An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

NCT01168856 | Terminated Results

• 2 other identifiers: NV226882009-016560-36
• Study Type: observational
• Target: 734
• Locations: 14 countries
• Sites: 116

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (53)

• 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 \[IU/mL\]).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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).

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Month 18

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic hepatitis C patients having received direct acting antiviral treatment in donor protocol

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (126)

Unknown Facility

La Jolla, California, 92037-1030, United States

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Long Beach, California, 90822, United States

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Sacramento, California, 95817, United States

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Sacramento, California, 95825, United States

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San Diego, California, 92103-8465, United States

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San Francisco, California, 94115, United States

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Aurora, Colorado, 80045, United States

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Englewood, Colorado, 80113, United States

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Bradenton, Florida, 34209, United States

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Atlanta, Georgia, 30309, United States

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Decatur, Georgia, 30033, United States

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Marietta, Georgia, 30060, United States

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Honolulu, Hawaii, 96814, United States

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Chicago, Illinois, 60637, United States

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Indianapolis, Indiana, 46202, United States

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Kansas City, Kansas, 66160-7222, United States

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New Orleans, Louisiana, 70112, United States

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Detroit, Michigan, 48202, United States

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Kansas City, Missouri, 64131, United States

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Lebanon, New Hampshire, 03756, United States

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Hillsborough, New Jersey, 08844, United States

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Newark, New Jersey, 07102, United States

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Manhasset, New York, 11030, United States

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New York, New York, 10003, United States

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New York, New York, 10021, United States

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Providence, Rhode Island, 02905, United States

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Nashville, Tennessee, 37211, United States

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Dallas, Texas, 75246, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78212, United States

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San Antonio, Texas, 78234, United States

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Newport News, Virginia, 23602, United States

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Richmond, Virginia, 23249, United States

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Vancouver, Washington, 98604, United States

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Darlinghurst, New South Wales, 2010, Australia

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Kingswood, New South Wales, 2747, Australia

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Sydney, New South Wales, 2050, Australia

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Westmead, New South Wales, 2145, Australia

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Greenslopes, Queensland, 4120, Australia

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Herston, Queensland, 4029, Australia

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Woolloongabba, Queensland, 4102, Australia

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Adelaide, South Australia, 5000, Australia

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Melbourne, Victoria, 3181, Australia

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Melbourne, Victoria, 3186, Australia

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Vienna, 1080, Austria

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Salvador, Estado de Bahia, 40210-341, Brazil

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Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

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Ribeirão Preto, São Paulo, 14049-900, Brazil

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Calgary, Alberta, T2N 4Z6, Canada

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Edmonton, Alberta, T6G 2B7, Canada

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Edmonton, Alberta, T6L5X8, Canada

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Vancouver, British Columbia, V5Z 1H2, Canada

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Vancouver, British Columbia, V5Z 1M9, Canada

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Vancouver, British Columbia, V6Z 2C7, Canada

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Vancouver, British Columbia, V6Z 2K5, Canada

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Victoria, British Columbia, V8V 3P9, Canada

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Winnipeg, Manitoba, R3E 3P4, Canada

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London, Ontario, N6A 5A5, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Toronto, Ontario, M5G 1L7, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Montreal, Quebec, H3A 1A1, Canada

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Clichy, 92118, France

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Créteil, 94010, France

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Lille, 59037, France

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Marseille, 13285, France

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Montpellier, 34094, France

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Montpellier, 34295, France

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Nice, 06202, France

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Paris, 75651, France

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Paris, 75679, France

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Pessac, 33604, France

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Rennes, 35033, France

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Toulouse, 31059, France

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Vandœuvre-lès-Nancy, 54511, France

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Berlin, 10969, Germany

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Berlin, 13353, Germany

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Frankfurt am Main, 60590, Germany

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Hamburg, 20099, Germany

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Hanover, 30625, Germany

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München, 81377, Germany

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Bari, Apulia, 70124, Italy

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Napoli, Campania, 80131, Italy

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Bologna, Emilia-Romagna, 40138, Italy

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Milan, Lombardy, 20121, Italy

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Milan, Lombardy, 20162, Italy

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Pavia, Lombardy, 27100, Italy

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Turin, Piedmont, 10126, Italy

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Pisa, Tuscany, 56124, Italy

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Guadalajara, 44280, Mexico

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Guadalajara, 44650, Mexico

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Monterrey, 64710, Mexico

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Christchurch, 8011, New Zealand

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Dunedin, 9016, New Zealand

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Grafton, 1010, New Zealand

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Bydgoszcz, 85-030, Poland

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Chorzów, 41-500, Poland

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Lodz, 91-347, Poland

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Lodz, 91-357, Poland

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Mysłowice, 41-400, Poland

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Warsaw, 01-201, Poland

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Warsaw, 02-507, Poland

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Wroclaw, 50-349, Poland

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San Juan, 00927, Puerto Rico

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Bratislava, 831 01, Slovakia

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Palma de Mallorca, Balearic Islands, 07010, Spain

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Badalona, Barcelona, 08915, Spain

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Barcelona, Barcelona, 08003, Spain

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Barcelona, Barcelona, 08035, Spain

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Santander, Cantabria, 39008, Spain

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A Coruña, La Coruña, 15006, Spain

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Madrid, Madrid, 28029, Spain

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Madrid, Madrid, 28034, Spain

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Madrid, Madrid, 28222, Spain

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Pontevedra, Pontevedra, 36071, Spain

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Seville, Sevilla, 41014, Spain

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San Cristóbal de La Laguna, Tenerife, 38320, Spain

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Valencia, Valencia, 46014, Spain

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Dorset, BH7 7DW, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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London, E1 1BB, United Kingdom

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London, SE5 9RS, United Kingdom

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London, SW17 0QT, United Kingdom

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London, W2 1NY, United Kingdom

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Manchester, M8 5RB, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Biospecimen

Retention: NONE RETAINED

Serum specimens collected from patients with partial viral response or viral load rebound of viral response to monitor for resistance mutations in viral RNA

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Investigators were notified of the early termination of study in Jan2015 due to the completion of assessment for resistance monitoring arm and were encouraged to complete scheduled visits until Apr2015 for participants enrolled in SVR durability arm.

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2010
• First Posted: July 23, 2010
• Study Start: September 1, 2010
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: March 11, 2016
• Results First Posted: March 11, 2016

Record last verified: 2016-02

Locations

ME (3); US (34); AU (1); CA (14); PR (1); ES (13); NZ (3); SL (1); GB (8); PL (8); DE (6); BR (3); IT (8); FR (13)