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Interesting Indiana University New Research Study

http://medicine.iupui.edu/ctp/trials/HepC.htm

Hepatitis C

Hepatitis C is a virus that attacks the liver
Purpose: This study will evaluate patients with Hepatitis C and normal liver chemistries.  To compare 48 weeks of Peg-Intron 1.5 mcg/kg sc each week, plus Rebetol 13 +  2 mg po daily to no interferon therapy (Vitamin E/Milk thistle) in genotype 1 patients with mild liver disease:  Fibrosis scale of 0-2. Compare the quality of life during treatment of the two treatment groups.  Reference normal ALT levels in multicenter trial.  80% will receive Peg-Intron, Rebetol, Milk Thistle and Vitamin E.  the other 20% will receive Milk Thistle and Vitamin E.  Investigator: Paul Kwo, M.D. To qualify you must:

    * Be 18 years of age or older
    * No ALT > the institutional upper limit of normal within 6 months of registration  (A minimum of 2 measurements within normal limits over the last 6 months)
    * Positive for hepatitis C
    * Liver biopsy within 3 years prior to entry with report stating fibrosis scale from F0 - F2.
    * Not have a history of seizures, poorly controlled diabetes, serious pulmonary disease, uncontrolled hypertension.
    * If history of substance abuse, must have abstained from using substance (drugs or alcohol) for at least 6 months

Length/Duration: Treatment duration will be determined upon viral level at week 12 of treatment.  Treatment may last from    12 - 48 weeks with 24 weeks of follow up.  Location: Indiana University Hospital                                          Medical Diagnostic Clinic, 2nd Floor Outpatient Clinic
550 N. University Blvd                                  Indianapolis, IN 46202 Benefits: Possible clearance of the virus and increased quality of life.  Compensation:

    * Milk Thistle and Vitamin E will be provided free for all patients
    * If patient's insurance does not cover Peg-Intron and Rebetol the medications will be provided by the sponsor
    * Patients that receive the Vitamin E and Milk Thistle only after completing treatment and follow-up will be given the option to be treated and receive Peg-Intron and Rebetol free of charge.
    * Free parking

Risks:

Will be disclosed prior to enrollment in the study
Whom to contact:

Name: Patricia Anderson, RN
Phone:(317) 278-2586
Email: ***@****
17 Responses
Avatar universal
Thank you for taking the time to post the study.  Hope someone here can benefit.
Avatar universal
I sympathize with people who are trying to get drugs without insurance.  When you shoot the standard Peg-intron dose of 150 mcg you dissolve a tablet containing 222 mcg then discard the excess, 72 mcg.  Three people could shoot up with two vials.  I've never seen this discussed but there should be a way for them to find each other.  How about right here?  Also, there are compounding pharmacies with good reputations selling generic ribavirin.  I understnd there's one in Pittsburgh called Fisher's selling 200 mg caps for $1.75.
Avatar universal
i was fortunate my interferon cost me nothing.   i waited for Roche Pegasys to come out and as a drug promotion i was given the first 3 months for free from my drs. office.  then later down the road the nurse told me they had more medicine then they needed  and that i could get the whole time period for free.   i was very grateful for that as even with my insurance paying 80%  it still would have been a sizable sum to pay out  of pocket for the meds.   i used to take a little styrofoam mini ice chest with blue ice to the drs. office where they would transfer the interferon vials from their fridge to my ice chest.
   pegasys is nice, no mixing - just draw up the vials.  sure used to dread those shots.  at the same time i looked forward to getting each one over with..... one less to go....
Avatar universal
Schering paid for all my meds.  No insurance.  My MD arranged everything.  I answered about 10 questions and that was that.  Of course I was in a study for ESLD-the benefits of treating verus not treating.  Since I cl by 3wks and would be dead if I hadn't tx, I'm glad I was given the chance to tx.  B/months before, I started an extreme herbal regime, Chinese and Western, in addition to overhauling my complete diet.

Boy, I would have been p.o.ed if I had not received the real deal.  What a mind trip to go thru all the hassle and anxiety for nothing!

Maybe this study will finally answer the questions about milk thistle and vit E.  B/hippies have been using herbs for years.  It seems to help b/not cure (SVR).  I, myself, take large amts of both and have for the last 26mo.  I added milk thistle and SAM-e and switched to 1000mg tablets of vit c, potasium, calcium w/zinc and ginsing.  Also switched to brown rice protein powders.  And green tea. lotsa, lotsa green tea.
Avatar universal
go to jail. go directly to jail. are you nuts?
Avatar universal
Susan,  
Dr. Stechschulte at Mt. Carmel is one of the best "bedside manor" docs i've been to. He just isn't interested in spending much time with pts. He told me hvc pts are almost like treating "well"patients.(??) He has a good GIPA. He has a brother and sister that are docs in this area. His brother did my cornea transplants. My mom is a retired nurse, and has known their family for 50 years.
I have an idea on another hvc subject. e mail me ***@****
         BIG CHUCK
Avatar universal
yes...for most people there is some left in the vial that you must discard.....a little under half of a full dose for many....so, you can see what the delemia is.....it is awful to waste this liquid gold!
Avatar universal
The clinical study that I posted on this thread could be your ticket to getting treatment for free.  Do you think you'd qualify?

Susan

Avatar universal
Throwing away a lot of INF I couldn't handle either. I have insurance to pay for doc bt not meds. Didn't qualify for free meds. Since I had to pay for them I injected 133% of recommended dose(without doc's knowledge). I figured I could only afford to do it once so I better take my best shot. I thought if I could handle the sides it wasn't going to do me any harm. I certainly don't recommend this, it's just what I did. I didn't count on Procrit and Neupogen since week 10 and the cost about did me in. But I've been clear since week 12. Whoever came up with their marketing plan must be a genius(actually more like a thief). If I could figure how to get my customers to throw away almost half of what they bought as soon as they got it I would really be doing good. If this medicine is so expensive it makes NO sence to throw away any. Think how many people realy need the meds. I think the drug company should be ashamed.
Avatar universal
okay, i'm just jumping in here with both feet, what a way to finally find this site and introduce myself to you all, didn't know i hhad sooooo many opinions ....as a single parent, self employed business/bar owner...and unfortunately ..medically uninsured ( because every plan i attempted to buy into had the same questions....one being  "do you have any liver deseases, ie; hepatitis, never really could lie and certainly not with something that huge and legal)person living with hep for a very long time now.....i have been scourering pages and pages for about a year and ahalf DESPERATELY looking for some guidance and a way to get treatment covered...to no avail, until recently...so..in blueskies defense, and to further agree with simpleman...it is criminal and shameful, that so VERY very many people do WITHOUT this treatment becuase of economics and political bullshit and capitalism on the backs of the ill !!!! so therefore i would also sugest there be some way of "partnering" several people together to perhaps ensure more are treated should they, like i, desperately seek any means possible to do so, this COULD be done to ensure that those without means, could somehow benifit from the incredible waste that is impossed on us, i know what some will say...it is structured that way because of the weight requirerments variying from person to person, i know, but still....i find it agonising each week that i waste these precious meds.....blueskies/lori....your heart IS in the right place.....stay cool....peace...kimmy
Avatar universal
I did Peg-Intron where you mix .7 ml water with the IFN. You then inject .5 or .4 ml and throw the rest away. It doesn't last so you can't save it.
Ringading--The problem with partnering is you really need a doctor and I don't know if they would agree to this. You also need the ribaviron lots of lab tests, etc., so there would still be quite an expense. To try to do this tx without a good doctor would be insane. I tried to keep sort of a journal during tx and told my doc what I did and gave him the journal when I was finished. I think he thinks I'm crazy but seemed happy to get it.
26471 tn?1211940121
As per my recent post, if you want treatment for HCV and you do not have cirrhosis, you may want to check into SciClone's final clinical trial for their immune system enhancer, Zadaxin.  

This is a double-blind placebo trial for Zadaxin, so there is 50% chance of getting sugar water instead of Zadaxin.  However, all patients will receive 48 weeks of Pegasys + ribavirin.  So if you don't have cirrhosis, and you don't have insurance to pay for treatment, this is a great way to get treatment for free.

I'd also like to comment on the study including milk thistle and vitamin E.  When I was in Boston for the AASLD Liver Meeting, I attended a symposium that focused on treatment for nonresponders.  The panel included Dr. Robert Gish, Douglas Dietrich, and two other well-known hepatologists.  There seemed to be consensus about the value of antioxidant therapy in the presence of viremia.  The antioxidants included milk thistle, vitamin E, and our favorite drug, interferon itself.  

Hepatitis C alters the mitochondria of liver cells.  This creates oxidative stress on hepatocytes.  Oxidative stress can set off apoptosis (programmed cell death) in hepatocytes.  Relieving oxidative stress is believed to stop or reverse disease progression, and powerful antioxidants are known to prevent cancer.  Of course, I've been told by my own doc to avoid the most popular antioxidant, beta carotene, because of the high content of vitamin A.

You will notice that the main requirement for this study is mild disease progression.  My guess on this requirement is that clinical results will be easier to document in this population - improvements in health are easier to see.

The panel discussion I attended also suggested that half-dose maintenance therapy of a peginterferon for two years might push back liver injury as much as two full stages.  More and more, the focus of therapy is beginning to include reversing liver damage in an environment of viremia.  The point is to turn the immune system around so that it stops destroying the liver and starts healing it.

Avatar universal
Hi. I am a patient of Dr. Kwo's. It was my understanding that this study was with reduced dosages to address quality of life issues with regard to side effects. I'm not hip on dosage amounts. Is the dosage you quoated wnl? Thanks for providing this info!
Avatar universal
I cut and pasted the info directly from the website, so I can't address your question about dosages.  By the way, what do you think of Dr. Kwo?  I haven't been happy with my GI and would be willing to travel to Indiana for a top-notch doctor.

Susan
Avatar universal
Can anyone tell me if this is the usual dosage for treatment?
{Peg-intron 1.5 mcg/kg sc each week, plus Rebetol 13 + 2 mg po daily}
Dr. Kwo is very young but seems to know what he is talking about, however he is decisive and basically tells you what to do rather than offering alternatives. He is knowledgable about HCV and really had a clue with regard to my sxs and test results....but....I had to redo some of the blood tests that he ordered and that was upsetting. Not sure if his office was responsible or if the lab was responsible. I have been putting off treatment and his office continues to contact me saying basically that I need to treat, so he does follow up. He is highly respected at I.U.
Avatar universal
hey there susan.......well after tons of letters and calls and general **** disturbing non stop, and tons of suport and guidance from a friend here in canada andy aitkens.....finally...the quebec goverment has agreed to pay for the whole wack just about....my cost is 67.00 a month....so i feel rather priveledged i must say and grateful.....ALTHOUGH for ONCE...living in the HIGHEST TAXED provience or state in all of north america....has paid off...sorta!

S.M....yes, i guess your right, it would become a nightmare of coordination to utilize the left over drug....still breaks my heart to waste it when so many need it....btw i too am journaling the experience i think it was incredibly generous of you to give that to your doc...hope he /she realises how valuable a tool it is....
Avatar universal
Go to janis7hepc.com. They have numbers to call for both peg-itron and pegasys for financial help. They even found out what my co-pays would be when I couldn't get any info. Also, my meds are delivered to my house( I live in nowhere N.D.)free.             Joni
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