| Primary | Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) | SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug. | Full Analysis Set (FAS) included participants who were enrolled into the study and received at least 1 dose of study drug. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Week 12 | | | | ID | Title | Description |
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| OG000 | LDV/SOF 8 Weeks (TN, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis | | OG001 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1 | | OG002 | LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000100.0(94.6 to 100.0)
- OG00196.6(88.3 to 99.6)
- OG00296.3(81.0 to 99.9)
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| Primary | Percentage of Participants Who Discontinued Study Drug Due to Any Adverse Event (AE) | | | Posted | | Number | | percentage of participants | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF 8 Weeks (TN, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis | | OG001 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1 | | OG002 | LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study |
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| Secondary | Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24) | SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively. | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Posttreatment Weeks 4 and 24 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF 8 Weeks (TN, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis | | OG001 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1 | | OG002 | LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study |
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| Secondary | Percentage of Participants With HCV RNA < LLOQ on Treatment | | | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF 8 Weeks (TN, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis | | OG001 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1 | | OG002 | LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study |
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| Secondary | HCV RNA Change From Day 1 | | Participants in Full Analysis Set with available data were analyzed. | Posted | | Mean | Standard Deviation | log10 IU/mL | | Up to 12 weeks | | | | ID | Title | Description |
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| OG000 | LDV/SOF 8 Weeks (TN, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis | | OG001 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1 | | OG002 | LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study |
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| Secondary | Percentage of Participants With Virologic Failure | Virologic failure was defined as | | Posted | | Number | | percentage of participants | | Up to Posttreatment Week 24 | | | | ID | Title | Description |
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| OG000 | LDV/SOF 8 Weeks (TN, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosiss | | OG001 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1 | | OG002 | LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected) | LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study |
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| Secondary | Percentage of HIV/HCV- Coinfected Participants That Maintain HIV-1 RNA < 50 Copies/mL While on HCV Treatment and at Posttreatment Week 4 | | Participants in the Safety Analysis Set (who had HIV RNA < 50 Copies/mL at baseline) with available data were analyzed. | Posted | | Number | | percentage of participants | | Up to Posttreatment Week 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1 |
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| Secondary | For HIV/HCV- Coinfected Participants, Change From Baseline in CD4 T-cell Count at the End of Treatment and Posttreatment Week 4 | | Participant in the Safety analysis set (with or without prior antiretroviral (ARV) treatment) with available data were analyzed. | Posted | | Mean | Standard Deviation | cells/µL | | Up to Posttreatment Week 4 | | | | ID | Title | Description |
|---|
| OG000 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV- Naive) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants did not receive any prior ARV therapy. | | OG001 | LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV Experienced) | LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants were on a stable ARV regimen for at least 8 weeks prior to screening. |
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