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Your instincts on the current focus being on Geno Ones match the words of my
specialist who told me three weeks ago that "...we are concentrating on
Genotype One right now..."  meaning that conventional IFN/Rba retreatment
for geno ones and even initial treatment, are not up to satisfactory success
levels, as in my particular case.  The expanded costs of treating infected
patients for the rest of their lives must be pretty steep compared to the
(low?) costs of treating the virus successfully.

cactus jammies -------------------------

This is the abstract for one of Vertex' poster sessions scheduled for
tomorrow. This study was exclusively g1 patients.

Cheers

/greyhackles

CURRENT STATUS OF SUBJECTS RECEIVING PEG-INTERFERON-ALFA-2a (Peg-IFN) AND
RIBAVIRIN (RBV) AFTER A 14-DAY STUDY OF THE HEPATITIS C PROTEASE INHIBITOR
TELAPREVIR (VX-950), WITH Peg-IFN
N. Forestier1; C. J. Weegink2; S. Purdy3; L. McNair3; P. L. Jansen2; S.
Zeuzem1; H. W. Reesink2
1. Saarland University Hospital, Homburg/Saar, Germany.
2. Academic Medical Center, Amsterdam, Netherlands.
3. Vertex Pharmaceuticals Incorporated, Cambridge, MA, USA.

 
Purpose: Telaprevir (VX-950) is a highly selective peptidomimetic inhibitor of
the hepatitis C virus (HCV) NS3-4A protease that is designed to block HCV
replication. This 14-day study was designed to explore the viral kinetics and
safety during dosing with telaprevir in combination with peginterferon-
alfa-2a (Peg-IFN). Results previously reported indicated that telaprevir, with
and without Peg-IFN was well-tolerated in this study with no serious adverse
events, and the addition of Peg-IFN increased the strong antiviral effects of
telaprevir. Here we report patient status during off-study follow-on therapy
with Peg-IFN and RBV.
Methods: The VX04-950-103 clinical study randomized twenty treatment-naïve
patients with chronic genotype 1 hepatitis C infection to three dosing arms.
Eight patients received telaprevir (750 mg as tablets q8h) and Peg-IFN on Days
1 and 8 and eight patients received telaprevir alone. Four patients received
Peg-IFN alone on Days 1 and 8. At the completion of the 14-day study,
off-study standard therapy with Peg-IFN and RBV was offered to all patients,
and response to this therapy was collected periodically. Results: In patients
receiving telaprevir and Peg-IFN, the median decrease in HCV RNA was 5.5-log10
at the end of dosing, with 6/8 patients below the limit of quantitation (30
IU/mL) and 4/8 below the limit of detection (10 IU/mL). None of the patients
in the telaprevir /Peg-IFN group had an increase in HCV RNA levels during
dosing. In patients receiving telaprevir alone, the median HCV RNA decrease
was 4.0-log10, with 1/8 patients below 10 IU/mL. In patients receiving Peg-IFN
alone, the median HCV RNA decrease was 1.0-log10. Nineteen of 20 patients
began standard therapy within 5 days of completing the 14-day dosing period.
At the last on-study follow-up day (12 weeks after the completion of the
study), all patients in the telaprevir and Peg-IFN group had undetectable HCV
RNA, and 5 of 7 patients in the telaprevir alone group had undetectable HCV
RNA. Current responses of the patients who continued standard therapy will be
discussed.
Conclusions: The clinical data continue to demonstrate the substantial
antiviral effects of telaprevir monotherapy and the increased antiviral
effects of telaprevir in combination with Peg-IFN. Nineteen patients started
standard therapy at the completion of study dosing; 8 of 8 patients who
received telaprevir and Peg-IFN remained HCV RNA undetectable 12 weeks later,
and continue to be followed for antiviral response.