yes, that very small study is chugging along, though I think my Dr.'s might be getting a tad irritaded by my procrastination. Life is good.
you're right about my being overly optimistic about the 60%. However, I also believe the 26% is unduly pessimistic and that the best estimate of Sue's current outlook lies somewhere between those two points. The trouble is the tables don't give a complete breakdown : how many of those 242 patients who had a >2 drop by week 4 were still detectable at 12 ? and how many of the 133 who were detectable at 12 had benefited from a >2 drop by week 4 ? By picking either 26% or 60% you're throwing away part of the available information. I wrote to Reddy to see whether he would release the actual vl counts( probably not, I've tried with Roche before). The best prediction would use all the available information, including actual VL counts rather than binary cuttoffs, but this requires the actual data...it's unfortunate drug companies are so closed to making it available.
I'm glad you wrote to Reddy and I hope you get a complete response.
I, too, was concerned when looking at the percentages, that patients can overlap and 'bounce' in and out of various categories. To come up with 'true' SVR figures, they would need to have a more exacting breakdown that would separate them all the way through the study, as you suggest.
The good news for BostonGirl is that she is tx-naive. The bad news is her extremely high starting VL figure - though the encouraging news there is the very large, continuing VL drop by week #12. As far as the other 'big' factors that go into SVR predictors (liver histology, age, sex, BMI) - only one of these is obvious. Assuming the others are in her favor (no higher than Stage 1 liver damage, age 45 or below, normal BMI), then I would suggest that she monitor her VL every 4 weeks past week #12 to best determine when the point of undetectability is reached, then tack on a minimum of 36 weeks more of tx. If liver histology is an issue, then I would consider going for the full 72 - both for SVR chances and for potential histological improvement via the interferon.
(note on very high VL figures: - I think the Hep C medical/research community is doing a great disservice by lumping anyone above the 2,000,000 mark into a single category of 'high' VL. For example, mine was 2,400,000 going into tx, putting me at the low end of 'high'. Yet someone such as BostonGirl (with a VL of 56,000,000) is catagorized (as far as studies and trials go) the same. This seems rather unreasonable given how well known the inverse relationship is between VL and SVR. I think a more detailed approach of three or more categories would be of benefit to researchers, doctors and patients - giving all a more useful info to work with and therefore a more focused approach to tx).
TnHepGuy
Here's a new study that may be somewhat applicable in your case: <a href="http://www.hivandhepatitis.com/2005icr/ddw2005/docs/hcv_052305_b.html">Correlations Between Rapid Virologic Response (RVR), Early Virologic Response (EVR) AND Sustained Virologic Response (SVR) in HCV Genotype 1 Patients Treated with Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin"</a>. (I say "somewhat applicable" since in this study they used tx-naive patients and in your case you have already done tx on multiple occasions. Even so, I believe that the data here can be useful for your decision making.)
You experienced a >2 log decrease by week 12. The chart in the above study shows that the 23% of patients who received a >2 log decrease by week 12 (but did not become undetectable) had an overall SVR rate of 26% for a 48 week tx time-frame.
Given that you've tried tx before, the fact that you have cryo and the low SVR odds (26%) shown here for 48 weeks on tx-naives, I'd think that a full course of 72 weeks should be considered in your case. You'd (of course) want to get another PCR done no later than week 24, to be sure that your viral load has continued decreasing (hopefully to undetectable). And make sure that your doc will be proactive in keeping your dosages at full amounts via early intervention with Procrit and/or Neupogen, should either of those be needed based upon your bloodwork.
As far as doubling the dosage of the interferon, there have been conflicting reports in the past about it's effecacy, but here is a new study showing positive results: <a href="http://www.hivandhepatitis.com/2005icr/ddw2005/docs/hcv_051805c.html">Double-dose Peginterferon Alfa-2b Plus Weight-based Ribavirin for Retreatment of African-American Non-Responders with Hepatitis C</a>.
Here is another new study you may find of interest: <a href="http://www.hivandhepatitis.com/2005icr/ddw2005/docs/hcv_051605a.html">Sustained Virologic Response (SVR) with Peginterferon Alfa- 2b (PegIntron) Plus Ribavirin Weight-based Dosing in Previous Interferon/ribavirin HCV Treatment Failures: Week 12 Virology as a Predictor of SVR in the EPIC3 Trials</a>
Also, here's a recent study looking at: <a href="http://www.natap.org/2005/HCV/050305_02.htm">Treatment with peg-interferon alfa-2b and ribavirin of hepatitis C virus-associated mixed cryoglobulinemia: a pilot study</a>
May God's blessings and mercy be upon you.
TnHepGuy
it is nice to see you are still checking up on MH, the wealth of information you share is invaluable and irreplaceble. I wish you had time for more visits.
I never actually saw any numbers on reduced odds for people with cryo reaching SVR, but the GI's all seemed convinced of it. This is the link for a study on the safety and efficacy on Rituximab for Cryo:
http://www.bloodjournal.org/cgi/content/full/101/10/3827
Take care, Dave
Did you know that more than 75% of people with HCV test positive for cryoglobulins? I'm one of them, but I don't have cryoglobulenmia, according to both of my GI's. I'm wondering if you're just someone, like me, who has simply tested positive for it.
If you still have the copy of your cryocrit lab results, could you please tell me exactly what it says?
Here's what mine says from my 12/04 test:
Cryo Quantitative Bl 63 (>50 = High)
By the way, when I was first tested for cryo 18 months ago, the result was 83. But like everything else (viral load and enzymes), it has decreased.
Any thoughts?
Susan