A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ABT-493/ABT-530 for 8 weeks HCV Genotype (GT)1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks |
Drug: ABT-493 coformulated with ABT-530
Tablet
Other Names:
|
| Experimental: ABT-493/ABT-530 for 12 weeks HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks |
Drug: ABT-493 coformulated with ABT-530
Tablet
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) [12 weeks after last 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 active study drug.
Secondary Outcome Measures
- Percentage of Participants With On-treatment Virologic Failure [Up to 12 weeks]
On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female, at least 18 years of age at time of Screening.
-
Screening laboratory result indicating Hepatitis C virus (HCV) genotype (GT)1-, 2-, 3-, 4-, 5-, or 6-infection.
-
Subject has positive anti-HCV antibody (Ab) and plasma HCV ribonucleic acid (RNA) viral load greater than or equal to 1000 IU/mL at Screening visit.
-
Subjects must be HCV treatment-naïve (i.e., subject has never received a single dose of any approved or investigational anti-HCV medication) or HCV treatment-experienced (subject who has failed prior IFN or pegylated-interferon [pegIFN] with or without ribavirin [RBV], or sofosbuvir [SOF] plus RBV with or without pegIFN). GT3 subjects must be HCV treatment-naïve. Previous HCV treatment must have been completed greater than or equal to 2 months prior to Screening.
-
Subjects naïve to antiretroviral treatment (ART) must have CD4+ count greater than or equal to 500 cells/mm^3 (or CD4+ % greater than or equal to 29%) at Screening; or Subjects on a stable ART regimen must have
-
CD4+ count greater than or equal to 200 cells/mm^3 (or CD4+ % greater than or equal to 14%) at Screening; and
-
Plasma HIV-1 RNA below lower limit of quantification (LLOQ) at Screening and at least once during the 12 months prior to Screening.
Exclusion Criteria:
-
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
-
Positive test result at Screening for hepatitis B surface antigen (HBsAg).
-
Positive Human Immunodeficiency virus, type 2 (HIV-2) Ab at Screening.
-
Receipt of any other investigational or commercially available direct acting anti-HCV agents other than sofosbuvir (e.g., telaprevir, boceprevir, simeprevir, paritaprevir, grazoprevir, daclatasvir, ledipasvir, ombitasvir, elbasvir or dasabuvir).
-
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)
More Information
Additional Information:
Publications
- M14-730
- 2015-005577-20
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | The study included a 35-day screening period. |
| Arm/Group Title | ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 for 12 Weeks |
|---|---|---|
| Arm/Group Description | HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks | HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks |
| Period Title: Overall Study | ||
| STARTED | 137 | 16 |
| COMPLETED | 134 | 15 |
| NOT COMPLETED | 3 | 1 |
Baseline Characteristics
| Arm/Group Title | ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 for 12 Weeks | Total |
|---|---|---|---|
| Arm/Group Description | HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks | HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks | Total of all reporting groups |
| Overall Participants | 137 | 16 | 153 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
45.00
(10.22)
|
50.00
(8.36)
|
45.00
(10.16)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
17.5%
|
1
6.3%
|
25
16.3%
|
| Male |
113
82.5%
|
15
93.8%
|
128
83.7%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
6
4.4%
|
0
0%
|
6
3.9%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
24
17.5%
|
1
6.3%
|
25
16.3%
|
| White |
106
77.4%
|
15
93.8%
|
121
79.1%
|
| More than one race |
1
0.7%
|
0
0%
|
1
0.7%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
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 active study drug. |
| Time Frame | 12 weeks after last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol, all efficacy analyses were performed using the intention-to-treat (ITT) population (all enrolled participants who received at least 1 dose of study drug); in addition, efficacy analyses were performed overall, combining Treatment Arms A and B. |
| Arm/Group Title | ABT-493/ABT-530 |
|---|---|
| Arm/Group Description | HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) |
| Measure Participants | 153 |
| Number (95% Confidence Interval) [percentage of participants] |
98.0
71.5%
|
| Title | Percentage of Participants With On-treatment Virologic Failure |
|---|---|
| Description | On-treatment virologic failure was defined as confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment; confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline in HCV RNA during treatment; or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment. |
| Time Frame | Up to 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol, all efficacy analyses were performed using the ITT population; in addition, efficacy analyses were performed overall, combining Treatment Arms A and B. |
| Arm/Group Title | ABT-493/ABT-530 |
|---|---|
| Arm/Group Description | HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) |
| Measure Participants | 153 |
| Number (95% Confidence Interval) [percentage of participants] |
0.7
0.5%
|
| 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. |
| Time Frame | From the end of treatment through 12 weeks after the last dose of study drug |
Outcome Measure Data
| Analysis Population Description |
|---|
| Per protocol, all efficacy analyses were performed using the ITT population including only those participants who had post-treatment data available, excluding reinfection (N = 151). In addition, efficacy analyses were performed overall, combining Treatment Arms A and B. |
| Arm/Group Title | ABT-493/ABT-530 |
|---|---|
| Arm/Group Description | HCV GT1-6/HIV-1 co-infected participants treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) |
| Measure Participants | 151 |
| Number (95% Confidence Interval) [percentage of participants] |
0
0%
|
Adverse Events
| Time Frame | Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 16 weeks). | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | TEAEs and SAEs are defined as any AE or SAE from the first dose of study drug to 30 days after the last dose of study drug (up to 16 weeks). | |||
| Arm/Group Title | ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 for 12 Weeks | ||
| Arm/Group Description | HCV GT1-6/HIV-1 co-infected non-cirrhotic subjects will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 8 weeks | HCV GT1-6/HIV-1 co-infected subjects with compensated cirrhosis will be treated with ABT-493/ABT-530 300 mg/120 mg once a day (QD) for 12 weeks | ||
All Cause Mortality |
||||
| ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 for 12 Weeks | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/137 (0%) | 0/16 (0%) | ||
Serious Adverse Events |
||||
| ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 for 12 Weeks | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/137 (2.2%) | 1/16 (6.3%) | ||
| Gastrointestinal disorders | ||||
| UPPER GASTROINTESTINAL HAEMORRHAGE | 1/137 (0.7%) | 1 | 0/16 (0%) | 0 |
| Nervous system disorders | ||||
| CEREBRAL HAEMORRHAGE | 0/137 (0%) | 0 | 1/16 (6.3%) | 1 |
| CEREBROVASCULAR ACCIDENT | 0/137 (0%) | 0 | 1/16 (6.3%) | 1 |
| Renal and urinary disorders | ||||
| CALCULUS URINARY | 1/137 (0.7%) | 1 | 0/16 (0%) | 0 |
| Vascular disorders | ||||
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 1/137 (0.7%) | 1 | 0/16 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
| ABT-493/ABT-530 for 8 Weeks | ABT-493/ABT-530 for 12 Weeks | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 50/137 (36.5%) | 7/16 (43.8%) | ||
| Gastrointestinal disorders | ||||
| ABDOMINAL PAIN | 2/137 (1.5%) | 2 | 1/16 (6.3%) | 1 |
| CONSTIPATION | 1/137 (0.7%) | 1 | 1/16 (6.3%) | 1 |
| DENTAL CARIES | 1/137 (0.7%) | 1 | 1/16 (6.3%) | 1 |
| GASTROINTESTINAL SOUNDS ABNORMAL | 0/137 (0%) | 0 | 1/16 (6.3%) | 1 |
| NAUSEA | 12/137 (8.8%) | 12 | 1/16 (6.3%) | 1 |
| General disorders | ||||
| FATIGUE | 18/137 (13.1%) | 18 | 0/16 (0%) | 0 |
| Immune system disorders | ||||
| SEASONAL ALLERGY | 0/137 (0%) | 0 | 1/16 (6.3%) | 1 |
| Infections and infestations | ||||
| CANDIDA INFECTION | 0/137 (0%) | 0 | 1/16 (6.3%) | 1 |
| SINUSITIS BACTERIAL | 0/137 (0%) | 0 | 1/16 (6.3%) | 1 |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | 12/137 (8.8%) | 12 | 0/16 (0%) | 0 |
| Nervous system disorders | ||||
| DIZZINESS | 3/137 (2.2%) | 3 | 1/16 (6.3%) | 1 |
| HEADACHE | 12/137 (8.8%) | 12 | 0/16 (0%) | 0 |
| Psychiatric disorders | ||||
| ANXIETY | 2/137 (1.5%) | 2 | 1/16 (6.3%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| COUGH | 2/137 (1.5%) | 2 | 1/16 (6.3%) | 1 |
| SINUS CONGESTION | 1/137 (0.7%) | 1 | 1/16 (6.3%) | 1 |
| UPPER-AIRWAY COUGH SYNDROME | 0/137 (0%) | 0 | 1/16 (6.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||||
| PRURITUS | 3/137 (2.2%) | 3 | 1/16 (6.3%) | 1 |
| RASH | 5/137 (3.6%) | 5 | 1/16 (6.3%) | 1 |
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 |
| abbvieclinicaltrials@abbvie.com |
- M14-730
- 2015-005577-20