Hepatitis C, Chronic
Conditions
Brief summary
This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>/=18 years of age * chronic hepatitis C * participation in Roche DAA treatment protocol for CHC infection * DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response \>/= 20 weeks after last dose of study medication in donor study
Exclusion criteria
* For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA * For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Pulse Rate in Resistance Monitoring Arm at Month 3 | Month 3 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3 | Month 3 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter \[IU/mL\]). |
| Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6 | Month 6 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9 | Month 9 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12 | Month 12 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18 | Month 18 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| HCV RNA Levels in Resistance Monitoring Arm at Month 3 | Month 3 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| HCV RNA Levels in Resistance Monitoring Arm at Month 6 | Month 6 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| HCV RNA Levels in Resistance Monitoring Arm at Month 9 | Month 9 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| HCV RNA Levels in Resistance Monitoring Arm at Month 12 | Month 12 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| HCV RNA Levels in Resistance Monitoring Arm at Month 18 | Month 18 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3 | Month 3 | Any abnormalities in systolic blood pressure (units: millimeters of Mercury \[Hg\] \[mmHg\]) were reported at the discretion of principal investigator. |
| Systolic Blood Pressure in Resistance Monitoring Arm at Month 6 | Month 6 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. |
| Systolic Blood Pressure in Resistance Monitoring Arm at Month 9 | Month 9 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. |
| Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12 | Month 12 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. |
| Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18 | Month 18 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3 | Month 3 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6 | Month 6 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9 | Month 9 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12 | Month 12 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18 | Month 18 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Pulse Rate in Resistance Monitoring Arm at Month 6 | Month 6 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Mean Pulse Rate in Resistance Monitoring Arm at Month 9 | Month 9 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Mean Pulse Rate in Resistance Monitoring Arm at Month 12 | Month 12 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Mean Pulse Rate in Resistance Monitoring Arm at Month 18 | Month 18 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm | Up to 18 months | Percentage of participants who received any anti-HCV medication during the monitoring period was reported. |
| Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6 | Month 6 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12 | Month 12 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24 | Month 24 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36 | Month 36 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6 | Month 6 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12 | Month 12 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24 | Month 24 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36 | Month 36 | Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL). |
| Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 | Month 6 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. |
| Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 | Month 12 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. |
| Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 | Month 24 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. |
| Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 | Month 36 | Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 | Month 6 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 | Month 12 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 | Month 24 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 | Month 36 | Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator. |
| Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6 | Month 6 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12 | Month 12 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24 | Month 24 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36 | Month 36 | Any abnormalities in pulse rate were reported at the discretion of principal investigator. |
| Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | Month 3-18 | Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis. |
| Number of Participants With DNV Resistance Status-Clonal Sequencing | Month 3-18 | Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study. |
| Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing | Month 3-18 | Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis. |
| Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing | Month 3-18 | Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688. |
| Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing | Month 3-18 | Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis. |
| Number of Participants With STV Resistance Status-Clonal Sequencing | Month 3-18 | Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688. Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688. |
| Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | Month 18 | Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol. |
Countries
Australia, Austria, Brazil, Canada, France, Germany, Italy, Mexico, New Zealand, Poland, Puerto Rico, Slovakia, Spain, United Kingdom, United States
Participant flow
Recruitment details
Participants from following studies were enrolled: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\].
Pre-assignment details
This study was terminated early and participants discontinued due to study termination were included under reason unspecified in the participant flow.
Participants by arm
| Arm | Count |
|---|---|
| Resistance Monitoring Arm Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months. | 172 |
| SVR Durability Monitoring Arm Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 \[NCT00869661\], NV21075 \[NCT00963885\], WV21913 \[NCT01331850\], NV22621 \[NCT01057667\], NP22660 \[NCT01185860\], NV22688 \[NCT01168856\], NV22776 \[NCT01220947\], PP25213 \[NCT01278134\], NV27779 \[NCT01482390\], NV27780 \[NCT01482403\], NP27946 \[NCT01483742\], YV28218 \[NCT01749150\], NP28266 \[NCT01628094\]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months. | 552 |
| Total | 724 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Confirmed Quantifiable HCV RNA | 0 | 1 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lost to Follow-up | 4 | 34 |
| Overall Study | Other | 1 | 291 |
| Overall Study | Participant received anti-HCV treatment | 1 | 0 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 4 | 6 |
| Overall Study | Withdrawal by Subject | 6 | 8 |
Baseline characteristics
| Characteristic | Resistance Monitoring Arm | SVR Durability Monitoring Arm | Total |
|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 8.48 | 51.0 years STANDARD_DEVIATION 10.79 | 51.2 years STANDARD_DEVIATION 10.29 |
| Sex: Female, Male Female | 47 Participants | 222 Participants | 269 Participants |
| Sex: Female, Male Male | 125 Participants | 330 Participants | 455 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 172 | 0 / 552 |
| serious Total, serious adverse events | 0 / 172 | 0 / 552 |
Outcome results
Primary
HCV RNA Levels in Resistance Monitoring Arm at Month 12
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 12
Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | HCV RNA Levels in Resistance Monitoring Arm at Month 12 | 4955311 IU/mL | Standard Deviation 6595493 |
Primary
HCV RNA Levels in Resistance Monitoring Arm at Month 18
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 18
Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | HCV RNA Levels in Resistance Monitoring Arm at Month 18 | 4830852 IU/mL | Standard Deviation 6621059 |
Primary
HCV RNA Levels in Resistance Monitoring Arm at Month 3
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 3
Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | HCV RNA Levels in Resistance Monitoring Arm at Month 3 | 3922296 IU/mL | Standard Deviation 5111469 |
Primary
HCV RNA Levels in Resistance Monitoring Arm at Month 6
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 6
Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | HCV RNA Levels in Resistance Monitoring Arm at Month 6 | 4369148 IU/mL | Standard Deviation 6803658 |
Primary
HCV RNA Levels in Resistance Monitoring Arm at Month 9
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 9
Population: Resistance monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | HCV RNA Levels in Resistance Monitoring Arm at Month 9 | 5016299 IU/mL | Standard Deviation 7235510 |
Primary
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 12
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12 | 77.7 mmHg | Standard Deviation 9.92 |
Primary
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 18
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18 | 79.3 mmHg | Standard Deviation 9.77 |
Primary
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 3
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3 | 79.8 mmHg | Standard Deviation 10.67 |
Primary
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 6
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6 | 78.0 mmHg | Standard Deviation 10.6 |
Primary
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 9
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9 | 78.5 mmHg | Standard Deviation 9.6 |
Primary
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 12
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 | 78.0 mmHg | Standard Deviation 10.31 |
Primary
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 24
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 | 78.3 mmHg | Standard Deviation 10.28 |
Primary
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 36
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 | 78.3 mmHg | Standard Deviation 10.11 |
Primary
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 6
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 | 77.9 mmHg | Standard Deviation 10.67 |
Primary
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 12
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 12.
Primary
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 24
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 24.
Primary
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 36
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 36.
Primary
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 6
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with detectable HCV RNA at Month 6.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Resistance Monitoring Arm | Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6 | 896000 IU/mL |
Primary
Mean Pulse Rate in Resistance Monitoring Arm at Month 12
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 12
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in Resistance Monitoring Arm at Month 12 | 70.3 Beats per minute | Standard Deviation 10.68 |
Primary
Mean Pulse Rate in Resistance Monitoring Arm at Month 18
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 18
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in Resistance Monitoring Arm at Month 18 | 70.8 Beats per minute | Standard Deviation 10.75 |
Primary
Mean Pulse Rate in Resistance Monitoring Arm at Month 3
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 3
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in Resistance Monitoring Arm at Month 3 | 70.6 Beats per minute | Standard Deviation 9.89 |
Primary
Mean Pulse Rate in Resistance Monitoring Arm at Month 6
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 6
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in Resistance Monitoring Arm at Month 6 | 71.1 Beats per minute | Standard Deviation 10.14 |
Primary
Mean Pulse Rate in Resistance Monitoring Arm at Month 9
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 9
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in Resistance Monitoring Arm at Month 9 | 70.3 Beats per minute | Standard Deviation 12.08 |
Primary
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 12
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12 | 72.9 Beats per minute | Standard Deviation 9.61 |
Primary
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 24
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24 | 72.7 Beats per minute | Standard Deviation 10.45 |
Primary
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 36
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36 | 73.0 Beats per minute | Standard Deviation 11.1 |
Primary
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
Time frame: Month 6
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6 | 72.0 Beats per minute | Standard Deviation 10.41 |
Primary
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 12
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12 | 127.1 mmHg | Standard Deviation 14.97 |
Primary
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 18
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 18.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18 | 130.3 mmHg | Standard Deviation 17.53 |
Primary
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3
Any abnormalities in systolic blood pressure (units: millimeters of Mercury \[Hg\] \[mmHg\]) were reported at the discretion of principal investigator.
Time frame: Month 3
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 3.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3 | 128.1 mmHg | Standard Deviation 16.15 |
Primary
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 12
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 | 127.4 mmHg | Standard Deviation 16.66 |
Primary
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 24
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 24.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 | 128.0 mmHg | Standard Deviation 15.56 |
Primary
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 36
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 36.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 | 130.1 mmHg | Standard Deviation 16.68 |
Primary
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 6
Population: SVR durability monitoring population. Here, number of participants analyzed = participants with vital signs assessments at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 | 126.8 mmHg | Standard Deviation 16.83 |
Primary
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688
Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.
Time frame: Month 18
Population: Resistance monitoring population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Resistance Monitoring Arm | Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | NV20536 | 1 participants |
| Resistance Monitoring Arm | Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | NV27780 | 2 participants |
| Resistance Monitoring Arm | Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | NP27946 | 3 participants |
| Resistance Monitoring Arm | Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | NV27779 | 5 participants |
| Resistance Monitoring Arm | Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | NP28266 | 6 participants |
| Resistance Monitoring Arm | Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | WV21913 | 44 participants |
| Resistance Monitoring Arm | Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 | PP25213 | 49 participants |
Primary
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing
Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Time frame: Month 3-18
Population: Resistance monitoring population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Resistance Monitoring Arm | Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing | TVR study NV22779 Category 1 | 3 participants |
| Resistance Monitoring Arm | Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing | TVR study NV22779 Category 2 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing | TVR study NV22779 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing | BOC study NV22780 Category 1 | 3 participants |
| Resistance Monitoring Arm | Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing | BOC study NV22780 Category 2 | 0 participants |
| Resistance Monitoring Arm | Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing | BOC study NV22780 Category 3 | 1 participants |
Primary
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing
Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.
Time frame: Month 3-18
Population: Resistance monitoring population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Resistance Monitoring Arm | Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing | TVR study NV22779 Category 1 | 2 participants |
| Resistance Monitoring Arm | Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing | TVR study NV22779 Category 2 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing | TVR study NV22779 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing | BOC study NV22780 Category 1 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing | BOC study NV22780 Category 2 | 2 participants |
| Resistance Monitoring Arm | Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing | BOC study NV22780 Category 3 | 1 participants |
Primary
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing
Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Time frame: Month 3-18
Population: Resistance monitoring population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP22660 Category 1 | 3 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP22660 Category 2 | 0 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP22660 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP27946 Category 1 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP27946 Category 2 | 3 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP27946 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NV21075 Category 1 | 4 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NV21075 Category 2 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NV21075 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP28266 Category 1 | 4 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP28266 Category 2 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NP28266 Category 3 | 6 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NV22776 Category 1 | 17 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NV22776 Category 2 | 6 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | NV22776 Category 3 | 6 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | PP25213 Category 1 | 37 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | PP25213 Category 2 | 11 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | PP25213 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | WV21913 Category 1 | 33 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | WV21913 Category 2 | 11 participants |
| Resistance Monitoring Arm | Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing | WV21913 Category 3 | 14 participants |
Primary
Number of Participants With DNV Resistance Status-Clonal Sequencing
Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.
Time frame: Month 3-18
Population: Resistance monitoring population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP27946 Category 1 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP27946 Category 2 | 0 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP27946 Category 3 | 0 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP22660 Category 1 | 3 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP22660 Category 2 | 0 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP22660 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NV21075 Category 1 | 2 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NV21075 Category 2 | 2 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NV21075 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP28266 Category 1 | 3 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP28266 Category 2 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NP28266 Category 3 | 4 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NV22776 Category 1 | 9 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NV22776 Category 2 | 8 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | NV22776 Category 3 | 6 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | PP25213 Category 1 | 21 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | PP25213 Category 2 | 16 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | PP25213 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | WV21913 Category 1 | 25 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | WV21913 Category 2 | 8 participants |
| Resistance Monitoring Arm | Number of Participants With DNV Resistance Status-Clonal Sequencing | WV21913 Category 3 | 13 participants |
Primary
Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing
Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.
Time frame: Month 3-18
Population: Resistance monitoring population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Resistance Monitoring Arm | Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing | NP28266 Category 1 | 5 participants |
| Resistance Monitoring Arm | Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing | NP28266 Category 2 | 3 participants |
| Resistance Monitoring Arm | Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing | NP28266 Category 3 | 3 participants |
Primary
Number of Participants With STV Resistance Status-Clonal Sequencing
Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance. Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis. Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis. Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688. Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.
Time frame: Month 3-18
Population: Resistance monitoring population. Here, n1=total number of participants with loss of STV resistance in NV22688 (by population sequencing). n2= total number of participants who had no STV resistance at the end of donor study they experienced a viral relapse in NV22688.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Resistance Monitoring Arm | Number of Participants With STV Resistance Status-Clonal Sequencing | NP28266 Category 1 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With STV Resistance Status-Clonal Sequencing | NP28266 Category 2 | 4 participants |
| Resistance Monitoring Arm | Number of Participants With STV Resistance Status-Clonal Sequencing | NP28266 Category 3 | 1 participants |
| Resistance Monitoring Arm | Number of Participants With STV Resistance Status-Clonal Sequencing | NP28266 Category 4 | 2 participants |
Primary
Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm
Percentage of participants who received any anti-HCV medication during the monitoring period was reported.
Time frame: Up to 18 months
Population: Resistance monitoring population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm | 1.2 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter \[IU/mL\]).
Time frame: Month 3
Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3 | 99.1 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 12
Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12 | 99.2 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 18
Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 18.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18 | 100 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 6
Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6 | 99.3 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 9
Population: Resistance monitoring population included all participants who were enrolled in resistance monitoring arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 9.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9 | 99.2 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 12
Population: SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12 | 0 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 24
Population: SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 24.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24 | 0 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 36
Population: SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 36.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36 | 0 Percentage of participants |
Primary
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
Time frame: Month 6
Population: SVR durability monitoring population included all participants who were enrolled in SVR durability arm. Here, number of participants analyzed = participants with HCV RNA assessment at Month 6.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Resistance Monitoring Arm | Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6 | 0.2 Percentage of participants |
Primary
Systolic Blood Pressure in Resistance Monitoring Arm at Month 6
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 6
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 6.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Systolic Blood Pressure in Resistance Monitoring Arm at Month 6 | 126.0 mmHg | Standard Deviation 16.58 |
Primary
Systolic Blood Pressure in Resistance Monitoring Arm at Month 9
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
Time frame: Month 9
Population: Resistance monitoring population. Here, number of participants analyzed = participants with vital signs assessment at Month 9.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Resistance Monitoring Arm | Systolic Blood Pressure in Resistance Monitoring Arm at Month 9 | 126.9 mmHg | Standard Deviation 15.48 |