Hepatitis C, Chronic
Conditions
Keywords
VIEKIRA PAK
Brief summary
This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin).
Detailed description
This is a Phase IV, open-label, multi-center study to evaluate the real world sustained virological response rate, subject adherence, and subject reported outcomes during and after treatment of non-cirrhotic genotype 1 chronic hepatitis C subjects aged 18 years and older, with the AbbVie 3 direct-acting antiviral (3-DAA) regimen of VIEKIRA PAK (ombitasvir, paritaprevir/r, dasabuvir), with or without RBV (ribavirin). Subjects may be treatment-naïve or treatment experienced with pegylated-interferon based regimens excluding regimens with direct-acting antiviral agents. The study will be conducted at multiple Kaiser Permanente Southern California Medical Centers. The primary objective of this open label study is to evaluate the rate of sustained virological response rate 12 weeks after completion of treatment (SVR12) with VIEKIRA PAK, with or without ribavirin in a large real world setting.
Interventions
DRUGombitasvir, paritaprevir/r, dasabuvir + ribavirin
VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) + RBV (ribavirin tablets) for 12 weeks
DRUGombitasvir, paritaprevir/r, dasabuvir
VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets)
Sponsors
AbbVie
Kaiser Permanente
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria * Male or female at least 18 years of age at time of screening. * Subject, if female must not use estrogen-containing hormonal contraception including oral, injectable, implantable, patch and ring varieties during study drug treatment * Subject, if male, who is not surgically sterile and is sexually active with female partner of childbearing potential must agree to practice 2 effective contraceptive methods for study duration * Subject must have at least one of the following indicators of chronic hepatitis C virus infection prior to study enrollment: Positive anti-HCV antibody or HCV RNA \> 10,000 IU/mL at least 6 months before screening, and positive for HCV RNA at the time of screening, or HCV RNA \> 10,000 IU/mL at screening and liver biopsy consistent with chronic HCV infection * Subject has a screening laboratory result indicating HCV genotype 1-infection Key
Exclusion criteria
* Subject, if female is pregnant or is breastfeeding, of if male, with female partner who is currently pregnant * Subject has positive test result for hepatitis B surface antigen or confirmed positive anti-HIV antibody test * Subject received study contraindicated medications prior to study drug administration * Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inducers of cytochrome P450 2C8 (CYP2C8) or strong inhibitors of CYP2C8 within 2 weeks of the respective medication/supplement prior to initial dose of study drug. * Clinically significant abnormalities or co-morbidities, other than HCV infection that in opinion of the investigator makes subject unsuitable for this study or drug regimen * Current enrollment in another interventional clinical study or prior or current use of any investigational or commercially available anti-HCV agents other than interferon or ribavirin including previous exposure to ABT450 (paritaprevir) , ABT-267 (ombitasvir) or ABT-333 (dasabuvir) or receipt of any investigational product within 6 weeks prior to study drug administration * Prior treatment of chronic HCV infection with a direct acting antiviral agent(s): telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral * History of solid organ transplant * Evidence of cirrhosis * History of liver decompensation: ascites noted on a physical exam, imaging or other test; variceal bleeding; hepatic encephalopathy * Confirmed presence of hepatocellular carcinoma indicated on computed tomography, magnetic resonance, or other imaging techniques within 3 months prior to screening * HCV genotype performed during screening indicates infection with any genotype other than genotype 1 * Recent history of drug or alcohol abuse that could, in the opinion of the investigator, affect adherence to the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virological Response (SVR) at Week 12 | 12 weeks | Percentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sustained Virological Response (SVR) at Week 4 | 4 weeks | Percentage of study participants achieving sustained virological response (SVR) at Week 4 per protocol among subjects who completed 12-week course of treatment in the study. |
Countries
United States
Participant flow
Recruitment details
Recruitment period started in June 2015 until October 2016 at four (4) different Kaiser Permanente Southern California medical clinics.
Pre-assignment details
228 study participants screened for the study had 28 days from signing the study consent form to their first dose of study drug to confirm their eligibility to continue with the study. The screening period was also used as a wash-out period for concomitant medications that may interact with the study drug.
Participants by arm
| Arm | Count |
|---|---|
| Genotype 1a Study participants with chronic Hepatitis C Genotype 1a receiving VIEKIRA PAK and Ribavirin for 12 weeks. | 130 |
| Genotype 1b Study participants with chronic Hepatitis C Genotype 1b receiving VIEKIRA PAK for 12 weeks. | 70 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 9 | 1 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Total | Genotype 1b | Genotype 1a |
|---|---|---|---|
| Age, Continuous | 58.12 years | 60.87 years | 56.64 years |
| Baseline HCV RNA >6 million | 39 Participants | 10 Participants | 29 Participants |
| Baseline HCV RNA <800,000 IU/mL | 44 Participants | 17 Participants | 27 Participants |
| Baseline HCV RNA Between 800,000 - 6 million | 117 Participants | 43 Participants | 74 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants | 6 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 177 Participants | 56 Participants | 121 Participants |
| Region of Enrollment United States | 200 Participants | 70 Participants | 130 Participants |
| Sex: Female, Male Female | 80 Participants | 31 Participants | 49 Participants |
| Sex: Female, Male Male | 120 Participants | 39 Participants | 81 Participants |
| Treatment-experience Experienced | 31 Participants | 9 Participants | 22 Participants |
| Treatment-experience Naive | 169 Participants | 61 Participants | 108 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 130 | 0 / 70 |
| other Total, other adverse events | 102 / 130 | 30 / 70 |
| serious Total, serious adverse events | 4 / 130 | 3 / 70 |
Outcome results
Primary
Sustained Virological Response (SVR) at Week 12
Percentage of study participants achieving sustained virological response (SVR) at Week 12 per protocol among study participants who completed 12-week course of treatment.
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Genotype 1a | Sustained Virological Response (SVR) at Week 12 | 116 Participants |
| Genotype 1b | Sustained Virological Response (SVR) at Week 12 | 66 Participants |
Secondary
Sustained Virological Response (SVR) at Week 4
Percentage of study participants achieving sustained virological response (SVR) at Week 4 per protocol among subjects who completed 12-week course of treatment in the study.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Genotype 1a | Sustained Virological Response (SVR) at Week 4 | 116 Participants |
| Genotype 1b | Sustained Virological Response (SVR) at Week 4 | 65 Participants |