| Primary | Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 12 (Follow-up period) | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
| | | Title | Denominators | Categories |
|---|
| | |
| |
| Secondary | Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) | RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. | | OG001 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
| |
| Secondary | Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) | cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. | | OG001 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
| |
| Secondary | Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) | EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to the end of treatment (up to 24 weeks) | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. | | OG001 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
| |
| Secondary | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Percentage of participants who achieved HCV RNA \ | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 1, 2, 6, 8 (treatment period) | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. | | OG001 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
| |
| Secondary | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND) | Percentage of participants who achieved HCV RNA \ | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period) | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. | | OG001 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
| |
| Secondary | Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin. Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. The 'n' signifies the number of evaluable participants with or without cirrhosis in the reporting arm and time point, respectively. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Baseline, Week 12 (Follow-up period) | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. | | OG001 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
|
| Secondary | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12) | Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. Here, ''n'' signifies number of participants evaluable for the specified category. | Posted | | Number | 95% Confidence Interval | Percentage of participants | | Week 12 (Follow-up period) | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. | | OG001 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
|
| Primary | Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) | SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Week 12 (Follow-up period) | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
| |
| Secondary | Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. | The analysis was performed in all treated participants who received at least 1 dose of active study therapy. | Posted | | Number | | Participants | | From Day 1 first dose to last dose plus 7 days | | | | ID | Title | Description |
|---|
| OG000 | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks. | | OG001 | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks. |
|