Labs/Tx-Pls use for anything else also

[DallasStar]

I was wondering if anyone has gone thru Tx, with perfect Labs.
I had lab work done last thursday, and they faxed my results this morn. I just did shot #16 Friday.. My Doctor wrote me a comment, he says he has never seen anyone's lab work so perfect, and he considers me an early SVR, what does that mean,(I was negative on my 12 wk PCR) my labs have always been great!! Am I just lucky or am I about to get slammed into the wall with sides.My WBC-7.0/RBC-4.07/Platelet-178/Alt-10/AST-9. Also thanks to everyone who helped me on the weight issue and lowering dose, the Doc sees no reason to lower since everything looks great. Please let me know what ya think..Would appreciate it:=)

[Tim in Tenn]

I have read that the ast/alt levels often go up after starting treatment even for those that had normal values before tx.

[donv]

I just received my 4 week labs and starting to get concerned although Doc says no problem.

Since first test two weeks ago WBC dropped from 4.3 to 3.0, platelets from 98-80. Red blood count seems OK at 5.15 and about the same as it was pre TX.

On the positive side ALT dropped to 45 from 65, AST 33 from 41.

I did shot #5/48 on sunday and so far I am coping with sides pretty well, each week seems a little better. I would hate to have to stop or reduce dose, maybe next test will show some stabilizing?

don

[louisep]

Hi there, thanks for taking the time to post...This is all new to me, and I'm still a novice on this forum, it's pretty easy to misinterpret some comments...maybe I'm over sensitive....but I'm learning quick!
It kinda sucks that you didn't get any help with your tx costs, $3,400 a month!  Thats a hell of a lot of money!I'm pretty p....d that I have Hep C as I'm sure everyone is!  I'm told that I either got it from a blood transfusion(my records have conveniently gone missing,  and the hospital I had surgery at is now an old folks home,  I had surgery 16 years ago.  Would I know if I'd had a tranfusion???)  Tattoos(I have 2 very small ones & all my friends & 2 sisters had them at the same place!) or a body piercing( I had my belly button pierced at the same place as the tattooos)
I live in a very small holiday resort and the thought of all those people going in the same tattoo place scares the hell out of me!  All I know is, right now, I feel like I wanna kick some a..!  And help make people more aware of the dangers out there.  I know I shouldn't dwell on it but it's kinda hard not to.  And if I were paying the amount of money you guys pay, well, I don't know what I'd do?  It was nice to talk to you, Dallasstar, I hope you're as well as can be expected and wish you lots of health, wealth & happiness.
Louise

[Revenire]

I've been undetectable since week 12 but when I received my bloodwork yesterday I notice my ALT was 38 and my AST was 40 ... those have crept up a bit. Is this normal during treatment?

Thanks,

Scott

[louisep]

Hi Dallas star, glad to hear you're doing so well.  Hope you don't mind this.
I heard on UK news a couple of weeks ago that the British Government were offering financial assistance to people who had got HCV through blood transfusions etc.  This was all that was said, and there wasn't any follow up that I'm aware of in the press.  It's not so bad for me being in the UK as I don't have to pay for tx.  I'm just curious if the US Gov has offered the same, as a few people here seem to know where the HCV came from.  I just wandered if any of you were compensated by being given free tx...It's just a thought as I know you guys have to pay a fortune for tx.
Louise

[MichaelT]

<a href="www.frontiernet.net/~monty/hcvipel.html">drug pipeline </a>

[Revenire]

The most recent AASLD Conference presented the below study:

<a href="http://www.hivandhepatitis.com/2003icr/03_assld/docs/pegasys/102703_a.html">Viral Kinetics Can Predict Sustained Viral Response to Treatment with Pegasys and Ribavirin, independent of Genotype, as Early as 1 or 4 Weeks of Treatment</a>

[ral]

I will say a prayer for you.

Bob

[Revenire]

All good questions and I'd like to know too.

My understanding is that new drugs are 3-5 years off; BILN I don't know about, except what I've read in the press releases etc.

[sugie]

HepC in the news tonight with BILN 2061. I am interested cuz tomorrow I find out if I finally cleared the virus at six months or no. Does anyone know if the protease inhibitors are on the near hozion or will it be five or ten years down the road. Is there more studies going on? Erin do you know how the research is going? I would love to think there are going to be something for non responders to the interferon or relapsers. I have felt really shxxy lately and hard to be positive about my numbers since I didn't clear by 12 wks. I just don't want to go through this for nothing short of SVR for ever. Well sure no one does. Also wondering, after clearing the virus what can you do to keep it from coming back? Besides extended TX. OR does it come back cuz it wasn't all really ever gone. What is the most sensitive VL test? And are relapsers the ones with that small amount still left. Any research being done to tell any markers in blood work or symptoms to tell who is likely to have a SVR?????????Other than the numbers they use now? Thanks for info.

[MichaelT]

I'm sorry you are feeling poorly. Like ral (Bob) you have my prayers.

We are several years away from having some of these treatments become available outside of drug trials. When I get to work tomorrow, I'll post a link to a site that is tracking meds in various  stages of trials.

Relapsers never really got rid of all the virus. The bugs were present, just not detectable. It has been shown that the virus can be present in the liver even when it is not detectable in the blood.

Heptimax and UltraQual or UltraQuant are the most sensitive tests for measuring viral load.

We are slowly getting more pieces of the puzzle together to better predict a favorable response to the current treatment, but we still don't know enough or have enough experience yet to do better reliably.  -Michael

[DownThisRoad]

Congratulations on your good numbers.  Looks like you are winning.  Keep going !!

[GI.PA]

We will typically see the liver enymes trend to the abnormal range during relapse, but not always.

A subtle drop in your platlets is a little concerning and may reflect your baseline liver dysfunction which will take some time to improve post treatment.  They should be keeping an eye on this but it doesnt neccessarily signal a relapse.

Erin

[lackalustre]

erin:   do liver enzymes generally get elevated shortly after treatment in the case of relapse?  is there a lag time or do they generally go up again at the time virus comes back?   mine are fine 2 mon. post tx. in normal range. but platlets have dropped again to 91.   platelets had been low around 100 for several years but came to normal range 140 right after tx. ended.  this seems to be puzzling.  any thoughts??

[lackalustre]

New drug hope for millions of hepatitis C victims

A new drug that prevents a contagious virus from duplicating in the body could be a new weapon against hepatitis C, a disease that could kill more people than AIDS, scientists said.

More than 170 million people around the globe are infected with the virus that can cause permanent liver damage and in many cases death.

There is no vaccine against the hepatitis C virus (HVC) and current treatments can cause unwanted side effects.

But scientists working for the German drugs giant Boehringer Ingelheim have developed a drug that could offer new hope to patients with the illness.

Called BILN 2061, the drug targets an enzyme to block the replication of the virus.

In eight people given four doses of the treatment viral loads, or the amount of virus in the blood, dropped by 100 to 1,000 fold after 48 hours without producing any unpleasant reactions in the patients.

"The antiviral results of protease inhibitor BILN 2061 in a proof-of-concept human trial clearly demonstrate the great potential of selective and anti-HCV agents," Daniel Lamarre, of the company research centre in Laval, Canada, said in a report published online by the science journal Nature.

BILN 2061 is the first of a class of drugs called NS3 protease inhibitors to be tested in humans.

Although more longer trials are needed to see if the drug keep the viral load down and if resistance develops, the scientists believe it "holds great promise to markedly improve treatments of chronic HCV infection."

Former US surgeon general Dr C Everett Koop has described the illness as a graver threat to public health than AIDS.

"Hepatitis C already infects three times more people than does AIDS. It is responsible for more than one-third of all liver transplants," Dr Koop warned in an Internet message, adding that the illness could kill more people than AIDS each year.

--Reuters



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  From:  AZSPAZ     Oct-25 8:57 am  
To:  ALL   (2 of 3)  

  10011.2 in reply to 10011.1  

AASLD (American Association for the Study of Liver Diseases)

Nov 2-5, 2002, Boston, MA  Back  

  
  
  
  
Orally available Hepatitis C Virus (HCV) Protease Inhibitor (BILN 2061, Boehringer Ingelheim Pharma) Demonstrates Potent Anti-viral Activity in Persons Infected with HCV Genotype 1

Written by Mark Sulkowski, MD, Johns Hopkin University School of Medicine  
  
  The results of two studies presented at the 53rd Annual Meeting of the American Association of the Study of Liver Disease (AASLD) provided a stunning glimpse into the future of HCV therapy and shook the foundation of the new 2002 NIH Consensus Statement on the Management of Hepatitis C.

Researcher presented four papers describing the discovery, safety and early antiviral activity of BILN 2061, a serine protease inhibitor (Hepatology Volume 36 October 2002).

Abstract 464. Lamaree and colleagues from BI reported the discovery of a small, selective and potent inhibitor of the NS3 serine protease. The drug, BILN 2061, demonstrated potent in vitro activity and good pharmacokinetics and safety in animal species. Furthermore, BILN 2061 demonstrated low nanomolar inhibition of replication in the replicon cell model system. Based on these data, the drug was selected for further evaluation in man.

Abstract 800. Narjes and coworkers reported on the tolerability and pharmacokinetics of BILN 2061 after oral single doses (5 to 2400 mg) in healthy male subjects. The study evaluated increasing doses of the drug in groups of 8 mean (6 active drug and 2 placebo) and found no serious adverse events. The maximum tolerated dose was 2000 mg since the higher dose was limited by minor intestinal adverse events. The medication was administered in a PEG 400:ethanol solution and demonstrated pharmacokinetics evidence to support twice daily dosing of up to 200 mg with or without food.

Abstract 866. Hinrichsen and colleagues presented the results of the initial phase 1 study of BILN 2061 in 31 patients with HCV genotype 1 infection and minimal liver fibrosis. Subjects were treated with placebo, 25 mg, 200 mg or 500 mg of BILN 2061 given twice daily by mouth for two days with 10 -14 days of follow-up after treatment. The mean age of subjects was 47 years and 48% were HCV treatment naive. The serum HCV RNA level decreased by greater than one (1.0) log10 in 7 of 9 subjects at the 25 mg dose and 8 of 8 subjects at the 200 and 500 mg dose. No differences were noted in the responsiveness of interferon naive patients and those who had previously failed interferon based therapy. HCV RNA levels returned to baseline within 1 - 7 days after stopping the drug. Tolerability was good and no safety issues were identified among the 25 active drug recipients including clinical, laboratory and ECG assessments.

Abstract 563. Benamou and coworkers reported on the safety, tolerability and antiviral effect of BILN 2061 after oral treatment over two day in subjects with HCV genotype 1 and significant liver fibrosis (Ishak stage 3 and 4 but not cirrhosis). In a randomized, double-blind group comparison, 10 patients were treated with BILN 2061 200 mg orally twice daily or placebo for 2 days (8 active drug and 2 placebo). The mean age of the patient was 46 years and 50% were HCV treatment naive. All 8 patients treated with BILN 2061 demonstrated at least a two (2.0) log10 decrease in serum HCV RNA level at the end of the two day dosing period (Cobas Amplicor Monitor v2.0) and 2 patients had a decrease of greater than three (3.0) log10. After stopping therapy, the HCV RNA level returned to baseline in all subjects. No safety issues were identified by analysis of adverse events, vital signs, routine laboratory tests, and ECG.

Phase 2 studies of BILN 2061 for patients with chronic HCV are currently planned in the United States and Europe in early 2003.    
  






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   From:  AZSPAZ     Oct-25 9:16 am  
To:  ALL   (3 of 3)  

  10011.3 in reply to 10011.2  

AASLD (American Association for the Study of Liver Diseases)

Nov 2-5, 2002, Boston, MA  Back  

  
  
  
  
1st HCV protease Inhibitor: effective over 2-day study

Reported by Jules Levin  
  
  Today at AASLD Boerhinger Ingleheim researchers, the maker of nevirapine (a non-nucleoside reverse transcriptase inhibitor for HIV), presented for the first time publicly data on study results where HCV+ patients received the HCV protease inhibitor. Patients have chronic HCV, genotype 1, and advanced liver fibrosis. This study found short-term administration of this protease inhibitor had antiviral effect and was well tolerated.

BILN 2061 is a potent and specific inhibitor of HCV serine protease. It

[Revenire]

Your EVR boosts your chances of SVR a lot. Great news!

[layla]

My doc said the same thing to me. I'm on week 35 and did end up with low WBC one month of 2.7, which I was told wasn't much of a problem, then it was back to normal by my next lab. I do have sides now but they are normally much milder than what I see reported here and are not continuous. You sound lucky to me. Happy to hear this and hope it stays that way for you. LL

[mikesimon]

Your labs do indeed look great. You're one of the fortunate ones and I wouldn't expect that you will get slammed. I believe that the blood chemistry generally suffers by this time in tx and maybe you will just coast through with no major problems. When your doctor said you were "early" I think he was referring to EVR or early viral responder which is a description applied to those who clear the virus or become undetectable early in tx. This is thought to be an indication that your chance of becoming an SVR (sustained viral responder = "cured") are quite good. I wish you the best. I think you have good reason to be optimistic. Keep it up. Mike