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.

[Susie2007]

Sorry to hear that news. But, you should be able to respond beautifully to triple therapy with a protease inhibitor since you have been able to reach undetected. So the news is not bad for you!

[Tallahassee]

I believe this strategy was implemented for a few of my past treatments.

I would reach UND on Infergen, after my dose will be reduce to maintenance levels,  but, unfortunately, my viral level also will show up at smaller, suppressed values.

Thank to both of you for all you work!

All the best!

[Susie2007]

He re-starts treatment (on SOC) after a relapse and then drops to maintance as soon as you reach UND?

[jmjm530]

I just re-read your post again. So what you're saying is that his strategy is to first get to UND by SOC and then drop to maintenance before relapse? It's an interesting approach, but then how do you know you wouldn't be SVR if you stopped? Or, does he re-start treatment (on SOC) after a relapse and then drop to maintance as soon as you reach UND?

[jmjm530]

Yes, the thought makes sense -- but considering he just published a study that concluded maintenance didn't work -- with no caveats -- I'm still a little puzzled.
Because if notion that maintenance works (if it keeps you UND)comes out of the Halt-C data, then why isn't there at least a mention of it? One would think it easy enough to extract data on the sub-group who stayed UND with maintenance. Maybe I'm just missing something. In any event, I'm assuming that maintenance is keeping you UND, which seems like a very good thing, just confused a little because of the report.

-- Jim

[Susie2007]

I think you are missing the fact that he believes if maintenance can keep a person undetected it is worth it. The study showwed no benefit to  relapsers because they didn't put them back on treatment to get back to undetected. They went straight from relapse onto maintenance and the 1/2 dose was not enough to take them to undetected although he believes if you can get them to undetected again by retreating, then keep them there with maintenance. Make sense?

[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.
-------------------------------
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;
-------------------------------------------------------------------------------------------------------------
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.
--------------------------------------------------------------------------------------------------

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

[jmjm530]

I started getting nervrous if I didn't have at least 4-weeks worth of Peg shots in the fridge at all times and an xtra bottle of riba. BTW how is your treatment going? What week? What viral response so far? How are the sides? How long are you going?

Be well,

-- Jim

[miked]

Thanks Susie.

[charm27]

thanks alot. I need all the help I can get. :}
much appreciated.

[spcecst2]

One thing I can suggest is wait a couple of weeks after you get your meds to start, that way you will always have a couple left when your refill is due!! Just in case!!

[charm27]

Thank you for answering and explaining all that you did. Im not  a relapser. actually Im starting SOC next week for the first time. Just asking lots of questions and trying to learn whatever I can.
Just trying to understand my options if the tx doesnt work.

Your posts were extremely helpful.
Thanks
I wish you the best

[TravelMom]

Pharmasset Presents R7128 14-Day Monotherapy Study Results for the Treatment of Chronic Hepatitis C


  
  -Nucleoside polymerase inhibitor demonstrates >99% mean decrease in HCV RNA with no serious adverse events-

PRINCETON, N.J., Nov 02, 2007 /PRNewswire-FirstCall via COMTEX News Network/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces the results of a 14-day Phase 1 multiple ascending dose monotherapy study of R7128 for the treatment of chronic hepatitis C infection. In this study, being presented as a "late-breaker" abstract at the 58th Annual Meeting of the American Association for the Study of Liver Diseases, R7128 demonstrated potent antiviral activity and was generally safe and well-tolerated. R7128 is an orally administered prodrug of PSI-6130, a cytidine nucleoside analogue polymerase inhibitor of hepatitis C virus (HCV) that is being developed through Pharmasset's collaboration with Roche.

"R7128 has provided positive proof-of-concept that a single, direct-acting antiviral can deliver sufficient potency to suppress HCV in an interferon non- responder population," stated Dr. Michelle Berrey, Pharmasset's Vice President, Clinical Development & Chief Medical Officer. "Since robust synergy has been observed with other potent inhibitors when combined with the standard of care for HCV, we hope that these monotherapy results will translate well when R7128 is used with standard of care for longer duration in a treatment-naive population."

Dr. Rajender Reddy, Professor of Medicine and Surgery in the Division of Gastroenterology at the University of Pennsylvania and a clinical investigator in the study, noted "R7128's safety profile is encouraging, with no serious or treatment-limiting adverse events reported even at the highest dose tested. In addition, there were actually a higher number of adverse events reported in the placebo group than in the treated arms of this study. Safety is an important aspect of new HCV therapies, because the current standard of care is not always as well tolerated as desired."

The R7128 scientific presentation will be available for download in PDF format following the conference in the "R7128 Presentations & Publications" section of Pharmasset's website at http://www.pharmasset.com/pipeline/R7128-publications.asp.

R7128 Phase 1 Multiple Ascending Dose Study Overview

The Phase 1 clinical trial is a multiple center, observer-blinded, randomized and placebo-controlled study was conducted in 40 patients chronically-infected with HCV genotype 1 who previously failed interferon therapy. The primary objective was to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily (QD) or twice-daily (BID) dosing for 14 days. The secondary objective was to assess antiviral activity by measuring the change in HCV RNA.

R7128 Safety Summary

R7128 was generally safe and well tolerated, and all patients completed the study. There were no serious adverse events, no adverse events requiring dose modification, no dose-related gastrointestinal adverse events and no clinically significant changes in hematologic or other laboratory parameters. The preliminary data on adverse events (AEs) reported shows the highest incidence of AEs was in the placebo group with 34 events in 7 of 8 patients receiving placebo. During treatment in patients receiving R7128, most of the AEs reported were of mild intensity. Eighteen AEs were reported in 7 of 8 subjects that received 750mg QD, 6 AEs in 3 of 8 subjects receiving 1500mg QD, 13 AEs in 4 of 8 subjects receiving 750mg BID and 14 AEs in 4 of 8 subjects receiving 1500mg BID. The most frequently reported AEs for patients receiving R7128 were headache (13), dry mouth (3), nausea (2), fatigue (2), tiredness (2) and upper respiratory infection (2). In subjects on placebo, the most commonly reported AEs were headache (4) and diarrhea (4).

R7128 Antiviral Activity Summary

R7128 demonstrated potent, dose-dependent antiviral activity across the four patient cohorts (8 active, 2 placebo per cohort) receiving 750 mg or 1500 mg administered either QD or BID for 14 days as monotherapy. Both the greatest mean and maximum decrease in HCV RNA from baseline were demonstrated in the patient cohort that received 1500 mg BID. R7128 demonstrated a mean HCV RNA decrease of -0.9 log10 IU/mL (87.4%), -1.5 log10 IU/mL (96.8%), -2.1 log10 IU/mL (99.2%) and -2.7 log10 IU/mL (99.8%) in patients receiving 750mg QD, 1500mg QD, 750mg BID and 1500 mg BID, respectively. All four dose groups reached nadir values at Day 15. A maximum -4.2 log10 IU/mL (99.9%) HCV RNA decrease was demonstrated in a patient following 14 days of monotherapy with 1500 mg BID of R7128, which was also below the level of detection (<15 IU/ml). There was no clinical evidence of viral rebound in any dose cohort during the 14 days of dosing, which provides early evidence of high genetic barrier for nucleoside inhibitors of NS5b polymerase.

Pharmasset is currently enrolling a 4-week Phase 1 clinical trial to evaluate R7128 in combination with Pegasys(R) (pegylated interferon) plus Copegus(R) (ribavirin) in up to 75 treatment-naAve patients chronically infected with hepatitis C virus (HCV) genotype 1. The primary objective is to assess the safety, tolerability and pharmacokinetics of R7128 in combination with Pegasys plus Copegus. The secondary objective is to evaluate the short- term change in HCV RNA. The study will investigate up to three oral dose levels of R7128 (500 mg to 1500 mg) administered twice-daily with Pegasys plus Copegus for 4 weeks. Please see www.clinicaltrials.gov or e-mail ***@**** for more information.

About Pharmasset

Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).

Pharmasset is currently developing three product candidates. Clevudine, for the treatment of chronic HBV infection, is enrolling Phase 3 clinical trials for registration in the Americas and Europe. Clevudine is already approved for HBV in South Korea and marketed by Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128, an orally administered treatment for chronic HCV infection, is enrolling a 4-week Phase 1 clinical trial in combination with Pegasys(R) and Copegus(R) through a strategic collaboration with Roche. Racivir, which is being developed for the treatment of HIV in combination with other approved HIV drugs, has completed a Phase 2 clinical trial.

About R7128

Also, lots of excitment about this drug as well...

R7128 is being developed for the treatment of chronic HCV infection. R7128 is a prodrug of PSI-6130, a pyrimidine nucleoside analog inhibitor of HCV RNA polymerase. A prodrug is a chemically modified form of a molecule designed to enhance the absorption, distribution and metabolic properties of that molecule. Results from an oral single ascending dose study of PSI-6130 in 24 healthy male volunteers showed that PSI-6130 was generally well tolerated with no serious adverse events in doses up to 3000 mg.

[TravelMom]

Heard it is very promising...

Roche's Oral Polymerase Inhibitor Shows Robust Antiviral Efficacy in Treatment of Chronic Hepatitis C


  
  BASEL, Switzerland, November 2 /PRNewswire/ --
- Roche Progresses R1626 Into Phase IIb Study Called POLI 1
R1626, one of Roche's new investigational drugs for hepatitis C (HCV), has shown promising antiviral efficacy when given in combination with PEGASYS(R) (peginterferon alfa-2a (40KD)) and COPEGUS(R) (ribavirin), according to results being presented at the American Association for the Study of the Liver (AASLD) meeting in Boston(1). After 4 weeks of treatment with the triple combination, the hepatitis C virus could no longer be detected in up to 81% of the HCV-infected patients. Patients receiving the triple combination had a mean decrease in viral load of 5.2 log10 from baseline, indicating a robust and rapid virological response.

R1626 belongs to a class of antivirals called polymerase inhibitors, which are being investigated in combination with the current standard of care, pegylated interferon and ribavirin. The hope is that this potent combination will increase the number of patients who manage to clear the hepatitis C virus from their system and become cured of this disease.

Lack of Resistance Demonstrated
R1626 has also demonstrated a high barrier to the development of resistance, according to a second abstract being presented at the conference(2). Resistance to R1626 was not identified following intensive testing for either 2 weeks of treatment with R1626 as monotherapy or for 4 weeks in patients treated with R1626 in combination with the standard of care.

"The results from this phase IIa study show that R1626 has a profound effect when used in combination with PEGASYS plus COPEGUS," said Dr Paul Pockros (Scripps Clinic, San Diego, California), the lead investigator of the study. "The synergistic antiviral effect of R1626 along with the lack of resistance means that R1626 could be an exciting antiviral treatment option for patients with hepatitis C if a safe and acceptable dosage regimen can be determined in future studies."

The study found(1):
- Up to 81% of patients treated with R1626 1500 mg BID + PEGASYS + ribavirin had an undetectable HCV viral load by week 4 (mean reduction of 5.2 log10 IU/ml)
- ALT, a liver enzyme, normalised in approximately 50% of patients in R1626 treatment groups
- Most reported adverse events were mild to moderate. A higher incidence of grade 4 neutropaenia was reported in R1626 treatment arms (ie, 39% of patients receiving the R1626 1500 mg dose in combination with PEGASYS and ribavirin), and it was the main reason for dose reductions and discontinuations

Further phase II studies are underway to investigate R1626 in combination with PEGASYS plus COPEGUS.

Start of the Phase IIb Trial
As a result of the robust antiviral effect seen in the phase IIa study, R1626 is being progressed into a phase IIb study to further investigate new treatment regimens, in combination with a standard or lower dose of PEGASYS(R) plus a standard dose of COPEGUS(R). This phase IIb trial, called POLI 1, is now open and about to enroll patients in eight countries - Austria, Australia, Canada, France, Germany, Italy, Spain and the US. More information about R1626 and these clinical studies can be found on http://www.roche-trials.com.

"The strong synergistic antiviral effect seen among R1626, PEGASYS and COPEGUS in the Phase IIa study together with the design of the phase IIb study makes me confident that we will find the right balance between the safety and efficacy," said Dr. Stefan Zeuzem, Professor of Medicine at J.W. Goethe University Hospital, Frankfurt, Germany, and a lead investigator in this Phase IIb study.

About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, is transmitted primarily through blood or blood products. Hepatitis C chronically infects 180 million people worldwide, with an additional three to four million people newly infected each year(3). It is a leading cause of cirrhosis, liver cancer and liver failure, despite being potentially curable. The future of hepatitis C therapy is likely to involve combinations of new small-molecule antiviral drugs and pegylated interferon-based treatment, like PEGASYS.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's largest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, is a market leader in virology and is active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2006, sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invests approximately 7 billion Swiss francs a year in R&D. Worldwide, the Group employs about 75,000 people. Additional information is available on the Internet at http://www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References:
1. Pockros P. Robust synergistic antiviral effect of R1626 in combination with Peginterferon alfa-2a (40KD), with or without ribavirin - interim analysis results of phase 2a sudy. In: 58th Annual Meeting of the American Association for the Study of Liver Diseases; 2007 November 2-6; Boston, USA; 2007.
2. Le Pogam S. A high barrier to resistance may contribute to the robust antiviral effect demonstrated by R1626 in HCV genotype 1-infected treatment-naive patients. In: 58th Annual Meeting of the American Association for the Study of Liver Diseases; 2007 November 2-6, 2007; Boston, USA; 2007.
3. World Health Organization. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. 2006. (Accessed July 24, 2006, at http://www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html) Contact: Janet Kettels, Roche, [phone]; Natalie Henson, Axon Communications, [phone]  
  
  



  

[copyman]

do you know anything or hear anything about a new drug from pharmasett & roche. not sure of the name. it is in the very early development stage with phase 1 trial starting in the next month or so.  was suppose to have some abstracts about it at the boston meeting? if i remember the name i will post. thanks for the great info.

[Susie2007]

Hang in there. It sounds to me like you might be one of the ones who can benefit from re-treatment with telaprevir. Dr Shiffman repeated numerous times during his part of the discussion that multiple PCRs need to be done because they are needed for the doctor to know if someone is truly a null responder. I do not think you are by his definition which said it is someone who has never achieved a 2 log drop.

[Susie2007]

I'm going to try and answer some of your questions. But please bear with me because I am not a medical professional and I have tons of articles, abstracts, notes, etc and I will do the best I can answering the questions I feel confident about.

First, Travelmom, I can't believe you and Amanda were there and I didn't know about it. Big bummer. Miles, you stinker, I love ya! Copyman, it is me, from Voices, and thank you so much for your kind words. I needed that today. Susan, I know who you are and I do believe that you have even beat Miles and me with the number of treatments you have tried. Charm, a relapser can certainly retreat with higher doses, longer duration and with PI's successfully. It's the null responders who have a problem. I'm guessing that what you were told is that you can only join the next Telaprevir trials if you are a relapser or non-responder. So if you do SOC and can't treat in the next Telaprevir trial it means you would have been successful with SOC.

What I said about maintanence treatment comes from two places. I had a face-to-face talk with Dr. Shiffman in his hospital while he was performing a biopsy on my friend in May. The rest I got from the HALT C trial paper that was published as a late breaking abstract at AASLD and attending an evening session with Emmett Keeffe, Stephen Harrison, David Nelson, Mitchell Shiffman and Norah Terrault, all hepatologists who did a 90 minute discussion on Treatment Challenges in an Era of Advances.

We also attended an hour long discussion with Dr. Zezeum and Dr. Mark Sulkowski and the name of that discussion was Current and New Therapies for HCV. At that discussion and again, at the evening discussion with the doctors mentioned above who did the Treatment Challenges Discussion,  they discussed why the PI's will not work for null responders. Whoever mentioned that there have been no trials with Telaprevir in previous non-responders/relapsers, I believe you are correct. If we understand this correctly, the doctors are making these statements based on the fact that hep C is made up of wild type virus and mutant virus. The wild type is the main and much larger number of virons and the mutant type is the type that if, as Dr Shiffman mentioned, your interferon switch is broken, will not be gotten rid of by interferon. Protease does not affect the mutant type at all. So if you are a non-responder, and it is due to being interferon resistant, or having a "broken switch" any other drug that MUST be paired with interferon will not work.

That is the best I can remember and I double checked with the person who attended with me, and this is what she remembers also.

Miked, I agree that this has to be considered speculative at this point in time. However, my experience with these doctors, who I have been listening to lecture for many years, and in fact one or two of them make themselves available to me as advisors to my organization, has been that they have hit it on the head just about every time. It would be wonderful if they are wrong this time, but what's the chance?

Plus, we all know people who have been previous non-responders, and the ones I know who somehow  got in the trial and got in the arm that got all 3 meds, have  broken through after being originally undetected.That is not to say that some few previous non-responders won't respond because their lack of response to SOC may have been for other reasons than interferon resistance. I certainly hope that is the case with you guys here who are waiting for results.

I don't want to be the bearer of bad news. And, I would give almost anything to be wrong, but I promised on this board, and my own, that I would come back with the best information I could. I just wish it could have been different.

Miked, Miles and I are trying to get some decent information on Alinia.

Oh, something else really exciting to me. Last spring I found out about a study that was going on at Mayo for late stage people to reduce fibrosis...which is just as important as getting rid of the virus. They are using a simple ace inhibitor called Diovan (80mg) and it looks like it is working. I saw an abstract out of UMass (Dr. Ray Chung) who published results from a study they did with an ace inhibitor (didn't say which one) and with paired biopsies and insulin resistant people vs regular hep people, they got good reduction in fibrosis scores with no side effects in both sets of people. So it looks like there will be help for future non-responders to cut down on the amount of fibrosis.

[charm27]

thanks for your comment. Good luck to you in finishing up 24 weeks!
Ive been in a liitle state of confusion re the resistant issue.
just trying to understand it all.

best of luck to you!!

[miked]

I had a viral breakthrough on my first treatment of PegIntron + Ribivirin.  Just finished 24 weeks on Prove 3.