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Medical Forum / Diseases and Disorders / Hepatitis / December 2006

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Nasty side effects with VX-950

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anonymousone - 15 Dec 2006 03:09 GMT
http://www.investors.com/editorial/IBDArticles.asp?artsec=9&issue=20061213

Vertex Pharmaceuticals (VRTX) had 9% of patients involved in clinical
trials for hepatitis C drug VX-950 drop out of the tests because of
adverse effects, including gastrointestinal disorders and rash. Shares
fell 1.8% to 38.70.
greyhackles - 15 Dec 2006 03:38 GMT
>http://www.investors.com/editorial/IBDArticles.asp?artsec=9&issue=20061213
>
> Vertex Pharmaceuticals (VRTX) had 9% of patients involved in clinical
>trials for hepatitis C drug VX-950 drop out of the tests because of
>adverse effects, including gastrointestinal disorders and rash. Shares
>fell 1.8% to 38.70.

Yes, the press release was pointed to by smith21347 yesterday
http://www.vrtx.com/Pressreleases2006/pr121306.html
and there were some hints in their presentations at the AASLD Boston
convention in November. I didn't want to say anything lest be accused
of....something or another ;-) but now that you've let the cat out o' the
bag....

All study arms are populated with g-1 patients, without regard to viral load
at onset of therapy, weight, or race/ethnicity. That's goodness - raises the
likelihood they didn't cherry-pick the cohort. All arms are using Pegasys and
Copegus (I think PegIntron would probably have an even higher success rate,
but Vertex is working with Roche and not Schering). The VX950 arms got a fixed
dose three times per day along with the standard doses of Peg and Riba.

The down-side of the results so far in this Phase 2b study is the control
group (IFN + Riba, no VX950) had a 3% drop-out rate while the arms with VX950
combined to a 9% drop-out rate, "due to rash, gastrointestinal disorders, and
anemia".

Very much on the up side, however, to this point the VX950 arms are sporting
an 88% early response rate - 65 of 74 patients were *undetectable* (below 10
IU/ml) at week 12, compared to 52% for the control arms.

That's a huge improvement, and if a similar advance is demonstrated in the SVR
rates as the study runs its course, I can see this drug being rolled out early
in 2008.

Cheers - and keep the faith!

/greyhackles
waz - 15 Dec 2006 07:05 GMT
>>http://www.investors.com/editorial/IBDArticles.asp?artsec=9&issue=20061213
>>
[quoted text clipped - 35 lines]
>
> /greyhackles

Having been to hell and back a number of times myself, I can say that
anemia, rash and gastrointestinal complaints are recognised side effects
from the current treatment (peg and riba. So they might be a little worse
with vertex. Big deal.
smith21347@msn.com - 15 Dec 2006 23:27 GMT
> >>http://www.investors.com/editorial/IBDArticles.asp?artsec=9&issue=20061213
> >>
[quoted text clipped - 40 lines]
> from the current treatment (peg and riba. So they might be a little worse
> with vertex. Big deal.

I want to see the results from Europe where only vx-950 was used
without riba.

                                                             Ron
Cody - 16 Dec 2006 01:16 GMT
>>>> http://www.investors.com/editorial/IBDArticles.asp?artsec=9&issue=20061213
>>>>
[quoted text clipped - 43 lines]
>
>                                                               Ron

Me too.

Cody
greyhackles - 16 Dec 2006 02:03 GMT
>>>>> http://www.investors.com/editorial/IBDArticles.asp?artsec=9&issue=20061213
>>>>>
[quoted text clipped - 43 lines]
>
>Me too.

Do either of you have any expectations?
wrt to efficacy, or sides, or ?

Cheers

/greyhackles
Russian - 18 Dec 2006 09:52 GMT
> Having been to hell and back a number of times myself, I can say that
> anemia, rash and gastrointestinal complaints are recognised side effects
> from the current treatment (peg and riba. So they might be a little worse
> with vertex. Big deal.

We laugh in the face of anemia, rash and gi complaints!  Okay, maybe we
don't laugh in the face of anemia, but we laugh in the face of rash and
GI complaints.  Nothing new there.
Cactus Jammies - 18 Dec 2006 11:50 GMT
I figure I am about due for those GI complaints, so I volunteer for the
relapser's phase (I am begining to wish...)

cactus jammies ====================
>> Having been to hell and back a number of times myself, I can say that
>> anemia, rash and gastrointestinal complaints are recognised side effects
[quoted text clipped - 4 lines]
> don't laugh in the face of anemia, but we laugh in the face of rash and GI
> complaints.  Nothing new there.
 
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