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.
Study Type
OBSERVATIONAL
Enrollment
734
Unnamed facility
La Jolla, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Diego, California, United States
Unnamed facility
San Francisco, California, United States
Unnamed facility
Aurora, Colorado, United States
Unnamed facility
Englewood, Colorado, United States
Unnamed facility
Bradenton, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
...and 116 more locations
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
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