To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.
DARE-C is a prospective open label multi-centre pilot study examining the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin and Telaprevir) for the treatment of early chronic HCV genotype 1 infection in individuals with and without HIV infection.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly.
St Vincent's Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)
Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)
Time frame: 12 weeks post-treatment
SVR24
To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)
Time frame: 24 weeks post-treatment
Undetectable HCV RNA (ETR)
To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)
Time frame: Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Undetectable HCV RNA (Week 1)
To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.
Time frame: Week 1 of therapy
Undectectable HCV RNA (Week 2)
To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.
Time frame: Week 2 of therapy
Undetectable HCV RNA (Week 3)
To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy.
Time frame: Week 3 of therapy
Undetectable HCV RNA (Week 4)
To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy.
Time frame: Week 4 of therapy
Decrease in Absolute Neutrophil Count (ANC) ≤0.75
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Time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Decrease in Platelets <50
Time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Change in Hemoglobin at End of Treatment
To evaluate indicators of toxicity during telaprevir based therapy
Time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Resistance-associated Variants
To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection
Time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Baseline Resistance-associated Variants
To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection.
Time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Plasma Ribavirin Levels
To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy
Time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
CD4 and HIV RNA
In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy
Time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Gene IL28B Polymorphism
To examine treatment outcome by IL28B polymorphism
Time frame: Baseline