Trial Outcomes & Findings for A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study (NCT NCT01773070)

Results Overview

Relapse is defined as a confirmed HCV ribonucleic acid (RNA) ≥ the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA \< LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

478 participants

Primary outcome timeframe

Up to 3 years post-treatment

Results posted on

2017-12-06

Participant Flow

This follow-up study was open to participants from AbbVie studies M11-646 (NCT01716585), M11-652 (NCT01464827), M12-746 (NCT01306617), M12-998 (NCT01458535), M13-098 (NCT01715415), M13-099 (NCT01704755), M13-386 (NCT01563536), M13-389 (NCT01674725)' M13-393 (NCT01685203), M13-961 (NCT01767116), M14-002 (NCT01833533), and M14-103 (NCT01911845).

Participant milestones

Participant milestones
Measure	All Participants Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic hepatitis C virus (HCV), followed for up to 3 years post-treatment.
Overall Study STARTED	478
Overall Study COMPLETED	397
Overall Study NOT COMPLETED	81

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic hepatitis C virus (HCV), followed for up to 3 years post-treatment.
Overall Study Withdrawal by Subject	24
Overall Study Lost to Follow-up	39
Overall Study Other	15
Overall Study Death (unrelated to study procedures)	3

Baseline Characteristics

A Follow up Study Designed to Obtain Long Term Data on Participants Who Either Achieved a Sustained Virologic Response or Did Not Achieve a Sustained Virologic Response in an AbbVie Sponsored Hepatitis C Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=478 Participants Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Age, Continuous	53.0 years STANDARD_DEVIATION 9.85 • n=5 Participants
Sex: Female, Male Female	227 Participants n=5 Participants
Sex: Female, Male Male	251 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 years post-treatment

Population: Participants who achieved SVR12 and had post-SVR12 HCV RNA data available. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.

Relapse is defined as a confirmed HCV ribonucleic acid (RNA) ≥ the lower limit of quantitation (LLOQ) at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12overall is defined as a confirmed HCV RNA ≥ LLOQ at any time after the sustained virologic response at Week 12 post-dosing (SVR12) assessment time point for a participant who achieved SVR12 and had post-SVR12 HCV RNA data available. SVR12 is defined as HCV RNA \< LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. New HCV infection is defined as re-infection with a different HCV isolate.

Outcome measures

Outcome measures
Measure	All Participants n=457 Participants Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection Relapse12overall With New HCV Infection	0.2 percentage of participants
Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection Relapse12overall Without New HCV Infection	0.2 percentage of participants

PRIMARY outcome

Timeframe: from the last dose of study drug in the previous study up to 3 years post-treatment

Population: GT1a-infected participants who experienced virologic failure after receiving ABT-450, ABT-333 or ABT-267, and had not achieved SVR12 and had post-baseline sequencing data for NS3, NS5A, or NS5B at given time point.

The persistence of specific hepatitis C amino acid variants (treatment-emergent substitutions) associated with drug resistance in NS3, NS5A, or NS5B was evaluated in participants who had not achieved SVR12. Post-baseline time points were calculated relative to the last dose of study drug in the previous study.

Outcome measures

Outcome measures
Measure	All Participants n=18 Participants Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS3: time of failure	7 Participants
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS3: post-treatment week 48	0 Participants
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS5A: time of failure	13 Participants
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS5A: post-treatment week 48	10 Participants
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS5A: post-treatment week 96	6 Participants
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS5A: post-treatment week 132	4 Participants
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS5B: time of failure	7 Participants
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS5B: post-treatment week 24	3 Participants
Number of HCV Genotype (GT)1a-Infected Participants With Persistence of Treatment-Emergent Substitutions in NS3, NS5A, or NS5B NS5B: post-treatment week 96	1 Participants

SECONDARY outcome

Timeframe: From the end of treatment through 12 weeks post-treatment

Population: Participants with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.

Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse12 is defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of study drug (up to and including the SVR12 assessment time point) for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.

Outcome measures

Outcome measures
Measure	All Participants n=458 Participants Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection Relapse12 Without New HCV Infection	2.0 percentage of participants
Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection Relapse12 With New HCV Infection	0 percentage of participants

SECONDARY outcome

Timeframe: From the end of treatment through 24 weeks post-treatment

Population: Participants who achieved SVR12 and had HCV RNA data available in the SVR24 window. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.

Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse24 is defined as a confirmed HCV RNA ≥ LLOQ within the sustained virologic response at Week 24 post-dosing (SVR24) window for a participant who achieved SVR12 and had HCV RNA data available in the SVR24 window.

Outcome measures

Outcome measures
Measure	All Participants n=403 Participants Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection Relapse24 Without New HCV Infection	0.2 percentage of participants
Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection Relapse24 With New HCV Infection	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 3 years post-treatment

Population: Participants with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment. Participants who did not have any post-treatment HCV RNA values were excluded from the relapse analyses.

Relapse is defined as a confirmed HCV RNA ≥ LLOQ at any time during the post-treatment period for a participant who had HCV RNA \< LLOQ at the end of treatment. Relapse˅overall was defined as a confirmed HCV RNA ≥ LLOQ between end of treatment and up to and including the last HCV RNA measurement collected in the post-treatment Period for a participant with HCV RNA \< LLOQ at Final Treatment Visit who completed treatment.

Outcome measures

Outcome measures
Measure	All Participants n=458 Participants Participants who received ABT-450, ABT-333 or ABT-267 at any dose level in an eligible prior AbbVie Phase 2 or 3 study for the treatment of chronic HCV, followed for up to 3 years post-treatment.
Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection Relapse˅overall Without New HCV Infection	2.2 percentage of participants
Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection Relapse˅overall With New HCV Infection	0.2 percentage of participants

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Global Medical Services

AbbVie (prior sponsor Abbott)

Phone: 800-633-9110

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER