I had heard about the HALT-C study while at a seminar in Southern California. Dr. Karen Lindsay of USC spoke about it. My first thoughts were "geeze it's 4 YEARS on treatment!" At the time, I didn't think too much about it because I couldn't see doing that. I had already done 22 months on Interferon and wasn't too excited about going down THAT road again.

In July my doctor called me and told me he thought I would be a great candidate for the study. Since USC is only about an hour from where I live, I decided to give it some serious thought. I had all but decided not to do it, but then some things occured that completely changed my mind. First, a very good friend of mine lost her husband after 2 transplant attempts. I had helped this wonderful lady get her husband, a Veteran, on the road to VA disability, the transplant list, and retired from the military. Les' death hit me like a ton of bricks. Two weeks after losing him, I lost another very good friend to HepC. Kevin and I had been running the Veterans Helping Veterans website for over 2 years. I had been stationed in Germany with both him and his brother. His death has been a total shock. A woman in my support group, who is only 38 years old, is now going through end-stage liver failure. Because of a lung disease, she was not a candidate for a transplant. Watching her slowly leave us is the most difficult thing in the world.

It was at this point that I decided that I didn't want my family to go through what the families of these 3 wonderful people have had to endure. I knew that if I did this study, it could at least give me some more time. My doctor had told me that he forsaw a transplant in my future, in the next 5 or so years. Well, there was no way I wanted to be on that road yet. Larry and Erika didn't quite understand why I would want to go through all those side effects again. I told them how I felt and that they would have to buck up and endure it with me! I don't think I would consider a transplant in the next 5 or so years, so this would at least give me more time to think about that. I told them both that I wanted to be around when my granddaughter graduates from high school. If the HALT-C study gives me that 17 years, I'll be happy as a clam in a shell.

I called the doctor back and told him I would do it. Then I contacted USC. Once I got my initial appointment, I packed up my medical files and trekked the freeways down to USC Medical Center. That in itself was an experience. I hate driving the LA freeways and doing it during rush hour is even more nerve racking. Once there, we had to find the clinic. Another trek through the medical center found us at the main door of the clinic.

We were only there about an hour but boy was I busy! My mother went with me, because she is so interested in all of this. Right now she is my biggest cheerleader! I had to go down fasting so they could draw blood. They didn't tell me they were going to DRAIN me. After filling 16 viles of blood, they fed me lunch. They test the blood for EVERYTHING under the sun. They also had me filling out all kinds of consent forms and questionaires.

There will be 2 ancillary studies within the HALT-C study. One is a study of the Cognitive Effects of Long Term treatment. It really looks exciting. The purpose is to better understand the side effects of long-term treatment on moods and thinking. We will be taking oral and written tests of speech, concentration, memory and reaction times.

The second ancillary study is the Immunological and Virological Correlates of Liver Fibrosis. This one consists of giving a bit more blood at the labs to help study the Hepatitis C virus in the blood and immune system. They want to identify how the body's immune system responds to HCV and how it relates to liver fibrosis.

Both of these sub-studies sound exciting in that we know we all have side effects but don't know why some are worse than others. We also know HCV affects the immune system, but not why it effects everyone so differently. Hopefully, these sub-studies will shed some light on those 2 important factors.

The next step will be another visit, about 4 - 6 weeks after the first one. I'll see the doctor at that one. Since I had a biopsy in April 2000 I may not have to have another one. Those who haven't had one recently, will have a baseline biopsy. Further down the road will be an endoscopy to check for varices. I don't look forward to that one.

The study procedure is:
 
I will be given the meds, which will be Roche's Pegesus (Interferon-Alpha 2b) and Ribavirin, and have to save the viles to return. We will all be doing this treatment for 24 weeks. Office visits will be at the 2, 4, 8, 12, 16, 20, and 24 week mark. They will be draining blood at each of these visits. The PCR will be going to Washington State, using the brand new AMPLICORE PCR (Roche), which goes down to 10 copies!! This is the BEST test out there now!  At week 20 the PCR will be done to determine if the virus is undetected.

A physical exam and liver exam will be performed every 12 weeks following entry into the initial treatment phase. Fasting is necessary, but they said they will continue to provide us lunch. Not a bad deal either.  We will be completing several questionnaires regarding our general health, daily activities, mood and diet.

If, at week 20, the virus is undetected, those people will remain on the initial treatment for 48 weeks. Those who do NOT go undetected will move into the next phase of the study. There are actually 2 phases to this part. One group will only be monitored for the next 3.5 years.

Those who are chosen to continue with the Long Term Maintenance Treatment will then be given Pegesus alone, at a lower dose for the next 3.5 years. (42 months).

Everyone will continue to visit the clinic at 3 month intervals for the entire Long Term Maintenance Therapy Phase, and for an additional visit 6 months after the final phase visit. (4 years in all)  Blood will be drawn at each of these visits and a physical exam, including a liver exam will be performed. Questionnairs will be completed and PCR's will be taken. Yearly ultrasounds will be performed and a biopsy will be done at the 2 year and 4 year marks. They will be looking for any improvement or worsening of the disease.

We will be given our blood work results as well as all PCR and biopsy results. There is no placebo in this study.

All in all, I am actually excited to be starting this program. The nurses who are running the show, so to speak, at USC are real enthusiastic which just rubs off on the patients.  We will also be in on the ground floor for any new treatments that may be made available. I'm a believer that some kind of maintenance therapy IS the right way to go, and with the good results showing up from all the Pegesus studies, I think this is an excellent opportunity for me.

As with all my previous treatments, I plan to keep an online journal while on this study. I'll be posting my labs as well. This should be an interesting journey and I feel very positively about it. I feel I am seeing one of the very best Hepatologists in California and I just KNOW this will be the right thing for me to do.