Waiting 3 months

[fullmoon123]

Even though my Type 1 Hep C is at Stage 2, (last year is was 0.3) my doctor says he wants me to begin treatment asap.  I asked if I could wait to begin in January and he agreed.  Honestly, the treatment scares the H-- out of me and because I am Black w/Type 1, my hesitency is because of the odds.  The doctor says he thinks if the present does not cure my Hep C, it will hopefully slow it down and hopefully the new drug will be available in 2011.  Do you think waiting 3 months will matter that much?

[T_Bear]

My husband's gastroenterologist kept putting off treatment for 3 years, saying his labs showed things were not bad, and wanting him to lose a lot of weight before starting (he was 100 lbs. overweight - pushing 260 when he first went in). We also have no insurance that would cover the treatment, have been self-paying the doctor visits. Don't know if that was an issue with this GI but we did know there are programs for treatment assistance from the manufacturers and would have found a way to pay for treatment if we couldn't get the assistance. Didn't hear a thing about any studies from the GI but again he wasn't pushing treatment, he seemed to be avoiding it. We knew the weight was an issue for treatment response and he really tried, but a knee injury threw a wrench in the exercise plan and he wasn't losing it very quickly. The GI wanted him to go on Opti-Fast which is crazy expensive and the meetings were an hour away and hubby can't drive himself that far on the highway. We finally told him last year that the extrahepatic symptoms and the waiting were unbearable and wanted to do something. So he referred him to a hepatologist, who gave us a food list he uses for NASH. The weight dropped off. This guy is also involved in a lot of research and told us about a couple of studies that would be coming up, and the Phase 2b study for lambda interferon in particular. Called it "Manna from Heaven." Now completing week 15. Passed the 12 week milestone to stay in the study - so far so good!

[kittyface]

Hi, since the previous tx was hard to tolerate have you thought about waiting until the new meds are released, maybe in a year or two?  They increase SVR percentage and reduce tx time in some cases to 6 months instead of 12.

I know what you mean about the "mess."

[skb28642]

I'm glad my doc didn't act like that. I did the peginton and ribavarin 5 yrs ago. Really made me a mess physically, emotionally and mentally. I survived it for 12 months because my doc stayed on top of what was happening to me. Unfortunately the treatment knocked down the viral load but it started rising again as soon as i stopped. My doc was in Wilmington, NC at New Hanover Hospital  I have since moved to central part of NC. My new doc is concerned that i should probably start the pegintron ribovarin again. He is leaving it up to me. I'm concerned about my family's reaction, since they know how it affected me and everyone around me. I have had 4 liver biopsies since 1995. I was stage 3, the meds helped to get me back to 2 and my liver has done pretty good so far, but i am due for another biopsy....the fatigue was my first clue that i need to return to my doc and see what's going on with me. My last blood work showed the viral load is at 380,000, when i started therapy the first time it was at 2,000,000, i don't want to wait that long this time. Maybe the meds will work better.

[kittyface]

Glad you concur -- don't like to be paranoid and jaded all by myself.  It's real easy for doctors to push treatment.  If you fail the first time and have to treat again that's win-win for them.  
And it's not THEIR bodies grinding in the interferon mill.  I would not trust any doctor who minimized the possibility of sx, during or post tx..

I realized my interests were not at the forefront due to something I witnessed at one doc's office.  I asked for Pegasys due to fewer reported sx but was told I'd be getting Pegintron instead.  I happened to notice an attractive pharmaceutical rep for the company that makes Pegintron swoop in with a lavish lunch for the doctor and staff.  I then realized that doctors have their own agenda.  I've even read that the interferon manufacturers keep tabs on what doctors prescribe and apply pressure if they don't get with the program.

We are our own advocates.  Thank God for this forum.

[CoStudy]

I am glad to see someone mention the Dr’s bottom line. My GI pushed me for treatment for more than 2 years. I keep telling them I would wait for a study. The amount of money a Dr makes off of a Hep C patient is huge. The insurance, the kick back from the pharmaceutical company etc… Not to mention helper meds and additional visits to get those meds.  I truly believe in research and teaching hospitals for diseases like Hep C or Cancer.  They are cutting edge and get a lot of funding from pharmaceutical companies.  Not to mention that’s where the best Drs. Hang out.

Just my opinion.

[Upbeat]

The importance of the IL-28B genetic polymorphism was first reported in the journal Nature (September 2009) by scientific teams from Merck and Duke University. Specific variants in this gene have been associated with an approximately 2-3 fold greater rate of sustained viral suppression in response to treatment with combination pegylated interferon alfa/ribavirin therapy among patients infected with HCV genotype 1 with a CC genotype as compared with either the CT or TT genotypes. HCV genotype 1 is the most common form of the virus, accounting for approximately 70 percent of HCV cases in the U.S.

[Bill1954]

Aw, thanks Ms Kittyface :o)

--Bill

[kittyface]

Great study for Fullmoon's review!  You're a researching machine  :)

[orleans]

some times ya just gotta play the odds. DO NOT want to have to treat twice if you can help it. I delayed 2 years with stage 3 liver looking to up the odds.  settled on alinia+ soc and did well.  good luck, jerry

[fullmoon123]

I'll definitely ask about the Lab Corp IL-28B Test.  Thanks

[fullmoon123]

You are all awesome!  I'll continue to investigate and will stay in touch ...

[Bill1954]

Hi FullMoon,

As you’re doctor has likely explained, African Americans with HCV tend to have relatively poor response rates with interferon/ribavirin combo therapy. Over the years, I’ve seen studies that demonstrate anything from sub par to abysmal results. Sadly, up to now there really hasn’t been much that medicine has had to offer for this patient group.

I was reviewing some articles just now, and came up with some encouraging statistics regarding one of the new protease inhibitors ‘Boceprevir’. I’ll include some of the pertinent data in an excerpt here:

“As specified by the HCV SPRINT-2 study protocol, results for the non-African-American/Black and African-American/Black patient cohorts were analyzed separately. Several previous studies have shown that African-American/Black patients have a lower response to HCV treatment than non-African-American/Black patients.[1-3] Among the non-African-American/Black patients in the boceprevir 48-week treatment group, 69 percent achieved SVR, and in the response-guided therapy group, 67 percent of patients achieved SVR, compared to 40 percent in the control group (p < 0.0001 for both, intent-to-treat analysis). Among the African-American/Black patients, 53 percent of patients in the 48-week treatment group and 42 percent of patients in the response-guided therapy group achieved SVR, compared to 23 percent in the control group (p = 0.004 and p = 0.044, respectively, intent-to-treat analysis).”

http://www.hivandhepatitis.com/hep_c/news/2010/0806_2010_a.html

If I’m interpreting this correctly, the study yielded 53% and 42% success, as opposed to 23% in the control arm (control being Pegintron/ribavirin only, without the study drug).

This underscores why it might be prudent to hold off until one of these new drugs are available to you, whether in a clinical trial setting or as they become available on open market.

For more studies on HCV and African American patients as they respond to HCV therapy, here’s a link to review if you like:

http://www.google.com/cse?cx=000772985894926410863%3Awvp_6dwxpvm&cof=FORID%3A0&q=african+american+response+hcv&sa=Search

I’m glad you found Kittyface from Austin to help you too; it’s nice to know someone in your area.

All the best—

Bill

[kittyface]

Wow that's impressive!  How are the results expressed?

[Upbeat]

Have you heard of the Lab Corp IL-28B Test?   This is a test that will tell you the odds of interferon based drugs working for you.  I just took the test and am waiting for the results now.  

[kittyface]

I'm glad to help.  Come back and let us know how you're doing.

[fullmoon123]

You have definitely given me food for thought.  I agree that it's almost pointless given my odds to begin treatment with the present meds. I truly appreciate your open and honest opinion and information.  I'll check out the website you gave me and continue to look, listen, and share.

[kittyface]

Fullmoon,

IMHO it would be more detrimental at Stage 2 to expose yourself to interferon/riba for a year with a 26% chance of clearing.  That almost guarantees that you'll have to do treatment again.  What if you can't/won't tolerate it?  Personally, had I not cleared I would not do treatment again.  It destroyed my physical and mental health.  Please, I'm not trying to scare you, everybody is different in terms of side effects, but it was very hard for me and 18 months later I'm still dealing with residuals, now visiting immunologists to ascertain what autoimmune diseases I may have that could have been triggered by interferon.  

Was the cure worse than the disease?  For me, that is a question to be answered.  Yet I'm not anti-treatment because HCV left alone will ravage more than one's liver. It gave me insulin dependent type 1 diabetes.  So this is my position:  I'm for treatment if you have a good chance of clearing with as little exposure to the drugs as possible.

If I were you I would do one of two things: 1) find a trial investigating an add-on PI to SOC.  The Lambda interferon which has fewer sx sounds very appealing; or 2) wait for the newer PI add-ons to SOC and even try to choose Lambda instead of the pegs if available.  With the newer drugs there's a 75%+ chance of SVR in only 6 months.  Believe me, it's those last 6 months of SOC that are killer!

Here's a link to a study that states HCV progresses more slowly in black people so you are the exception according to your biopsies.  

http://www.hcvadvocate.org/hepatitis/factsheets_pdf/African_Americans_09.pdf

It may sound scary, but Stage 2 is still the lesser of the two evils given the low odds of you clearing.   Please remember I'm not a medical professional just a soldier on the front lines.  

I hate to bring this up but I've run into doctors who were more concerned about meeting their business model income goals than the patient's best interest.  And there's doctors who don't know a lot about this disease and it's treatment.  Just food for thought.

KF

[fullmoon123]

Kittyface,
So you don't think it would be detrimental to wait for treatment verses going with what's available?  I have a doctor's appt. for Oct. 1 to get a second opinion.
Thanks for the info

[kittyface]

My fibrosis (scarring?) was at stage 1.  I am not a doctor but having been through the tx I would want every possible assurance that I did it just ONCE.   Maybe others will chime in here about this:  Is it possible that the biopsies are showing incorrect progression due to the nature of the procedure?  For example, what if the first biopsy was really stage 2 instead of stage 1 because they took the sample from a different part of the liver.  From what I've learned on this board this scenario is possible.

If I were you I would wait for a better chance in a couple of years.  I say this with knowledge of what this disease can do to the whole body while waiting.  


KF

[fullmoon123]

Thanks for the feedback!  
Kittyface - what was your scarring when you began treatment?  Mine is at Stage 2 and I'm leaning toward waiting, but my doctor seemed very concerned and wants me to do something even if it just slowly the disease down...
Thanks CoStudy - I'll continue to look for studies and will keep you all posted.
It feels like I'm being proactive and that gives me a little power over this.

[kittyface]

I did 2 weeks of the trial in 2007 before dropping out.  The protocol was interferon plus a PI (can't recall name) that was discontinued due to sx.  The tx was a little tougher than SOC.

Re: your question about waiting for tx, if the new drugs are to be released in 2-3 years, I would wait.  In 2008 I did 48 weeks IFN/Riba/Alinia and cleared.  Believe that a shorter duration will result in less misery and less complications, short and long term.

Good luck!

[CoStudy]

I am in the study Bill referred to. It is study with Zymogenetics Interferon Lambda also known as iL29. I received my 12 week blood test results yesterday and I am UND. I do have sx but they minor compared to what others on the soc are having. Personally I think getting into any study is the way to go. There are some stage 3 studies starting after the first of the year you may want to consider. Even if you have to travel it may be worth it. By the sound of your biopsy result you might be able to wait for a while. If there is a teaching hospital in your area you may want to contact them. I know the University of Colorado has studies that are not posted anywhere. Good luck and keep us posted.

[fullmoon123]

Thanks again, I'm still not good at moving around the site but will take your advice about asking others about the trial study in San Antonio.  It helps to lay out my fears and questions to others that understand.

[Bill1954]

Interesting… there doesn’t seem to be too much out there right now; at least that I can find in either Austin or San Antonio.

This came up through clinicaltrials.gov (which is a good site, by the way; you might want to look at it yourself). It’s a phase two trial for interferon Lamda; I don’t know much about it, but it’s purported to have fewer side effects than the currant interferon alpha we now use. This particular study has a San Antonio location, by the way:

http://clinicaltrials.gov/ct2/show/NCT01001754?term=hcv+AND+san+antonio+texas&rank=13

Again, I haven’t scrutinized the trial myself; and I’m personally a bit shy of phase 2 trials; they haven’t necessarily worked all the bugs out as they might in phase 3 trial.

I do believe there are others enrolled in this trial on the forum; one that comes to mind is ‘COstudy’, if you’d like to contact him and discuss the trial, here’s his homepage; just click on the ‘send message’ link in the upper right of this page:

http://www.medhelp.org/personal_pages/user/1372757

If something else pops up, I’ll try to remember to let you know. Alternately, you could try a new post with a question about trials and your location in the title of the thread. I’d discuss this with your doctor and get his input to see if he/she thought you might benefit from it too… genotype 1 coupled with a rather poor response profile for African Americans make this a tough one, huh? Stuff to consider anyway...

Good luck to you,

Bill