New HepC Med...looks promising

[Commdude]

Study: Drug Mimics Ribavirin Without Anemia Risk
  
by John C. Martin
Article Date: 03-24-04



A potential hepatitis medication that achieves results similar to ribavirin, but reduces the risk of a serious ribavirin-related side effect

[honey1616]

Your vl is great and it won't take much to get rid of that will it..As far as the iron/ferritin, I would work with your dr if you feel you have a good one and not worry too much.  You can only do one thing at a time...Don't get ahead of yourself! God Bless!

[grouchyOldGuy]

Hi Tina...Thanks so much for getting back to me and asking your doc about me! Amazing that you would like you don't have your hands full already!, like I said before you are a good person and tell your hubby he has friends rooting for him he don't even know about and the best of luck to you both! I posted above about Iron/Ferritin to see how many have that so called acute phase reaction to HCV causing those to be elevated. I forgot to ask about high protein in the 24 hour urine test. Anybody had that? My total iron is now 213 which is still high on a 42-135 range but it is a lot lower than it has been in the past. I have been decreasing my iron intake with diet, don't know if it helped, maybe, but tests seem to fluctuate so much. My viral load is down to 250,00 and I have no idea why but I'm happy about that. Be good and take care all.

[tina b]

Sorry to break in on this thread, the other is full,

grouchyOldGuy: Hubby went to doc yesterday and I ask doc about you. He said, your gene type is not hemochromatosis but high iron should be treated, if only ferritin were high he would not treat, but high iron he would treat.

Everyone: Hubby is 3a and 8/48, doc did a bunch of labs yesterday including viral load, his vl was something like 450,000 at begenning......everyone......keep your fingers crossed....we will find out in about a week. He has lost 7 pounds in the first 8 weeks.
Has catherine194 ( I am so tired ) answered any ones request to e-mail them?

[honey1616]

Your hubby is in my prayers for a new undetectable vl.  I'm so glad that you posted what your dr said about iron level and ferritin because that is what we have been told also.  That my hubby's level on iron is fine but just high ferritin that going on with treatment is fine!  I don't think anyone has heard from catherine and if they have....had not posted!  I'm really worried about her and wish she would post something!  Let us know when you get the new results!

[cuteus]

Ty for that info, someone had mentioned it within a thread a week or so ago.  I looked it up and found at least one study linking reverse transcriptase nucleosides to hepatoxicity.  I hope we are not trading anemia for another dangerous side.  I don't know how much more refined this new med is, but is in the same family of the meds in that study.  I guess we'll find out at end of trials.

[Commdude]

The results after 6 months showed that outcomes in patients using Viramidine were similar to those using ribavirin. Eighty-three percent of those in the Viramidine group achieved at least a 100-fold reduction, or non-detectable, HCV RNA, the genetic material that indicates the presence of the virus.

Comparably, 83 percent of those taking the ribavirin combination treatment also achieved at least a 100-fold, or non-detectable, HCV RNA in the study, the authors reported.

Even more significant, while 24 percent of the patients taking ribavirin contracted anemia, a mere 2 percent did in the group taking Viramidine, according to the study results.

Those receiving the lower doses (800-1200 mg) of Viramidine had no anemia 24 months later. Other side effects that did occur were similar in both groups.

Anemia is a common side effect of ribavirin. It's a blood condition in which too few red blood cells are being produced. As a result, too little oxygen is being supplied to your organs and tissues, and fatigue is the most common symptom.3

The Next Phase
In January, Valeant announced its plans to expedite research and development of Viramidine. "Our clinical data have allowed us to begin Phase III clinical trials for Viramidine after 12 weeks of our 72-week Phase II program," said Robert O'Leary, the company's chairman and CEO, in a press release.

Phase II trials are typically smaller than Phase III studies. Phase II trials are conducted with several hundred patients to see certain medications are effective and to further evaluate their safety.

In Phase III trials, the study drug or treatment is given to larger groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Valeant plans to enroll 1000 patients each in two Phase III studies at 80 sites around the world. Recruitment for the first trial is underway, and patients are expected to begin enrolling for the second study in mid-2004, the company said.

Comparable Objectives
As in the Phase II trials, the larger studies will compare Viramidine with ribavirin, each in conjunction with pegylated interferon. PEG-Intron will be used in the first Phase III study, while the other pegylated interferon, Pegasys, will be tested in the second trial.

These final studies, typically the last in the drug approval pipeline, are designed to treat patients for either 24 or 48 weeks, depending on viral strain; take patients off therapy for an additional 24 weeks; and then determine the percentage of patients with undetectable virus in their blood, as well as the incidence of anemia during the course of the entire 72-week study periods.

Valeant refused to comment on the trials, pending their outcome.

1. European Association for the Study of the Liver (EASL) 2004. The 39th Annual Meeting. 2004 Apr 14-18. Berlin, Germany.
2. Digestive Disease Week.  2004 May 15-20. New Orleans, LA.
3. Mayo Foundation for Medical Education and Research.

John Martin is a long-time health journalist and an editor for Priority Healthcare. His credits include coverage of health news for the website of Fox Television's The Health Network, and articles for the New York Post and other consumer and trade publications.