HCV RWE: Observational, Multi-Center Study of the Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation

• Sponsor: AbbVie (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02669940
• Collaborator: (none)
• Enrollment: 158
• Actual Duration (Months): 14.6

Study Details

Study Description

Brief Summary

This study seeks to assess the effectiveness, patient reported outcomes, work productivity and healthcare resource utilization of the interferon-free regimen of paritaprevir /ritonavir (r) - ombitasvir, ± dasabuvir ± ribavirin (RBV) in participants with chronic hepatitis C in a real life setting across clinical practice populations.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C; Genotype 1

Study Design

• Study Type: Observational
• Actual Enrollment: 158 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C in the Russian Federation - An Observational, Multi-Center Study
• Actual Study Start Date: Apr 15, 2016
• Actual Primary Completion Date: Jul 4, 2017
• Actual Study Completion Date: Jul 4, 2017

Arms and Interventions

Arm	Intervention/Treatment
Participants With Chronic Hepatitis C Genotype 1 Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label.

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) [12 weeks after the last actual dose of study drug]

   SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.

Secondary Outcome Measures

1. Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse [12 weeks after last actual dose of study drug]

   Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.

2. SVR12 Non-Response: Percentage of Participants With Breakthrough [12 weeks after the last actual dose of study drug]

   Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.

3. SVR12 Non-Response: Percentage of Participants With Failure to Suppress [12 weeks after the last actual dose of study drug]

   Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.

4. SVR12 Non-Response: Percentage of Participants With Relapse [12 weeks after last actual dose of study drug]

   Relapse is defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.

5. SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure [12 weeks after last actual dose of study drug]

   On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.

6. SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data [12 weeks after last actual dose of study drug]

7. Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) [24 weeks after last actual dose of study drug]

   SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.

8. Percentage of Participants Achieving Virological Response at End of Treatment [From baseline until end of treatment (12 or 24 weeks after actual first dose)]

   Virologic response is defined as HCV RNA < 50 IU/mL.

Other Outcome Measures

1. Percentage of Participants Achieving SVR12: Additional Analysis [12 weeks after the last actual dose of study drug]

   SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.

2. Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis [12 weeks after last actual dose of study drug]

   Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.

3. SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis [12 weeks after the last actual dose of study drug]

   Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.

4. SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis [12 weeks after the last actual dose of study drug]

   Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.

5. SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis [12 weeks after last actual dose of study drug]

   Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.

6. Percentage of Participants Achieving SVR24: Additional Analysis [24 weeks after last actual dose of study drug]

   SVR24 is defined as HCV RNA levels < 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.

7. Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis [From baseline until end of treatment (12 or 24 weeks after actual first dose)]

   Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients are eligible for observation in this cohort if the following applies:

• Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype 1, receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir ± RBV according to standard of care and in line with the current local label

• If RBV is co-administered with paritaprevir/r - ombitasvir with or without dasabuvir, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)

• Patients must voluntarily sign and date informed consent prior to inclusion into the study

Exclusion Criteria:

• Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• AbbVie

Investigators

• Study Director: Andrey Strugovschikov, MD, AbbVie

Study Documents (Full-Text)

• Statistical Analysis Plan - Feb 2, 2018
• Study Protocol - Jun 26, 2015

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02669940
• Other Study ID Numbers: P15-743
• First Posted: Feb 1, 2016
• Last Update Posted: Nov 14, 2018
• Last Verified: Jul 1, 2018

• Keywords provided by AbbVie: Ombitasvir; Dasabuvir; Paritaprevir
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic

Study Results

Participant Flow

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/ritonavir [r] - ombitasvir with or without dasabuvir with ribavirin (RBV) according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.
Period Title: Overall Study
STARTED	63	95
COMPLETED	62	92
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV	Total
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Total of all reporting groups
Overall Participants	63	93	156
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	50.8 (11.38)	46.2 (11.59)	48.1 (11.69)
Sex: Female, Male (Count of Participants)
Female	34 54%	45 48.4%	79 50.6%
Male	29 46%	48 51.6%	77 49.4%
Race/Ethnicity, Customized (Count of Participants)
Asian/Oriental	1 1.6%	1 1.1%	2 1.3%
White/Caucasian	62 98.4%	92 98.9%	154 98.7%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12)
Description	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for >55 days (for 12-week treatment) or >139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	22.2 35.2%	16.1 17.3%	18.6 11.9%
Core Population Subgroup	23.3 37%	17.0 18.3%	19.6 12.6%

2. Secondary Outcome

Title	Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse
Description	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. Relapse is defined as HCV RNA < 50 IU/mL at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	73.0 115.9%	78.5 84.4%	76.3 48.9%
Core Population Subgroup	76.7 121.7%	83.0 89.2%	80.4 51.5%

3. Secondary Outcome

Title	SVR12 Non-Response: Percentage of Participants With Breakthrough
Description	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	1.6 2.5%	3.2 3.4%	2.6 1.7%
Core Population Subgroup	1.7 2.7%	3.4 3.7%	2.7 1.7%

4. Secondary Outcome

Title	SVR12 Non-Response: Percentage of Participants With Failure to Suppress
Description	Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	61.9 98.3%	54.8 58.9%	57.7 37%
Core Population Subgroup	65.0 103.2%	58.0 62.4%	60.8 39%

5. Secondary Outcome

Title	SVR12 Non-Response: Percentage of Participants With Relapse
Description	Relapse is defined as HCV RNA <50 IU/mL at EoT or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL posttreatment.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	9.5 15.1%	20.4 21.9%	16.0 10.3%
Core Population Subgroup	10.0 15.9%	21.6 23.2%	16.9 10.8%

6. Secondary Outcome

Title	SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure
Description	On-treatment virologic failure included virological breakthrough and failure to suppress. Virological breakthrough was defined as at least one documented HCV RNA < 50 IU/mL or undetectable/negative followed by HCV RNA ≥ 50 IU/mL during treatment. Failure to suppress was defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	0 0%	0 0%	0 0%
Core Population Subgroup	0 0%	0 0%	0 0%

7. Secondary Outcome

Title	SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment).

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Number (95% Confidence Interval) [percentage of participants]	4.8 7.6%	5.4 5.8%	5.1 3.3%

8. Secondary Outcome

Title	Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24)
Description	SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Time Frame	24 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	20.6 32.7%	14.0 15.1%	16.7 10.7%
Core Population Subgroup	20.0 31.7%	13.6 14.6%	16.2 10.4%

9. Secondary Outcome

Title	Percentage of Participants Achieving Virological Response at End of Treatment
Description	Virologic response is defined as HCV RNA < 50 IU/mL.
Time Frame	From baseline until end of treatment (12 or 24 weeks after actual first dose)

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	31.7 50.3%	30.1 32.4%	30.8 19.7%
Core Population Subgroup	31.7 50.3%	30.7 33%	31.1 19.9%

10. Other Pre-specified Outcome

Title	Percentage of Participants Achieving SVR12: Additional Analysis
Description	SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL or undetectable/negative 12 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for >55 days (for 12-week treatment) or >139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	93.7 148.7%	93.5 100.5%	93.6 60%
Core Population Subgroup	98.3 156%	98.9 106.3%	98.6 63.2%

11. Other Pre-specified Outcome

Title	Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis
Description	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment. Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	1.6 2.5%	1.1 1.2%	1.3 0.8%
Core Population Subgroup	1.7 2.7%	1.1 1.2%	1.4 0.9%

12. Other Pre-specified Outcome

Title	SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis
Description	Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL or undetectable/negative followed by HCV RNA ≥50 IU/mL or positive during treatment.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	0 0%	0 0%	0 0%
Core Population Subgroup	0 0%	0 0%	0 0%

13. Other Pre-specified Outcome

Title	SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis
Description	Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive.
Time Frame	12 weeks after the last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir) with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	1.6 2.5%	0 0%	0.6 0.4%
Core Population Subgroup	1.7 2.7%	0 0%	0.7 0.4%

14. Other Pre-specified Outcome

Title	SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis
Description	Relapse is defined as HCV RNA < 50 IU/mL or undetectable/negative at end of treatment or at the last on-treatment HCV RNA measurement followed by HCV RNA ≧ 50 IU/mL or positive posttreatment.
Time Frame	12 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	0 0%	1.1 1.2%	0.6 0.4%
Core Population Subgroup	0 0%	1.1 1.2%	0.7 0.4%

15. Other Pre-specified Outcome

Title	Percentage of Participants Achieving SVR24: Additional Analysis
Description	SVR24 is defined as HCV RNA levels < 50 IU/mL or undetectable/negative 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV.
Time Frame	24 weeks after last actual dose of study drug

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	93.7 148.7%	92.5 99.5%	92.9 59.6%
Core Population Subgroup	95.0 150.8%	95.5 102.7%	95.3 61.1%

16. Other Pre-specified Outcome

Title	Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis
Description	Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative.
Time Frame	From baseline until end of treatment (12 or 24 weeks after actual first dose)

Outcome Measure Data

Analysis Population Description

Core population: eligible, enrolled participants with known fibrosis status who started the treatment combination recommended in the current local label for their disease characteristics, and remained on treatment for > 55 days (for 12-week treatment) or > 139 days (for 24-week treatment). Subgroup: excludes participants with missing SVR12 results.

Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
Measure Participants	63	93	156
Core Population	93.7 148.7%	95.7 102.9%	94.9 60.8%
Core Population Subgroup	95.0 150.8%	96.6 103.9%	95.9 61.5%

Adverse Events

Time Frame	The observational period for participants receiving 12 weeks of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV was maximum 36 weeks (12 weeks treatment and 24 weeks posttreatment observation). For participants receiving 24 weeks of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV the observational period was maximum 48 weeks (24 weeks treatment and 24 weeks posttreatment observation).
Arm/Group Title	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV		Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV		Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
Arm/Group Description	Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with RBV according to standard of care and in line with the current local label.		Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir without RBV according to standard of care and in line with the current local label.		Participants with confirmed chronic hepatitis C genotype 1 receiving combination therapy with paritaprevir/r - ombitasvir with or without dasabuvir with or without RBV according to standard of care and in line with the current local label.
All Cause Mortality
	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV		Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV		Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/63 (0%)		0/95 (0%)		0/158 (0%)
Serious Adverse Events
	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV		Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV		Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/63 (3.2%)		0/93 (0%)		2/156 (1.3%)
Cardiac disorders
Arrhythmia	1/63 (1.6%)		0/93 (0%)		1/156 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma	1/63 (1.6%)		0/93 (0%)		1/156 (0.6%)
Other (Not Including Serious) Adverse Events
	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV		Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV		Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	14/63 (22.2%)		16/95 (16.8%)		30/158 (19%)
Blood and lymphatic system disorders
Anaemia	2/63 (3.2%)		0/95 (0%)		2/158 (1.3%)
Thrombocytopenia	1/63 (1.6%)		0/95 (0%)		1/158 (0.6%)
Gastrointestinal disorders
Abdominal discomfort	1/63 (1.6%)		0/95 (0%)		1/158 (0.6%)
Diarrhoea	0/63 (0%)		1/95 (1.1%)		1/158 (0.6%)
Nausea	0/63 (0%)		1/95 (1.1%)		1/158 (0.6%)
General disorders
Asthenia	7/63 (11.1%)		6/95 (6.3%)		13/158 (8.2%)
Fatigue	1/63 (1.6%)		2/95 (2.1%)		3/158 (1.9%)
Hepatobiliary disorders
Hepatic pain	0/63 (0%)		1/95 (1.1%)		1/158 (0.6%)
Hyperbilirubinaemia	1/63 (1.6%)		0/95 (0%)		1/158 (0.6%)
Jaundice	1/63 (1.6%)		0/95 (0%)		1/158 (0.6%)
Infections and infestations
Hepatitis C	1/63 (1.6%)		2/95 (2.1%)		3/158 (1.9%)
Pharyngitis	0/63 (0%)		1/95 (1.1%)		1/158 (0.6%)
Respiratory tract infection	1/63 (1.6%)		0/95 (0%)		1/158 (0.6%)
Sinusitis	1/63 (1.6%)		0/95 (0%)		1/158 (0.6%)
Urinary tract infection	0/63 (0%)		1/95 (1.1%)		1/158 (0.6%)
Viral upper respiratory tract infection	0/63 (0%)		1/95 (1.1%)		1/158 (0.6%)
Investigations
Blood bilirubin increased	1/63 (1.6%)		0/95 (0%)		1/158 (0.6%)
Haemoglobin decreased	1/63 (1.6%)		0/95 (0%)		1/158 (0.6%)
Nervous system disorders
Headache	0/63 (0%)		1/95 (1.1%)		1/158 (0.6%)
Skin and subcutaneous tissue disorders
Pruritus	1/63 (1.6%)		1/95 (1.1%)		2/158 (1.3%)
Vascular disorders
Axillary vein thrombosis	0/63 (0%)		1/95 (1.1%)		1/158 (0.6%)

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.