Lucy I'm Home!

It was a beautiful day for a ride.

All and all it was a pretty good day. Lots of info. Consent forms to sign. Lots of checking this and that and LOTS of blood drawn.

I'm kind of glad that they weighed me before they took my blood because by the time that they filled all of those vials I think I had to weigh about 2 lbs. lighter :-) As it is I lost 9 lbs. in the past month. Keeping my weight is a challenge that I'm going to have to work harder on.

I do have a better grasp on the treatment time line and a better understanding of what is to come.

Today was a day of screening. In about 2 weeks, as soon as my blood work comes back, I go for the Liver biopsy. After about another week I go back to start treatment.

That is if, of course, the blood work and liver biopsy come back as planned and I am put into this study.(which I would say at this point my chances are very good.)

The trial drug is RO4588161. It's describe like this:

"HCV polymerase is an enzyme necessary for the hepatitus C virus to make copies of itself. There are currently no approved HCV polymerase inhibitors but there are simular types of drugs used in treating Hepatitus B virus and HIV. RO1048297 is a strong inhibitor of the polymerase enzyme. The study drug RO4588161(which I'll be taking) is the prodrug of RO1048297 which means, RO4588161 rapidly converts to RO1048297 inside the body." say's the paper that I have in my hand right now from my Doctors visit.

If you're anything like me, you'd convert all of that to say "Bla Bla Bla Bla". Because thats the way it sounded in my head. Except for the "Oh...Ok...I can follow that! I don't know what the hell it means.....but alrighty then". lol

Sandy, who is a pretty cool nurse and who I enjoyed having as a teacher today, put it like this: There are pretty much 2 kinds of drugs being worked on right now through research. One is a drug that will go into the viral cell and try to attack it from within. The second is a drug that attaches itself to the outer shell of the viral cell. It then tries to attack the shell to expose the cell, causing the cell to die.

This Prodrug is the later of the 2.

Now this I understand without the bla bla bla -

We're going to try to skin the dragon. :~}

This is a Phase II trial that will include approximately 490 people internationally with Geno type 1.

There have been about 130 people given this drug in a previous research study(s). (Which, by the way, sort of surpised the hell out of me. LOL....I don't really know why it surprised me, but it did.).....Anyway, this is the 6th clinical study with this drug. I assume that with only 130 before me and it being called a phaes II drug, that only 1 study was administered to Humans.

The most commonly seen side effects where:

*Flu-like symptoms such as fever, chills, muscle aches, body weakness, joint pain and headaches

*Upset stomache (nausea, diarrhea and vomiting)

*Decrease in white blood cells, red blood cells and platelets

*Insomnia

*irritability (oh boy!!)

*infections

*rash

Now lets combine that with the side effects of the Pegasys and Copegus side effects:

*Flu like symptoms (same as above)

*Extreme Fatigue (got that....gonna get worse..ok.)

*Upset stomach (same as above)

*Blood sugar problems

*Skin reactions such as rash, dry skin or itchy skin, redness and swelling at the sight of injection.

*Hair loss (I just really hope I don't loos my eyebrows....It freaks me out the way people look without eye brows!lol)

*Decreased appetite, weight loss (Oh Boy Here We Go! That Sucks!)

*Coughing (I should really think about stopping smoking.....naw, not right now. I have one nerve left and my quiting smoking right now would be a health risk to the general public)

*Dizziness

*Trouble sleeping

*Pain, Back pain

*Laryngitis, sore throat (Jimmy would love this side effect as long as it comes at the same time as the irratibility!)

*Increased Liver Function

*Loss of concentration, confusion. (Brain fog right?)

Possible serious side effects:

*Mental Health problems including irritability, depression, anxiety, aggressive behaviour, suicidal behaviour and homicidal thoughts. (Oh boy! Look out old ladies driving slow in the passing lane!)

*Blood problems - drop in cell counts (same as above)

* Infections

*Lung problems - pneumonia

*Eye problems-Blurred or loss of vision

*Autoimmune problems (Oh boy! Now I'm gonna have car trouble?!......lol...no I know what that means!)

*Macular degeneration (Optic nerve stuff right?)

* Development of an unusual rash - Stevens-Johnson syndrome (huh?lol.. I got a flash of myself covered in diaper rash ointment.)

The majority of this list of symptoms are contected to the standard treatment and not the study drug. The sypmtoms for the study drug are actually only the first 7 symptoms listed. (see I think that's what bothered me about the 130 people before me....they just don't know what all of the side effects are yet) What the hell....I might as well go for the gusto!

There are 7 arms of the study. It's a double blinded study with 6 groups recieving various dosages of the study drug along with various dosages of Pegasys and Copegus. 1 group will recieve a placebo with Pegasys and Copegus.

6 of the groups (5 recieving the study drug and the 1 group recieving the placebo) will ungo 24 weeks of the drug, pegasys and Copegus and then Pegasys and Copegus alone for an additional 24 weeks. 48 weeks total treatment.

In the 7th group they'll recieve the drug, Pegasys and Copegus but those who have no virus by week 4 and continue to have no virus until week 22 will stop all medication at week 24.

After the first 12 weeks anyone in any treatment group that is less effective compared to the standard of care arm will be offered re-treatment with a full 48-week course of treatment with the currently approved standard of care therapy in a seperate protocol. (I take this as if you fail to clear it and you were not on the full dosages of Pegasys and Copegus you'll be retreated with the full course. But what I don't yet understand, and I will ask is - If it's a double blinded study how does the research team know that you where given a less than standard treatment?)

So....here's the plan man. :-)

My blood work will come back within the next 2 weeks. If that went well I'll be scheduled for my biopsy right away. After the biopsy, assuming that that goes well also(no cancer or other problem causing liver damage), I'll be scheduled to have a visit with Sandy who will teach me how to inject myself and how to take the drugs.

And a new path in this little lourney of mine will begin.

Oh, and from today's date they have 35 days to get that first injection into me. The study Protocal says that after the 35 days they would have to start all over again with blood work, EKG, etc. They don,t want to do that.

After I start, I go for blood work once a week for the first four weeks. Then I go once on the 6th and the 8th week. Then the 12th, 18th, 22nd and 24th week. After that I guess we see what happens.

Oh yeah....if I'm in the unlucky part of the 7th group who did not clear the virus by the 4th through the 22nd week, I'll be on the study drug with pegasys and Copegus for week 25 through 48.

So thats it I think.

I've searched the net but I can't really find anything on it. If anyone finds anything please let me know.

All in all I think I'm ok. A little scared and concerned maybe. I'm trying to keep it all in perspective. Trying to constantly remind myself that just because they list side effects, it doesn't mean I'll have all of them....maybe I'll just have a few easy ones....maybe I'll have none. (boy I pray)

Sort of excited too...just to get this over with and get back to "normal" life again. I know what I have to do, so I pretty much want to get started doing it.

To end this post on the lighter side...A life insurance salesman stopped by tonight to present life insurance quotes for us. Believe it or not my premium was way cheaper than Jimmy's! He's healthy as hell and I didn't hide anything from the insurance salesman. PLUS I smoke! Go figure.

lol....it's good to be 8 years younger!