The purpose of this study is to evaluate the effectiveness and safety of telaprevir, given with pegylated-interferon-alfa-2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in the treatment of hepatitis C in patients infected with both chronic hepatitis C virus (HCV-1) and human immunodeficiency virus (HIV-1).
This is an open-label (both participant and investigator know the name of the medication given at a certain moment), single-arm, multicenter study in HCV treatment-naive and treatment-experienced patients infected with both chronic HCV-1 and HIV-1 to determine the efficacy and safety of telaprevir given with Peg-IFN-alfa-2a and RBV. The study will consist of 3 phases: a screening phase, an open-label treatment phase up to 48 weeks, and a follow-up period of 24 weeks. All patients will receive 12 weeks of treatment with telaprevir given with Peg-IFN-alfa-2a and RBV. At week 12 telaprevir dosing will end and patients will continue on Peg-IFN-alfa-2a and RBV. The total treatment duration in this study will be 24 or 48 weeks depending on the patient's prior HCV treatment status, liver disease status, and individual on-treatment virologic response in this study (equal response guided therapy). The maximum total duration of participation in the study for an individual participant will be approximately 76 weeks (screening included). Approximately 150 patients infected with both chronic HCV-1 and HIV-1 are planned to be enrolled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
163
Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.
Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.
Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.
Unnamed facility
Cairns, Australia
Unnamed facility
Darlinghurst, Australia
Proportion of patients achieving undetectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
Proportion of patients achieving sustained virologic response (SVR) undetectable plasma HCV RNA levels 12 weeks after the last planned dose of study medication.
Time frame: Up to 48 weeks
Change from baseline in log HCV RNA values
Change from baseline in log HCV RNA values at each time point during treatment.
Time frame: Baseline and week 48
Proportiond of patients achieving undetectable HCV RNA levels
Proportion of patients achieving SVR24 planned, defined as having undetectable plasma HCV RNA levels 24 weeks after the last planned dose of study medication.
Time frame: Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA levels at Week 4
The proportion of patients who achieve rapid virologic response (RVR) and undetectable HCV RNA levels at Week 4 of treatment.
Time frame: Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA levels at Week 12
Proportion of patients achieving undetectable HCV RNA levels at Week 12 of treatment.
Time frame: Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 (eRVR)
Proportion of patients achieving undetectable HCV RNA levels at Week 4 and Week 12 of treatment (eRVR).
Time frame: Up to 48 weeks
Proportion of patients achieving undetectable HCV RNA at the actual end of treatment
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Unnamed facility
Melbourne, Australia
Unnamed facility
Campinas, Brazil
Unnamed facility
Rio de Janeiro, Brazil
Unnamed facility
Santo André, Brazil
Unnamed facility
São Paulo, Brazil
Unnamed facility
Le Kremlin-Bicêtre, France
Unnamed facility
Marseille, France
Unnamed facility
Nice, France
...and 21 more locations
Proportion of patients having undetectable HCV RNA levels at the actual end of treatment (ie, Week 24, Week 48, or early discontinuation).
Time frame: Up to 48 weeks
Proportion of patients achieving less than 25 IU/mL
Proportion of patients having less than 25 IU/mL at the planned end of treatment (ie, Week 24 or Week 48).
Time frame: Up to 48 weeks
Proportion of patients with on-treatment virologic failure
Proportion of patients with on-treatment virologic failure (an increase greater than 1 log in HCV RNA level from the lowest level reached, or a value of HCV RNA greater than 100 IU/mL in patients whose HCV RNA has previously become less than 25 IU/mL during treatment).
Time frame: Up to 48 weeks
Proportion of patients with relapse achieving detectable HCV RNA levels after previously undetectable HCV RNA levels
Proportion of patients who relapse (having confirmed detectable HCV RNA during the follow-up period after previous undetectable HCV RNA levels (less than 25 IU/mL, undetectable) at planned end of treatment.
Time frame: Up to 48 weeks
Proportion of patients with relapse achieving detectable HCV RNA levels after previous HCV RNA levels
Proportion of patients who relapse, defined as having confirmed detectable HCV RNA during the follow-up period after previous HCV RNA less than 25 IU/mL at planned end of treatment.
Time frame: Up to 48 weeks