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

A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

A follow-up study to assess resistance and durability of response to 3 experimental drugs ABT-450/r, ABT-267, and ABT-333 in participants who have participated in AbbVie Phase 2 or 3 clinical studies with these agents for the treatment of chronic hepatitis C virus (HCV). Studies include: 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).

Study Overview

• Status: Completed
• Conditions: Hepatitis C
• Intervention / Treatment: Drug: ABT-450/ritonavir; Drug: ABT-333; Drug: ABT-267

• Study Type: Interventional
• Enrollment (Actual): 478
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has received at least one dose of ABT-450, ABT-333 or ABT-267 in a prior AbbVie HCV Phase 2 or 3 study which is being submitted as a US IND.
• The interval between the last dose of the AbbVie DAA therapy from the previous clinical study and enrollment in Study M13-102 must be no longer than 2 years.
• The subject must voluntarily sign and date the informed consent form.
• Subject completed the post-treatment period of an eligible prior study.

Exclusion Criteria:

• The investigator considers the subject unsuitable for the study for any reasons.
• Receipt of any investigational product from Day 1 and while enrolled in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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 HCV, followed for up to 3 years post-treatment.

Drug: ABT-450/ritonavir; ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.; Other Names: ABT-450 also known as paritaprevir; Drug: ABT-333; Drug is not administered -- this study is follow-up for participants previously receiving the drug.; Other Names: dasabuvir; Drug: ABT-267; Drug is not administered -- this study is follow-up for participants previously receiving the drug.; Other Names: ombitasvir

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Experienced Relapse12overall With and Without New HCV Infection	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.	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	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.	from the last dose of study drug in the previous study up to 3 years post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Experienced Relapse12 Without and With New HCV Infection	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.	From the end of treatment through 12 weeks post-treatment
Percentage of Participants Who Experienced Relapse24 Without and With New HCV Infection	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.	From the end of treatment through 24 weeks post-treatment
Percentage of Participants Who Experienced Relapse˅Overall Without and With New HCV Infection	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.	Up to 3 years post-treatment

Collaborators and Investigators

• Sponsor: AbbVie (prior sponsor, Abbott)

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: November 19, 2012
• First Submitted That Met QC Criteria: January 18, 2013
• First Posted (Estimate): January 23, 2013

Study Record Updates

• Last Update Posted (Actual): December 6, 2017
• Last Update Submitted That Met QC Criteria: November 2, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Sustained Virologic Response; Chronic Hepatitis C; Hepatitis C virus; Hepatitis C; Direct Acting Antiviral; Persistence of treatment-emergent substitutions
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Protease Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; HIV Protease Inhibitors; Viral Protease Inhibitors; Ritonavir
• Other Study ID Numbers: M13-102; 2012-003073-26 (EudraCT Number)