Good News/Bad News from AASLD

[Susie2007]

I've just returned from AASLD and was able to learn some good things and bad things. The good news is that both the Schering protease and Telaprevir are doing rather well with treatment naive and relapsers. The bad news is that patients who have treated before and are null responders (didn't have a 2 log drop by 12 weeks) will not respond to the protease inhibitors. A number of the hepatologists talked about this, among them Drs. Sulkowski, Shiffman, Terrault and Zezeum....all very well respected. If a patient had enough viral load checks, complied with treatment and didn't miss injections or ribavirin, had no dose reductions, and didn't have at least a 2 log drop by week 12, they are now considered interferon resistant. The combination of SOC and protease will not be enough to overcome that resistance. They feel that these patients will need combinations of protease and polymerase and that these are about 10 years out. I, for one, as a non-responder, is really bummed about this.

The other lousy news is from the HALT C trial regarding maintenance therapy. Unless a person can keep their viral load undetected (in other words, they relapse without interferon) it does not work. If  the doctor can get them to undetected again and play with the dose of Peg to keep them at that level, it probably will work. HALT C showed no improvement in fibrosis scores, HCC, ascites, from maintenance in virus detected people. The only benefit was a reduction in the incidence of varices.

This was not a happy year for me at AASLD.

[jmjm530]

Thanks. #6 from Shiffman (and what he told you) from seems to contradict the findings in his own study that state "These findings do not support maintenance therapy with peginterferon in patients with chronic hepatitis C and advanced hepatic fibrosis who are nonresponders". Am I missing something?

-- Jim

[Susie2007]

JIm, All I have so far is the abstract entitled "Prolonged Antiviral Therapy With Peginterferon to Prevent Complications of Advanced Liver Disease Associated With Hepatitis C: Results of the Hepatitis C Antiviral Long-term Treatment against Cirrhosis (HALT-C) Trial ". It just says that "These findings do not support maintenance therapy with peginterferon in patients with chronic hepatitis C and advanced hepatic fibrosis who are nonresponders". The only other thing I have is a slide from Dr Shiffman's Discussion entitled: Failure to Achieve SVR: Summary: It states the following:
1. Make sure the histology warrants retreatment
2. Document the virologic response pattern. This may require retreatment with frequent HCV RNA monitoring
3. Do not interrupt Dosing
4. Partial responders need more interferon
5. Late responders need a longer duration of treatment
6. Maintenance therapy remains unproven but is logical only in those patients with cirrhosis, prior relapse and can be maintained HCV RNA undetectable.

He did tell me privately that if maintenance was easy for me, and I could keep my viral load under 100,000 to go for it.

There is no abstract at this time because this is just his opinion and the opinion of others because of the disappointing results on the HALT C trial.

[Susie2007]

Happy Deb, I told you all I know about Diovan. I would guess that it does not interfere with treatment but is good for slowing progression of fibrosis. It is also used in pulmonary fibrosis.As a person who had a 2.5 log drop at 12 weeks, I would think you have a decent chance of clearing in the future.

Willy, the abstracts you posted are for treatment naive patients. But to answer your question, please remember that not all null responders are interferon resistant. My info is on interferon resistant people only. I don't know if interferon resistant people who had a RVR would then relapse or fail to achieve SVR. All I know from the conference is that interferon resistant people can not achieve SVR with telaprevir, inf and riba.

Jim, I will look for that abstract for you and post it if I can find it.

[jmjm530]

Susie: The other lousy news is from the HALT C trial regarding maintenance therapy. Unless a person can keep their viral load undetected (in other words, they relapse without interferon) it does not work. If  the doctor can get them to undetected again and play with the dose of Peg to keep them at that level, it probably will work. HALT C showed no improvement in fibrosis scores, HCC, ascites, from maintenance in virus detected people. The only benefit was a reduction in the incidence of varices.
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I've been trying to find the study/presentation that talks about viral load being undetected. In other words, the above suggests that mainteance is a viable option if it keeps viral load UND. Couldn't find the abstract anyway, thought you might be able to help. Thanks.

-- Jim

[HappyDeb]

Hi, you meantioned in one of these threads, about Diovan ( 80 ml) . I have been on this for 6 yrs. for my high blood pressure. I am a slow responder. I had to go off of tx. after 12 weeks, due in part of a rash and only a 2.5 log drop. I am 1A , stated out at 6.8 million VL. biopsy 1-2-1 Minimal liver damage. My question to you is, could it be because of taking the Diovan, it at least has helped me keep my liver some what healthy ? I have an Appt. in Jan. at the university of Miami with Dr. Schiff. Hoping I can get results with him as to treating me. My previous Dr. was not up to date on things. Great, Interesting thread.


                                                        Warmest Wishes,

                                                         Debbie

[Willy50]

I'm not directing this to you as a challenge; I know you are just the one trying to report what you heard.  I'm just trying to clarify the issues.  Like yourself I'm just a layman at this trying to understand.

Here is an excerpt from a news story.  Pay attention to the final sentance;
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http://www.hivandhepatitis.com/2007icr/aasld/docs/110607_a.html
Boston, Nov 02, 2007 (Business Wire) -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced results from interim analyses of PROVE 1 and PROVE 2, two large Phase 2b clinical trials evaluating the investigational hepatitis C protease inhibitor telaprevir (VX-950), dosed in combination with pegylated interferon and ribavirin. In 24-week telaprevir-based treatment regimens, genotype 1 treatment-naive HCV patients achieved sustained viral response rates of 61% and 65% in PROVE 1 (SVR 12 and SVR 24) and PROVE 2 (SVR 12), respectively. In addition, clinical researchers reported a correlation between achieving rapid viral response (RVR) and achieving SVR in a 24-week telaprevir-based regimen.
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Am I understanding that the top researchers are saying that resistance to interferons (in prior non-responders) will in effect "trump" a very early RVR?

One of the members here, Andiamo has failed treatment 6 times and is in his 60's.  He would seem to be an example of a person not likely to clear or stay clear.  Andiamo cleared in his first week of triple dosing.  Due to the strong response and RVR it would seem that he might be on track to expect at least a greater chance of an SVR..  Am I to understand that the common thought now is that interferon resistant virii will make that unlikely in spite of the super response time?

Also....since the other PI in trials that reported results on prior treatment failures (Boceprevir) did not really post much info at the AASLD I wonder if this could be too early to make predictions about outcomes?  Even if I had the info I might be hard pressed to draw a strong conclusion.  It seems that all that we've seen so far is VERY preliminary results on PI response in prior non-responders, both in the SGP and Vertex trials.  I hope that the news is better than is being reported.  It still would be safe to reiterate that this is mainly a theoretical response rather than one borne from response data from either trial?  It is also a little frustrating trying to compare the 2 compounds but I rather expect that we'll have to get used to that.

I'm envious that you were able to go to the AASLD.  Maybe that would be a future fun road trip for us heppers to make.  (it almost sounds tax-deductable)  : )

best,
Willy