BigPat hep C - REPEAT Trial

As of today (26 Mar 2004), I begin this Hoffmann-LaRoche REPEAT trial, picked up a month's worth of meds, and the Pegasys is in fridge. Haven't figured out if it's a good thing or not, but am randomized to Group A below - had it of been a matter of choice, that's the group I would have selected. But who knows, it definitely wouldn't have been my first bad decision. This equates to a double dose of interferon for first 12 weeks of my trial.

As well, even doing trial study medication, the following (or similar) is still applicable:

Genotype 1: At week 12, retest for HCV RNA level. If HCV RNA is negative or has decreased by at least two log₁₀ units (such as from 2 million IU to 20,000 IU or from 500,000 IU to 5,000 IU or less), continue therapy for a full 48 weeks, monitoring symptoms, blood counts, and ALT at 4- to 8-week intervals. If HCV RNA has not fallen by two log₁₀ units, stop therapy.
(based on: National Institute of Diabetes & Digestive & Kidney Diseases - Chronic Hepatitis C: Current Disease Management )

Which means by above "rule set", at the 12 week mark, my viral load needs to go down from 881,590 (by latest Kaiser blood lab 20 Feb 2004) to < 8,815.9. Not sure how the viral load count varies between Kaiser and USC, but that will be kept in mind as well.

I am closing in on final acceptance/denial to a hep C medication trial, at USC Hepatitis Research & Treatment Center, 1640 Marengo St., Suite 103, Los Angeles, CA 90033.

This is the Hoffmann-La Roche, Inc. REPEAT trial, MV17150. Medications quite similar to meds I was already declared a non responder to.

The meds will be PEGASYS® (peginterferon alfa-2a) and COPEGUS®(ribavirin)

There is no placebo involved in this trial, but different dosages and different durations.

At ramdom, if accepted, I will be assigned to one of four groups:

Group A: Will get a high dose, 360 micrograms (µg), of PEGASYS® once weekly for 12 weeks, followed by a standard dose for 60 weeks plus a standard daily dose of COPEGUS® for a total of 72 weeks. The chance of assignment to this group are 1 in 3.

Group B: Will get a high dose, 360 micrograms (µg), of PEGASYS® once weekly for 12 weeks, followed by a standard dose for 36 weeks plus a standard daily dose of COPEGUS® for a total of 48 weeks. The chance of assignment to this group are 1 in 6.

Group C: Will get a standard dose, 180 micrograms (µg), of PEGASYS® once weekly for 72 weeks plus a standard daily dose of COPEGUS® for a total of 72 weeks. The chance of assignment to this group are 1 in 6.

Group D: Will get a standard dose, 180 micrograms (µg), of PEGASYS® once weekly for 48 weeks plus a standard daily dose of COPEGUS® for a total of 48 weeks. The chance of assignment to this group are 1 in 3.

Obviously, if I had my druthers, I'd happily opt for Group A, believing it to obtain the best potential of turning my viral load into undetectable. But I'm sure the random nature of the trial will over rule my preferences.

Whatever, if accepted, I will do this trial in 100% good faith, and let the meds do what they will attempt to do.

On a personal note, keeping up to date on trials, and where they're being performed at, is some very mysterious stuff! I found a link to one trial, HALT-C, which was actually beyond any recruiting, though I wasn't aware of it then, and with link information to USC and a Dr. Susan Milstein, that was what I originally approached USC with.

Shortly after my email approach to them, I was contacted by phone where much was explained, and thus far I was on ground floor of their recruitment process. And believe I am still #1 on their list of potential candidates, expecting closere to this part of it within about 30 days from now, or perhaps a little less.

Surprisingly, for me (never being involved in a med trial before)m I needed to return to Kaiser Permanente for a chest xray (done), report of PSA (blood sample - done), I have contacted Providence Holy Cross seeking report of Colonoscopy that was performed in 1991-1992, and Kaiser Permanente for report of Stool sample for occult blood (done). And Kaiser Permanente once more to perform an Ultrasound (scheduled 3 March 2004) again, and forward report to USC. As well as dental being up to date (done).

I will visit USC once again on March 10th most likely, for followup meeting, progress check, and eye exam (eyes need to be checked for glaucoma sometime within previous year).

And as well, I have authored a 'standard' release form for release of any medical information from kaiser Permanente to USC for anything related to my liver, hepatitis, medications, blood pressure, heart, I suppose any internal organ.

Lastly, with my last go-around with similar meds, I got moody and depressed (mostly noticed by my wife), so much so, after arranging for and meeting with a doctor of psychology at Kaiser Permanente and discussing this, Prozac was prescribed. Though I still have 50 or 60 Prozacs in a littel bottle, I need to contact this doctor again to arrange for a quick turn-around if I feel I need to return back to these meds, and perhaps for refills.

WHEW! Who'd a guessed all this would be involved.

-Pat (29 Feb 2004 - leap year)

New Pegasys Trial to Enroll Hepatitis C Patients Not Helped by PEG-Intron 07-04-03 1220ET

Hepatitis C patients who failed to respond to the first pegylated interferon combination therapy (peginterferon alfa-2b and ribavirin) are being recruited for a new global trial of peginterferon alfa-2a and ribavirin, it was announced at the 38th Annual Meeting of the European Association for the Study of the Liver.

Roche, which markets peginterferon alfa-2a as Pegasys, said the trial, which ultimately expects to enroll 1,000 patients in this study from Europe, North America and Latin America, will be known as REPEAT (REtreatment with Pegasys in pATients not responding to prior Peginterferon alfa-2b/Ribavirin combination therapy).

"Non-responders," as these hepatitis C patients are called, are those who failed to achieve a sustained virological response (increasingly regarded as a "cure") as a result of their treatment, and who continued to have virus present throughout their course of therapy.

The trial will be the first to compare repeat treatment of "non-responders" who previously were treated with peginterferon alfa-2b, which is marketed by Roche competitor Schering. Previous studies using pegylated interferon to retreat "non responders" have measured themselves against earlier therapies.

Today, the standard of care is pegylated interferon and ribavirin, and most hepatitis C patients receive one of the two pegylated interferon combination therapies.

"The two pegylated interferons are different drugs, with different properties and we know that Pegasys with Copegus (ribavirin) has yielded impressive results in hepatitis C patients," said William M. Burns, head of the pharmaceutical division at Roche. "We feel it is important for this pivotal trial to show how Pegasys with Copegus can help that sizeable group of patients who have not responded to the first pegylated interferon combination therapy."

The REPEAT study will evaluate the efficacy and safety of the combination of Pegasys and Copegus given for a longer, 72-week period, as well as examining the role of an induction regimen in this treatment- resistant population, Roche said.

"We've already seen that Pegasys in combination with Copegus is a highly effective treatment in [first-time] patients with some of the most difficult-to-treat strains of the virus,"said the European lead researcher Dr. Patrick Marcellin from Hospital Beaujon in France. "Given this performance, Pegasys may prove to give these particular patients another chance to respond and be cured."