Trial Outcomes & Findings for DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C) (NCT NCT01743521)
NCT ID: NCT01743521
Last Updated: 2017-03-29
Results Overview
Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
14 participants
Primary outcome timeframe
12 weeks post-treatment
Results posted on
2017-03-29
Participant Flow
Participant milestones
| Measure |
Group A - 8 Weeks Total Therapy
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
No Group Allocated
Early treatment discontinuation or non-responder (participants in whom therapy was terminated at week 4 due to HCV RNA \>1000 IU/mL or week 8 due to detectable HCV RNA)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
2
|
2
|
|
Overall Study
COMPLETED
|
7
|
3
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)
Baseline characteristics by cohort
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
No Group Allocated
n=2 Participants
Early treatment discontinuation or non-responder
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
49 years
n=5 Participants
|
45 years
n=7 Participants
|
44 years
n=5 Participants
|
57 years
n=4 Participants
|
48 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Estimated Duration of infection at baseline
|
39 weeks
n=5 Participants
|
46 weeks
n=7 Participants
|
50 weeks
n=5 Participants
|
33 weeks
n=4 Participants
|
40.9 weeks
n=21 Participants
|
|
HIV infection
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
11 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeks post-treatmentProportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)
Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)
|
71 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks post-treatmentTo evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)
Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
SVR24
|
43 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)
Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Undetectable HCV RNA (ETR)
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Week 1 of therapyTo evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.
Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Undetectable HCV RNA (Week 1)
|
71.43 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2 of therapyTo evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.
Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Undectectable HCV RNA (Week 2)
|
100 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 3 of therapyPopulation: Missing data carried forward if previously \<LLoQ (lower limit of quantification)
To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy.
Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=5 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=2 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Undetectable HCV RNA (Week 3)
|
100 percentage of participants
|
33.33 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4 of therapyPopulation: Missing data carried forward if previously \<LLoQ
To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy.
Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=5 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Undetectable HCV RNA (Week 4)
|
100 percentage of participants
|
66.67 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Decrease in Absolute Neutrophil Count (ANC) ≤0.75
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Decrease in Platelets <50
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)To evaluate indicators of toxicity during telaprevir based therapy
Outcome measures
| Measure |
Group A - 8 Weeks Total Therapy
n=7 Participants
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 Participants
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 Participants
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Change in Hemoglobin at End of Treatment
|
-31 g/L
Interval -43.0 to -15.0
|
-53 g/L
Interval -63.0 to -47.0
|
-17.5 g/L
Interval -21.0 to -14.0
|
SECONDARY outcome
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)Population: Resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date.
To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)Population: Baseline resistance-associated variants analysis have not yet been performed. These are planned to be performed at a later date.
To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)Population: Ribavirin concentration have not yet been performed. These are planned to be performed at a later date.
To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)Population: This data will not be analysed.
In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselinePopulation: IL28B polymorphisms have not yet been performed. These are planned to be performed at a later date.
To examine treatment outcome by IL28B polymorphism
Outcome measures
Outcome data not reported
Adverse Events
Group A - 8 Weeks Total Therapy
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Group B - 12 Weeks Total Therapy
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group C - 24 Weeks Total Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A - 8 Weeks Total Therapy
n=7 participants at risk
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 participants at risk
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 participants at risk
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
14.3%
1/7 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/3 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Infections and infestations
Axillary Abscess
|
14.3%
1/7 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/3 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Gastrointestinal disorders
Appendicitis
|
0.00%
0/7 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
33.3%
1/3 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
Other adverse events
| Measure |
Group A - 8 Weeks Total Therapy
n=7 participants at risk
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group B - 12 Weeks Total Therapy
n=3 participants at risk
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
Group C - 24 Weeks Total Therapy
n=2 participants at risk
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
TPV/PEG-IFN/RBV: 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.
|
|---|---|---|---|
|
General disorders
Fatigue
|
57.1%
4/7 • Number of events 4 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
66.7%
2/3 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
100.0%
2/2 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Skin and subcutaneous tissue disorders
Rash
|
57.1%
4/7 • Number of events 4 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
66.7%
2/3 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
50.0%
1/2 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
100.0%
3/3 • Number of events 3 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
50.0%
1/2 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Psychiatric disorders
Insomnia
|
57.1%
4/7 • Number of events 4 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
66.7%
2/3 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
42.9%
3/7 • Number of events 3 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
33.3%
1/3 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
100.0%
2/2 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Psychiatric disorders
Change in mood
|
28.6%
2/7 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
66.7%
2/3 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
50.0%
1/2 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Gastrointestinal disorders
Nausea
|
28.6%
2/7 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
33.3%
1/3 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
100.0%
2/2 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
28.6%
2/7 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/3 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
33.3%
1/3 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
50.0%
1/2 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
General disorders
Injection site reaction
|
14.3%
1/7 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
33.3%
1/3 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
Gastrointestinal disorders
Perianal pain
|
14.3%
1/7 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
66.7%
2/3 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
0.00%
0/2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
|
General disorders
Irritability
|
0.00%
0/7 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
66.7%
2/3 • Number of events 2 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
50.0%
1/2 • Number of events 1 • Adverse events encountered during treatment and for 24 weeks after treatment discontinuation were reported for each participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place