Here's an interesting read from someone with HCV who talks about Zadaxin. ---------------------------------------------
Beyond Hope: A Journey of Faith, by Miles Keatopn Andrew
Let's begin at the beginning. My hepatitis C profile: Male, genotype 1a, over 45, probably infected for more than 30 years, former non-responder to Rebetron therapy, bridging stage: III - IV (early cirrhosis, extensive fibrosis). Besides the damage to my liver, I'm experiencing what is becoming known as the HCV syndrome: Diabetes (insulin dependent), hypertension, chronic fatigue, arthritic-type symptoms, co-infected with cytomegalovirus and Epstein-Barr virus. There's a good chance I'm also developing glaucoma. That's the bad news.
Here's the good news: I'm one of few Americans getting to try out the latest drugs: Pegasys, Ribavirin, and Zadaxin. My insurance pays for the peg-riba combination. Zadaxin comes out of my own pocket - about $15,000 for a year of treatment. Zadaxin is an immune system enhancer. It's available in 36 countries now. It won't be FDA approved for HCV in the USA until late 2003 - early 2004. I can't wait that long. Without scientific detail, let me just say that as far as viral clearance is concerned, the Sustained Virological Response (SVR) of pegylated interferon + Zadaxin is about the same as peg + ribavirin. In other words, I'm adding significantly to my chances of survival. Early results of this triple-combination therapy, used only with former non-responders with or without cirrhosis is approximately 78%. However, given my profile, triple therapy gives me a 50/50 chance. This is where the faith part comes in. I wonder if I should be celebrating life or picking out my casket. I mean, when you're on protocol, you're pretty sure you're going to die anyway. That's how awful the treatment is.
I chose Pegasys instead of Peg-Intron because the Pegasys molecule is heavier - 40kd, almost twice as heavy as the Peg-Intron molecule. Another possible advantage of Pegasys is that it metabolizes in the liver itself. Peg-Intron metabolizes in the kidneys. Like Peg-Intron, Pegasys is administered once a week. However, I have read some news briefs suggesting that the Peg-Intron injection doesn't last a full week. The heavier molecule of Pegasys gives me that extra edge I may need.
I'm going to try to add to this page as often as possible throughout the course of my treatment. The first 12 weeks are critical, as Early Virological Response (EVR) is a known predictor of SVR. If my viral load has decreased after 12 weeks, there's a good chance I'll clear the virus within a year. If I'm HCV-free after 6 months of therapy, most sources will tell you that I'm as cured as you can possibly be. Unless I relapse, of course.
I'm keeping this journal online for 2 reasons: 1; So that those of you infected with HCV can follow my progress on these new drugs - an experiment of sorts. 2; I'm already familiar with the psychiatric effects of Interferon + Ribavirin - actually, I should make that psychotic effects. Anybody who's been on ribavirin knows what I'm talking about. During my first round of Rebetron therapy, I remember the lies: Expect mild to moderate flu-like symptoms. Well, that's what I was expecting. After my first shot, I remembered how many people have died from the flu. I thought I was going to be one of them - got the chills so bad I thought I'd break a bone. They didn't even bother to tell me what happens when you take ribavirin. This is one evil drug, man. Several months after I completed therapy, Roche admitted that ribavirin causes "psychiatric event" in people who have never experienced "psychiatric event." What is psychiatric event? It's what Charles Whitman did from the tower in Austin, Texas. So I'm getting prepa red. My antidepressant is Wellbutrin. I'm already on 3Mg. per day of Xanax, so my shrink is going to have to come up with elephant tranquilzer to calm me down on ribavirin. Anyway, it will be my priviledge as a writer to share with you my psychiatric events. Hell, we can trade stories.
I'll be starting protocol soon. I'd love your prayers. You have mine in return.
Today I ordered Pegasys and Ribavirin. They will arrive tomorrow. I prefer not to start them until I visit my psychiatrist next week. Meanwhile, I'm getting ready. I'm re-learning how to drink a gallon of water every day. I hate water. I prefer coffee, but I can't drink it while I'm on ribavirin - it's like overdosing on Ritalin. I'm going to buy an electric blanket and a space heater. Oh yeah, and a case of Ensure. Eating is the toughest part for me. Everything tastes like coins in my mouth. Still, the thing I'm dreading the most is the morning after my first shot. So the really crazy thing is that I wrote this novel about death - a comedy that takes place in a funeral home. I used to be an undertaker, and I wrote a comedy about death, not knowing that I was carrying a potentially fatal disease. I wrote an article about that. It's short, and you can read it by clicking here.
About Zadaxin Okay, here's what I know about the mechanism of Zadaxin. It's classified as an immune system enhancer (ISE). HCV is an elusive bug. It survives by tricking the immune system - it calls for a response from the T-Helper cells, Th2. Unfortunately, Th2 will not kill the virus. Meanwhile, the Th1 cells are just sitting there doing nothing, because they think Th2 has got the situation under control, and it's the Th1 cells that enable the immune system to kill the virus. The problem with interferon has always been it's tendency to cancel itself out. Interferon does stimulate the production of Th1 cells, but it also stimulates Th2, and usually fails to shift the immune system into a Th1 response. Zadaxin not only stimulates Th1, it suppresses Th2, and discloses the location of the virus to Interferon and Ribavirin. Every recorded case of spontaneous recovery from HCV has shown a definite "Th1 shift" in the immune system. Zadaxin alone cannot cure HCV. The drug is an adjuvant - it opens a door in the immune system. Since 1999, I've followed the progress of adjunctive therapy from Milk Thistle to Amantadine. Zadaxin made it into 36 countries for HCV, HBV, malignant melanoma, and has been declared an orphan drug by the FDA for the treatment of hepatocellular carcinoma. Zadaxin has no side effects, except in those persons with autoimmune problems such as lupus and transplant recipents, in which case the immune system must be suppressed. Now the numbers: I've seen them as high as 78% overall with Zadaxin + Peg-Intron and ribavirin, all in studies with previous non-responders with a high viral load, genotype 1a, with or without cirrhosis. However, it's probably closer to a 50/50 chance with the heavier Pegasys molecule - it's 36% with Peg-Intron. Of course, nobody wants to be exact, and they do want to sell their product. Zadaxin is made by SciClone Pharmaceuticals in San Mateo, CA. It is not approved by the FDA for the treatment of HCV, but you can order it from another country with a prescription. Zadaxin is now in Phase 3 FDA trials. Last I heard, it should be approved late 2003 - early 2004. My doctor says I can't wait that long.
Oh yeah, here's something else you might want to ask your doctor about - ketoprofen. It's sold under the brand name, Orudis. It is an NSAID, similar to ibuprofen, only much longer lasting. There are a few abstracts out there stating that ketoprofen might raise the SVR numbers. The reason for this is not clear, but it is believed that ketoprofen prolongs the metabolism of interferon. If not, I have read reports that ketoprofen helps with side effects for some better than Tylenol - especially that deep bone pain.