VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

This is an open-label (i.e all people involved know the identity of the intervention),
single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN)
alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for
patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred
to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy,
safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be
evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein
associated with the hepatitis C virus) protease domain will be evaluated. The trial will
consist of a screening period of approximately 28 days, a 48-week treatment period, and a
24-week follow-up period. It is expected that approximately 120 patients could be eligible
for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have
discontinued earlier), patients can only enter the current trial upon invitation. The
investigator will receive an invitation sent by the unblinded independent virology monitor
of the C216 trial for those patients of the C216 trial who were randomized to the control
group and who failed therapy for virologic reasons. Next to this invitation, the patient
will need to fulfill the inclusion and exclusion criteria of the current trial in order to
be eligible to participate. The screening visit for the current trial can only occur after
the patient completes all assessments in the C216 trial, including the Safety Follow-up
Visit. Patients must not enter this trial later than 80 weeks after their first dose in the
C216 trial. In the current trial, all patients will receive 12 weeks of telaprevir 750 mg
every 8 hours (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180
microgram once weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36
weeks of Peg IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA
levels < 25 IU/mL undetectable at the end of treatment (Week 48 or having discontinued
earlier) will be followed for 24 weeks after the last dose of study medication to assess
sustained virologic response (SVR). Safety/tolerability assessments will be performed and
adverse events (AEs), regardless of severity, will be collected continuously until the
Safety Follow-up Visit, scheduled 4 weeks after the last dose of study medication.
Thereafter, only serious adverse events (SAEs) will be reported. All patients will receive
12 weeks of telaprevir 750 mg q8h (orally) in combination with Peg-IFN alfa-2a and RBV at
standard doses, i.e., 180 microgram once weekly (injection) and 1,000 or 1,200 mg/day
(weight-based) (orally), respectively, followed by 36 weeks of Peg IFN alfa-2a and RBV at
standard doses.