| Primary | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-Treatment (SVR12) | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after the last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | 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. |
| | | Title | Denominators | Categories |
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| Core Population | - ParticipantsOG00063
- ParticipantsOG00193
- ParticipantsOG002156
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| Secondary | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. |
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| Secondary | SVR12 Non-Response: Percentage of Participants With Breakthrough | Breakthrough is defined as at least 1 documented HCV RNA <50 IU/mL followed by HCV RNA ≥50 IU/mL during treatment. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after the last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV |
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| Secondary | SVR12 Non-Response: Percentage of Participants With Failure to Suppress | Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after the last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV |
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| Secondary | SVR12 Non-Response: Percentage of Participants With Relapse | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV |
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| Secondary | SVR12 Non-Response: Percentage of Participants With Premature Study Drug Discontinuation With No On-Treatment Virologic Failure | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. |
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| Secondary | SVR12 Non-Response: Percentage of Participants With Missing SVR12 Data | | 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). | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV | 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. |
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| Secondary | Percentage of Participants Achieving Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) | SVR24 is defined as HCV RNA levels < 50 IU/mL 24 weeks after the last actual dose of paritaprevir/r - ombitasvir, ± dasabuvir, ± RBV. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 24 weeks after last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV |
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| Secondary | Percentage of Participants Achieving Virological Response at End of Treatment | Virologic response is defined as HCV RNA < 50 IU/mL. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From baseline until end of treatment (12 or 24 weeks after actual first dose) | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV |
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| Other Pre-specified | Percentage of Participants Achieving SVR12: Additional Analysis | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after the last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir + RBV | 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. | | OG001 | 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. | | OG002 |
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| Other Pre-specified | Percentage of Participants Meeting SVR12 Non-Response Categories of Breakthrough, Failure to Suppress, and/or Relapse: Additional Analysis | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. |
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| Other Pre-specified | SVR12 Non-Response: Percentage of Participants With Breakthrough: Additional Analysis | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after the last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 |
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| Other Pre-specified | SVR12 Non-Response: Percentage of Participants With Failure to Suppress: Additional Analysis | Failure to suppress is defined as each measured on-treatment HCV RNA value ≥ 50 IU/mL or positive. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after the last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV |
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| Other Pre-specified | SVR12 Non-Response: Percentage of Participants With Relapse: Additional Analysis | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 12 weeks after last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 |
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| Other Pre-specified | Percentage of Participants Achieving SVR24: Additional Analysis | 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. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | 24 weeks after last actual dose of study drug | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV |
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| Other Pre-specified | Percentage of Participants Achieving Virological Response at End of Treatment: Additional Analysis | Virologic response is defined as HCV RNA < 50 IU/mL or undetectable/negative. | 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. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From baseline until end of treatment (12 or 24 weeks after actual first dose) | | | | ID | Title | Description |
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| OG000 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, + RBV | 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. | | OG001 | 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. | | OG002 | Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± RBV |
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