EXPEDITION-1: A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: ABT-493/ABT-530 ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
Drug: ABT-493/ABT-530
Tablet; ABT-493 coformulated with ABT-530
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [12 weeks after the last actual dose of study drug]
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug.
Secondary Outcome Measures
- Percentage of Participants With On-treatment Virologic Failure [Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment]
On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
- Percentage of Participants With Post-treatment Relapse [From the end of treatment through 12 weeks after the last dose of study drug]
Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
-
Chronic HCV infection
-
Subject must be HCV treatment-naïve or have failed prior HCV treatment
-
Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease
Exclusion Criteria:
-
Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
-
HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
-
Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie
Investigators
- Study Director: AbbVie Inc, AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- M14-172
- 2015-003797-32
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail | This study included a 35-day screening period. |
Arm/Group Title | ABT-493/ABT-530 |
---|---|
Arm/Group Description | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
Period Title: Overall Study | |
STARTED | 146 |
COMPLETED | 138 |
NOT COMPLETED | 8 |
Baseline Characteristics
Arm/Group Title | ABT-493/ABT-530 |
---|---|
Arm/Group Description | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
Overall Participants | 146 |
Age (years) [Mean (Standard Deviation) ] | |
Mean (Standard Deviation) [years] |
60.12
(10.43)
|
Sex: Female, Male (Count of Participants) | |
Female |
56
38.4%
|
Male |
90
61.6%
|
Outcome Measures
Title | Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
---|---|
Description | SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification [<LLOQ]) 12 weeks after the last dose of study drug. |
Time Frame | 12 weeks after the last actual dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
Intent-to-treat (ITT) population: all participants who received at least 1 dose of study drug; participants with missing data after backwards imputation were imputed as nonresponders. |
Arm/Group Title | ABT-493/ABT-530 |
---|---|
Arm/Group Description | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
Measure Participants | 146 |
Number (95% Confidence Interval) [percentage of participants] |
99.3
68%
|
Title | Percentage of Participants With On-treatment Virologic Failure |
---|---|
Description | On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. |
Time Frame | Treatment Weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study drug (ITT population). |
Arm/Group Title | ABT-493/ABT-530 |
---|---|
Arm/Group Description | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
Measure Participants | 146 |
Number (95% Confidence Interval) [percentage of participants] |
0.0
0%
|
Title | Percentage of Participants With Post-treatment Relapse |
---|---|
Description | Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection. |
Time Frame | From the end of treatment through 12 weeks after the last dose of study drug |
Outcome Measure Data
Analysis Population Description |
---|
All participants who received at least 1 dose of study drug, completed treatment, and had HCV RNA <LLOQ at the final treatment visit. |
Arm/Group Title | ABT-493/ABT-530 |
---|---|
Arm/Group Description | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. |
Measure Participants | 144 |
Number (95% Confidence Interval) [percentage of participants] |
0.7
0.5%
|
Adverse Events
Time Frame | Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the time of study drug administration until 30 days after the last dose of study drug (up to 16 weeks). | |
---|---|---|
Adverse Event Reporting Description | TEAEs and TESAEs are defined as any AE or SAE event with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug and were collected whether elicited or spontaneously reported by the participant. | |
Arm/Group Title | ABT-493/ABT-530 | |
Arm/Group Description | ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks. | |
All Cause Mortality |
||
ABT-493/ABT-530 | ||
Affected / at Risk (%) | # Events | |
Total | / (NaN) | |
Serious Adverse Events |
||
ABT-493/ABT-530 | ||
Affected / at Risk (%) | # Events | |
Total | 11/146 (7.5%) | |
Gastrointestinal disorders | ||
GASTRIC ULCER | 1/146 (0.7%) | |
OESOPHAGEAL VARICES HAEMORRHAGE | 1/146 (0.7%) | |
Infections and infestations | ||
ENDOPHTHALMITIS | 1/146 (0.7%) | |
RECTAL ABSCESS | 1/146 (0.7%) | |
URINARY TRACT INFECTION | 1/146 (0.7%) | |
Investigations | ||
TUMOUR MARKER INCREASED | 1/146 (0.7%) | |
Metabolism and nutrition disorders | ||
HYPERGLYCAEMIA | 1/146 (0.7%) | |
HYPOGLYCAEMIA | 1/146 (0.7%) | |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||
HEPATOCELLULAR CARCINOMA | 2/146 (1.4%) | |
Nervous system disorders | ||
SYNCOPE | 1/146 (0.7%) | |
Psychiatric disorders | ||
ALCOHOL ABUSE | 1/146 (0.7%) | |
Respiratory, thoracic and mediastinal disorders | ||
EPISTAXIS | 1/146 (0.7%) | |
Other (Not Including Serious) Adverse Events |
||
ABT-493/ABT-530 | ||
Affected / at Risk (%) | # Events | |
Total | 63/146 (43.2%) | |
Gastrointestinal disorders | ||
DIARRHOEA | 12/146 (8.2%) | |
NAUSEA | 13/146 (8.9%) | |
General disorders | ||
FATIGUE | 27/146 (18.5%) | |
Infections and infestations | ||
URINARY TRACT INFECTION | 9/146 (6.2%) | |
Nervous system disorders | ||
HEADACHE | 20/146 (13.7%) | |
Skin and subcutaneous tissue disorders | ||
PRURITUS | 14/146 (9.6%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
Name/Title | Global Medical Services |
---|---|
Organization | AbbVie |
Phone | 800-633-9110 |
- M14-172
- 2015-003797-32