MALACHITE 1: 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

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01854697
• Collaborator: (none)
• Enrollment: 311
• Arms: 5
• Duration (Months): 28

Study Details

Study Description

Brief Summary

This is 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Infection	Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin; Drug: Telaprevir; Drug: Pegylated Interferon alpha 2-a (PegIFN)	Phase 3

Detailed Description

The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegIFN) and RBV and to compare the safety of these regimens in treatment-naive hepatitis C virus (HCV) genotype (GT) 1a- and 1b-infected adults.

Study Design

• Study Type: Interventional
• Actual Enrollment: 311 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With and Without Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I)
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm A: 3-DAA + RBV in GT1a ABT-450/r/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based RBV for 12 weeks (3 direct-acting antivirals [DAAs] with RBV in GT1a)	Drug: ABT-450/r/ABT-267, ABT-333; Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Other Names: Viekira Pak ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ABT-333 also known as dasabuvir Holkira Pak ; Drug: Ribavirin; Tablet
Active Comparator: Arm B: TPV/PR in GT1a Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegIFN 180 µg/week and weight-based RBV (PR) 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)	Drug: Ribavirin; Tablet; Drug: Telaprevir; Film-coated tablet; Drug: Pegylated Interferon alpha 2-a (PegIFN); Pre-filled syringe
Experimental: Arm C: 3-DAA + RBV in GT1b 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)	Drug: ABT-450/r/ABT-267, ABT-333; Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Other Names: Viekira Pak ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ABT-333 also known as dasabuvir Holkira Pak ; Drug: Ribavirin; Tablet
Experimental: Arm D: 3-DAA 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)	Drug: ABT-450/r/ABT-267, ABT-333; Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Other Names: Viekira Pak ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ABT-333 also known as dasabuvir Holkira Pak
Active Comparator: Arm E: TPV/PR 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)	Drug: Ribavirin; Tablet; Drug: Telaprevir; Film-coated tablet; Drug: Pegylated Interferon alpha 2-a (PegIFN); Pre-filled syringe

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses [12 weeks after the last actual dose of active study drug]

   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.

Secondary Outcome Measures

1. Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS) [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]

   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).

2. Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS) [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]

   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).

3. Percentage of Participants With SVR12 - Secondary Efficacy Analyses [12 weeks after the last actual dose of active study drug]

   The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 12 weeks after the last dose of study drug.

4. Percentage of Participants With Virologic Failure During Treatment [12 weeks for Arms A, C and D and 24 weeks or 48 weeks for Arms B and E]

   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.

5. Percentage of Participants With Post-treatment Relapse [Within 24 weeks post treatment]

   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.

6. Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24) [24 weeks after the last actual dose of active study drug]

   The percentage of participants with sustained virologic response (plasma HCV RNA level < LLOQ) 24 weeks after the last dose of study drug.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males or females between 18 and 65 years, inclusive, at time of Screening

• Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control

• Subject has never received antiviral treatment for hepatitis C infection

• Chronic HCV Genotype-1 infection prior to study enrollment

Exclusion Criteria:

• Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab)

• Females who are pregnant or plan to become pregnant, or breastfeeding

• Any current or past clinical evidence of cirrhosis

• Screening laboratory analyses that showing abnormal laboratory results

• Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for telaprevir, pegIFN and RBV

• Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol

• Positive screen for drugs or alcohol

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Yan Luo, MD, PhD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT01854697
• Other Study ID Numbers: M13-774; 2012-003754-84
• First Posted: May 15, 2013
• Last Update Posted: Jun 6, 2018
• Last Verified: Jul 1, 2016

• Keywords provided by AbbVie: Chronic Hepatitis C; Interferon Free; Hepatitis C Treatment Naive; Hepatitis C Virus; Hepatitis C Genotype 1
• Additional relevant MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic; Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a

Study Results

Participant Flow

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
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

Baseline Characteristics

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
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 Participants	69	34	84	83	41	311
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	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 (participants) [Number]
< 55 years	46 66.7%	23 67.6%	59 70.2%	60 72.3%	31 75.6%	219 70.4%
>= 55 years	23 33.3%	11 32.4%	25 29.8%	23 27.7%	10 24.4%	92 29.6%
Sex: Female, Male (Count of Participants)
Female	21 30.4%	17 50%	46 54.8%	43 51.8%	24 58.5%	151 48.6%
Male	48 69.6%	17 50%	38 45.2%	40 48.2%	17 41.5%	160 51.4%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses
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

Outcome Measure Data

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
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)
Measure Participants	69	34	84	83	41
Number [percentage of participants]	97.1 140.7%	82.4 242.4%	98.8 117.6%	97.6 117.6%	78.0 190.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
	Comments
	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	14.7
	Confidence Interval	(2-Sided) 95%; 1.3 to 28.2
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
	Comments
	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	19.5
	Confidence Interval	(2-Sided) 95%; 6.4 to 32.6
	Parameter Dispersion	Type: Value:
	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)
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

Outcome Measure Data

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
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)
Measure Participants	69	32	84	83	40
Mean (Standard Deviation) [units on a scale]	-4.2 (10.59)	-5.8 (12.18)	-0.3 (8.89)	-0.1 (7.73)	-6.4 (11.78)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.351
	Comments
	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

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	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

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	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

3. Secondary Outcome

Title	Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS)
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

Outcome Measure Data

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
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)
Measure Participants	69	32	84	83	40
Mean (Standard Deviation) [units on a scale]	0.5 (8.63)	-5.5 (8.26)	0.4 (5.80)	2.2 (4.34)	-5.5 (11.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	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

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	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

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	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

4. Secondary Outcome

Title	Percentage of Participants With SVR12 - Secondary Efficacy Analyses
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

Outcome Measure Data

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
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)
Measure Participants	69	34	84	83	41
Number [percentage of participants]	97.1 140.7%	82.4 242.4%	98.8 117.6%	97.6 117.6%	78.0 190.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.021
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
	Comments
	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	20.8
	Confidence Interval	(2-Sided) 95%; 7.9 to 33.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	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
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.005
	Comments
	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
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

Outcome Measure Data

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
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)
Measure Participants	69	34	84	83	41
Number [percentage of participants]	2.9 4.2%	5.9 17.4%	0 0%	1.2 1.4%	12.2 29.8%

6. Secondary Outcome

Title	Percentage of Participants With Post-treatment Relapse
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

Outcome Measure Data

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
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)
Measure Participants	66	28	84	81	32
Number [percentage of participants]	0 0%	0 0%	1.2 1.4%	0 0%	6.3 15.4%

7. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24)
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

Outcome Measure Data

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
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)
Measure Participants	69	34	84	83	41
Number [percentage of participants]	95.7 138.7%	82.4 242.4%	97.6 116.2%	97.6 117.6%	78.0 190.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm A: 3-DAA + RBV in GT1a, Arm B: TPV/PR in GT1a
	Comments
	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	13.3
	Confidence Interval	(2-Sided) 95%; -0.4 to 27.0
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference (95% CI) from TPV/PR within GT1a. Calculated using the normal approximation to the binomial distribution.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Arm C: 3-DAA + RBV in GT1b, Arm E: TPV/PR in GT1b
	Comments
	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	19.6
	Confidence Interval	(2-Sided) 95%; 6.5 to 32.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Arm D: 3-DAA in GT1b, Arm E: TPV/PR in GT1b
	Comments
	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%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference
	Estimated Value	19.5
	Confidence Interval	(2-Sided) 95%; 6.4 to 32.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference (95% CI) from TPV/PR within GT1b. Calculated using the normal approximation to the binomial distribution.

Adverse Events

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.
Arm/Group Title	3 DAA + RBV		3 DAA		TPV + PEGIFN + RBV
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	3 DAA + RBV		3 DAA		TPV + PEGIFN + RBV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/153 (0.7%)		0/83 (0%)		9/75 (12%)
Blood and lymphatic system disorders
ANAEMIA	0/153 (0%)		0/83 (0%)		2/75 (2.7%)
Eye disorders
RETINOPATHY	0/153 (0%)		0/83 (0%)		1/75 (1.3%)
Gastrointestinal disorders
HAEMATOCHEZIA	0/153 (0%)		0/83 (0%)		1/75 (1.3%)
General disorders
CHEST PAIN	0/153 (0%)		0/83 (0%)		1/75 (1.3%)
Infections and infestations
ABSCESS LIMB	0/153 (0%)		0/83 (0%)		1/75 (1.3%)
CELLULITIS	0/153 (0%)		0/83 (0%)		1/75 (1.3%)
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE	0/153 (0%)		0/83 (0%)		1/75 (1.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER	1/153 (0.7%)		0/83 (0%)		0/75 (0%)
Respiratory, thoracic and mediastinal disorders
COUGH	0/153 (0%)		0/83 (0%)		1/75 (1.3%)
Skin and subcutaneous tissue disorders
TOXIC SKIN ERUPTION	0/153 (0%)		0/83 (0%)		1/75 (1.3%)
Other (Not Including Serious) Adverse Events
	3 DAA + RBV		3 DAA		TPV + PEGIFN + RBV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	100/153 (65.4%)		29/83 (34.9%)		74/75 (98.7%)
Blood and lymphatic system disorders
ANAEMIA	10/153 (6.5%)		1/83 (1.2%)		32/75 (42.7%)
LEUKOPENIA	0/153 (0%)		0/83 (0%)		4/75 (5.3%)
NEUTROPENIA	0/153 (0%)		0/83 (0%)		14/75 (18.7%)
Eye disorders
VISION BLURRED	0/153 (0%)		1/83 (1.2%)		5/75 (6.7%)
Gastrointestinal disorders
ABDOMINAL PAIN UPPER	3/153 (2%)		1/83 (1.2%)		6/75 (8%)
ANAL PRURITUS	1/153 (0.7%)		0/83 (0%)		10/75 (13.3%)
ANORECTAL DISCOMFORT	1/153 (0.7%)		0/83 (0%)		4/75 (5.3%)
DIARRHOEA	15/153 (9.8%)		7/83 (8.4%)		12/75 (16%)
DRY MOUTH	5/153 (3.3%)		0/83 (0%)		4/75 (5.3%)
HAEMORRHOIDS	0/153 (0%)		0/83 (0%)		4/75 (5.3%)
NAUSEA	32/153 (20.9%)		7/83 (8.4%)		30/75 (40%)
VOMITING	11/153 (7.2%)		1/83 (1.2%)		14/75 (18.7%)
General disorders
ASTHENIA	11/153 (7.2%)		2/83 (2.4%)		15/75 (20%)
CHILLS	3/153 (2%)		3/83 (3.6%)		7/75 (9.3%)
FATIGUE	21/153 (13.7%)		4/83 (4.8%)		23/75 (30.7%)
INFLUENZA LIKE ILLNESS	3/153 (2%)		1/83 (1.2%)		7/75 (9.3%)
INJECTION SITE ERYTHEMA	0/153 (0%)		0/83 (0%)		5/75 (6.7%)
PYREXIA	4/153 (2.6%)		2/83 (2.4%)		16/75 (21.3%)
Infections and infestations
NASOPHARYNGITIS	13/153 (8.5%)		4/83 (4.8%)		7/75 (9.3%)
UPPER RESPIRATORY TRACT INFECTION	10/153 (6.5%)		1/83 (1.2%)		3/75 (4%)
URINARY TRACT INFECTION	2/153 (1.3%)		1/83 (1.2%)		5/75 (6.7%)
Metabolism and nutrition disorders
DECREASED APPETITE	6/153 (3.9%)		1/83 (1.2%)		17/75 (22.7%)
HYPERTRIGLYCERIDAEMIA	0/153 (0%)		0/83 (0%)		4/75 (5.3%)
HYPOKALAEMIA	1/153 (0.7%)		0/83 (0%)		5/75 (6.7%)
HYPOPHOSPHATAEMIA	1/153 (0.7%)		0/83 (0%)		4/75 (5.3%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	3/153 (2%)		2/83 (2.4%)		6/75 (8%)
BACK PAIN	4/153 (2.6%)		1/83 (1.2%)		4/75 (5.3%)
MYALGIA	7/153 (4.6%)		2/83 (2.4%)		12/75 (16%)
Nervous system disorders
DIZZINESS	7/153 (4.6%)		2/83 (2.4%)		13/75 (17.3%)
DYSGEUSIA	2/153 (1.3%)		0/83 (0%)		6/75 (8%)
HEADACHE	41/153 (26.8%)		16/83 (19.3%)		23/75 (30.7%)
LETHARGY	6/153 (3.9%)		0/83 (0%)		4/75 (5.3%)
Psychiatric disorders
DEPRESSION	3/153 (2%)		0/83 (0%)		7/75 (9.3%)
INSOMNIA	14/153 (9.2%)		0/83 (0%)		7/75 (9.3%)
IRRITABILITY	11/153 (7.2%)		0/83 (0%)		7/75 (9.3%)
Respiratory, thoracic and mediastinal disorders
COUGH	11/153 (7.2%)		1/83 (1.2%)		8/75 (10.7%)
DYSPNOEA	7/153 (4.6%)		0/83 (0%)		5/75 (6.7%)
Skin and subcutaneous tissue disorders
ALOPECIA	1/153 (0.7%)		1/83 (1.2%)		10/75 (13.3%)
DRY SKIN	3/153 (2%)		1/83 (1.2%)		4/75 (5.3%)
ECZEMA	1/153 (0.7%)		0/83 (0%)		4/75 (5.3%)
ERYTHEMA	1/153 (0.7%)		0/83 (0%)		4/75 (5.3%)
PRURITUS	19/153 (12.4%)		5/83 (6%)		26/75 (34.7%)
RASH	12/153 (7.8%)		0/83 (0%)		17/75 (22.7%)
RASH PRURITIC	1/153 (0.7%)		0/83 (0%)		7/75 (9.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.