Status of trial for PEG INT w Riba + Teleprevir

[rls123]

Can anyone comment about 12 week follow up from European patients as to the rash side effects using Teleprevir (VX 950).
Is the 24 week study showing a clearer SVR.
Is the current issue more prevalent than the trial sponsors have led the non responder community to believe.

[jmjm530]

Good question, but we can only give anecdotal information here from quite a small group of participants. Until more complete trial data is released and analyzed, we can only speculate. Someone mentioned that more complete results will be offered in a conference (Barcelona?) around Mid April. Stay tuned.

[mremeet]

Have you heard something from a doctor or someone working within the medical profession that has led you to believe the rash is more serious than originally reported? Reason I ask, is that you are the second person to ask about this subject in the last few days (copyman made a similar post recently).

Anyway, I'm treating in the prove 1 group (in the US) and was one of the ones that had an awful telaprevir rash. If you missed copyman's post, take a look at it at this link:

http://www.medhelp.org/forums/hepatitis/messages/45415.html

And here's the reported details about the rash straight out of the Vertex Prove 1 consent form:

"Blood Sampling: If you already had a rash or if you develop a rash while on this study, one of the blood samples that have been collected will be used to look at certain genes in your immune cells. The samples will be used to see if there are changes in the genes that determine how these cells function. Certain enzymes that are involved in breaking down the drug will also be looked at to see if they have changed. Differences in these genes and enzymes may cause some people to have a higher risk of developing a skin rash.

Potential risks based on clinical studies: Skin rash appears to be the most common side effect associated with telaprevir. About 34% of study subjects receiving telaprevir in combination with pegylated interferon and ribavirin for up to 3 months experienced rash. This is compared to about 15% of those who received pegylated interferon and ribavirin alone. Most rashes have been mild to moderate in intensity. Up to 3% of subjects have experienced severe rash. Some of the subjects with severe rash have also had swelling, swollen lymph nodes or fever. Many of the rashes have been associated with itching. The rashes have resolved following discontinuation of the study medications and treatments applied to the skin or taken orally.

Other side effects that may have been associated with telaprevir given in combination with pegylated interferon and ribavirin include low red blood cell count (anemia) requiring discontinuation of the study medications, gastrointestinal problems (nausea 36%, diarrhea 23%, vomiting 12% and hemorrhoids 10%). Each of these events also occurred in subjects treated with pegylated interferon and ribavirin without telaprevir, but in about 10% fewer subjects. Most of the gastrointestinal events have been mild or moderate in intensity.

Additional uncommon but serious side effects occurring in people taking telaprevir in combination with pegylated interferon and ribavirin included anxiety, mood disorder, itching skin, eye problems, heart attack and mass in a gland in the abdomen found on a CT scan.

Additional side effects that were reported by more than 10% of subjects in the study included fatigue, flu-like illness, redness at the Peg-IFN injection site, fever, chills, general rain (ed note: "rain" probably means "pain"), dizziness, insomnia, joint pain and muscle aches.

Potential Risks Based on Non-Clinical Studies: "Studies to look at the safety of telaprevir have also been done in laboratory tests and in animals. Some of the lab tests on a type of mouse cells done using a mixture of telaprevir and related substances showed that damage to the genetic material of cells could occur. Pure telaprevir, the drug that is used for human studies has been re-tested in these same tests and has not shown genetic damages.

In one study, rats in the higher dose groups, there were signs of damage to the testicles that included low sperm production and smaller and softer testicles. This was not seen in similar studies in dogs. Other tests showed that telaprevir may interfere with sex hormone receptors in rats but not in humans. Laboratory tests (inhibin B) to examine for changes in testicular function in humans have not shown adverse effects, but men in this study will continue to be studied."

[Willy50]

"Can anyone comment about 12 week follow up from European patients as to the rash side effects using Teleprevir (VX 950)?"
I AM ONLY AWARE OF TWO (on PROVE2)AT THIS MOMENT NEITHER HAD A SEVERE ISSUE (ONE ON AND ONE OFF THE RIBIVIREN ARM) THE PROVE 2 STUDY HASN'T BEEN ON FOR 12 WEEKS YET.

"Is the 24 week study showing a clearer SVR?"
I DON'T THINK INFORMATION IS RELEASED FOR PROVE 1. AND WON'T BE TILL THE EASL (STARTS APR 11). MOST FOLKS ON PROVE 2 HAVE NOT YET TREATED EVEN 12 WEEKS SINCE PROVE 2 ONLY STARTED THE FIRST OF THE YEAR.

"Is the current issue more prevalent than the trial sponsors have led the non responder community to believe?"
VERTEX HAS KEPT A LID ON THE INFO. THEY ADMIT THAT THERE IS A HIGHER INCIDENCE OF DIGESTIVE AND RASH TYPE ISSUES THAN SOC.  THEY ONLY CAUTIOUSLY NOTE THEY APPEAR TO LOOK THE SAME AS CURRENT EXISTING SOC ISSUES.  I THINK THEY ARE WORKING HARD TO NOT CAUSE PEOPLE TO MAKE ASSUMPTIONS. MOST OF US WOULD PREFER TO HAVE SOME DATA.  

Best,
Willy