GIFT-II: Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02023112
• Collaborator: (none)
• Enrollment: 171
• Arms: 2
• Duration (Months): 20

Study Details

Study Description

Brief Summary

This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Virus	Drug: ABT-450/r/ABT-267; Drug: Ribavirin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 171 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) Co-administered With Ribavirin (RBV) for 12 or 16 Weeks in Treatment-Naïve and Treatment-Experienced Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT-II)
• Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-450/r/ABT-267 plus RBV for 12 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks	Drug: ABT-450/r/ABT-267; Tablet; ABT-450 coformulated with ritonavir and ABT-267; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir also known as Norvir VIEKIRAX Combination Tablets VIEKIRA Combination Tablets Technivie Qurevo ; Drug: Ribavirin; Capsule
Experimental: ABT-450/r/ABT-267 plus RBV for 16 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks	Drug: ABT-450/r/ABT-267; Tablet; ABT-450 coformulated with ritonavir and ABT-267; Other Names: ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir also known as Norvir VIEKIRAX Combination Tablets VIEKIRA Combination Tablets Technivie Qurevo ; Drug: Ribavirin; Capsule

Outcome Measures

Primary Outcome Measures

1. Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [12 weeks after 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.

Secondary Outcome Measures

1. Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period [12 or 16 weeks (end of treatment period)]

   On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).

2. Percentage of Participants With Post-treatment Relapse [within 12 weeks after the last dose of study drug]

   Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.

3. Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations [12 weeks after last dose of study drug]

   The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.

4. Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations [12 or 16 weeks (end of treatment period)]

   The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).

5. Percentage of Participants With Post-treatment Relapse Within Different Subpopulations [within 12 weeks after the last dose of study drug]

   The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Chronic HCV-infection prior to study enrollment

• Screening laboratory result indicating HCV genotype 2 infection

• Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening

• Voluntarily sign an informed consent

Exclusion Criteria:

• Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2

• Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir

• Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease

• Clinically significant laboratory abnormalities

• Uncontrolled clinically significant disease, disorder or medical illness

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Yasunori Yachi, AbbVie GK.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Sato K, Chayama K, Alves K, Toyoda H, Suzuki F, Kato K, Rodrigues L Jr, Zhang X, Setze C, Pilot-Matias T, Burroughs M, Redman R, Kumada H. Randomized Phase 3 Trial of Ombitasvir/Paritaprevir/Ritonavir and Ribavirin for Hepatitis C Virus Genotype 2-Infected Japanese Patients. Adv Ther. 2017 Jun;34(6):1449-1465. doi: 10.1007/s12325-017-0506-y. Epub 2017 May 23.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02023112
• Other Study ID Numbers: M14-153
• First Posted: Dec 30, 2013
• Last Update Posted: Jul 30, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by AbbVie: Japanese; Hepatitis C; Treatment naive; Treatment experienced; Genotype 2; Ombitasvir; Paritaprevir; Ritonavir; Ribavirin; VIEKIRAX Combination Tablets
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Ritonavir; Ribavirin

Study Results

Participant Flow

Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Period Title: Overall Study
STARTED	85	86
COMPLETED	83	85
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks	Total
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks	Total of all reporting groups
Overall Participants	85	86	171
Age, Customized (participants) [Number]
< 65 years	56 65.9%	62 72.1%	118 69%
≥ 65 years	29 34.1%	24 27.9%	53 31%
Sex: Female, Male (Count of Participants)
Female	40 47.1%	48 55.8%	88 51.5%
Male	45 52.9%	38 44.2%	83 48.5%

Outcome Measures

1. Primary Outcome

Title	Percentage of Non-cirrhotic, Treatment-naive Participants in Each Treatment Group With a Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
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 last dose of study drug

Outcome Measure Data

Analysis Population Description

Primary efficacy population: all treatment-naïve, noncirrhotic participants in the intent-to-treat (ITT) population (all randomized participants who received at least 1 dose of study drug).

Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Measure Participants	48	47
Number [percentage of participants]	75.0 88.2%	91.5 106.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-450/r/ABT-267 Plus RBV for 16 Weeks
	Comments	Among non-cirrhotic treatment-naïve participants, superiority of the 16-week treatment arm to a clinically relevant threshold. Lower bound of 95% confidence interval (LCB) must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-interferon (IFN) alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants with SVR12
	Estimated Value	91.5
	Confidence Interval	(2-Sided) 95%; 80.1 to 96.6
	Parameter Dispersion	Type: Value:
	Estimation Comments	Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABT-450/r/ABT-267 Plus RBV for 12 Weeks
	Comments	Among non-cirrhotic treatment-naïve participants, superiority of the 12-week treatment arm to a clinically relevant threshold. LCB must have exceeded 67% to achieve superiority. Threshold indicates value the LCB had to exceed to demonstrate superiority for the treatment arm and was based on the SVR rates with pegylated-IFN alfa-2a or 2b/RBV in treatment-naïve, noncirrhotic HCV genotype 2-infected participants.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	percentage of participants with SVR12
	Estimated Value	75.0
	Confidence Interval	(2-Sided) 95%; 61.2 to 85.1
	Parameter Dispersion	Type: Value:
	Estimation Comments	Tested using the following hierarchical order: among non-cirrhotic treatment-naïve participants 1) superiority of 16-week treatment arm to a clinically relevant threshold; 2) superiority of 12-week treatment arm to a clinically relevant threshold.

2. Secondary Outcome

Title	Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period
Description	On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).
Time Frame	12 or 16 weeks (end of treatment period)

Outcome Measure Data

Analysis Population Description

Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug).

Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Measure Participants	48	47
Overall	8.3 9.8%	8.5 9.9%
Rebound	8.3 9.8%	8.5 9.9%
Failure to suppress	0 0%	0 0%

3. Secondary Outcome

Title	Percentage of Participants With Post-treatment Relapse
Description	Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.
Time Frame	within 12 weeks after the last dose of study drug

Outcome Measure Data

Analysis Population Description

Primary efficacy population: all treatment-naïve, noncirrhotic participants in the ITT population (all randomized participants who received at least 1 dose of study drug) with HCV RNA < LLOQ at the final treatment visit who completed treatment.

Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Measure Participants	41	47
Number [percentage of participants]	12.2 14.4%	0 0%

4. Secondary Outcome

Title	Percentage of Participants With SVR12 Weeks Post-treatment for Each Treatment Arm Within Different Subpopulations
Description	The percentage of participants with SVR12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; noncirrhotic participants who relapsed after prior IFN-based therapy (relapsers); noncirrhotic T-exp participants who were non-responders to prior IFN-based therapy; noncirrhotic T-exp participants who were intolerant to IFN-based therapy; participants with compensated cirrhosis.
Time Frame	12 weeks after 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; n=participants in given subpopulation.

Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Measure Participants	85	86
All participants; n=85, 86	72.9 85.8%	81.4 94.7%
Noncirrhotic participants; n=80, 80	72.5 85.3%	85.0 98.8%
Noncirrhotic T-exp; n=32, 33	68.8 80.9%	75.8 88.1%
Noncirrhotic T-exp Relapser; n=15, 16	80.0 94.1%	93.8 109.1%
Noncirrhotic T-exp Nonresponder; n=5, 6	40.0 47.1%	50.0 58.1%
Noncirrhotic T-exp IFN-intolerant; n=12, 11	66.7 78.5%	63.6 74%
Cirrhotic Participants; n=5, 6	80.0 94.1%	33.3 38.7%

5. Secondary Outcome

Title	Percentage of Participants in Each Treatment Arm With On-treatment Virologic Failure During the Treatment Period for Each Treatment Arm Within Different Subpopulations
Description	The percentage of participants with on-treatment virologic failure in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. On-treatment virologic failure was defined as rebound (confirmed HCV RNA ≥ LLOQ after HCV RNA < LLOQ during treatment, or confirmed increase from nadir in HCV RNA [> 1 log10 IU/mL above nadir] at any time point during treatment) or failure to suppress HCV during treatment (all on-treatment values of HCV RNA ≥ LLOQ with at least 6 weeks of treatment).
Time Frame	12 or 16 weeks (end of treatment period)

Outcome Measure Data

Analysis Population Description

ITT population: all randomized participants who received at least 1 dose of study drug; n=participants in given subpopulation.

Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Measure Participants	85	86
All Participants: Overall; n=85, 86	15.3 18%	16.3 19%
All Participants: Rebound; n=85, 86	15.3 18%	15.1 17.6%
All Participants: Failure to Suppress; n=85, 86	4.7 5.5%	4.7 5.5%
Noncirrhotic: Overall; n=80, 80	15.0 17.6%	13.8 16%
Noncirrhotic: Rebound; n=80, 80	15.0 17.6%	12.5 14.5%
Noncirrhotic: Failure to Suppress; n=80, 80	3.8 4.5%	3.8 4.4%
Noncirrhotic T-exp: Overall; n=32, 33	25.0 29.4%	21.2 24.7%
Noncirrhotic T-exp: Rebound; n=32, 33	25.0 29.4%	18.2 21.2%
Noncirrhotic T-exp: Failure to Suppress; n=32, 33	9.4 11.1%	9.1 10.6%
Cirrhotic: Overall; n=5, 6	20.0 23.5%	50.0 58.1%
Cirrhotic: Rebound; n=5, 6	20.0 23.5%	50.0 58.1%
Cirrhotic: Failure to Suppress; n=5, 6	20.0 23.5%	16.7 19.4%

6. Secondary Outcome

Title	Percentage of Participants With Post-treatment Relapse Within Different Subpopulations
Description	The percentage of participants with relapse by post-treatment Week 12 in each treatment arm within the following subpopulations: noncirrhotic participants; noncirrhotic treatment-experienced (T-exp) participants; participants with compensated cirrhosis. Relapse by post-treatment Week 12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug for a participant with HCV RNA < LLOQ at the final treatment visit and who completed study treatment. Completion of treatment was defined as a study drug duration ≥ 77 days for the 12-week treatment arm or ≥ 105 days for the 16-week treatment arm.
Time Frame	within 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 with HCV RNA < LLOQ at the final treatment visit who completed treatment; n=participants in given subpopulation.

Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks	ABT-450/r/ABT-267 Plus RBV for 16 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
Measure Participants	69	70
All Participants; n=69, 70	10.1 11.9%	0 0%
Noncirrhotic Participants; n=65, 68	10.8 12.7%	0 0%
Noncirrhotic T-exp Participants; n=24, 25	8.3 9.8%	0 0%
Cirrhotic Participants; n=4, 2	0 0%	0 0%

Adverse Events

Time Frame	Non-serious adverse events collected from initiation of study drug through 30 days post-study drug dosing (12 weeks or 16 weeks, depending on arm assignment); serious adverse events collected from signing of Informed Consent up to Post-treatment Week 48.
Arm/Group Title	ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants		ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants		ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants		ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants
All Cause Mortality
	ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/80 (0%)		3/80 (3.8%)		0/5 (0%)		0/6 (0%)
Gastrointestinal disorders
GASTRITIS ALCOHOLIC	0/80 (0%)		1/80 (1.3%)		0/5 (0%)		0/6 (0%)
Infections and infestations
BRONCHOPNEUMONIA	0/80 (0%)		1/80 (1.3%)		0/5 (0%)		0/6 (0%)
Injury, poisoning and procedural complications
INCISIONAL HERNIA	0/80 (0%)		1/80 (1.3%)		0/5 (0%)		0/6 (0%)
Other (Not Including Serious) Adverse Events
	ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)		ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/80 (65%)		53/80 (66.3%)		3/5 (60%)		4/6 (66.7%)
Blood and lymphatic system disorders
ANAEMIA	16/80 (20%)		20/80 (25%)		0/5 (0%)		1/6 (16.7%)
Cardiac disorders
PALPITATIONS	1/80 (1.3%)		0/80 (0%)		0/5 (0%)		1/6 (16.7%)
Eye disorders
VITREOUS HAEMORRHAGE	0/80 (0%)		0/80 (0%)		0/5 (0%)		1/6 (16.7%)
Gastrointestinal disorders
DIARRHOEA	4/80 (5%)		0/80 (0%)		0/5 (0%)		1/6 (16.7%)
NAUSEA	5/80 (6.3%)		3/80 (3.8%)		0/5 (0%)		0/6 (0%)
General disorders
FATIGUE	6/80 (7.5%)		2/80 (2.5%)		0/5 (0%)		0/6 (0%)
MALAISE	4/80 (5%)		7/80 (8.8%)		0/5 (0%)		0/6 (0%)
PYREXIA	2/80 (2.5%)		4/80 (5%)		0/5 (0%)		0/6 (0%)
Infections and infestations
NASOPHARYNGITIS	10/80 (12.5%)		13/80 (16.3%)		0/5 (0%)		0/6 (0%)
Injury, poisoning and procedural complications
CONTUSION	0/80 (0%)		4/80 (5%)		0/5 (0%)		0/6 (0%)
HEAT ILLNESS	0/80 (0%)		0/80 (0%)		1/5 (20%)		0/6 (0%)
Investigations
BLOOD BILIRUBIN INCREASED	16/80 (20%)		14/80 (17.5%)		0/5 (0%)		1/6 (16.7%)
BLOOD CHOLESTEROL DECREASED	3/80 (3.8%)		4/80 (5%)		0/5 (0%)		0/6 (0%)
HAEMOGLOBIN DECREASED	6/80 (7.5%)		4/80 (5%)		1/5 (20%)		0/6 (0%)
NEUTROPHIL COUNT DECREASED	1/80 (1.3%)		4/80 (5%)		0/5 (0%)		0/6 (0%)
RED BLOOD CELL COUNT DECREASED	4/80 (5%)		3/80 (3.8%)		0/5 (0%)		0/6 (0%)
RETICULOCYTE COUNT INCREASED	6/80 (7.5%)		5/80 (6.3%)		0/5 (0%)		0/6 (0%)
WHITE BLOOD CELL COUNT DECREASED	1/80 (1.3%)		4/80 (5%)		0/5 (0%)		0/6 (0%)
BLOOD URIC ACID INCREASED	0/80 (0%)		0/80 (0%)		1/5 (20%)		0/6 (0%)
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS	0/80 (0%)		0/80 (0%)		1/5 (20%)		0/6 (0%)
Nervous system disorders
HEADACHE	11/80 (13.8%)		6/80 (7.5%)		1/5 (20%)		0/6 (0%)
DIZZINESS	2/80 (2.5%)		2/80 (2.5%)		0/5 (0%)		1/6 (16.7%)
SOMNOLENCE	0/80 (0%)		0/80 (0%)		1/5 (20%)		0/6 (0%)
Renal and urinary disorders
POLLAKIURIA	0/80 (0%)		0/80 (0%)		1/5 (20%)		0/6 (0%)
URINARY RETENTION	0/80 (0%)		0/80 (0%)		1/5 (20%)		0/6 (0%)
Respiratory, thoracic and mediastinal disorders
COUGH	4/80 (5%)		5/80 (6.3%)		0/5 (0%)		0/6 (0%)
Skin and subcutaneous tissue disorders
PRURITUS	7/80 (8.8%)		9/80 (11.3%)		0/5 (0%)		1/6 (16.7%)
RASH	4/80 (5%)		4/80 (5%)		0/5 (0%)		0/6 (0%)
PRURITUS GENERALISED	0/80 (0%)		1/80 (1.3%)		1/5 (20%)		0/6 (0%)
Vascular disorders
HOT FLUSH	0/80 (0%)		1/80 (1.3%)		1/5 (20%)		0/6 (0%)
HYPOTENSION	2/80 (2.5%)		0/80 (0%)		0/5 (0%)		1/6 (16.7%)

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.