A Study to Investigate HCV Response Rates in Real World Patients: HEARTLAND Study

Study Overview
=================
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.

Official Title
-----------------
A Study to Investigate HCV Response Rates in Real World Patients Traditionally Excluded From Clinical Trials: The HEARTLAND Study

Conditions
-----------------
Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This is a Phase IV, open label, single arm study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single<br>Ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) + databuvir (DSV) +/- ribavirin (RBV) | Drug: paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin<br>* OMB/PTV/r + DSV +/- RBV<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population. | Primary Analysis | 12 weeks after last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs) | Secondary Analysis | 12 weeks after last treatment | 
| Evaluate patient reported outcomes via the SF36v2 survey (subgroups: those who achieve SVR12 and those who do not) | Secondary Analysis. Comparison between baseline and end of treatment | 12 weeks after last treatment | 
| Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not) | Secondary Analysis | 12 weeks after last treatment |