Hepatitis C
Conditions
Brief summary
A study of the efficacy and safety of the combination of daclatasvir and sofosbuvir in the treatment of hepatitis C virus and HIV coinfection.
Interventions
DRUGDaclatasvir
DRUGSofosbuvir
Sponsors
Bristol-Myers Squibb
Study design
Allocation
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: * Patients 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 * Patients chronically infected with hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6, as documented by positive HCV RNA at screening * Patients who are HCV treatment-naive * Patients who are HCV treatment-experienced and who have had prior anti-HCV therapies discontinued or completed at least 12 weeks prior to screening * Patients with HCV RNA ≥10,000 IU/mL at screening * Patients with HIV-1 infection Key
Exclusion criteria
* Presence of AIDs-defining opportunistic infections, as defined by the Centers of Disease Control and Prevention, within 12 weeks prior to study entry * Patients infected with HIV-2 * 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 radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | At follow-up Week 12 | SVR12 was defined as HCV RNA \<lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | At follow-up Week 12 | SVR12 was defined as HCV RNA \<lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. |
| Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12) | At follow-up Week 12 | SVR12 was defined as HCV RNA levels \<lower limit of quantitation, target detected or target not detected. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. |
| Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 1, 2, 4, 6, 8, 12, End of treatment, and follow-up Week 4 and 24 | Participants with hepatitis C virus CV) levels to be \<lower limit of quantitation, TD or TND at each visit. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. |
| Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment | Participants with HCV RNA levels \<LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. |
| Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | At follow-up Week 12 | SVR12 was defined as HCV RNA\<lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks) | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. |
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period. | AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. |
| Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | From screening up to week 24 of post treatment follow--up | Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0\*upper limit of normal (ULN) for grade 3 and \>3.0\*ULN for grade 4. Leukocytes as 1.0\*10\^9-1.5\*10\^9/L for grade 3 and \<1.0\*10\^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0\*ULN for grade 3 and \>10.0\*ULN for grade 4. Bilirubin (total) as 2.6-5.0\*ULN for grade 3 and \>5.0\*ULN for grade 4. Lipase (total) as 3.1-5.0\*ULN for grade 3 and \>5.0\*ULN for grade 4. Alanine aminotransferase as 5.1-10.0\*ULN for grade 3 and \>10.0\*ULN for grade 4. |
| Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | At Follow-up Week 12 | SVR is defined as hepatitis C virus RNA \<lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at 37 sites in the United States.
Pre-assignment details
A total of 238 participants were enrolled, and 203 received treatment. Of the 35 participants who were enrolled but did not receive treatment, 2 withdrew consent, 31 no longer met study criteria, 1 was lost to follow-up, and 1 was eliminated for other reasons.
Participants by arm
| Arm | Count |
|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up. | 101 |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up. | 50 |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up. | 52 |
| Total | 203 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Follow-up Period | Death | 1 | 1 | 0 |
| Follow-up Period | Lost to Follow-up | 1 | 1 | 0 |
| Follow-up Period | Other | 1 | 0 | 0 |
| Treatment Period | Other | 1 | 1 | 0 |
| Treatment Period | Poor compliance/noncompliance | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Total |
|---|---|---|---|---|
| Age, Continuous | 55.7 years STANDARD_DEVIATION 6.21 | 50.1 years STANDARD_DEVIATION 9.77 | 50.8 years STANDARD_DEVIATION 9.19 | 51.7 years STANDARD_DEVIATION 9.12 |
| Age, Customized <65 years | 49 participants | 96 participants | 47 participants | 192 participants |
| Age, Customized >=65 years | 3 participants | 5 participants | 3 participants | 11 participants |
| Hepatitis C Virus RNA | 6.52 log10 IU/mL STANDARD_DEVIATION 0.789 | 6.50 log10 IU/mL STANDARD_DEVIATION 0.758 | 6.40 log10 IU/mL STANDARD_DEVIATION 0.71 | 6.48 log10 IU/mL STANDARD_DEVIATION 0.753 |
| Hepatitis C Virus RNA distribution <800,000 IU/mL | 8 participants | 22 participants | 6 participants | 36 participants |
| Hepatitis C Virus RNA distribution ≥800,000 IU/mL | 44 participants | 79 participants | 44 participants | 167 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 8 Participants | 26 Participants |
| Sex: Female, Male Male | 43 Participants | 92 Participants | 42 Participants | 177 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 51 / 101 | 14 / 50 | 25 / 52 |
| serious Total, serious adverse events | 1 / 101 | 0 / 50 | 3 / 52 |
Outcome results
Primary
Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNA \<lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time frame: At follow-up Week 12
Population: All genotype 1 treatment-naive participants who received at least 1 dose of study therapy. Here, 'number of participants analyzed' (N) signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Genotype 1 Hepatitis C Virus (HCV)-Infected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | 96.4 Percentage of participants |
Secondary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time frame: AEs: Day 1 to 7 days after last dose of study treatment (8 weeks or 12 weeks). SAEs: Day 1 to 30 days after last dose of study treatment (8 weeks or 12 weeks)
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | SAEs | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Treatment-related Grade 3 to 4 AEs | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Treatment-related AEs | 39 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AEs | 75 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Death | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Grade 3 to 4 AEs | 3 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AEs requiring dose interruption or discontinuation | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Treatment-related AEs | 13 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AEs | 29 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | SAEs | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AEs requiring dose interruption or discontinuation | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Treatment-related Grade 3 to 4 AEs | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Grade 3 to 4 AEs | 2 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Death | 0 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Treatment-related Grade 3 to 4 AEs | 0 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | SAEs | 3 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Death | 0 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Grade 3 to 4 AEs | 4 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | Treatment-related AEs | 17 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AEs requiring dose interruption or discontinuation | 0 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), AEs Leading to Interruption or Discontinuation, Treatment-related AEs/SAEs and Grade 3 to 4 AEs/SAEs and Who Died During Treatment Period | AEs | 37 Participants |
Secondary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may or may not 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. AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.
Time frame: AEs: Day 1 of follow-up period (Week 9 or Week 13) to 7 days after end of 24 weeks follow-up period. SAEs: Day 1 of follow-up period (Week 9 or Week 13) to 30 days after end of 24 weeks follow-up period.
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | SAEs Grade 3 to 4 | 2 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AEs Grade 3 to 4 | 3 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AEs | 11 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | SAEs | 3 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | Death | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AEs Grade 3 to 4 | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AEs | 5 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | SAEs | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | SAEs Grade 3 to 4 | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | Death | 1 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | Death | 0 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | SAEs Grade 3 to 4 | 0 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AEs | 5 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | AEs Grade 3 to 4 | 0 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-related AEs/SAEs, Grade 3 to 4 AEs/SAEs, and Who Died During Follow-up Period | SAEs | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results
Grade 3-4 abnormalities on laboratory test results were defined as: International normalized ratio as 2.1-3.0\*upper limit of normal (ULN) for grade 3 and \>3.0\*ULN for grade 4. Leukocytes as 1.0\*10\^9-1.5\*10\^9/L for grade 3 and \<1.0\*10\^9/L for grade 4. Aspartate aminotransferase as 5.1-10.0\*ULN for grade 3 and \>10.0\*ULN for grade 4. Bilirubin (total) as 2.6-5.0\*ULN for grade 3 and \>5.0\*ULN for grade 4. Lipase (total) as 3.1-5.0\*ULN for grade 3 and \>5.0\*ULN for grade 4. Alanine aminotransferase as 5.1-10.0\*ULN for grade 3 and \>10.0\*ULN for grade 4.
Time frame: From screening up to week 24 of post treatment follow--up
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | International normalized ratio | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Leukocytes | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Aspartate aminotransferase | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Bilirubin (total) | 5 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Lipase (total) | 5 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Alanine aminotransferase | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Alanine aminotransferase | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | International normalized ratio | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Bilirubin (total) | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Lipase (total) | 1 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Leukocytes | 0 Participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Aspartate aminotransferase | 1 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Leukocytes | 1 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Aspartate aminotransferase | 1 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Alanine aminotransferase | 1 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Bilirubin (total) | 2 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | International normalized ratio | 1 Participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Number of Participants With Treatment-emergent Grade 3-4 Abnormalities on Laboratory Test Results | Lipase (total) | 1 Participants |
Secondary
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNA \<lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time frame: At follow-up Week 12
Population: All treatment-experienced participants coinfeted with HCV/HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | 97.7 Percentage of participants |
Secondary
Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNA\<lower limit of quantitation, 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. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time frame: At follow-up Week 12
Population: All treatment-naive participants coinfected with genotype 1 HCV and HIV who received at least 1 dose of study therapy. Here, 'N' signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Hepatitis C Virus (HCV)/HIV-coinfected Treatment-naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) | 75.6 Percentage of participants |
Secondary
Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND)
Participants with HCV RNA levels \<LLOQ, TND. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Time frame: At Weeks 1, 2, 4, 6, 8, and 12 and at End of Treatment
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 2 | 33.7 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 8 | 98.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 6 | 89.1 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 1 | 9.9 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | End of treatment | 99.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 12 | 96.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 4 | 70.3 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 6 | 90.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 1 | 6.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 2 | 34.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 4 | 78.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 8 | 96.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 12 | NA Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | End of treatment | 100.0 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 8 | 100.0 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 2 | 23.1 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | End of treatment | 100.0 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 12 | 98.1 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 6 | 94.2 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 4 | 63.5 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Coinfected With Hepatitis C Virus/HIV Who Achieved HCV RNA Levels<Lower Limit of Quantitation (LLOQ), Target Not Detected (TND) | Week 1 | 5.8 Percentage of participants |
Secondary
Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12)
SVR12 was defined as HCV RNA levels \<lower limit of quantitation, target detected or target not detected. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Time frame: At follow-up Week 12
Population: All participants who received at least 1 dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12) | 97.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12) | 76.0 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants of All Genotypes Coinfected With Hepatitis C Virus (HCV)/HIV Who Achieved Sustained Virologic Response Rate at Follow-up Week 12 (SVR12) | 98.1 Percentage of participants |
Secondary
Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24
Participants with hepatitis C virus CV) levels to be \<lower limit of quantitation, TD or TND at each visit. 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, and follow-up Week 4 and 24
Population: All participants who received at least 1 dose of study drug
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 6 | 99.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Follow-up Week 24 | 92.1 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 12 | 96.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 8 | 98.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 1 | 34.7 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Follow-up Week 4 | 98.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 4 | 93.1 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 2 | 77.2 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | End of treatment | 99.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 8 | 96.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 1 | 44.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 2 | 78.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 4 | 98.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 6 | 98.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 12 | NA Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | End of treatment | 100.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Follow-up Week 4 | 82.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Follow-up Week 24 | 72.0 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 4 | 92.3 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 1 | 34.6 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | End of treatment | 100.0 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 2 | 71.2 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Follow-up Week 24 | 92.3 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 8 | 100.0 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 6 | 98.1 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Follow-up Week 4 | 96.2 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants Who Achieve Hepatitis C Virus RNA Levels to be <Lower Limit of Quantitation, Target Detected (TD)or Target Not Detected (TND) at Weeks: 1, 2, 4, 6, 8, and 12; at End of Treatment; and at Follow-up Weeks 4 and 24 | Week 12 | 98.1 Percentage of participants |
Secondary
Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
SVR is defined as hepatitis C virus RNA \<lower limit of quantitation, target detected or target not detected at follow-up Week 12. Percentage calculated as number of responders/number of patients receiving treatment.
Time frame: At Follow-up Week 12
Population: All participants who received at least 1 dose of study drug. n=participants with CC or non-CC Genotype.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | CC Genotype (n=28,13,13) | 100.0 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | Non-CC Genotype (n=73,37, 39) | 95.9 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | CC Genotype (n=28,13,13) | 69.2 Percentage of participants |
| Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | Non-CC Genotype (n=73,37, 39) | 78.4 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | CC Genotype (n=28,13,13) | 100.0 Percentage of participants |
| Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks | Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12) | Non-CC Genotype (n=73,37, 39) | 97.4 Percentage of participants |