On
December 13, Tibotec and
Vertex Pharmaceuticals announced
the first results from a planned 12-week interim analysis of data from the PROVE
1 study, an ongoing Phase IIb trial of the investigational hepatitis C virus (HCV)
protease inhibitor telaprevir (VX-950).
This
double-blind study included 250 treatment-naive participants with genotype 1 HCV
infection who received 750 mg telaprevir or placebo every 8 hours, in addition
to pegylated
interferon alpha-2a (Pegasys) plus ribavirin. All patients (n = 175) in the
three arms that received telaprevir were pooled, and results were compared to
those observed in the placebo arm (n = 75). At the time of the analysis, approximately
100 patients had completed 12 weeks of therapy.
Results
•
Of the 74 patients in the telaprevir arms for whom 12-week data were available,
65 (88%) achieved undetectable HCV RNA (less than 10 IU/mL), compared to 17 of
33 patients (52%) in the control arm.
•
The most common adverse
events were similar in the telaprevir and placebo groups, and were consistent
with known side effects of pegylated interferon and ribavirin.
•
Adverse events reported
more often in the telaprevir arms included gastrointestinal symptoms and skin
rash.
•
In the telaprevir arms,
9% of patients discontinued therapy due to adverse events, compared to 3% of patients
in the control arm, due to the greater number of discontinuations for gastrointestinal
disorders, rash, and anemia.
•
3% of subjects in the
telaprevir arms discontinued due to rash the most common adverse event leading
to treatment discontinuation.
•
Serious adverse events
were observed in 3% of patients in the telaprevir groups compared with 1% of patients
in the control group.
"Chronic
hepatitis C infection is a major public health problem, and our goal is to increase
the success rate of hepatitis C treatment with short-duration therapy," said
Roger Pomerantz, MD, President of Tibotec Research and Development. "This
interim analysis of PROVE 1 is an important step forward in the telaprevir clinical
development program, as it strongly supports the initiation and conduct of large
Phase III clinical trials designed to evaluate the safety and antiviral activity
of telaprevir."
The company noted that these interim data must be
confirmed by the results of the final analysis before conclusions can be drawn
about the safety and efficacy of telaprevir.
Vertex is conducting a global
Phase IIb clinical development program for telaprevir consisting of 3 large clinical
trials that together are expected to enroll approximately 1000 patients with chronic
hepatitis C at clinical centers in the United States and Europe. PROVE 1, conducted
in the U.S., is fully enrolled. PROVE 2 is underway in Europe and is expected
to complete enrollment soon.
Additional
VX 950 (Telaprevir)
Articles Posted on HIV and Hepatitis.com
Source Tibotec
and Vertex Pharmaceuticals. Results of First Interim Safety and Antiviral Analysis
of the PROVE 1 Clinical Trial of Investigational HCV Protease Inhibitor Telaprevir
(VX-950). Press Release. December 13, 2006.
