Chronic Hepatitis C
Conditions
Brief summary
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting.
Detailed description
This is a Phase IV, open label, single center study of OBV/PTV/r + DSV +/- RBV for 12 or 24 weeks for the treatment of chronic HCV-1 infection in a real world urban clinical setting. The study will enroll chronically infected GT 1 patients who are treatment naïve or who have failed a regimen including pegIFN/RBV +/- telaprevir, boceprevir, or simeprevir. In addition, up to 20 chronically infected GT1 patients who have traditionally been excluded from clinical trials due to mild to moderate renal insufficiency, irrespective of other co-morbid conditions including poorly controlled diabetes mellitus, high BMI, HIV infection will be enrolled.
Interventions
DRUGparitaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin
OMB/PTV/r + DSV +/- RBV
Sponsors
AbbVie
American Research Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a Phase IV, open label, single arm study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Patients must have chronic GT 1 HCV infection (GT1a, GT1b or GT1a/1b) * Patient and partner(s) must agree to use acceptable methods of contraception * Patient must be able to read and understand English and/or Spanish * Written informed consent
Exclusion criteria
* Currently taking or planning on taking any prohibited medications (see US PI) * Evidence of decompensated liver disease (Child-Pugh B or C) including the presence of clinical ascites, bleeding varices, or hepatic encephalopathy * Abnormal lab values, including: * Hemoglobin (Hgb) \<8 g/dL * Platelets \<25,000 cells/mm3 * Absolute neutrophil count (ANC)\<500 cells/mm3 * Bilirubin \>3 * INR\>2.3 ALT/AST \> 10 x ULN * Serum albumin \<2.8 * GFR \<30 mL * Alcohol use: \>3 drinks per day consistently * Uncontrolled HIV or HBV coinfection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population. | 12 weeks after last treatment | Primary Analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs) | 12 weeks after last treatment | Secondary Analysis |
| Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not) | 12 weeks after last treatment | Secondary Analysis. Comparison between baseline and end of treatment |
| Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not) | 12 weeks after last treatment | Secondary Analysis |
Outcome results
None listed