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A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before (MALACHITE 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01854697
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : February 22, 2016
Last Update Posted : June 6, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Hepatitis C Infection
Interventions Drug: ABT-450/r/ABT-267, ABT-333
Drug: Ribavirin
Drug: Telaprevir
Drug: Pegylated Interferon alpha 2-a (PegIFN)
Enrollment 311
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
Hide Arm/Group Description ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 Direct-Acting Antivirals (DAAs) with RBV in genotype [GT] 1a) Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a) ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b) ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b) Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Period Title: Overall Study
Started 69 34 84 83 41
Completed 63 31 82 80 39
Not Completed 6 3 2 3 2
Reason Not Completed
Adverse Event             1             0             0             0             1
Lost to Follow-up             4             1             1             2             0
To enter another AbbVie study             1             0             0             0             1
Withdrew Consent             0             1             0             1             0
Other             0             1             1             0             0
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b Total
Hide Arm/Group Description ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a) TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a) ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b) ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b) Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b) Total of all reporting groups
Overall Number of Baseline Participants 69 34 84 83 41 311
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 34 participants 84 participants 83 participants 41 participants 311 participants
46.1  (12.25) 44.5  (14.10) 46.2  (11.34) 47.1  (11.33) 45.9  (10.78) 46.2  (11.75)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 34 participants 84 participants 83 participants 41 participants 311 participants
< 55 years 46 23 59 60 31 219
>= 55 years 23 11 25 23 10 92
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 69 participants 34 participants 84 participants 83 participants 41 participants 311 participants
Female
21
  30.4%
17
  50.0%
46
  54.8%
43
  51.8%
24
  58.5%
151
  48.6%
Male
48
  69.6%
17
  50.0%
38
  45.2%
40
  48.2%
17
  41.5%
160
  51.4%
1.Primary Outcome
Title Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses
Hide Description The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid [HCV RNA] level less than the lower limit of quantitation [< LLOQ]) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of active study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
Hide Arm/Group Description:
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Number of Participants Analyzed 69 34 84 83 41
Measure Type: Number
Unit of Measure: percentage of participants
97.1 82.4 98.8 97.6 78.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of –10.5%.
Method of Estimation Estimation Parameter Difference
Estimated Value 14.7
Confidence Interval (2-Sided) 95%
1.3 to 28.2
Estimation Comments Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The primary endpoint assessment comparison was made within each of the 2 HCV genotypes (GT1a and GT1b). Within HCV GT1a, the 3-DAA + RBV and TPV/PR arms were compared. Within HCV GT1b, the 3-DAA and TPV/PR arms were compared. The test treatment arm was considered noninferior to the TPV/PR arm in the respective HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of –10.5%.
Method of Estimation Estimation Parameter Difference
Estimated Value 19.5
Confidence Interval (2-Sided) 95%
6.4 to 32.6
Estimation Comments Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.
2.Secondary Outcome
Title Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS)
Hide Description SF-36V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQoL) covering 2 summary measures: physical component summary (PCS) and MCS; it consists of 8 subscales. The MCS is represented by 4 subscales: vitality, social function, role limitations due to emotional problems, and mental health. Participants self-report on items in a subscale that have choices per item. Scoring is done for both MCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).
Time Frame From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
Hide Arm/Group Description:
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Number of Participants Analyzed 69 32 84 83 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.2  (10.59) -5.8  (12.18) -0.3  (8.89) -0.1  (7.73) -6.4  (11.78)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.351
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included baseline score and region as covariates and treatment arm as a factor.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 2.13
Confidence Interval (2-Sided) 95%
-2.39 to 6.65
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.28
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included baseline score and region as covariates and treatment arm as a factor.
Method of Estimation Estimation Parameter Least Squares Mean of Difference
Estimated Value 5.83
Confidence Interval (2-Sided) 95%
2.19 to 9.47
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.84
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included baseline score and region as covariates and treatment arm as a factor.
Method of Estimation Estimation Parameter Least Squares Mean of Difference
Estimated Value 5.28
Confidence Interval (2-Sided) 95%
2.01 to 8.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.65
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)
Hide Description SF-36V2 is a generic 36-item questionnaire measuring HRQoL covering 2 summary measures: PCS and MCS; it consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQoL) to 100 (best HRQoL).
Time Frame From Day 1 of treatment up to 12 weeks for Arms A, C and D and up to 24 or 48 weeks for Arms B and E
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and a baseline and post-baseline value.
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
Hide Arm/Group Description:
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Number of Participants Analyzed 69 32 84 83 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.5  (8.63) -5.5  (8.26) 0.4  (5.80) 2.2  (4.34) -5.5  (11.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included baseline score and region as covariates and treatment arm as a factor.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 6.08
Confidence Interval (2-Sided) 95%
2.72 to 9.44
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included baseline score and region as covariates and treatment arm as a factor.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 6.20
Confidence Interval (2-Sided) 95%
3.55 to 8.85
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.34
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA model included baseline score and region as covariates and treatment arm as a factor.
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 6.86
Confidence Interval (2-Sided) 95%
4.36 to 9.37
Parameter Dispersion
Type: Standard Error of the Mean
Value: 1.27
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Participants With SVR12 - Secondary Efficacy Analyses
Hide Description The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.
Time Frame 12 weeks after the last actual dose of active study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
Hide Arm/Group Description:
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Number of Participants Analyzed 69 34 84 83 41
Measure Type: Number
Unit of Measure: percentage of participants
97.1 82.4 98.8 97.6 78.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Regression, Logistic
Comments Logistic regression model with treatment arm, baseline log10 HCV RNA level, and interleukin 28B (IL28B) genotype (CC versus non-CC) as predictors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 7.2
Confidence Interval (2-Sided) 95%
1.4 to 38.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.
Method of Estimation Estimation Parameter Difference
Estimated Value 20.8
Confidence Interval (2-Sided) 95%
7.9 to 33.6
Estimation Comments Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Regression, Logistic
Comments Calculated using logistic regression model with treatment arm, baseline log10 HCV RNA level, and IL28B genotype (CC versus non-CC) as predictors.
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 28.2
Confidence Interval (2-Sided) 95%
3.3 to 241.1
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratum-adjusted Cochran-Mantel-Haenszel after adjusting for IL28B genotype (CC or non-CC).
5.Secondary Outcome
Title Percentage of Participants With Virologic Failure During Treatment
Hide Description

Participants in Arms A, C or D demonstrating any of the following were considered virologic failures and discontinued therapy:

  • Confirmed increase from nadir in HCV RNA (defined as 2 consecutive HCV RNA measurements of >1 log10 IU/mL above nadir) at any time point during treatment
  • Failure to achieve HCV RNA < LLOQ by Week 6 or
  • Confirmed HCV RNA ≥ LLOQ (defined as 2 consecutive HCV RNA measurements ≥ LLOQ) at any point after HCV RNA < LLOQ during treatment after HCV RNA < LLOQ.

Participants in Arms B and E followed virologic stopping criteria described in the TPV Summary of Product Characteristics; they were considered virologic failures and discontinued therapy as follows:

  • HCV RNA > 1000 IU/mL at Week 4 to Week 12, discontinue TPV and pegIFN and RBV
  • HCV RNA > 1000 IU/mL at Week 12, discontinue pegIFN and RBV
  • Confirmed HCV RNA > lower limit of detection (LLOD) at Week 24, discontinue pegIFN and RBV
  • Confirmed HCV RNA > LLOD at Week 36, discontinue pegIFN and RBV.
Time Frame 12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
Hide Arm/Group Description:
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Number of Participants Analyzed 69 34 84 83 41
Measure Type: Number
Unit of Measure: percentage of participants
2.9 5.9 0 1.2 12.2
6.Secondary Outcome
Title Percentage of Participants With Post-treatment Relapse
Hide Description Hepatitis C virus (HCV) ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (LLOQ) between the end of treatment and 24 weeks post treatment among participants completing treatment and with HCV RNA less than the LLOQ at the end of treatment.
Time Frame Within 24 weeks post treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug and had sustained virologic response at Week 24 (SVR24).
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
Hide Arm/Group Description:
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Number of Participants Analyzed 66 28 84 81 32
Measure Type: Number
Unit of Measure: percentage of participants
0 0 1.2 0 6.3
7.Secondary Outcome
Title Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
Hide Description The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.
Time Frame 24 weeks after the last actual dose of active study drug
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population: all randomized participants who received at least 1 dose of study drug.
Arm/Group Title Arm A: 3-DAA + RBV in GT1a Arm B: TPV/PR in GT1a Arm C: 3-DAA + RBV in GT1b Arm D: 3-DAA in GT1b Arm E: TPV/PR in GT1b
Hide Arm/Group Description:
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
Overall Number of Participants Analyzed 69 34 84 83 41
Measure Type: Number
Unit of Measure: percentage of participants
95.7 82.4 97.6 97.6 78.0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The test treatment arm was considered noninferior to the TPV/PR arm in the GT1a HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.
Method of Estimation Estimation Parameter Difference
Estimated Value 13.3
Confidence Interval (2-Sided) 95%
-0.4 to 27.0
Estimation Comments Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.
Method of Estimation Estimation Parameter Difference
Estimated Value 19.6
Confidence Interval (2-Sided) 95%
6.5 to 32.7
Estimation Comments Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The test treatment arm was considered noninferior to the TPV/PR arm in the GT1b HCV subtype if the lower bound of the 2-sided 95% CI for the treatment arm difference was above the noninferiority margin of -10.5%.
Method of Estimation Estimation Parameter Difference
Estimated Value 19.5
Confidence Interval (2-Sided) 95%
6.4 to 32.6
Estimation Comments Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.
Time Frame Adverse Events (AEs) collected from time of study drug administration until 30 days following discontinuation or completion of study drug administration, up to 96 weeks. Serious AEs collected from signing of informed consent until study completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 3 DAA + RBV 3 DAA TPV + PEGIFN + RBV
Hide Arm/Group Description ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks TPV 750 mg q8h and pegIFN 180 μg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir
All-Cause Mortality
3 DAA + RBV 3 DAA TPV + PEGIFN + RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
3 DAA + RBV 3 DAA TPV + PEGIFN + RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/153 (0.65%)   0/83 (0.00%)   9/75 (12.00%) 
Blood and lymphatic system disorders       
ANAEMIA  1  0/153 (0.00%)  0/83 (0.00%)  2/75 (2.67%) 
Eye disorders       
RETINOPATHY  1  0/153 (0.00%)  0/83 (0.00%)  1/75 (1.33%) 
Gastrointestinal disorders       
HAEMATOCHEZIA  1  0/153 (0.00%)  0/83 (0.00%)  1/75 (1.33%) 
General disorders       
CHEST PAIN  1  0/153 (0.00%)  0/83 (0.00%)  1/75 (1.33%) 
Infections and infestations       
ABSCESS LIMB  1  0/153 (0.00%)  0/83 (0.00%)  1/75 (1.33%) 
CELLULITIS  1  0/153 (0.00%)  0/83 (0.00%)  1/75 (1.33%) 
Injury, poisoning and procedural complications       
ACCIDENTAL OVERDOSE  1  0/153 (0.00%)  0/83 (0.00%)  1/75 (1.33%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
PROSTATE CANCER  1  1/153 (0.65%)  0/83 (0.00%)  0/75 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  0/153 (0.00%)  0/83 (0.00%)  1/75 (1.33%) 
Skin and subcutaneous tissue disorders       
TOXIC SKIN ERUPTION  1  0/153 (0.00%)  0/83 (0.00%)  1/75 (1.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
3 DAA + RBV 3 DAA TPV + PEGIFN + RBV
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   100/153 (65.36%)   29/83 (34.94%)   74/75 (98.67%) 
Blood and lymphatic system disorders       
ANAEMIA  1  10/153 (6.54%)  1/83 (1.20%)  32/75 (42.67%) 
LEUKOPENIA  1  0/153 (0.00%)  0/83 (0.00%)  4/75 (5.33%) 
NEUTROPENIA  1  0/153 (0.00%)  0/83 (0.00%)  14/75 (18.67%) 
Eye disorders       
VISION BLURRED  1  0/153 (0.00%)  1/83 (1.20%)  5/75 (6.67%) 
Gastrointestinal disorders       
ABDOMINAL PAIN UPPER  1  3/153 (1.96%)  1/83 (1.20%)  6/75 (8.00%) 
ANAL PRURITUS  1  1/153 (0.65%)  0/83 (0.00%)  10/75 (13.33%) 
ANORECTAL DISCOMFORT  1  1/153 (0.65%)  0/83 (0.00%)  4/75 (5.33%) 
DIARRHOEA  1  15/153 (9.80%)  7/83 (8.43%)  12/75 (16.00%) 
DRY MOUTH  1  5/153 (3.27%)  0/83 (0.00%)  4/75 (5.33%) 
HAEMORRHOIDS  1  0/153 (0.00%)  0/83 (0.00%)  4/75 (5.33%) 
NAUSEA  1  32/153 (20.92%)  7/83 (8.43%)  30/75 (40.00%) 
VOMITING  1  11/153 (7.19%)  1/83 (1.20%)  14/75 (18.67%) 
General disorders       
ASTHENIA  1  11/153 (7.19%)  2/83 (2.41%)  15/75 (20.00%) 
CHILLS  1  3/153 (1.96%)  3/83 (3.61%)  7/75 (9.33%) 
FATIGUE  1  21/153 (13.73%)  4/83 (4.82%)  23/75 (30.67%) 
INFLUENZA LIKE ILLNESS  1  3/153 (1.96%)  1/83 (1.20%)  7/75 (9.33%) 
INJECTION SITE ERYTHEMA  1  0/153 (0.00%)  0/83 (0.00%)  5/75 (6.67%) 
PYREXIA  1  4/153 (2.61%)  2/83 (2.41%)  16/75 (21.33%) 
Infections and infestations       
NASOPHARYNGITIS  1  13/153 (8.50%)  4/83 (4.82%)  7/75 (9.33%) 
UPPER RESPIRATORY TRACT INFECTION  1  10/153 (6.54%)  1/83 (1.20%)  3/75 (4.00%) 
URINARY TRACT INFECTION  1  2/153 (1.31%)  1/83 (1.20%)  5/75 (6.67%) 
Metabolism and nutrition disorders       
DECREASED APPETITE  1  6/153 (3.92%)  1/83 (1.20%)  17/75 (22.67%) 
HYPERTRIGLYCERIDAEMIA  1  0/153 (0.00%)  0/83 (0.00%)  4/75 (5.33%) 
HYPOKALAEMIA  1  1/153 (0.65%)  0/83 (0.00%)  5/75 (6.67%) 
HYPOPHOSPHATAEMIA  1  1/153 (0.65%)  0/83 (0.00%)  4/75 (5.33%) 
Musculoskeletal and connective tissue disorders       
ARTHRALGIA  1  3/153 (1.96%)  2/83 (2.41%)  6/75 (8.00%) 
BACK PAIN  1  4/153 (2.61%)  1/83 (1.20%)  4/75 (5.33%) 
MYALGIA  1  7/153 (4.58%)  2/83 (2.41%)  12/75 (16.00%) 
Nervous system disorders       
DIZZINESS  1  7/153 (4.58%)  2/83 (2.41%)  13/75 (17.33%) 
DYSGEUSIA  1  2/153 (1.31%)  0/83 (0.00%)  6/75 (8.00%) 
HEADACHE  1  41/153 (26.80%)  16/83 (19.28%)  23/75 (30.67%) 
LETHARGY  1  6/153 (3.92%)  0/83 (0.00%)  4/75 (5.33%) 
Psychiatric disorders       
DEPRESSION  1  3/153 (1.96%)  0/83 (0.00%)  7/75 (9.33%) 
INSOMNIA  1  14/153 (9.15%)  0/83 (0.00%)  7/75 (9.33%) 
IRRITABILITY  1  11/153 (7.19%)  0/83 (0.00%)  7/75 (9.33%) 
Respiratory, thoracic and mediastinal disorders       
COUGH  1  11/153 (7.19%)  1/83 (1.20%)  8/75 (10.67%) 
DYSPNOEA  1  7/153 (4.58%)  0/83 (0.00%)  5/75 (6.67%) 
Skin and subcutaneous tissue disorders       
ALOPECIA  1  1/153 (0.65%)  1/83 (1.20%)  10/75 (13.33%) 
DRY SKIN  1  3/153 (1.96%)  1/83 (1.20%)  4/75 (5.33%) 
ECZEMA  1  1/153 (0.65%)  0/83 (0.00%)  4/75 (5.33%) 
ERYTHEMA  1  1/153 (0.65%)  0/83 (0.00%)  4/75 (5.33%) 
PRURITUS  1  19/153 (12.42%)  5/83 (6.02%)  26/75 (34.67%) 
RASH  1  12/153 (7.84%)  0/83 (0.00%)  17/75 (22.67%) 
RASH PRURITIC  1  1/153 (0.65%)  0/83 (0.00%)  7/75 (9.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
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Name/Title: Global Medical Information
Organization: AbbVie
Phone: 800-633-9110
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01854697    
Other Study ID Numbers: M13-774
2012-003754-84 ( EudraCT Number )
First Submitted: April 8, 2013
First Posted: May 15, 2013
Results First Submitted: November 4, 2015
Results First Posted: February 22, 2016
Last Update Posted: June 6, 2018