MALACHITE II: A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01854528
• Collaborator: (none)
• Enrollment: 148
• Arms: 2
• Duration (Months): 25

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

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

Detailed Description

A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267] and ABT-333) plus ribavirin (3-DAA/RBV) compared with the combination of telaprevir (TPV) with RBV and pegIFN (TPV/RBV) in noncirrhotic participants with chronic hepatitis C virus genotype 1 (HCV GT1) infection who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Participants were randomized in a 2:1 ratio to receive 3-DAA/RBV (ABT-450/r/ABT-267 and ABT-333 plus RBV for 12 weeks) or TPV/RBV (TPV co-administered with pegIFN and RBV for 12 weeks, followed by followed by pegIFN and RBV for either 12 or 36 weeks, per local prescribing information).

Study Design

• Study Type: Interventional
• Actual Enrollment: 148 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon a-2a and Ribavirin in Treatment-Experienced Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE-II)
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3-DAA/RBV 3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	Drug: ABT-450/r/ABT-267, ABT-333; Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ABT-333 also known as dasabuvir Viekira PAK ; Drug: Ribavirin; Tablet
Active Comparator: TPV/RBV TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.	Drug: Ribavirin; Tablet; Drug: Pegylated Interferon a-2a (PegINF); Pre-filled syringe; Drug: Telaprevir; Film-coated tablet

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment [12 weeks after the last dose of 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. The LLOQ for the assay was 25 IU/mL.

Secondary Outcome Measures

1. Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) [Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)]

   The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being).

2. Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2) [Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)]

   The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).

3. Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment [24 weeks after the last dose of 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]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.

4. Percentage of Participants With Virologic Failure During Treatment [Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)]

   Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment.

5. Percentage of Participants With Virologic Relapse After Treatment [Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)]

   Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile

• Chronic hepatitis C infection (positive for anti-HCV antibody or HCV RNA at least 6 months before screening and at the time of screening; or positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection)

• Screening laboratory result indicating HCV genotype 1 infection (HCV GT1)

• Participant must have documentation of adherence to a prior pegIFN/RBV combination therapy and meet one of the protocol definitions for treatment failure: null responder, partial responder, relapser

• No evidence of liver cirrhosis

Exclusion Criteria:

• Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

• Positive screen for drugs or alcohol

• Significant sensitivity to any drug

• Use of contraindicated medications within 2 weeks of dosing

• Abnormal laboratory tests

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Yan Luo, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT01854528
• Other Study ID Numbers: M13-862; 2012-003738-18
• First Posted: May 15, 2013
• Last Update Posted: Jun 6, 2018
• Last Verified: Jun 1, 2016

• Keywords provided by AbbVie: Partial responder; Interferon free; Treatment-experienced; Relapser; Hepatitis C Virus; Null responder; Hepatitis C Genotype 1; paritaprevir; ombitasvir; dasabuvir; ribavirin; Viekira PAK; Chronic hepatitis C
• Additional relevant MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Interferons; Ribavirin

Study Results

Participant Flow

Pre-assignment Detail	A total of 154 participants were randomized: 6 participants did not receive at least 1 dose of study drug and were excluded from the analyses; 148 participants received at least 1 dose and were included in the intent-to-treat (ITT) population.

Arm/Group Title	3-DAA/RBV	TPV/RBV
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
Period Title: Overall Study
STARTED	101	47
COMPLETED	101	32
NOT COMPLETED	0	15

Baseline Characteristics

Arm/Group Title	3-DAA/RBV	TPV/RBV	Total
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.	Total of all reporting groups
Overall Participants	101	47	148
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	46.9 (12.15)	45.0 (10.35)	46.3 (11.61)
Sex: Female, Male (Count of Participants)
Female	46 45.5%	19 40.4%	65 43.9%
Male	55 54.5%	28 59.6%	83 56.1%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
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. The LLOQ for the assay was 25 IU/mL.
Time Frame	12 weeks after the last dose of study drug

Outcome Measure Data

Analysis Population Description

ITT population: All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	3-DAA/RBV	TPV/RBV
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
Measure Participants	101	47
Number [percentage of participants]	100.0 99%	66.0 140.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	3-DAA/RBV, TPV/RBV
	Comments	P-value for the difference in sustained virologic response rates 12 weeks after the last dose between treatment groups with HCV subgenotype (1a, non-1a) from stratum adjusted Mantel-Haenszel with previous type of response to pegIFN/RBV treatment (relapser, partial or null responder) as strata.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Stratum adjusted Mantel-Haenszel
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	34.26
	Confidence Interval	(2-Sided) 95%; 21.09 to 47.42
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Mean Change From Baseline to Final Treatment Visit in the Mental Component Summary (MCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)
Description	The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into an MCS score (from 0 to 100; a higher score indicates better mental function and well-being).
Time Frame	Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data.

Arm/Group Title	3-DAA/RBV	TPV/RBV
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
Measure Participants	101	45
Mean (Standard Deviation) [units on a scale]	-1.3 (8.32)	-9.8 (11.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	3-DAA/RBV, TPV/RBV
	Comments	P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	8.64
	Confidence Interval	(2-Sided) 95%; 5.43 to 11.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Mean Change From Baseline to Final Treatment Visit in the Physical Component Summary (PCS) Score of the Short-Form 36 Health Survey - Version 2 (SF-36v2)
Description	The SF-36v2 is a general health-related quality of life (HRQoL) instrument with extensive use in multiple disease states. The SF-36v2 instrument comprises a total of 36 items (questions) targeting a participant's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Domain scores were aggregated into a PCS score (range = 0 to 100; a higher score indicates better mental function and well-being).
Time Frame	Baseline and Final Treatment Visit (up to Week 12 for 3-DAA/RBV and up to Week 24 or 48 for TPV/RBV)

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data.

Arm/Group Title	3-DAA/RBV	TPV/RBV
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
Measure Participants	101	45
Mean (Standard Deviation) [units on a scale]	0.4 (7.16)	-7.7 (7.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	3-DAA/RBV, TPV/RBV
	Comments	P-value from ANCOVA model including baseline score and region as covariates and treatment arm as a factor.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	LS mean difference
	Estimated Value	7.55
	Confidence Interval	(2-Sided) 95%; 5.11 to 9.98
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment
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]) 24 weeks after the last dose of study drug. The LLOQ for the assay was 25 IU/mL.
Time Frame	24 weeks after the last dose of study drug

Outcome Measure Data

Analysis Population Description

All participants in the ITT population with evaluable data.

Arm/Group Title	3-DAA/RBV	TPV/RBV
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
Measure Participants	101	47
Number [percentage of participants]	99.0 98%	66.0 140.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	3-DAA/RBV, TPV/RBV
	Comments	P-value from logistic regression model including treatment arm, baseline log10 HCV RNA level, HCV subgenotype, and previous response to pegIFN/RBV treatment as predictors.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	54.7
	Confidence Interval	(2-Sided) 95%; 6.9 to 435.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Percentage of Participants With Virologic Failure During Treatment
Description	Virologic failure during treatment was defined as HCV ribonucleic acid (RNA) confirmed greater than or equal to the lower limit of quantification (≥ LLOQ) after HCV RNA < LLOQ during treatment or confirmed HCV RNA ≥ LLOQ at the end of treatment.
Time Frame	Baseline to end of treatment (12 weeks for 3-DAA/RBV and 24 or 48 weeks for TPV/RBV)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	3-DAA/RBV	TPV/RBV
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
Measure Participants	101	47
Number (95% Confidence Interval) [percentage of participants]	0 0%	19.1 40.6%

6. Secondary Outcome

Title	Percentage of Participants With Virologic Relapse After Treatment
Description	Participants who completed treatment with plasma HCV RNA less than the lower limit of quantification (<LLOQ) at the end of treatment were considered to have virologic relapse if they had confirmed HCV RNA ≥ LLOQ during the post-treatment period.
Time Frame	Between end of treatment (Week 12 for 3-DAA/RBV and Week 24 or 48 for TPV/RBV) and Post-treatment (up to Week 12 Post-treatment)

Outcome Measure Data

Analysis Population Description

ITT population.

Arm/Group Title	3-DAA/RBV	TPV/RBV
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.	TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
Measure Participants	101	47
Number (95% Confidence Interval) [percentage of participants]	0 0%	6.3 13.4%

Adverse Events

Time Frame	AEs were collected from the time of study drug administration to 30 days after last dose of study drug (up to 52 weeks); SAEs were also collected from the time that informed consent was obtained until the end of the study (total up to 101 weeks).
Adverse Event Reporting Description	AEs were collected from first dose to 30 days after last dose (16 weeks for 12-week treatment, 28 weeks for 24-week treatment, 52 weeks for 48-week treatment); SAEs were collected from the time that informed consent was obtained to end of study (up to 65 weeks for 12-week treatment, 77 weeks for 24-week treatment, 101 weeks for 48-week treatment).
Arm/Group Title	3-DAA/RBV		TPV/RBV
Arm/Group Description	3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.		TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
All Cause Mortality
	3-DAA/RBV		TPV/RBV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	3-DAA/RBV		TPV/RBV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/101 (1%)		5/47 (10.6%)
Blood and lymphatic system disorders
ANAEMIA	0/101 (0%)		2/47 (4.3%)
Gastrointestinal disorders
ABDOMINAL PAIN	0/101 (0%)		1/47 (2.1%)
General disorders
INJECTION SITE PHLEBITIS	0/101 (0%)		1/47 (2.1%)
Infections and infestations
APPENDICITIS	1/101 (1%)		0/47 (0%)
DIARRHOEA INFECTIOUS	0/101 (0%)		1/47 (2.1%)
STAPHYLOCOCCAL SEPSIS	0/101 (0%)		1/47 (2.1%)
Nervous system disorders
EPILEPSY	1/101 (1%)		0/47 (0%)
Skin and subcutaneous tissue disorders
ECZEMA	0/101 (0%)		1/47 (2.1%)
Other (Not Including Serious) Adverse Events
	3-DAA/RBV		TPV/RBV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	54/101 (53.5%)		43/47 (91.5%)
Blood and lymphatic system disorders
ANAEMIA	3/101 (3%)		14/47 (29.8%)
LEUKOPENIA	0/101 (0%)		5/47 (10.6%)
NEUTROPENIA	1/101 (1%)		12/47 (25.5%)
THROMBOCYTOPENIA	0/101 (0%)		4/47 (8.5%)
Gastrointestinal disorders
ABDOMINAL PAIN	3/101 (3%)		4/47 (8.5%)
ABDOMINAL PAIN UPPER	3/101 (3%)		4/47 (8.5%)
ANAL PRURITUS	0/101 (0%)		12/47 (25.5%)
APHTHOUS STOMATITIS	0/101 (0%)		3/47 (6.4%)
HAEMORRHOIDS	0/101 (0%)		3/47 (6.4%)
NAUSEA	10/101 (9.9%)		20/47 (42.6%)
VOMITING	3/101 (3%)		7/47 (14.9%)
General disorders
ASTHENIA	8/101 (7.9%)		16/47 (34%)
CHEST PAIN	0/101 (0%)		3/47 (6.4%)
CHILLS	3/101 (3%)		5/47 (10.6%)
FATIGUE	12/101 (11.9%)		12/47 (25.5%)
GENERAL PHYSICAL HEALTH DETERIORATION	0/101 (0%)		3/47 (6.4%)
INFLUENZA LIKE ILLNESS	0/101 (0%)		4/47 (8.5%)
INJECTION SITE ERYTHEMA	0/101 (0%)		3/47 (6.4%)
PYREXIA	2/101 (2%)		15/47 (31.9%)
Infections and infestations
GASTROENTERITIS	2/101 (2%)		3/47 (6.4%)
NASOPHARYNGITIS	5/101 (5%)		5/47 (10.6%)
Metabolism and nutrition disorders
DECREASED APPETITE	3/101 (3%)		8/47 (17%)
HYPERTRIGLYCERIDAEMIA	1/101 (1%)		3/47 (6.4%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	3/101 (3%)		8/47 (17%)
MUSCLE SPASMS	2/101 (2%)		3/47 (6.4%)
MYALGIA	3/101 (3%)		9/47 (19.1%)
Nervous system disorders
DIZZINESS	5/101 (5%)		7/47 (14.9%)
DYSGEUSIA	1/101 (1%)		4/47 (8.5%)
HEADACHE	29/101 (28.7%)		21/47 (44.7%)
LETHARGY	5/101 (5%)		3/47 (6.4%)
PARAESTHESIA	0/101 (0%)		3/47 (6.4%)
Psychiatric disorders
DEPRESSED MOOD	0/101 (0%)		3/47 (6.4%)
DEPRESSION	0/101 (0%)		3/47 (6.4%)
INSOMNIA	6/101 (5.9%)		10/47 (21.3%)
IRRITABILITY	2/101 (2%)		5/47 (10.6%)
Respiratory, thoracic and mediastinal disorders
COUGH	7/101 (6.9%)		12/47 (25.5%)
OROPHARYNGEAL PAIN	1/101 (1%)		3/47 (6.4%)
Skin and subcutaneous tissue disorders
ALOPECIA	0/101 (0%)		6/47 (12.8%)
DRY SKIN	0/101 (0%)		7/47 (14.9%)
ECZEMA	0/101 (0%)		3/47 (6.4%)
PRURITUS	13/101 (12.9%)		19/47 (40.4%)
PRURITUS GENERALISED	0/101 (0%)		3/47 (6.4%)
RASH	3/101 (3%)		12/47 (25.5%)

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.