NEWS: Encouraging results for VX-950

From the HCV Advocate Newsletter:

Vertex released very promising data today from their PROVE3 clinical
trial that I wanted to share with you.  PROVE3 is a phase II clinical
trial using telaprevir combination therapy to treat people with HCV
genotype 1 who had been previously treated with pegylated interferon
plus ribavirin, but who did not achieve a sustained virological response
(SVR). 

The SVR12 results in the people who received telaprevir ranged from 41%
(prior non-reponders) to 73% (prior treatment relapsers).  

More information: 
In this phase II study, the patient population included treatment
non-responders, treatment relapsers and people who had a viral
breakthrough while on therapy.  The trial participants received 12 weeks
of telaprevir in combination with Pegasys plus ribavirin followed by an
additional 12 weeks of therapy with Pegasys plus ribavirin (without
telaprevir).  The total treatment duration in the telaprevir arm was 24
weeks.  The control arm consisted of HCV genotype 1 patients previously
treated with pegylated interferon plus ribavirin who were deemed
treatment nonresponders, relapsers, and breakthroughs.  The patients in
the control arms were treated with Pegasys plus ribavirin (without
telaprevir) for a treatment duration of 48 weeks.  Since the treatment
duration of the control arm is 48 weeks the SVR12 or SVR rates are not
available.    

The patient population of the group that received the telaprevir
combination therapy consisted of prior non-responders (66 patients),
relapsers (40 patients) and breakthroughs (9 patients):  

The SVR12 results (undetectable HCV RNA twelve weeks after therapy ends)
for the categories of people who did not achieve an SVR while on prior
therapy with pegylated interferon plus ribavirin were re****ted as:  

Non-responders           41% 

Relapsers                   73%

Breakthroughs             44%

Full text at:
http://www.hcvadvocate.org/news/newsRev/2008/News_alert_VX950_june_08.htm

Thomas
-- 
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