Trial Outcomes & Findings for 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 (NCT NCT02669940)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

158 participants

Primary outcome timeframe

12 weeks after the last actual dose of study drug

Results posted on

2018-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV 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.
Overall Study STARTED	63	95
Overall Study COMPLETED	62	92
Overall Study NOT COMPLETED	1	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV 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.
Overall Study Failure to return	0	3
Overall Study Insufficient follow-up data	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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 n=156 Participants Total of all reporting groups
Age, Continuous	50.8 years STANDARD_DEVIATION 11.38 • n=5 Participants	46.2 years STANDARD_DEVIATION 11.59 • n=7 Participants	48.1 years STANDARD_DEVIATION 11.69 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	45 Participants n=7 Participants	79 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants	48 Participants n=7 Participants	77 Participants n=5 Participants
Race/Ethnicity, Customized Asian/Oriental	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	62 Participants n=5 Participants	92 Participants n=7 Participants	154 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) Core Population	22.2 percentage of participants Interval 12.7 to 34.5	16.1 percentage of participants Interval 9.3 to 25.2	18.6 percentage of participants Interval 12.8 to 25.6
Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) Core Population Subgroup	23.3 percentage of participants Interval 13.4 to 36.0	17.0 percentage of participants Interval 9.9 to 26.6	19.6 percentage of participants Interval 13.5 to 26.9

SECONDARY outcome

Timeframe: 12 weeks after last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse Core Population	73.0 percentage of participants Interval 60.3 to 83.4	78.5 percentage of participants Interval 68.8 to 86.3	76.3 percentage of participants Interval 68.8 to 82.7
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse Core Population Subgroup	76.7 percentage of participants Interval 64.0 to 86.6	83.0 percentage of participants Interval 73.4 to 90.1	80.4 percentage of participants Interval 73.1 to 86.5

SECONDARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: 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.

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

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
SVR12 Non-Response: Percentage of Participants With Breakthrough Core Population	1.6 percentage of participants Interval 0.0 to 8.5	3.2 percentage of participants Interval 0.7 to 9.1	2.6 percentage of participants Interval 0.7 to 6.4
SVR12 Non-Response: Percentage of Participants With Breakthrough Core Population Subgroup	1.7 percentage of participants Interval 0.0 to 8.9	3.4 percentage of participants Interval 0.7 to 9.6	2.7 percentage of participants Interval 0.7 to 6.8

SECONDARY outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: 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.

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

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
SVR12 Non-Response: Percentage of Participants With Failure to Suppress Core Population	61.9 percentage of participants Interval 48.8 to 73.9	54.8 percentage of participants Interval 44.2 to 65.2	57.7 percentage of participants Interval 49.5 to 65.6
SVR12 Non-Response: Percentage of Participants With Failure to Suppress Core Population Subgroup	65.0 percentage of participants Interval 51.6 to 76.9	58.0 percentage of participants Interval 47.0 to 68.4	60.8 percentage of participants Interval 52.5 to 68.7

SECONDARY outcome

Timeframe: 12 weeks after last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
SVR12 Non-Response: Percentage of Participants With Relapse Core Population	9.5 percentage of participants Interval 3.6 to 19.6	20.4 percentage of participants Interval 12.8 to 30.1	16.0 percentage of participants Interval 10.6 to 22.7
SVR12 Non-Response: Percentage of Participants With Relapse Core Population Subgroup	10.0 percentage of participants Interval 3.8 to 20.5	21.6 percentage of participants Interval 13.5 to 31.6	16.9 percentage of participants Interval 11.2 to 23.9

SECONDARY outcome

Timeframe: 12 weeks after last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure Core Population	0 percentage of participants Interval 0.0 to 5.7	0 percentage of participants Interval 0.0 to 3.9	0 percentage of participants Interval 0.0 to 2.3
SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure Core Population Subgroup	0 percentage of participants Interval 0.0 to 6.0	0 percentage of participants Interval 0.0 to 4.1	0 percentage of participants Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: 12 weeks after last actual dose of study drug

Population: 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).

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data	4.8 percentage of participants Interval 1.0 to 13.3	5.4 percentage of participants Interval 1.8 to 12.1	5.1 percentage of participants Interval 2.2 to 9.9

SECONDARY outcome

Timeframe: 24 weeks after last actual dose of study drug

Population: 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.

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

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) Core Population	20.6 percentage of participants Interval 11.5 to 32.7	14.0 percentage of participants Interval 7.7 to 22.7	16.7 percentage of participants Interval 11.2 to 23.5
Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) Core Population Subgroup	20.0 percentage of participants Interval 10.8 to 32.3	13.6 percentage of participants Interval 7.2 to 22.6	16.2 percentage of participants Interval 10.7 to 23.2

SECONDARY outcome

Timeframe: From baseline until end of treatment (12 or 24 weeks after actual first dose)

Population: 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.

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

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
Percentage of Participants Achieving Virological Response at End of Treatment Core Population	31.7 percentage of participants Interval 20.6 to 44.7	30.1 percentage of participants Interval 21.0 to 40.5	30.8 percentage of participants Interval 23.6 to 38.6
Percentage of Participants Achieving Virological Response at End of Treatment Core Population Subgroup	31.7 percentage of participants Interval 20.3 to 45.0	30.7 percentage of participants Interval 21.3 to 41.4	31.1 percentage of participants Interval 23.7 to 39.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
Percentage of Participants Achieving SVR12: Additional Analysis Core Population Subgroup	98.3 percentage of participants Interval 91.1 to 100.0	98.9 percentage of participants Interval 93.8 to 100.0	98.6 percentage of participants Interval 95.2 to 99.8
Percentage of Participants Achieving SVR12: Additional Analysis Core Population	93.7 percentage of participants Interval 84.5 to 98.2	93.5 percentage of participants Interval 86.5 to 97.6	93.6 percentage of participants Interval 88.5 to 96.9

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis Core Population	1.6 percentage of participants Interval 0.0 to 8.5	1.1 percentage of participants Interval 0.0 to 5.8	1.3 percentage of participants Interval 0.2 to 4.6
Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis Core Population Subgroup	1.7 percentage of participants Interval 0.0 to 8.9	1.1 percentage of participants Interval 0.0 to 6.2	1.4 percentage of participants Interval 0.2 to 4.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis Core Population	0 percentage of participants Interval 0.0 to 5.7	0 percentage of participants Interval 0.0 to 3.9	0 percentage of participants Interval 0.0 to 2.3
SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis Core Population Subgroup	0 percentage of participants Interval 0.0 to 6.0	0 percentage of participants Interval 0.0 to 4.1	0 percentage of participants Interval 0.0 to 2.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after the last actual dose of study drug

Population: 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.

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

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis Core Population	1.6 percentage of participants Interval 0.0 to 8.5	0 percentage of participants Interval 0.0 to 3.9	0.6 percentage of participants Interval 0.0 to 3.5
SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis Core Population Subgroup	1.7 percentage of participants Interval 0.0 to 8.9	0 percentage of participants Interval 0.0 to 4.1	0.7 percentage of participants Interval 0.0 to 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks after last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis Core Population Subgroup	0 percentage of participants Interval 0.0 to 6.0	1.1 percentage of participants Interval 0.0 to 6.2	0.7 percentage of participants Interval 0.0 to 3.7
SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis Core Population	0 percentage of participants Interval 0.0 to 5.7	1.1 percentage of participants Interval 0.0 to 5.8	0.6 percentage of participants Interval 0.0 to 3.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 24 weeks after last actual dose of study drug

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
Percentage of Participants Achieving SVR24: Additional Analysis Core Population	93.7 percentage of participants Interval 84.5 to 98.2	92.5 percentage of participants Interval 85.1 to 96.9	92.9 percentage of participants Interval 87.7 to 96.4
Percentage of Participants Achieving SVR24: Additional Analysis Core Population Subgroup	95.0 percentage of participants Interval 86.1 to 99.0	95.5 percentage of participants Interval 88.8 to 98.7	95.3 percentage of participants Interval 90.5 to 98.1

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline until end of treatment (12 or 24 weeks after actual first dose)

Population: 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.

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

Outcome measures

Outcome measures
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV n=63 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir - RBV n=93 Participants 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=156 Participants 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.
Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis Core Population	93.7 percentage of participants Interval 84.5 to 98.2	95.7 percentage of participants Interval 89.4 to 98.8	94.9 percentage of participants Interval 90.1 to 97.8
Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis Core Population Subgroup	95.0 percentage of participants Interval 86.1 to 99.0	96.6 percentage of participants Interval 90.4 to 99.3	95.9 percentage of participants Interval 91.4 to 98.5

Adverse Events

Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV

Serious events: 2 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV n=63 participants at risk 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, - RBV n=95 participants at risk；n=93 participants at risk 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.	Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV n=158 participants at risk；n=156 participants at risk 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.
Cardiac disorders Arrhythmia	1.6% 1/63 • 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).	0.00% 0/93 • 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).	0.64% 1/156 • 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).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	1.6% 1/63 • 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).	0.00% 0/93 • 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).	0.64% 1/156 • 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).

Other adverse events

Additional Information

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Principal investigator is a sponsor employee 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.
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