An observational study in Hepatitis C, Chronic, sponsored by Hoffmann-La Roche. Terminated at 126 sites in 15 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-11.
Sponsored by Hoffmann-La Roche · Observational
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.
1,090 studies on the registry are indexed under Hepatitis C, Chronic; 9 are open to participants now.
This study's enrollment of 734 is above the median of 250 across 247 observational studies indexed under Hepatitis C, Chronic.
Browse Hepatitis C, Chronic studies →Hoffmann-La Roche is the lead sponsor of 2,099 studies on the registry; 87 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 245 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Chronic hepatitis C patients having received direct acting antiviral treatment in donor protocol
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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 \[NCT01628094\].
| Milestone | Resistance Monitoring Arm | Sustained Virological Response (SVR) Durability Monitoring Arm |
|---|---|---|
| Started | 176 | 558 |
| Completed | 158 | 215 |
| Not completed | 18 | 343 |
| Withdrew: Lost to follow-up | 4 | 34 |
| Withdrew: Withdrawal by subject | 6 | 8 |
| Withdrew: Physician decision | 2 | 1 |
| Withdrew: Confirmed quantifiable hcv rna | 0 | 1 |
| Withdrew: Participant received anti-hcv treatment | 1 | 0 |
| Withdrew: Death | 0 | 2 |
| Withdrew: Other | 1 | 291 |
| Withdrew: Protocol violation | 4 | 6 |
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 | Resistance Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3 | 99.1 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| Percentage of participants | Resistance Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6 | 99.3 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| Percentage of participants | Resistance Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9 | 99.2 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| Percentage of participants | Resistance Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12 | 99.2 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| Percentage of participants | Resistance Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18 | 100 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| IU/mL | Resistance Monitoring Arm |
|---|---|
| HCV RNA Levels in Resistance Monitoring Arm at Month 3 | 3922296 ± 5111469 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| IU/mL | Resistance Monitoring Arm |
|---|---|
| HCV RNA Levels in Resistance Monitoring Arm at Month 6 | 4369148 ± 6803658 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| IU/mL | Resistance Monitoring Arm |
|---|---|
| HCV RNA Levels in Resistance Monitoring Arm at Month 9 | 5016299 ± 7235510 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| IU/mL | Resistance Monitoring Arm |
|---|---|
| HCV RNA Levels in Resistance Monitoring Arm at Month 12 | 4955311 ± 6595493 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| IU/mL | Resistance Monitoring Arm |
|---|---|
| HCV RNA Levels in Resistance Monitoring Arm at Month 18 | 4830852 ± 6621059 |
Any abnormalities in systolic blood pressure (units: millimeters of Mercury \[Hg\] \[mmHg\]) were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3 | 128.1 ± 16.15 |
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Systolic Blood Pressure in Resistance Monitoring Arm at Month 6 | 126.0 ± 16.58 |
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Systolic Blood Pressure in Resistance Monitoring Arm at Month 9 | 126.9 ± 15.48 |
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12 | 127.1 ± 14.97 |
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18 | 130.3 ± 17.53 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3 | 79.8 ± 10.67 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6 | 78.0 ± 10.60 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9 | 78.5 ± 9.60 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12 | 77.7 ± 9.92 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | Resistance Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18 | 79.3 ± 9.77 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | Resistance Monitoring Arm |
|---|---|
| Mean Pulse Rate in Resistance Monitoring Arm at Month 3 | 70.6 ± 9.89 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | Resistance Monitoring Arm |
|---|---|
| Mean Pulse Rate in Resistance Monitoring Arm at Month 6 | 71.1 ± 10.14 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | Resistance Monitoring Arm |
|---|---|
| Mean Pulse Rate in Resistance Monitoring Arm at Month 9 | 70.3 ± 12.08 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | Resistance Monitoring Arm |
|---|---|
| Mean Pulse Rate in Resistance Monitoring Arm at Month 12 | 70.3 ± 10.68 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | Resistance Monitoring Arm |
|---|---|
| Mean Pulse Rate in Resistance Monitoring Arm at Month 18 | 70.8 ± 10.75 |
Percentage of participants who received any anti-HCV medication during the monitoring period was reported.
| Percentage of participants | Resistance Monitoring Arm |
|---|---|
| Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm | 1.2 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| Percentage of participants | SVR Durability Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6 | 0.2 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| Percentage of participants | SVR Durability Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12 | 0 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| Percentage of participants | SVR Durability Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24 | 0 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| Percentage of participants | SVR Durability Monitoring Arm |
|---|---|
| Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36 | 0 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
| IU/mL | SVR Durability Monitoring Arm |
|---|---|
| Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6 | 896000 |
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
No measurements were reported for this outcome.
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
No measurements were reported for this outcome.
Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
No measurements were reported for this outcome.
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
| mmHg | SVR Durability Monitoring Arm |
|---|---|
| Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 | 126.8 ± 16.83 |
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
| mmHg | SVR Durability Monitoring Arm |
|---|---|
| Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 | 127.4 ± 16.66 |
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
| mmHg | SVR Durability Monitoring Arm |
|---|---|
| Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 | 128.0 ± 15.56 |
Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
| mmHg | SVR Durability Monitoring Arm |
|---|---|
| Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 | 130.1 ± 16.68 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | SVR Durability Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 | 77.9 ± 10.67 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | SVR Durability Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 | 78.0 ± 10.31 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | SVR Durability Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 | 78.3 ± 10.28 |
Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
| mmHg | SVR Durability Monitoring Arm |
|---|---|
| Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 | 78.3 ± 10.11 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | SVR Durability Monitoring Arm |
|---|---|
| Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6 | 72.0 ± 10.41 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | SVR Durability Monitoring Arm |
|---|---|
| Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12 | 72.9 ± 9.61 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | SVR Durability Monitoring Arm |
|---|---|
| Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24 | 72.7 ± 10.45 |
Any abnormalities in pulse rate were reported at the discretion of principal investigator.
| Beats per minute | SVR Durability Monitoring Arm |
|---|---|
| Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36 | 73.0 ± 11.10 |
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.
| participants | Resistance Monitoring Arm |
|---|---|
| NP22660 Category 1 | 3 |
| NP22660 Category 2 | 0 |
| NP22660 Category 3 | 1 |
| NP27946 Category 1 | 1 |
| NP27946 Category 2 | 3 |
| NP27946 Category 3 | 1 |
| NV21075 Category 1 | 4 |
| NV21075 Category 2 | 1 |
| NV21075 Category 3 | 1 |
| NP28266 Category 1 | 4 |
| NP28266 Category 2 | 1 |
| NP28266 Category 3 | 6 |
| NV22776 Category 1 | 17 |
| NV22776 Category 2 | 6 |
| NV22776 Category 3 | 6 |
| PP25213 Category 1 | 37 |
| PP25213 Category 2 | 11 |
| PP25213 Category 3 | 1 |
| WV21913 Category 1 | 33 |
| WV21913 Category 2 | 11 |
| WV21913 Category 3 | 14 |
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.
| participants | Resistance Monitoring Arm |
|---|---|
| NP27946 Category 1 | 1 |
| NP27946 Category 2 | 0 |
| NP27946 Category 3 | 0 |
| NP22660 Category 1 | 3 |
| NP22660 Category 2 | 0 |
| NP22660 Category 3 | 1 |
| NV21075 Category 1 | 2 |
| NV21075 Category 2 | 2 |
| NV21075 Category 3 | 1 |
| NP28266 Category 1 | 3 |
| NP28266 Category 2 | 1 |
| NP28266 Category 3 | 4 |
| NV22776 Category 1 | 9 |
| NV22776 Category 2 | 8 |
| NV22776 Category 3 | 6 |
| PP25213 Category 1 | 21 |
| PP25213 Category 2 | 16 |
| PP25213 Category 3 | 1 |
| WV21913 Category 1 | 25 |
| WV21913 Category 2 | 8 |
| WV21913 Category 3 | 13 |
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.
| participants | Resistance Monitoring Arm |
|---|---|
| TVR study NV22779 Category 1 | 3 |
| TVR study NV22779 Category 2 | 1 |
| TVR study NV22779 Category 3 | 1 |
| BOC study NV22780 Category 1 | 3 |
| BOC study NV22780 Category 2 | 0 |
| BOC study NV22780 Category 3 | 1 |
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.
| participants | Resistance Monitoring Arm |
|---|---|
| TVR study NV22779 Category 1 | 2 |
| TVR study NV22779 Category 2 | 1 |
| TVR study NV22779 Category 3 | 1 |
| BOC study NV22780 Category 1 | 1 |
| BOC study NV22780 Category 2 | 2 |
| BOC study NV22780 Category 3 | 1 |
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.
| participants | Resistance Monitoring Arm |
|---|---|
| NP28266 Category 1 | 5 |
| NP28266 Category 2 | 3 |
| NP28266 Category 3 | 3 |
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.
| participants | Resistance Monitoring Arm |
|---|---|
| NP28266 Category 1 | 1 |
| NP28266 Category 2 | 4 |
| NP28266 Category 3 | 1 |
| NP28266 Category 4 | 2 |
Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.
| participants | Resistance Monitoring Arm |
|---|---|
| NV20536 | 1 |
| NV27780 | 2 |
| NP27946 | 3 |
| NV27779 | 5 |
| NP28266 | 6 |
| WV21913 | 44 |
| PP25213 | 49 |
Collected over Up to 36 Months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Resistance Monitoring Arm | — | 0/172 (0%) | 1/172 (0.6%) |
| SVR Durability Monitoring Arm | — | 0/552 (0%) | 0/552 (0%) |
| Event | Resistance Monitoring Arm | SVR Durability Monitoring Arm |
|---|---|---|
| VENIPUNCTURE SITE BRUISEGeneral disorders | 1/172 | 0/552 |
Eligible population included all enrolled participants excluding participants with protocol violations.
| Age, Continuous(years) | Resistance Monitoring Arm | SVR Durability Monitoring Arm | Total |
|---|---|---|---|
| Mean | 52.1 ± 8.48 | 51.0 ± 10.79 | 51.2 ± 10.29 |
| Sex: Female, Male(Participants) | Resistance Monitoring Arm | SVR Durability Monitoring Arm | Total |
|---|---|---|---|
| Female | 47 | 222 | 269 |
| Male | 125 | 330 | 455 |
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