Replies to post #76968 on Biotech Values

[DewDiligence]

Quiz re NEJM Pub on Telaprevir PROVE-1/2 Data

http://finance.yahoo.com/news/New-England-Journal-of-bw-15075801.html

This PR has a table that shows the relapse rates in the “12+12” arms of PROVE-1 and PROVE-2 were 2% and 14%, respectively. A footnote says this:

The relapse rate in the 24-week telaprevir-based treatment arm of PROVE 1 reflects only those patients who achieved RVR and remained undetectable through week 20. For patients in the 24-week telaprevir-based treatment arm of PROVE 2 who achieved RVR and remained undetectable through week 12 the relapse rate was 7%.

The relapse rate in the “12+12” arm of PROVE-2 was reported in two ways: it was 7% for patients who had an RVR/EVR and was 12% for all patients in the arm. On the other hand, the relapse rate in the “12+12” arm of PROVE-1 was reported in only one way: for patients who had an RVR and had undetectable virus at week 20.

Q: Why was the relapse rate in the “12+12”arm reported differently in PROVE-1 than in PROVE-2?

[rkrw]

Excluded patients with big anuses?

[woofer]

While I've been looking for the answer to the quiz, I came upon this note from a male participating in Phase 3 of the Telapavir trials. I figured that it's worth reading......

http://lloydwright.org/Hepatitis/index.php?option=com_content&task=view&id=310&Itemid=65
From: Jeff B
Sent: Tuesday, August 26, 2008 4:02 PM
To: Lloyd
Subject: LloydsHepCMessages: Stopped telapavir, INF & RVN after 18 days. Had
a heart attack

This is an enquiry e-mail via http://lloydwright.org/Hepatitis from: Jeff B

I entered a phase 3 drug trial for Telaprevir that lasted 18 days before I quit taking the 3 drugs; Interferon alfa-2a, Ribavirin and Telaprevir. The main reason that I quit was because I had a heart attack that lasted about 5 seconds on the 17th day of the trial. Today I read that Telaprevir and Interferon and cause this.

During the 18 days of treatment, I had ringing in my ears and buzzing in my head along with the usual restless sleep, stomach-abdominal aches and itching. Thinking, studying and concentration were not possible. These powerful drugs did alter the course of my HCV infection. It has been 4
days since my last doses of Ribavirin and Telaprevir and a week since my last Interferon injection. My brain has recovered about 90-95% from the drugs. During my 18 day trial, I was eating fish 4 times a week. I could tell that it helped my brain to recover from the drugs.

In 22 weeks, test results will be published. Then I will know how far the Viral load fell during my short trial.

I want to know if anyone has evaluated the short and long term effects on the brain with a pet scan or other analysis tools during Interferon-Ribavirin therapy?

I asked the research people at Cedars-Sinai about such testing but they had no information.
===============
Note: There's more in the link.

[woofer]

This isn't a technical answer, but it's about the best one I could find......

1) Kurt Graves, the Executive Vice President of Vertex answers a question, this being part of his response to a question about Telaprevir....

"Because in the study C208 not only are we seeing the highest on treatment response rates that we have ever seen with telaprevir to date over 80% for weeks. We are seeing the lowest discontinuation rates that we have seen in the study with telaprevir so far and that's because when we entered the study we see to it and our Phase 3 programs we have implemented the rash management program in those studies and are feeling good and hearing good things for investigators about how they are implementing that in the studies."
http://seekingalpha.com/article/119488-vertex-pharmaceuticals-incorporated-q4-2008-earnings-call-transcript?page=6

2) I'm guessing on this one, but since they doubled the dosage on some of the patients, perhaps they were/are less apt to get the fire in the hole because pruritus develops over time, not in the beginning stages of taking Telaprevir.

Quiz re Telaprevir’s “Fire in the Hole”

Recognizing that fire in the hole is a bona fide issue for Telaprevir-based regimens, VRTX introduced two wrinkles in the phase-3 trial designs to ameliorate this side effect. What are these two wrinkles?