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The group with a two log drop at week 12 had cure rates of 29% and 33% depending on whether they treated for 48 or 72 weeks. This is the same group that Berg identified as benefitting the most from the extended treatment. His earlier findings are not confirmed by this study. It seems like the overwhelming predictor of SVR is the time it takes to clear the virus. Extending treatment doesn't make that much difference in most treatment categories.
All of this becomes moot at the new PIs advance toward approval. But it is important to those who are now in the course of treatment, who did not get a RVR, and are considering extending treatment.
Of the 25 patients who achieved undetectable HCV RNA between 8 and 12 weeks, 7 (28%) relapsed, yielding an overall NPV of 72% (60% for the 48-week regimen, 80% for the 72-week regimen).
I think either way you slice it if you extend to 72 it gives you a 20% boost in your odds that you will succeed? I am glad I did it and I wasn't even UND until somewhere between 12 - 24 let alone 8. But using 8 as a critical guideline instead of 12-24 seems to me like it would really help the odds. Only a lot of people are going to get stuck in the extending group and not going to want to do it........it's not a very easy thing to do or agree to do and right now it's those of us that are pretty desperate being not UND at week 12.
One question, it doesn't answer for me, personally, is how cirrhotics figure into this. Usually there's a disclaimer, "except in the case of cirrhosis".
I agree, for those that can afford, time-wise to wait for the PI's, this probably has no bearing, but for those like me that don't have the wiggle room, I find 81-82% odds for a cEVR encouraging. Just not sure if 1% is worth the extra 6 months of tx, but I've got a ways to go before committing and perhaps more studies will be out by then.
"Detectable HCV RNA at week 12: 29% and 33%, respectively. "
This is the traditional group for extending treatment. Yes, there is a 4% difference in cure rates, but that is probably not statistically significant. So this study actually argues against extending treatment for most people with a slow response rate.
I think one of the key points here is dorng more PCR's earlier, and also using those sensitive tests. There are far too many people still being tested with a test to 615. Even tests to 50 are irrelevant except for before treating (to me). I think as far as the general treating public goes, we are going to have a hard time increasing the number of PCRs. I would advocate for the 4 week, and the 8 week is nice if you can afford it.
note to justme -- as I recall the the Berg study found that the highest benefit in doing 72 was achieved with those who had a VL uner 6000 at week 12 -- not just a 2 long drop.
frijole
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