Hepatitis C
Conditions
Brief summary
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection
Interventions
DRUGDaclatasvir
DRUGSofosbuvir
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Key Inclusion Criteria: * Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications * Subjects chronically infected with hepatitis C virus (HCV) genotype 3 * Subjects who are HCV treatment-naive * Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited) * HCV RNA ≥10,000 IU/mL at screening Key
Exclusion criteria
* HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted * Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair * Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening * Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed) * Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) | Week 12 (Follow-up period) | 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. |
| Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) | Week 12 (Follow-up period) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) | Up to the end of treatment (up to 24 weeks) | 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. |
| Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 1, 2, 6, 8 (treatment period) | Percentage of participants who achieved HCV RNA \<LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. |
| 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) | Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period) | Percentage of participants who achieved HCV RNA \<LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. |
| Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) | Week 4 | 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. |
| 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) | Week 12 (Follow-up period) | 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. |
| Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | From Day 1 first dose to last dose plus 7 days | 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. |
| Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | Baseline, Week 12 (Follow-up period) | 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. |
| Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) | Week 12 | 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. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The study was conducted at 31 sites in 2 countries.
Pre-assignment details
A total of 173 participants were enrolled in the study. 152 were treated. 21 participants were not treated as they no longer met the study criteria.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 101 |
| 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. | 51 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-Up Period (24 Weeks) | Lost to Follow-up | 0 | 1 |
| Treatment Period (12 Weeks) | Pregnancy | 1 | 0 |
Baseline characteristics
| Characteristic | Daclatasvir + Sofosbuvir in Treatment-naive Participants | Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Total |
|---|---|---|---|
| Age, Continuous | 50.3 years STANDARD_DEVIATION 10.73 | 56.3 years STANDARD_DEVIATION 6.64 | 52.3 years STANDARD_DEVIATION 9.94 |
| Age, Customized <65 years | 95 participants | 47 participants | 142 participants |
| Age, Customized >= 65 years | 6 participants | 4 participants | 10 participants |
| Sex: Female, Male Female | 43 Participants | 19 Participants | 62 Participants |
| Sex: Female, Male Male | 58 Participants | 32 Participants | 90 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 73 / 152 |
| serious Total, serious adverse events | 1 / 152 |
Outcome results
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.
Time frame: Week 12 (Follow-up period)
Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) | 86.3 percentage of participants |
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.
Time frame: Week 12 (Follow-up period)
Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND) | 90.1 Percentage of participants |
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.
Time frame: From Day 1 first dose to last dose plus 7 days
Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | SAEs | 1 Participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Discontinuations Due to AEs | 0 Participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | SAEs | 0 Participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs) | Discontinuations Due to AEs | 0 Participants |
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 \<LLOQ,TD or TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Week 1 | 39.6 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Week 8 | 100.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Week 4 | 94.1 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Week 12 | 98.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Follow-up Week 4 | 91.1 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | End of treatment | 99.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Week 6 | 100.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Follow-up Week 24 | 89.1 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Week 2 | 77.2 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Follow-up Week 24 | 82.4 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Follow-up Week 4 | 86.3 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Week 1 | 23.5 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Week 2 | 68.6 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Week 4 | 98.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Week 6 | 98.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Week 8 | 100.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Week 12 | 100.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | End of treatment | 100.0 Percentage of participants |
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 \<LLOQ, TND was determined (LLOQ: 25 IU/mL). HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: Week 1, 2, 6, 8 (treatment period)
Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 1 | 11.9 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 2 | 34.7 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 6 | 86.1 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 8 | 95.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 8 | 98.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 1 | 2.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 6 | 90.2 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND) | Week 2 | 29.4 Percentage of participants |
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.
Time frame: Week 12 (Follow-up period)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Genotype: CC (n=40, 20) | 90.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | 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) | Genotype: Non-CC (n=61, 31) | 90.2 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Genotype: CC (n=40, 20) | 95.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | 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) | Genotype: Non-CC (n=61, 31) | 80.6 Percentage of participants |
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.
Time frame: Week 12
Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) | 98.0 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND) | 100.0 Percentage of participants |
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.
Time frame: Up to the end of treatment (up to 24 weeks)
Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) | 99.0 percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND) | 100.0 percentage of participants |
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.
Time frame: Baseline, Week 12 (Follow-up period)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | With cirrhosis (n= 19, 13) | 57.9 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | Without cirrhosis (n= 75, 34) | 97.3 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | With cirrhosis (n= 19, 13) | 69.2 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | Without cirrhosis (n= 75, 34) | 94.1 Percentage of participants |
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.
Time frame: Week 4
Population: The analysis was performed in all treated participants who received at least 1 dose of active study therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Daclatasvir + Sofosbuvir in Treatment-naive Participants | Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) | 63.4 Percentage of participants |
| Daclatasvir + Sofosbuvir in Treatment-experienced Participants | Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND) | 72.5 Percentage of participants |