| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12) | Participants were considered to have reached SVR12, if 12 weeks after the actual end of treatment (EOT), hepatitis C virus (HCV) ribonucleic acid (RNA) was less than lower limit of quantification (\ | The intent-to-treat (ITT) analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At 12 weeks after end of treatment | | | | ID | Title | Description |
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| OG000 | 12 Weeks Prior Amendment | Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented. | | OG001 | 12 Weeks Post Amendment | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment. | | OG002 | 24 Weeks Extension | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00070.6(44.04 to 89.69)
- OG001100(86.28 to 100)
- OG00293.8(84.76 to 98.27)
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| Secondary | Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Study Drug Treatment (SVR4) | Participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was \ | The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At 4 weeks after actual EOT | | | | ID | Title | Description |
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| OG000 | 12 Weeks Prior Amendment | Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented. | | OG001 | 12 Weeks Post Amendment | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment. | | OG002 | 24 Weeks Extension | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment. |
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| Secondary | Percentage of Participants With SVR 24 Weeks After End of Study Drug Treatment (SVR 24) | Participants were considered to have reached SVR24, if 24 weeks after the actual EOT, HCV RNA was \ | The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir. | Posted | | Number | 95% Confidence Interval | percentage of participants | | At 24 weeks after actual EOT | | | | ID | Title | Description |
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| OG000 | 12 Weeks Prior Amendment | Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented. | | OG001 | 12 Weeks Post Amendment | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment. | | OG002 | 24 Weeks Extension | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment. |
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| Secondary | Percentage of Participants With On-treatment Failure | Participants were considered on-treatment failures if they did not achieve SVR12 and had (confirmed) detectable HCV RNA, ie, <LLOQ detectable or greater than equal to (>=) LLOQ at EOT. | The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir. | Posted | | Number | | percentage of participants | | Up to Week 24 after actual EOT | | | | ID | Title | Description |
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| OG000 | 12 Weeks Prior Amendment | Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented. | | OG001 | 12 Weeks Post Amendment | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment. | | OG002 | 24 Weeks Extension | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment. |
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| Secondary | Number of Participants With Viral Breakthrough | Participants were considered to have had viral breakthrough if they had a confirmed greater than (>) 1.0 log10 international units/milliliter (IU/mL) increase in HCV RNA from nadir OR confirmed HCV RNA >100 IU/mL while previously having achieved HCV RNA \ | The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir. | Posted | | Number | | participants | | Up to Week 24 | | | | ID | Title | Description |
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| OG000 | 12 Weeks Prior Amendment | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented. | | OG001 | 12 Weeks Post Amendment | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment. | | OG002 | 24 Weeks Extension | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment. |
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| Secondary | Number of Participants With Viral Relapse | Participants were considered to have had viral relapse if they did not achieve SVR12 and met the following conditions: had HCV RNA <LLOQ (undetectable) at EOT and had HCV RNA >=LLOQ during the follow-up period. | The ITT analysis set is defined as all participants who received at least one dose of simeprevir or daclatasvir. | Posted | | Number | | participants | | Up to Week 24 after actual EOT | | | | ID | Title | Description |
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| OG000 | 12 Weeks Prior Amendment | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented. | | OG001 | 12 Weeks Post Amendment | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment. | | OG002 | 24 Weeks Extension | Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment. |
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