating factor."

(From "Customizing HCV Therapy With Current Agents: Optimizing Patient Outcomes", Hepatitis Annual Update 2006; reprinted at the Clinical Care Options site)

Here is a good very recent panel discussion on the topic "Chronic Hepatitis C: Strategies for Optimizing Current Treatment and the Potential Impact of Emerging Therapies."  Panel Includes Dr. Schiffman.

http://www.medicalcrossfire.com/online_learning/cme/2006/06-LC-27-M-100.pdf

Thanks for the link. I was able to save the PDF in text format and then translate it using the "Google" translator. Unfortunatly, the article is quite long and gues s would require half dozen or so posts to get it to fit within MH's word count limitation per post. Apparently, I'm unmotivated to spend my afternoon thus :) but anyone who is interested can minimally save the PDF as "text" and then use Google or any one of a number of online tranlators.

Yes, low pre-tx viral load is a positive predictor of SVR. Different studies define "low" differently. Many used 600,000 IU/ml, but some now use 400 or maybe 300,000 IU/ml.

-- Jim