Odds for SVR for a 1.a with <5 VL at 12 weeks?

[Kathy73]

Does anyone know what the odds are?

[HectorSF]

justme55-
"So not the 10 % overall that I often read...more like 30-40%?"
Yes. You are correct.

"Curious too if I'm hearing Dr. Terrault correctly that compensated cirrhotics that fail to reach UND at 12 weeks have little chance of reaching SVR?" This data would support my Dr.s recommendation to stop my tx at 12 weeks if not UND.  
You are correct. Did you drop more then 2 log? If no, then you are a null responder. Even for patients without advanced liver disease who are null responders, the chance of SVR during retreatment with SOC meds is least ten 10%. These are the more difficult patients to treat.

PI? Yes, by adding Telaprevir to Peg-Inf and Riba) 58% of null-responders (28/48) had 2 log by week 12. My sense is the percentage would be even lower then 10%. So what is the point if the odds are 95% that the patient won't achieve SRV and be on treatment for 72 weeks seems pointless. Which is why we need new treatment options. Hopefully we will see them starting in 2011. That's what I am waiting for.

Remember most people in the U.S. with HCV who know they have the disease, are not treating at the current time because the odds of SVR are poor. Plus most do not have advanced liver disease, so they can wait for more effective and perhaps shorter forms of treatment in the future. It's unfortunate that the patients whom are hardest to treatment successfully, are also the ones needing the treatment the most.

Hope this helps.
I just had surgery today, so I am spaced ...on meds, but wanted to respond.

HectorSF

[justme53]

That's what I read into it, but I'm just getting my head around this whole idea of 12 weeks as a potential cut off for tx now...in hard to treat cases anyway.

I was told I will extend to 72 weeks if UND at 12 weeks. If not, or without at least a 3 log drop, my tx would be halted. I believe in the Terrault video, they use a > 2 log drop or UND to determine the risk/benefit ratio of continuing tx.

Just trying to understand it all myself so I'm not the best one to decifer it.

[zazza]

"compensated cirrhotics that fail to reach UND at 12 weeks have little chance of reaching SVR"
Is this even if you extend tx to 72 weeks?

[justme53]

"Overall response to SOC treatment for cirrhotics is 10% below other populations of HCV patients."

So not the 10 % overall that I often read...more like 30-40% ?

Curious too if I'm hearing Dr. Terrault correctly that compensated cirrhotics that fail to reach UND at 12 weeks have little chance of reaching SVR? This data would support my Dr.s recomendation to stop my tx at 12 weeks if not UND.  Then what?  PI's?

[HectorSF]

Corrections and clarifications:

Overall response to SOC treatment for cirrhotics is 10% below other populations of HCV patients.

A turning point for compensated cirrhotics is when the patient develops portal hypertension. Having portal hypertension greatly reduces the chances for SVR. If the patient is treated earlier, before portal hypertension appears, they have a better chance of responding.

Also having cirrhosis has a greater impact on SVR then dose reductions of PEG-INF and Riba.


HectorSF

[zazza]

"Why the interest in relapsers vs. other types of responders?"

Because I think once you reach UND you might get fooled by the SVR rates to think that your chance of SVR is lower than it actually is. As you say many are not able to complete tx, many do not reach UND, therefore for someone who has reached UND and who is handling tx okay it is reasonable to look at relapse rates to estimate one's odds instead of looking at SVR rates.

This helped me as a slow responder. The SVR rates for slow responders are pretty low, but if you look at the relapse rates instead your hope gets a boost and it gets easier to stay on tx.

That is what I am hoping to show the cirrhotics. That if one manages to stay on tx after becoming UND, the odds might be better than you think.

Thanks for any help in getting relapse data.

[HectorSF]

I will need to get back to you, as I will have to reach this.
Cirrhotics are usually a subgroup of a treatment group so I would have to separate out the data.

Realize that many will not even to able to complete treatment to relapse. Many will not respond and have undetectable RNA HCV others will have to stop due to adverse affects of other blood levels. (Sorry for the generalities).

Why the interest in relapsers vs. other types of responders?
Relapsers are the group with the best chance of retreating and obtaining SVR. Null responders, like myself have the lowest chance of SVR when retreating.

Anyway zazza, I will try to get you more info when I can. The data may be in the following video.
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For those interested in the latest info on treating cirrhotics and the rates of SVR here is a link to a video which covers antiviral therapies for management of Hepatitis C in patients with both compensated cirrhosis and decompensated cirrhosis in the pre-transplant patient. This talk is given by my doctor Dr. Norah Terrault (Director of HCV at UCSF) in March 2008 to other doctors at U.C.S.F. in San Francisco.
http://www.uctv.tv/search-details.asp?showID=14086
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Cheers!
HectorSF

[zazza]

Do you know the relapse rates for patients with cirrhosis who manage to stay on tx for the full tx period?

[nygirl7]

Kathy,

Dont ask me why I'm so stupid if I read your post and it went into my brain in English I could have told you yesterday 12 weeks <5 is great and you're probably just where the guys above said in the 85% range or so.

I try to read while I'm at work and sometimes I go way too fast but I think those odds are REALLY awesome (personally I didn't clear till somewhere after 12 and before 24 so I got stuck treating for 72 weeks (i had two geno's 1a and 1b) but I beat them both........so if I could do it that late I think you've got every single chance of beating this in the world.

Just hang in there and make sure you take all your meds and I think you got it covered completely.  Keeping a good attitude will help you a LOT - it makes it easier to keep on going.

debby

[Kathy73]

You are too wonderful! Thank you for giving me a big boost today!

[nygirl7]

Kathy,

With a sensitivity down to 5 your chances are EXCELLENT if you are UND at week 5.  


:)

Just make sure now you are 100% compliant and take all the meds right on time and don't give those critters ANY chance to come back in (IF and that is a big IF there are even any still hiding anywhere) and I'd say you got it all handled already.

Good doctor giving you that <5 test.  Seriously you can rest pretty well in that compared to say the old tests of <615 and such.

YAY for you.

[Kathy73]

Heptimax (R) HCV RNA <5 IU/ml (95), Heptimax (R) HCV RNA <0.70 IU/ml (95). Is that the sensitive test?

[HectorSF]

If patient has stage 4, cirrhosis, and achieves RVR (UND by week 4) then they still have about a 90% chance of SVR. RVR trumps all other factors. These factors include: age, sex, race, weight, fatty liver disease, cirrhosis, insulin resistance, coinfection, genotype, HCV RNA level, dose, etc.

In general the number of patients who achieve SVR that stage 4 liver disease depends how advanced the liver disease is. The level of fibrosis. This affects the viral response of the patient. So very few will achieve RVR.
As you know there is compensated and decompensated cirrhosis. The CTP and MELD scores are used to measure the degree of liver disease at the more advance stages of the disease. At a certain point the amount of damage to the liver will prevent treatment. Treatment can cause the liver to fail in a certain percentage of patients. (About 3-10%). But more commonly a patient with cirrhosis will have other issues related to the liver damage that will affect the ability to treat. One such example can be that the patient will not have enough platelets due to splenomegaly to remain on the treatment because Interferon reduces platelet counts even further. This will stop further treatment.

Therefore the actual statistics from large studies of patients indicate that the percent of patients with cirrhosis who achieve SVR using the current SOC meds (PEG-INT & Riba) is only about 10%. Hopefully this will change as new meds are added to the current SOC meds.

Best -
HectorSF

[zazza]

Once I became UND, I couldn't care less about SVR rates. Relapse rates were the only thing that interested me. I tried to find relapse rates for a patient group with as many factors as possible which were the same as mine. Then I subtracted that relapse rate from 100% and got my own personal SVR rate.

[justme53]

Thanks for your input. I love hearing these positive stories, but usually there's a disclaimer at the end, "unless you're a Stage 4". This is encouraging.....

[zazza]

They do say RVR trumps every negative predictive pre treatment condition, don't they? So what is the case then for cEVR one might ask.

Being a cEVR, I still figure the sooner you get to UND after week 4 the better your odds probably are if you do 48 weeks. But if you do 72 weeks you would have undone that by adding extra time even though you are not a slow responder.

Being a stage 4 would in my opinion unfortunately increase the odds that you would be in the 15% that relapse. And isn't that exactly why you are treating more aggressively and longer than the norm? To try to counteract that negative factor.

There are so many factors that play in. The above numbers are for the total intent-to-treat cEVR group. Individual factors influence your own personal chance of SVR. But still the lower the relapse rate for a group of patients, the less risk of relapse it must be for everyone in the group compared with if one had belonged to a group with higher relapse rate instead.

Just my two cents.

[justme53]

Do those numbers apply across the board relative to liver bx? Could they be so good even for Stage 4's if they complete 72 weeks and are totally compliant?

Just curious......

[zazza]

That is how I interpret it as well. Since breakthrough is not that common, the reason for the 70-80% SVR rate for those cEVR must be that people drop out of tx before completing the entire 48 weeks because of adverse side effects or other reasons.

So if you are UND at week 12 and complete tx without breakthrough, then the relapse rate is <15 IU/ml, and thus the SVR rate would be 85%.

[comeagain]

< 15% must mean if no viral breakthrough still UND at EOT you have 85 % of SVR am I right here?

[zazza]

I have a chart here which says 70-80% SVR rate for EVR (UND between week 5 and week 12). It also says <15% relapse rate.

[nygirl7]

What was the sensitivity of the test down to?
That is extremely important to know.  It depeneds if it was to 615 or 50 to give you an honest and accurate answer but off hand if it's a real UND then you are doing very well.  4 weeks would be an RVR and that gives you excellent chances, especially as a geno1.