TURQUOISE-II: A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267; (ABT-267 Also Known as Ombitasvir) and ABT-333 (Also Known as Dasabuvir) Coadministered With Ribavirin (RBV) in Hepatitis C Virus (HCV) Genotype 1-infected Adults With Compensated Cirrhosis

• Sponsor: AbbVie (prior sponsor, Abbott) (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01704755
• Collaborator: (none)
• Enrollment: 381
• Arms: 2
• Duration (Months): 23

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) coadministered with ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected adults with compensated cirrhosis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Infection; Compensated Cirrhosis	Drug: ABT-450/r/ABT-267, ABT-333; Drug: Ribavirin (RBV)	Phase 3

Detailed Description

During the treatment period of the study, participants received treatment with ABT-450/ritonavir/ABT-267 and ABT-333 coadministered with RBV for either 12 or 24 weeks. Upon completing the treatment period or premature discontinuation of the treatment period, participants entered a 48-week post-treatment period.

Study Design

• Study Type: Interventional
• Actual Enrollment: 381 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered With Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (TURQUOISE-II)
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV for 12 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) 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: Viekira Pak; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir ; Drug: Ribavirin (RBV); Capsule
Experimental: ABT-450/r/ABT-267 and ABT-333, plus RBV for 24 weeks ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks	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-450 also known as paritaprevir; ABT-267 also known as ombitasvir; ABT-333 also known as dasabuvir ; Drug: Ribavirin (RBV); Capsule

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment [12 weeks after the last actual 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 With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm [12 weeks after the last actual dose of study drug]

   A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.

2. Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period [Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24]

   Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).

3. Percentage of Participants With Virologic Relapse After Treatment [within 12 weeks after the last dose of study drug]

   Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 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

• Male or female between 18 and 70 years, inclusive, at time of Screening.

• Chronic HCV-infection prior to study enrollment.

• Screening laboratory result indicating HCV genotype 1-infection.

• Compensated cirrhosis defined as a Child-Pugh Score of less than or equal to 6 at Screening

• Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening.

Exclusion Criteria:

• Significant liver disease with any cause other than HCV as the primary cause

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

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

• Any current or past clinical evidence of Child-Pugh B or C Classification or clinical history of liver decompensation including ascites (noted on physical exam), variceal bleeding or hepatic encephalopathy.

• A positive screening ultrasound for hepatocellular carcinoma (HCC) confirmed with a subsequent CT Scan or MRI during the screening period.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie (prior sponsor, Abbott)

Investigators

• Study Director: Roger Trinh, MD, AbbVie

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, Wedemeyer H, Berg T, Yoshida EM, Forns X, Lovell SS, Da Silva-Tillmann B, Collins CA, Campbell AL, Podsadecki T, Bernstein B. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med. 2014 May 22;370(21):1973-82. doi: 10.1056/NEJMoa1402869. Epub 2014 Apr 11.

• Responsible Party: AbbVie (prior sponsor, Abbott)
• ClinicalTrials.gov Identifier: NCT01704755
• Other Study ID Numbers: M13-099; 2012-003088-23
• First Posted: Oct 11, 2012
• Last Update Posted: Jul 12, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by AbbVie (prior sponsor, Abbott): Cirrhosis; Hepatitis C; Child Pugh A; Compensated Cirrhosis; Hepatitis C Genotype 1; Cirrhotic; Chronic Hepatitis C; Hepatitis C Virus; ombitasvir; paritaprevir; dasabuvir; Interferon-Free; Viekira Pak
• Additional relevant MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic; Liver Cirrhosis; Fibrosis; Ribavirin

Study Results

Participant Flow

Pre-assignment Detail	In the 12-week treatment group, one participant withdrew from the study before receiving study drug.

Arm/Group Title	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Period Title: Overall Study
STARTED	208	172
Completed Study Drug	204	163
COMPLETED	196	165
NOT COMPLETED	12	7

Baseline Characteristics

Arm/Group Title	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks	Total
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks	Total of all reporting groups
Overall Participants	208	172	380
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.1 (7.01)	56.5 (7.87)	56.8 (7.41)
Sex: Female, Male (Count of Participants)
Female	62 29.8%	51 29.7%	113 29.7%
Male	146 70.2%	121 70.3%	267 70.3%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-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.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Measure Participants	208	172
Number [Percentage of participants]	91.8 44.1%	96.5 56.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks
	Comments	The study planned to enroll 380 subjects to a 12- or 24-week treatment arm. The primary efficacy endpoint (SVR12) was assessed for each arm. With a total sample size of 380 and assuming that 68% of the subjects in each arm would achieve SVR12, the study had greater than 90% power to demonstrate non-inferiority and superiority with a 2-sided 97.5% lower confidence bound greater than 43% and 54%, respectively, based on the normal approximation of a single binomial proportion.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of Participants
	Estimated Value	91.8
	Confidence Interval	(2-Sided) 97.5%; 87.6 to 96.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks
	Comments	The primary efficacy endpoints were the SVR12 rates in each arm. The overall 2-sided significance level of 0.05 was split between the arms using a Bonferroni correction of 0.025. A 2-sided 97.5% CI of the SVR12 rate per arm was computed using the normal approximation to the binomial distribution. A gatekeeping testing procedure was used to control the Type I error rate at 0.05, and the primary endpoints for Arm A were tested separately from Arm B in a pre-specified order.
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 12-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of Participants
	Estimated Value	91.8
	Confidence Interval	(2-Sided) 97.5%; 87.6 to 96.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The noninferiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 43% to achieve noninferiority.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of Participants
	Estimated Value	96.5
	Confidence Interval	(2-Sided) 97.5%; 93.4 to 99.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
	Comments
	Type of Statistical Test	Non-Inferiority or Equivalence (legacy)
	Comments	The superiority of the rate of sustained virologic response for the ABT-450/r/ABT-333 plus ribavirin 24-week treatment group as compared with the historical rate for telaprevir plus peginterferon-ribavirin. The lower confidence bound of the 2-sided 97.5% CI for the percentage of participants with sustained virologic response at 12 weeks after treatment must have exceeded 54% to achieve superiority.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Percentage of Participants
	Estimated Value	96.5
	Confidence Interval	(2-Sided) 97.5%; 93.4 to 99.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment in the 24-week Arm Compared to the 12-week Arm
Description	A sustained virologic response is defined as plasma Hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (< LLOQ) 12 weeks after the last dose of study drug.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Measure Participants	208	172
Number [Percentage of participants]	91.8 44.1%	96.5 56.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks, ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
	Comments	To test the hypothesis that the percentages of participants who achieved sustained virologic response 12 weeks after treatment was different between the two treatment groups, the percentages were compared using a logistic regression model with treatment group, baseline log(subscript)10(subscript) HCV RNA level, HCV subgenotype (1a, non-1a), IL28B genotype (CC, non CC), and peginterferon-ribavirin treatment history (treatment-naïve or treatment-experienced) as predictors.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	Regression, Logistic
	Comments

3. Secondary Outcome

Title	Percentage of Participants in Each Arm With On-treatment Virologic Failure During the Treatment Period
Description	Virologic failure during treatment was defined as rebound (confirmed HCV RNA greater than or equal to the lower limit of quantitation [≥ LLOQ] after HCV RNA < LLOQ during treatment, or confirmed increase from the lowest value post baseline in HCV RNA [2 consecutive HCV RNA measurements > 1 log(subscript)10(subscript) IU/mL above the lowest value post baseline] at any time point during treatment), or fail to suppress (HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks [≥ 36 days] of treatment).
Time Frame	Baseline (Day 1), and Treatment Weeks 1, 2, 4, 6, 8, 10, 12, 16, 20, and 24

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Measure Participants	208	172
Number (95% Confidence Interval) [Percentage of participants]	0.5 0.2%	1.7 1%

4. Secondary Outcome

Title	Percentage of Participants With Virologic Relapse After Treatment
Description	Participants were considered to have virologic relapse after treatment if they had confirmed quantifiable plasma Hepatitis C virus ribonucleic acid (HCV RNA) ≥ lower limit of quantification (LLOQ) between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA < LLOQ at the end of treatment.
Time Frame	within 12 weeks after the last dose of study drug

Outcome Measure Data

Analysis Population Description

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 and ABT-333, Plus RBV for 12 Weeks	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
Measure Participants	203	164
Number (95% Confidence Interval) [Percentage of participants]	5.9 2.8%	0.6 0.3%

Adverse Events

Time Frame	Adverse events were collected from the time of study drug administration until 30 days after the last dose, 16 weeks for the 12-week treatment group and 28 weeks for the 24-week treatment group.
Adverse Event Reporting Description	Serious adverse events were collected from the time of informed consent until the end of participation in the study (up to 72 weeks).
Arm/Group Title	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks		ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
Arm/Group Description	ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks		ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
All Cause Mortality
	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks		ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks		ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/208 (6.3%)		7/172 (4.1%)
Blood and lymphatic system disorders
ANAEMIA	1/208 (0.5%)		1/172 (0.6%)
Cardiac disorders
ATRIAL FIBRILLATION	1/208 (0.5%)		0/172 (0%)
Gastrointestinal disorders
HAEMATEMESIS	0/208 (0%)		1/172 (0.6%)
MELAENA	0/208 (0%)		1/172 (0.6%)
NAUSEA	1/208 (0.5%)		0/172 (0%)
OESOPHAGEAL VARICES HAEMORRHAGE	0/208 (0%)		1/172 (0.6%)
VOMITING	1/208 (0.5%)		0/172 (0%)
General disorders
MULTI-ORGAN FAILURE	1/208 (0.5%)		0/172 (0%)
OEDEMA PERIPHERAL	1/208 (0.5%)		0/172 (0%)
Hepatobiliary disorders
CHOLECYSTITIS ACUTE	1/208 (0.5%)		0/172 (0%)
HEPATITIS ACUTE	1/208 (0.5%)		0/172 (0%)
Infections and infestations
CANDIDIASIS	1/208 (0.5%)		0/172 (0%)
CELLULITIS	0/208 (0%)		1/172 (0.6%)
ENTEROCOCCAL BACTERAEMIA	1/208 (0.5%)		0/172 (0%)
ESCHERICHIA SEPSIS	1/208 (0.5%)		0/172 (0%)
PHARYNGITIS	1/208 (0.5%)		0/172 (0%)
PNEUMONIA	1/208 (0.5%)		0/172 (0%)
UPPER RESPIRATORY TRACT INFECTION	1/208 (0.5%)		0/172 (0%)
Injury, poisoning and procedural complications
CLAVICLE FRACTURE	1/208 (0.5%)		0/172 (0%)
EXTRADURAL HAEMATOMA	1/208 (0.5%)		0/172 (0%)
FALL	0/208 (0%)		1/172 (0.6%)
FEMORAL NECK FRACTURE	1/208 (0.5%)		0/172 (0%)
HEAD INJURY	0/208 (0%)		1/172 (0.6%)
TOXICITY TO VARIOUS AGENTS	1/208 (0.5%)		0/172 (0%)
WOUND	1/208 (0.5%)		0/172 (0%)
Investigations
BLOOD GLUCOSE INCREASED	0/208 (0%)		1/172 (0.6%)
Metabolism and nutrition disorders
LACTIC ACIDOSIS	1/208 (0.5%)		0/172 (0%)
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS	0/208 (0%)		1/172 (0.6%)
RHABDOMYOLYSIS	1/208 (0.5%)		0/172 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA	1/208 (0.5%)		1/172 (0.6%)
Nervous system disorders
INTRACRANIAL ANEURYSM	0/208 (0%)		1/172 (0.6%)
Psychiatric disorders
MAJOR DEPRESSION	1/208 (0.5%)		0/172 (0%)
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0/208 (0%)		1/172 (0.6%)
Other (Not Including Serious) Adverse Events
	ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks		ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	175/208 (84.1%)		146/172 (84.9%)
Blood and lymphatic system disorders
ANAEMIA	15/208 (7.2%)		17/172 (9.9%)
Gastrointestinal disorders
ABDOMINAL DISTENSION	6/208 (2.9%)		9/172 (5.2%)
ABDOMINAL PAIN UPPER	11/208 (5.3%)		16/172 (9.3%)
DIARRHOEA	30/208 (14.4%)		29/172 (16.9%)
GASTROOESOPHAGEAL REFLUX DISEASE	7/208 (3.4%)		10/172 (5.8%)
NAUSEA	36/208 (17.3%)		35/172 (20.3%)
VOMITING	6/208 (2.9%)		14/172 (8.1%)
General disorders
ASTHENIA	29/208 (13.9%)		22/172 (12.8%)
FATIGUE	68/208 (32.7%)		80/172 (46.5%)
IRRITABILITY	15/208 (7.2%)		21/172 (12.2%)
OEDEMA PERIPHERAL	12/208 (5.8%)		10/172 (5.8%)
Hepatobiliary disorders
HYPERBILIRUBINAEMIA	15/208 (7.2%)		2/172 (1.2%)
Infections and infestations
NASOPHARYNGITIS	13/208 (6.3%)		13/172 (7.6%)
UPPER RESPIRATORY TRACT INFECTION	4/208 (1.9%)		13/172 (7.6%)
Investigations
BLOOD BILIRUBIN INCREASED	12/208 (5.8%)		9/172 (5.2%)
Metabolism and nutrition disorders
DECREASED APPETITE	12/208 (5.8%)		14/172 (8.1%)
Musculoskeletal and connective tissue disorders
ARTHRALGIA	10/208 (4.8%)		14/172 (8.1%)
BACK PAIN	4/208 (1.9%)		13/172 (7.6%)
MUSCLE SPASMS	14/208 (6.7%)		14/172 (8.1%)
Nervous system disorders
DIZZINESS	18/208 (8.7%)		10/172 (5.8%)
HEADACHE	58/208 (27.9%)		53/172 (30.8%)
MEMORY IMPAIRMENT	5/208 (2.4%)		12/172 (7%)
Psychiatric disorders
ANXIETY	15/208 (7.2%)		14/172 (8.1%)
DEPRESSION	8/208 (3.8%)		12/172 (7%)
INSOMNIA	32/208 (15.4%)		31/172 (18%)
Respiratory, thoracic and mediastinal disorders
COUGH	24/208 (11.5%)		19/172 (11%)
DYSPNOEA	12/208 (5.8%)		21/172 (12.2%)
DYSPNOEA EXERTIONAL	13/208 (6.3%)		11/172 (6.4%)
Skin and subcutaneous tissue disorders
DRY SKIN	18/208 (8.7%)		11/172 (6.4%)
PRURITUS	38/208 (18.3%)		33/172 (19.2%)
PRURITUS GENERALISED	10/208 (4.8%)		12/172 (7%)
RASH	23/208 (11.1%)		25/172 (14.5%)

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.