Hepatitis C
Conditions
Keywords
Chronic hepatitis C, Cyclophilin inhibitor
Brief summary
The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.
Interventions
DRUGAlisporivir
ALV 200 mg soft gel capsules administered orally
DRUGPeginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
DRUGRibavirin
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
DRUGPlacebo
ALV placebo soft gel capsules administered orally
Sponsors
Debiopharm International SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Chronic HCV genotype 1 viral infection * HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening * Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks
Exclusion criteria
* Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening * Women of child-bearing potential unless using highly effective * Any other cause of relevant liver disease other than HCV * Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) | after 12 weeks of treatment | cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | 12 weeks after treatment | SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 12 weeks after treatment, respectively. |
| Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | 24 weeks after treatment | SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 24 weeks after treatment, respectively. |
| Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | after 4 weeks of treatment | RVR-LOQ and RVR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch. |
| Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | after 12 weeks of treatment | pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch. |
| Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD) | after 12 weeks of treatment | cEVR-LOD was defined as serum HCV RNA below the limit of detection (\< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch. |
| Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | Up to 48 weeks | — |
| Percentage of Participants With On-treatment Viral Breakthrough | within 48 weeks | On-treatment viral breakthrough was defined as either: * Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or * HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOQ) during treatment |
| Percentage of Participants With Viral Relapse | within 24 weeks after treatment | Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (\< LOQ) during treatment. |
| Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | within 48 weeks | ETR-LOQ and ETR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD at treatment end (completed or prematurely discontinued), respectively. |
Countries
Australia, Belgium, France, Germany, Hungary, Italy, Poland, Puerto Rico, Romania, Spain, Taiwan, Turkey (Türkiye), United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment A ALV 600 mg QD with PEG and RBV for up to 48 weeks. | 121 |
| Treatment B ALV 800 mg QD with PEG and RBV for up to 48 weeks. | 115 |
| Treatment C Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV. | 114 |
| Treatment D ALV 400 mg BID with PEG and RBV for up to 48 weeks. | 109 |
| Total | 459 |
Baseline characteristics
| Characteristic | Treatment A | Treatment B | Treatment C | Treatment D | Total |
|---|---|---|---|---|---|
| Age, Continuous | 50.2 years STANDARD_DEVIATION 9.24 | 50.9 years STANDARD_DEVIATION 10.11 | 50.5 years STANDARD_DEVIATION 10.5 | 51.0 years STANDARD_DEVIATION 9.68 | 50.6 years STANDARD_DEVIATION 9.86 |
| Sex: Female, Male Female | 58 Participants | 47 Participants | 36 Participants | 40 Participants | 181 Participants |
| Sex: Female, Male Male | 63 Participants | 68 Participants | 78 Participants | 69 Participants | 278 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 116 / 120 | 108 / 115 | 58 / 59 | 54 / 55 | 106 / 108 | 22 / 120 | 21 / 115 | 13 / 59 | 10 / 55 | 19 / 108 |
| serious Total, serious adverse events | 7 / 120 | 11 / 115 | 5 / 59 | 1 / 55 | 18 / 108 | 2 / 120 | 4 / 115 | 0 / 59 | 0 / 55 | 0 / 108 |
Outcome results
Primary
Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)
cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time frame: after 12 weeks of treatment
Population: Full Analysis Set (FAS) For Efficacy, defined as all randomized participants who were randomized after the 2nd protocol amendment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) | 48.2 percentage of participants |
| Treatment B | Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) | 61.1 percentage of participants |
| Treatment C | Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) | 35.5 percentage of participants |
| Treatment D | Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) | 74.3 percentage of participants |
| Treatment C1A | Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) | 45.5 percentage of participants |
| Treatment C2A | Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) | 80.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD
SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 12 weeks after treatment, respectively.
Time frame: 12 weeks after treatment
Population: FAS For Efficacy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOQ | 42.7 percentage of participants |
| Treatment A | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOD | 40.9 percentage of participants |
| Treatment B | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOQ | 51.9 percentage of participants |
| Treatment B | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOD | 50.9 percentage of participants |
| Treatment C | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOQ | 14.5 percentage of participants |
| Treatment C | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOD | 14.5 percentage of participants |
| Treatment D | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOQ | 65.1 percentage of participants |
| Treatment D | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOD | 63.3 percentage of participants |
| Treatment C1A | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOQ | 18.2 percentage of participants |
| Treatment C1A | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOD | 18.2 percentage of participants |
| Treatment C2A | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOQ | 53.3 percentage of participants |
| Treatment C2A | Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD | SVR12-LOD | 53.3 percentage of participants |
Secondary
Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD
SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD 24 weeks after treatment, respectively.
Time frame: 24 weeks after treatment
Population: FAS For Efficacy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOQ | 41.8 percentage of participants |
| Treatment A | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOD | 40.0 percentage of participants |
| Treatment B | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOQ | 51.9 percentage of participants |
| Treatment B | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOD | 50.0 percentage of participants |
| Treatment C | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOQ | 14.5 percentage of participants |
| Treatment C | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOD | 14.5 percentage of participants |
| Treatment D | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOQ | 65.1 percentage of participants |
| Treatment D | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOD | 63.3 percentage of participants |
| Treatment C1A | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOQ | 18.2 percentage of participants |
| Treatment C1A | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOD | 18.2 percentage of participants |
| Treatment C2A | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOQ | 53.3 percentage of participants |
| Treatment C2A | Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD | SVR24-LOD | 53.3 percentage of participants |
Secondary
Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End
Time frame: Up to 48 weeks
Population: Participants in the FAS For Efficacy with abnormal ALT at baseline and available data at the respective time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Treatment (n = 53,49,60,53,14,7) | 77.4 percentage of participants |
| Treatment A | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Study (n = 49,42,18,46,13,6) | 54.7 percentage of participants |
| Treatment B | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Treatment (n = 53,49,60,53,14,7) | 77.6 percentage of participants |
| Treatment B | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Study (n = 49,42,18,46,13,6) | 61.2 percentage of participants |
| Treatment C | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Treatment (n = 53,49,60,53,14,7) | 59.0 percentage of participants |
| Treatment C | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Study (n = 49,42,18,46,13,6) | 18.0 percentage of participants |
| Treatment D | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Treatment (n = 53,49,60,53,14,7) | 83.0 percentage of participants |
| Treatment D | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Study (n = 49,42,18,46,13,6) | 67.9 percentage of participants |
| Treatment C1A | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Treatment (n = 53,49,60,53,14,7) | 35.7 percentage of participants |
| Treatment C1A | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Study (n = 49,42,18,46,13,6) | 21.4 percentage of participants |
| Treatment C2A | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Treatment (n = 53,49,60,53,14,7) | 28.6 percentage of participants |
| Treatment C2A | Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End | End of Study (n = 49,42,18,46,13,6) | 28.6 percentage of participants |
Secondary
Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)
cEVR-LOD was defined as serum HCV RNA below the limit of detection (\< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time frame: after 12 weeks of treatment
Population: FAS For Efficacy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD) | 39.1 percentage of participants |
| Treatment B | Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD) | 41.7 percentage of participants |
| Treatment C | Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD) | 20.9 percentage of participants |
| Treatment D | Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD) | 58.7 percentage of participants |
| Treatment C1A | Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD) | 39.4 percentage of participants |
| Treatment C2A | Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD) | 73.3 percentage of participants |
Secondary
Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD
ETR-LOQ and ETR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD at treatment end (completed or prematurely discontinued), respectively.
Time frame: within 48 weeks
Population: FAS For Efficacy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOD | 61.8 percentage of participants |
| Treatment A | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOQ | 68.2 percentage of participants |
| Treatment B | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOQ | 74.1 percentage of participants |
| Treatment B | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOD | 70.4 percentage of participants |
| Treatment C | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOQ | 33.6 percentage of participants |
| Treatment C | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOD | 31.8 percentage of participants |
| Treatment D | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOQ | 82.6 percentage of participants |
| Treatment D | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOD | 78.9 percentage of participants |
| Treatment C1A | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOQ | 51.5 percentage of participants |
| Treatment C1A | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOD | 36.4 percentage of participants |
| Treatment C2A | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOD | 66.7 percentage of participants |
| Treatment C2A | Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD | ETR-LOQ | 73.3 percentage of participants |
Secondary
Percentage of Participants With On-treatment Viral Breakthrough
On-treatment viral breakthrough was defined as either: * Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or * HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (\< LOQ) during treatment
Time frame: within 48 weeks
Population: FAS For Efficacy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Percentage of Participants With On-treatment Viral Breakthrough | 12.7 percentage of participants |
| Treatment B | Percentage of Participants With On-treatment Viral Breakthrough | 9.3 percentage of participants |
| Treatment C | Percentage of Participants With On-treatment Viral Breakthrough | 5.5 percentage of participants |
| Treatment D | Percentage of Participants With On-treatment Viral Breakthrough | 2.8 percentage of participants |
| Treatment C1A | Percentage of Participants With On-treatment Viral Breakthrough | 6.1 percentage of participants |
| Treatment C2A | Percentage of Participants With On-treatment Viral Breakthrough | 10.0 percentage of participants |
Secondary
Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD
pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.
Time frame: after 12 weeks of treatment
Population: FAS For Efficacy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOQ | 38.2 percentage of participants |
| Treatment A | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOD | 47.3 percentage of participants |
| Treatment B | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOQ | 28.7 percentage of participants |
| Treatment B | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOD | 48.1 percentage of participants |
| Treatment C | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOQ | 31.8 percentage of participants |
| Treatment C | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOD | 46.4 percentage of participants |
| Treatment D | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOQ | 11.9 percentage of participants |
| Treatment D | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOD | 27.5 percentage of participants |
| Treatment C1A | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOQ | 3.0 percentage of participants |
| Treatment C1A | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOD | 9.1 percentage of participants |
| Treatment C2A | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOQ | 6.7 percentage of participants |
| Treatment C2A | Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD | pEVR-LOD | 13.3 percentage of participants |
Secondary
Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD
RVR-LOQ and RVR-LOD were defined as serum HCV RNA \< LOQ and serum HCV RNA \< LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.
Time frame: after 4 weeks of treatment
Population: FAS For Efficacy
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Treatment A | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOD | 9.1 percentage of participants |
| Treatment A | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOQ | 20.9 percentage of participants |
| Treatment B | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOQ | 25.0 percentage of participants |
| Treatment B | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOD | 8.3 percentage of participants |
| Treatment C | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOQ | 7.3 percentage of participants |
| Treatment C | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOD | 2.7 percentage of participants |
| Treatment D | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOQ | 41.3 percentage of participants |
| Treatment D | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOD | 22.9 percentage of participants |
| Treatment C1A | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOQ | 39.4 percentage of participants |
| Treatment C1A | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOD | 18.2 percentage of participants |
| Treatment C2A | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOQ | 56.7 percentage of participants |
| Treatment C2A | Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD | RVR-LOD | 50.0 percentage of participants |
Secondary
Percentage of Participants With Viral Relapse
Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (\< LOQ) during treatment.
Time frame: within 24 weeks after treatment
Population: FAS For Efficacy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Percentage of Participants With Viral Relapse | 19.1 percentage of participants |
| Treatment B | Percentage of Participants With Viral Relapse | 18.5 percentage of participants |
| Treatment C | Percentage of Participants With Viral Relapse | 17.3 percentage of participants |
| Treatment D | Percentage of Participants With Viral Relapse | 12.8 percentage of participants |
| Treatment C1A | Percentage of Participants With Viral Relapse | 30.3 percentage of participants |
| Treatment C2A | Percentage of Participants With Viral Relapse | 13.3 percentage of participants |