| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12) | Participants were considered to have achieved SVR12 if the hepatitis C virus ribonucleic acid (HCV RNA) was less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable at 12 weeks after the end of study drug treatment. | The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 24 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000100(82.4 to 100)
- OG001100(83.9 to 100)
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| Secondary | Percentage of Participants With On-Treatment Virologic Response | On-treatment virologic response was determined by HCV RNA results satisfying a specified threshold. The following thresholds were considered at any time point: \ | The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point. | Posted | | Number | | Percentage of Participants | | Week 1, 2, 4, 6, 8, 10, 12 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Percentage of Participants With SVR 4 Weeks After End of Study Drug Treatment (SVR4) and SVR 24 Weeks After End of Study Drug Treatment (SVR24) | Participants were considered to have achieved SVR4 and SVR24 if the HCV RNA was \ | The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here , 'n' signifies number of participants evaluable for this outcome measure at specific time point. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | Week 16 and Week 36 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Percentage of Participants With HCV NS3/4A Sequence, NS5A and NS5B After End of Treatment in Participants Not Achieving SVR | Sequencing of the HCV nonstructural protein 3/4A (NS3/4A), nonstructural protein 5A (NS5A) and nonstructural protein 5B (NS5B) genes was done to identify pre-existing sequence polymorphisms and characterize emerging HCV viral variants in participants not achieving SVR. All participants in this study achieved SVR12. Therefore, reasons for not achieving SVR12 are not applicable. | The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint analysis was zero. | Posted | | | | | | Baseline, Day 3, Week 1, 2, 4, 6, 8, 10, 12, 16, 24, 36, and Year 1, 1.5, 2, 2.5, 3 after end of treatment | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Absolute Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Levels at Follow-up Week 24 (Week 36) | | The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here, 'n' signifies number of participants evaluable for this outcome measure at specific time point. | Posted | | Mean | Standard Deviation | Units per Liter (U/L) | | Follow-up Week 24 (Week 36) | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) | Tmax is the time to reach maximum observed plasma concentration. | Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point. | Posted | | Median | Full Range | Hours | | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24]) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) | The AUC(0-24) is area under the plasma concentration-time curve from time 0 to 24 hours after dosing. | Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point. | Posted | | Mean | Standard Deviation | ng.h/mL | | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Maximum Plasma Concentration (Cmax) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) | The Cmax is the maximum observed plasma concentration. | Pharmacokinetic (PK) analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point. | Posted | | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Minimum Plasma Concentration (Cmin) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) | The Cmin is the minimum observed plasma concentration. | PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point. | Posted | | Mean | Standard Deviation | ng/mL | | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Pre-dose (Trough) Concentration (C0h) of Simeprevir, Daclatasvir, Sofosbuvir and GS-331007 (Sofosbuvir Metabolite) | The C0h is the pre-dose plasma concentration. | PK analysis set included all participants who received atleast 1 dose of study drug and had valid pharmacokinetic profile. Here 'n' signifies number of participants analyzed for this outcome measure at specific time point. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, and 24 hours post-dose on Weeks 2 and 8 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Percentage of Participants With On-treatment Failure | On-treatment failure is defined as participants who do not achieve SVR12 and with confirmed detectable HCV RNA at the actual end of study drug treatment. | The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. Here "N" (Number of Participants Analyzed) signifies those participants who were evaluable for this outcome measure. | Posted | | Number | | Percentage of Participants | | Week 12 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Percentage of Participants With Viral Relapse | Viral relapse is defined as participants who do not achieve SVR12, with undetectable HCV RNA at the actual end of study drug treatment and confirmed HCV RNA greater than or equal to (>=) LLOQ (15 IU/mL) at Week 16, 24 or 36. | The ITT analysis set who failed achieving SVR. Since all participants achieved SVR, the number of participants for this endpoint (viral relapse) analysis was zero. | Posted | | | | | | Week 16, 24 and 36 | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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| Secondary | Percentage of Participants With SVR12 Who Maintained to Have HCV RNA <LLOQ Until the End of 3 Years Follow up | Percentage of participants with SVR12 who maintained to have HCV RNA \ | The intent-to-treat (ITT) analysis set included all enrolled participants who took at least 1 dose of study drug. | Posted | | Number | | Percentage of participants | | Week 24 post treatment until the end of 3-year follow-up | | | | ID | Title | Description |
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| OG000 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A | Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. | | OG001 | SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B | Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks. |
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