Teleprevir?

[springfever]

Just got biopsy results and Dr. advised treatment.  I've been lurking in the forum for a few months now.  Really, really glad this is available.  
I've been offered a spot in study with teleprevir.  I saw something in another post about a triple threat (talking about teleprevir, I think).  So I'm looking for info and anyone with experience with this drug.  
You all know the head spin I am in right now.    

[Marcia2202]

Congratulations on being offered a spot in the Telaprevir Study.

I don't know anything about it, but I just wanted to wish you a hearty welcome on our forum.


Marcia

[Fl_Gator]

I am in my second week of treatment in a telaprevir study. I don't have any great results to share with you at this time but I will tell you that when I found out I had HCV I hit the internet and read all there was. I read so many good things about this new drug that I waited for a study space to open and was fortunate enough to get in. My GI told me that I had time to wait till the drug hits the market but I wanted to get rid of this virus ASAP.

I look at it like this...SOC gives you a 50% chance of success in 48-72 months, enrolling in the study gives you at least that but the bonus is that if you receive the study drug your chances for success increase about 20% and you may be able to come off the drugs after 24 weeks.

Good luck to you...Stay tuned here. There are so many people ready help and you will read a lot of success stories to boost your confidence.

[mremeet]

Welcome and congrats on getting into a telaprevir trial. Telaprevir trial slots are pretty coveted nowadays, although there certainly are downsides to being in a drug trial too. I treated with teleprevir in 2006-2007 and am now cured. It was a really tough road, lots of very bad side effects. But in the end it was worth it, I feel great now and no longer have to worry about HCV ruining my life. I would suggest you spend every last minute educating yourself about IFN/riba treatment and make sure you read your consent form carefully well prior to your first day on the drugs. Know what you're getting into, know the side effect profile of all the drugs and be aware of the odds of getting a placebo and factor that into your decision to participate (or not). Above all, ask questions - ask your trial center and ask them here. Don't be shy, it's your body and your life, don't go into the trial with blind faith or trust. Be your own advocate, and keep track of what's going on with your healthcare.

In the meantime, best of luck whatever you decide.

[springfever]

Thanks for your responses.  I'm bleary eyed from research and feeling a little pressured to join the telaprevir study before it closes.  

Looks like I'm stage 3, grade 2.  But, feel like the report I got is incomplete compared to some of yours.  Dr. said he doesn't really believe I am stage 3.

I'm geno 1a; HCV 842,000 IU., in good health, exercise, live a healthier lifestyle now.  Dr. said natural progression is approx. one stage every five years from this point.  I may wait to treat..or I may not... or I might..or...****.

[orleans]

I feel ya. Exact process I went thru, along with many more. It is a tough decision. I had a chance to get into the Vertex trial, was going to go for it but changed my mind and have decided to try Alinia instead. I am 1a also. It was the sx that concerned me most along with not wanting to end up in the control. I could have gotten into the Aliia triall also but am going to do it myself. My Dr "off labeled" me. good luck, jerry

[orleans]

HEY, I'm in Atlanta too.

[Marcia2202]

I decided to treat now, after weighing out the pros and the cons, but this presentation of Prof. Douglas Dieterich, MD had quite some weight on my decision. It is a very interesting presentation with a good video explaining replication etc. of HCV. Maybe this video can shine some light upon the matter. At the least it is very informative.


http://www.mssmtv.org/player_alf/player.php?id=alf_2007_01


Good luck,

Marcia

[Magnum]

What will your treatment consist of? Is this your first attempt?

Magnum

[springfever]

To Fl_Gator:  Good luck with your treatment.  I'll be watching and pulling for you!

To Mremeet:  Congratulations..wow!  How long did you treat?  and did the bad sx's last the whole time??  Were you able to continue working?  Nosy nelly here.

To Orleans in Atlanta2:  Maybe it's the spot you gave up that I was offered :)  Now I have Alinia to research, thanks.  What made you lean in that direction?  And what does "off labeled" mean?  I'm intrigued by the do it yourself statement.  Good to have control. hmmm.

To Marcia:  Thanks for the video.  I've spent about 2 hours going all over it.  Very very helpful.  Honestly, the more statistics I learn, the more my SVR chances are going down.  Think I might be skewed.  But I'd rather know it going in.  I want to be informed.

Thanks for all your help.

[meNtoby]

I'd give my eye teeth to be in a teleprevir study, but haven't found any for geno 2's yet :-( because we're already considered to be easy to treat. The only study I've found that I'd be qualified for is in Bethesda MD and it's for another low dose Pegint/Ribavirin study that wouldn't be bad at all, except I'm smack dab in the middle of the country.

There are so many decisions to make when it comes to HCV!  I might end up saving money by moving to where the study is.  Have you checked out the cost of treating?  That is one reason that I would jump on a study, but that's just me and my dwindling savings.  Good luck to you!

Cathy

[FullOfHope77]

I completed Prove III Phase 2 48 weeks where 24 weeks also had the Telaprevir. I've been clear since 2nd or 3rd week and that was a little over a year ago and been out of tx for 7 weeks. Andiammo had the same tx regime, treated 8 times, and is clear at 12 weeks. I've tx'ed 3 times total and am hoping that i will stay clear for the long term and SVR... hope that helps.

Scott

[mremeet]

"To Mremeet:  Congratulations..wow!  How long did you treat?  and did the bad sx's last the whole time??  Were you able to continue working?  Nosy nelly here."

I was originally scheduled to take telaprevir + SOC (i.e. IFN/riba) for 12 weeks, and then continue on for another 36 weeks of SOC alone. I ended up only taking telaprevir for about 7 weeks, had to stop taking it because of a very bad rash it caused. Managed to hang on and keep going with SOC (at reduced riba dose) for a total of 41 weeks. Didn't make it to the full 48, but as it turns out I didn't need to. The side effects were the absolute worst when I was taking the telaprevir. The first few weeks were tolerable, but later a bad rash developed caused by an allergic reaction to the telaprevir. About 1 in 3 get a rash or some type of skin issue from taking telaprevir, although for most is isn't so bad they have to stop. But about 1 in 10 get a "super rash" that at the very least causes them to stop taking the telaprevir and in many cases gets so bad they will discontinue all drugs. The only reason I didn't drop out is because I'm a stubborn SOB and I was in for a dime in for a dollar. There was another woman I got to know in my trial (Prove 1) that also got the same bad rash I got. We both went through hell, but odds are you wont experience anything that bad.

As far as work, yes I continued working. Although I had to take off copious amounts of time during my rash fiasco, which went on a long time. I used a lot of sick time, but that's ok - that's what it's for. I earned it over years and years and almost never took any, so I had a lot saved up. But again, just because I used a lot of sick time that doesn't mean you'll have to. There are some tough cookies here who make it all the way through treatment, lose their hair, become anemic, experience inner rage, itch like a b*tch and march into work every day and do their duty. Some don't miss a single day of work. So it varies, odds are you'll be able to continue at work, although you may have to take off at least a few days.

Lastly, if you have stage 3 fibrosis, that's knocking on the door of cirrhosis. Getting into the telaprevir trial could be a real blessing. In my opinion, I'd strongly consider it - and this is coming from someone who got the worst side effects from the drug. I went UND in 2 weeks, which never ever would have happened with SOC alone. I also SVR-ed in only 41 weeks of treatment with reduced riba dose (remembering SOC SVR odds are about 40-50% with 48 weeks of treatment). So although I only took telaprevir for 7 weeks, that was enough to put me on the fast track to SVR. It's powerful stuff and will cure many people when it becomes widely available.

[springfever]

wow..these are strong endorsements and powerful stories.  I'm getting the picture now why people want telaprevir.  My doctor told me people were knockin on his door for this.

Thanks for sharing.  Real experiences from people who really know are priceless.  Congratulations to you both.  And to you too Andiammo.

[springfever]

I am checking on insurance.  Doesn't look bad at all, if Dr. will approve generic riba.     Thought about waiting couple of years for Telaprevir to be approved, but realize then, it will be very expensive and no generic available.  

Hope you find what you need without having to move.  Adjusting to a new place on top of treatment is just not fair for you.

[theeagle]

I am geno 1-A and treated through a clinical trial at Mayo in '96.......first time they added the riba and the intrfrn dose was 5 million units every other day for one year.....it was a long year with beacoup sx and such - at least I have PCR undectable since then....

Go for the clinical trials after you do your homework....my first Gastro dude didnt want to make the effort to get me in the trial. Therapy then was 3 mill units intrfrn alone - 13% success rate......my trial came in at 48% SVR and I was in the lucky group...all they have done since is learn more about it - now they even coat the intrfrn with a glycol for time release and weekly shots. Since viral loads and fibrotic states are not linear or good quality estimate of actual liver damage I would say treat ASAP - fellow hcv'r

[orleans]

Hey, Off label is when a Dr prescribes a med for something that that drug has not been approved for. It is fairly common as many meds designed, tested and approved for one condition are discovered to be helpful for another. Procrit is a good example. It has been approved for animea during some cancer chemos but is often used in other situations(HCV treatment for one). There were several reasons I leaned towards Alinia. 1- The sx. Around 17% of people getting Telapervir were dropping out of treatment and many of those staying in did it by the skin of thier teeth. I have the underlying issue of chronic migraines to deal with also. (those seem to have been resolved recently with beta-blockers, Glory be, and fingers crossed) I just couldn't face the possibility of the added sx. 2- There was ALOT of hype about TLV as the P2 trials were taking place. Expectations were VERY high but the results were more sobering with a SVR rate of around 61%(much better than the 40 or 50% rate with SOC but there was much talk of 85% or better for g1s!)  3- In a trial there is the "control arm" that has to be considered. There will be a 25% to 30% chance that I would be treated with a placebo.(Along with SOC, not all placebos) 4- The phase 2 folks were not allowed the use of rescue drugs and had to depend on dose reductions to control animea etc. 5- The trials were blinded so one would have NO idea if they were responding or not, didn't know if on a placebo. This was very difficult on those guys. (I, along with many others followed this drama, with bated breath, on this forum. Our hearts went out to these brave souls in thier distress. I thanked them then, and I thank them now for the service they did for us all.) The Alinia trials that took place in Egypt were much "quieter". The results were released at the same conference as the Telepriver results. The SVR rate was a surprising 79%! My understanding was that everyone was a little shocked. The relapse rate was an unheard of  0%. The additional sx (over and above those experienced in the control) were virtually non-existant. Alinia was not a new drug and had some history. BUT, before one dances a jig---The trail was with g4s, the most common geno in Egypt. Now, G4s are supposed to be somewhere between 2/3 and 1s in difficulty to treat.(Although the control in this study SRVed at only 43%) I will tell you, when this study was released I was SET to do the vertex trial. WHAT a struggle!!! I was thinking "I DON"T NEED THIS!!" What really pushed me over the edge towards Alinia were the headaches. Two of the most miserable things to experience is an uncontrolable ITCH (I have been bad to get poison ivy through out my life) and NAUSEA(riba). ADD a migraine with a little depression and I feared for my life. (The ability to use rescue drugs played a big part also, a little control goes a long way with me.) DO NOT take this post the wrong way, I am in NOOO WAYYY trying to lean you one way or the other. I have serious doubts about my own choice!! What I really want is INF/RIBA/ALINIA/TLV!!!! A 4 way attack!!!! I have all of my treatment drugs and will start pre-dosing the Alina Sun. morn, 7/6 after the Tom Waits concert at the FOX (B seats!!!) that Sat. This post will be followed by the summaries of the Alinia and Vertex trials. jerry ps I am headed downtown, will park at Underground for $3 and ride my bike down Peachtree to Mid- town and back tonite. Kinda of a Sat. nite ritual! I want to be in as good a shape as possible for this battle.  

[orleans]

Combination Therapy with HCV Protease Inhibitor Telaprevir (VX-950) plus Pegylated Interferon and Ribavirin Produces Sustained Response in 61% of Genotype 1 Patients

By Liz Highleyman

Telaprevir (VX-950), an investigational hepatitis C virus (HCV) protease inhibitor developed by Vertex Pharmaceuticals and Tibotec, produced a high rate of sustained virological response (SVR) when combined with pegylated interferon and ribavirin in hard-to-treat genotype 1 patients, according to interim study data presented at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2007) in Boston.

An international team of researchers conducted 2 Phase IIb clinical trials in which 573 previously untreated patients with genotype 1 HCV (250 in the U.S. and 323 in Europe) were randomly assigned to receive 750 mg telaprevir every 8 hours plus 180 mcg/week pegylated interferon alfa-2a (Pegasys), with or without 1000-1200 mg/day weight-based ribavirin, for 12, 24, or 48 weeks, or else standard therapy with pegylated interferon plus ribavirin for 48 weeks.

In the U.S. trial (PROVE 1), 61% of participants receiving triple-combination therapy with telaprevir for 24 weeks achieved SVR, or undetectable HCV RNA 24 weeks after the completion of treatment; the SVR rate is not yet available for the double-combination arm since that group was treated for 48 weeks. In the European trial (PROVE 2), 65% receiving the triple combination had undetectable HCV viral load 12 weeks after completing treatment (follow-up is ongoing). Extending treatment with telaprevir to 48 weeks did not improve response rates. SVR rates were significantly lower among patients receiving telaprevir without ribavirin.

These cure rates are among the highest seen to date. Treatment with pegylated interferon plus ribavirin alone produces a sustained response in only about half of HCV monoinfected genotype 1 patients, and even fewer HIV-HCV coinfected individuals (PROVE 1 and PROVE 2 did not include coinfected patients).

However, the rate of premature treatment discontinuation was significantly higher in the telaprevir arm compared with the double-combination arm (10%-13% vs 2%, respectively). Gastrointestinal side effects, skin rash, and anemia all were more common among patients receiving telaprevir. In practice, increased side effects may be balanced by the fact that treatment with telaprevir is half as long as treatment with pegylated interferon plus ribavirin alone.

The PROVE 2 researchers also reported that during the first 12 weeks on treatment, 4% of patients taking telaprevir/pegylated interferon/ribavirin and 25% taking telaprevir/pegylated interferon without ribavirin experienced viral breakthrough, which was associated with previously identified telaprevir-resistant HCV variants (mainly V36M, R155K, A156T, and T54A). The higher breakthrough rate in the group not receiving ribavirin suggests that "suboptimal inhibition of viral replication provides a greater probability for selection of tipranavir-resistant variants," the investigators concluded.

Below is an edited excerpt of a press release from Vertex with further details about the study design, patient population, and findings:

First Studies Demonstrating Greater than 60% Sustained Viral Response Rates with Half the Standard Treatment Duration in Genotype 1 Chronic Hepatitis C Patients (Vertex press release)

Two Large Phase 2 Trials of Telaprevir, an Investigational Hepatitis C Protease Inhibitor, Dosed in Combination with Pegylated Interferon and Ribavirin Show SVR Rates of 61% and 65%. Initial Rapid Viral Decline Appears Important to Achieve SVR. Safety Profile Consistent with Prior Interim Analyses

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.

[Editor's Note: SVR 12 refers to continued undetectable HCV RNA 12 weeks after completion of therapy.]

Interim analyses of telaprevir safety from PROVE 1 and PROVE 2 appear consistent with prior analyses, with the most common adverse events, regardless of treatment assignment, being fatigue, rash, headache and nausea. Gastrointestinal disorders, skin adverse events (rash, pruritus), and anemia were higher in the telaprevir arms compared to the control arm over the dosing period. Data from PROVE 1 and PROVE 2 being presented at the 58th Annual Meeting of the American Association of the Study of Liver Diseases (AASLD) in Boston November 2-6, 2007 represent interim analyses. Vertex is developing telaprevir, an investigational hepatitis C protease inhibitor, in collaboration with Tibotec.

"The SVR data from the PROVE studies are promising as the expectation today is that approximately 40% to 50% of people with genotype 1 hepatitis C who undergo 48-week treatment regimens with currently available therapies achieve sustained viral response. In this Phase 2 study, we saw 24-week telaprevir-based regimens result in SVR of greater than 60% in patients with genotype 1 hepatitis C," said John McHutchison, MD, Principal Investigator for the PROVE 1 study and Director of Gastroenterology and Hepatology Research at Duke Clinical Research Institute. "If these efficacy results are confirmed in larger studies, and there are no new safety or tolerability concerns, this 24-week regimen could be an important medical advance."

[orleans]

Sustained Viral Response in PROVE Studies:



Treatment Arm (Study) ITT SVR Rate
24-week treatment arm (PROVE 1), n=79 61%
24-week treatment arm (PROVE 2), n=81 65% (a)
12-week treatment arm with ribavirin (PROVE 1), n=17  35%
12-week treatment arm with ribavirin (PROVE 2), n=82  59%
ITT= Intention-to-treat; missing=failure

(a) SVR12: undetectable HCV RNA < 10 IU/mL at 12 weeks post-treatment and is an interim measurement. Other data represent SVR 24, defined as undetectable HCV RNA < 10 IU/mL at 24 weeks post-treatment. Across all the treatment arms above, there were no relapses between 12 and 24 weeks follow-up, i.e. there was 100% concordance between SVR 12 and SVR 24.

In addition, the SVR rate in the 12-week arm without ribavirin (n=78) in PROVE 2 was 29%.

In the 48-week telaprevir treatment arm (12+36; n=79) of PROVE 1, 65% had undetectable HCV RNA (<10 IU/mL) at end of treatment.

Sustained viral response results from the control arms of PROVE 1 and PROVE 2 are not available. At the time of the interim analysis, in the PROVE 1 control arm (n=75), 45% of patients receiving 48-weeks of pegylated interferon (peg-IFN) and ribavirin (RBV) had undetectable HCV RNA (<10 IU/mL) at end of treatment. At the time of the interim analysis, in the control arm of PROVE 2 (n=82), 59% of patients receiving 48 weeks of peg-IFN and RBV had undetectable HCV RNA (<10 IU/mL) at week 36 on-treatment. Typically, following the completion of 48 weeks of treatment with peg-IFN+RBV, a certain proportion of patients with undetectable HCV RNA relapse.

SVR rates given for the telaprevir arms include patients who completed dosing in their study arm as well as patients who discontinued treatment prior to completion of dosing, but who met the criteria for SVR 24 (defined as undetectable HCV RNA <10 IU/mL 24 weeks after completing treatment).

SVR results for the telaprevir 12+36-week treatment arm in PROVE 1 and the control arms for PROVE 1 and PROVE 2, including viral relapse observed post-treatment, will be presented at a future medical meeting. A detailed overview of the PROVE 1 and PROVE 2 clinical trial designs can be found in a Vertex press release dated May 23, 2006.

Rapid Viral Response (RVR)

In PROVE 1 and PROVE 2 combined, on an ITT basis, 77% of patients receiving telaprevir in combination with peg-IFN and RBV achieved a rapid viral response at 4 weeks (79% in PROVE 1, 75% in PROVE 2), defined as undetectable HCV RNA <10 IU/mL as measured by the Roche TaqMan assay, compared to an average of 12% of patients across the control arms of PROVE 1 and PROVE 2 (11% in PROVE 1, 13% in PROVE 2; p<0.001 for the comparison in each study).

For those patients that achieved RVR, completed 24 weeks of telaprevir-based therapy, and had data available for SVR analysis, 91% achieved an SVR 24 or SVR 12. This finding demonstrates a correlation between RVR and SVR in a 24-week telaprevir-based treatment regimen.

Viral Breakthrough

In PROVE 1 and PROVE 2 combined, 5% of patients receiving telaprevir in combination with peg-IFN and RBV experienced viral breakthrough in the first 12 weeks of treatment (7% in PROVE 1, 2% in PROVE 2). Most viral breakthroughs occurred in the first month of treatment, and were generally associated with low interferon blood levels. After patients had undetectable HCV RNA (<10 IU/mL), less than 2% of patients receiving telaprevir in combination with peg-IFN and RBV experienced viral breakthrough on treatment.

Viral Relapse

In PROVE 1 and PROVE 2 combined, the relapse rate for patients who completed 24 weeks of treatment was 9% (2% in PROVE 1, 14% in PROVE 2). In PROVE 1 and PROVE 2 combined, for those patients that achieved an RVR and completed 24 weeks of therapy, 7% experienced viral relapse in the post-treatment period (2% in PROVE 1, 11% in PROVE 2). Per protocol in PROVE 1, only patients who achieved an RVR were to stop treatment at 24 weeks of therapy; no such criteria were utilized in PROVE 2. Following completion of treatment, no patient in PROVE 1 that received telaprevir in combination with peg-IFN and RBV relapsed after week 12 of the 24-week post-treatment period.

PROVE 1 and PROVE 2 Safety

The types of adverse events that have been commonly observed with Peg-IFN and RBV were seen across all treatment arms of PROVE 1 and PROVE 2. The most common adverse events, regardless of treatment assignment, were fatigue, rash, headache, and nausea. Gastrointestinal disorders, skin adverse events (rash, pruritus), and anemia were higher in the telaprevir arms compared to the control arm over the dosing period.

In PROVE 1, the overall discontinuation rate through 12 weeks was 18% across all telaprevir treatment arms and 3% in the control arm. This includes discontinuations due to adverse events, withdrawal of consent and patients lost to follow-up. The incidence of treatment discontinuations through week 12 due to adverse events was 13% and 2% in the telaprevir and control arms, respectively. The most common reason for discontinuation was rash, with 7% of patients discontinued for this reason in the telaprevir arms during the first 12 weeks of treatment. After week 12, discontinuations due to adverse events were 8% each in the telaprevir and control arms. Over the full course of the treatment period, the incidence of severe adverse events was 27% in the telaprevir arms and 24% in the control arm.

In PROVE 2, the overall discontinuation rate through 12 weeks was 14% across all telaprevir treatment arms and 6% in the control arm. This includes discontinuations due to adverse events, withdrawal of consent and patients lost to follow-up. The incidence of treatment discontinuations through week 12 due to adverse events were 10% and 3% in the telaprevir and control arms, respectively. As with PROVE 1, the most common reason for discontinuation was rash, with 7% of patients discontinued due to rash in the telaprevir arms, compared to less than one percent in the control arm during the first 12 weeks of treatment. Through to week 12, the time of the interim safety analysis being reported, the incidence of severe adverse events was 17% in the telaprevir arms and 10% in the control arm.

[orleans]

by Andiamo1


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Andiamo1
Male, 68 years
FL
Member since Jun 2007
Mood: Andiamo1 is feeling more relaxed
  



, Nov 02, 2007 09:19AM
Romark Laboratories, a privately-owned biotechnology company, today announced results of a randomized phase II clinical trial showing that 79% of interferon-naïve patients with chronic hepatitis C genotype 4 receiving nitazoxanide plus the standard of care had a sustained virologic response (SVR), or undetectable level of virus, 12 weeks following treatment, compared to 43% of patients receiving the standard of care without nitazoxanide. The patients treated with nitazoxanide also experienced no relapse and no more side effects than patients who received the standard of care. Interim results from this Phase II clinical trial will be presented on Tuesday November 6 in an oral presentation at the 58th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) in Boston.

"Patients treated with nitazoxanide responded earlier and maintained their responses without relapse after receiving only 36 weeks of treatment with peginterferon and ribavirin," said Dr. Emmet B. Keeffe, Chief of Hepatology at Stanford University School of Medicine. "These data suggest the emergence of a new therapeutic approach for treating hepatitis C. While more study is needed to confirm these results in a broader population of patients, nitazoxanide appears to increase the potency of interferon without increasing toxicity or inducing resistance."

Study Details
This Phase II randomized, controlled trial was conducted at two centers in Egypt and is part of the company's STEALTH C (Studies to Evaluate Alinia for Treatment of Hepatitis C) clinical development program, which is designed to evaluate the safety and efficacy of nitazoxanide tablets in combination with peginterferon or peginterferon and ribavirin (standard of care) in patients with chronic hepatitis C.

In the trial, 96 treatment-naive patients with chronic hepatitis C genotype 4 were randomized into three groups to receive either 48 weeks of standard of care treatment (n=40), 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus peginterferon (a dual regimen, n=28), or 12 weeks of nitazoxanide followed by 36 weeks of nitazoxanide plus standard of care treatment (a triple regimen, n=28). An additional 24 interferon-experienced patients were randomized to receive 12 weeks of nitazoxanide followed by either the dual regimen (n=12) or the triple regimen (n=12) for 36 weeks. Patients received 180 microgram injections of pegylated interferon (Pegasys®) once per week; nitazoxanide was administered as one 500 mg tablet twice daily; and ribavirin was administered as 1,000 or 1,200 mg daily according to weight.

Results
At 12 weeks following the end of treatment, naïve patients who received a triple regimen that included standard of care and nitazoxanide showed a significantly higher SVR (HCV RNA < 10 IU/mL, Abbott m2000) than the group receiving the standard of care regimen (79% vs. 43%, respectively) (p=0.006). The data also suggest a potential for eliminating or reducing the role of ribavirin in treating hepatitis C. Patients treated with a dual regimen of nitazoxanide and peginterferon showed an SVR at week 12 following the end of treatment that was not inferior to standard of care (68% vs. 43%, respectively) (+25%; 95% CI: -1%, +47%). Of 24 treatment-experienced patients, the triple regimen (n=12) resulted in an SVR of 25% at week 12 post- treatment, and the dual regimen group (n=12) had an SVR of 8%.

"Results from this trial validate a new approach to treating HCV that focuses on the interaction between the virus and the cell," said Jean-François Rossignol, M.D., Director of the Romark Institute for Medical Research. "With confirmation provided by this data we are aggressively pursuing development of nitazoxanide and related drugs to treat chronic hepatitis C and other viral diseases."

Nitazoxanide is the first of a new class of small molecule drugs called thiazolides that inhibit replication of a broad range of viruses. The drug was discovered by Dr. Rossignol and was initially developed by Romark and approved for marketing in the United States as the first treatment of cryptosporidiosis. Serendipitously, the development of nitazoxanide for treating cryptosporidiosis led to the discovery of its antiviral properties and ultimately to the discovery of a promising new class of antiviral drugs.

Romark is currently conducting a U.S. Phase II trial with nitazoxanide plus standard of care in patients with hepatitis C genotype 1 who were previously treated with interferon. The Company also plans to initiate a Phase II trial in treatment naïve patients early in 2008.

[springfever]

thanks for the info.  With every new post from forum vets, more light is shed in this darkness.

orleans..I printed the trial info you posted and will scour it today.  I think I see now what they are testing and I think the % of getting in the group I would want also went down.  sometimes me thinks too much.
Good luck with your therapy.  I'm back at the gym, pumpin up myself, for whenever.  Waits should be awesome!  Nice to be able to see some of these old rockers and bluesers in smaller settings.  

thanks and thanks