Chronic Hepatitis C, Hepatitis C Virus
Conditions
Keywords
Hepatitis C, HCV, Interferon Free, Chronic Hepatitis C, Hepatitis C virus, Hepatitis C Genotype 3
Brief summary
The purpose of this study is to evaluate the safety and antiviral effect of ABT-450/r and ABT-530 coadministered with and without Ribavirin in adults with genotype 3 HCV infection.
Detailed description
Once the efficacy and safety data were obtained from participants administered ABT-450/r + ABT-530 + RBV weight-based (Arm 1) in Study M14-213, the decision was made to end this study before subjects were enrolled into Arm 2.
Interventions
Sponsors
AbbVie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female (of non-child bearing potential) between 18 and 70 years of age with Body Mass Index ≥18 to \<38 kg/m2. * Chronic HCV genotype 3 infection prior to study enrollment and has never received antiviral treatment for HCV. * Subject has plasma HCV RNA level \> 10,000 IU/mL at Screening. * Sexually active males must be sterile, have male partners only, or agree to use two effective forms of birth control for 7 months after stopping study drug.
Exclusion criteria
* History of severe, life-threatening or other significant sensitivity to any drug. * Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab). * Prior therapy for the treatment of HCV. * Any current or past clinical evidence of cirrhosis. * Any cause of liver disease other than chronic HCV-infection. * HCV genotype co-infection with any other HCV genotype. * Use of contraindicated medications within 2 weeks or 10 half-lives of dosing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) | 12 weeks after last dose of study drug | SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) | 24 weeks after last dose of study drug | SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug. |
| The Percentage of Subjects With Virologic Failure During Treatment | Up to Treatment Week 12 | Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment. |
| The Percentage of Subjects With Post-Treatment Relapse | Within 12 weeks after the last dose of study drug | Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ABT-450/r and ABT-530 Plus RBV ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
ABT-450/ritonavir (r): Tablet
ABT-530: Tablet
Ribavirin (RBV): Tablet | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | ABT-450/r and ABT-530 Plus RBV |
|---|---|
| Age, Continuous | 52.5 years STANDARD_DEVIATION 10.19 |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12)
SVR12 defined as hepatitis C (HCV) ribonucleic acid (RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug.
Time frame: 12 weeks after last dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-530 Plus RBV | The Percentage of Subjects Who Achieve 12-week Sustained Virologic Response (SVR12) | 90 percentage of participants |
Secondary
The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24)
SVR24 defined as HCV RNA LLOQ 24 weeks after last dose of study drug.
Time frame: 24 weeks after last dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-530 Plus RBV | The Percentage of Subjects Who Achieve 24-week Sustained Virologic Response (SVR24) | 90 percentage of participants |
Secondary
The Percentage of Subjects With Post-Treatment Relapse
Percentage of subjects with confirmed quantifiable HCV RNA within 12 weeks of last dose among subjects with unquantifiable hepatitis C virus ribonucleic acid at the end of treatment.
Time frame: Within 12 weeks after the last dose of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-530 Plus RBV | The Percentage of Subjects With Post-Treatment Relapse | 0 percentage of participants |
Secondary
The Percentage of Subjects With Virologic Failure During Treatment
Percentage of subjects with quantifiable HCV RNA throughout the entire treatment period, confirmed quantifiable HCV RNA after previously having unquantifiable HCV RNA, or a confirmed increase of at least one log10 in HCV RNA during treatment.
Time frame: Up to Treatment Week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ABT-450/r and ABT-530 Plus RBV | The Percentage of Subjects With Virologic Failure During Treatment | 10 percentage of participants |