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

American Research Corporation100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Chronic Hepatitis C

Interventions

paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirinDRUG

OMB/PTV/r + DSV +/- RBV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The primary analysis will be sustained virologic response 12 weeks after the last treatment dose (SVR12) for the all treated population.

Primary Analysis

Time frame: 12 weeks after last treatment

Secondary Outcomes

Effect of baseline resistance variants on SVR12 (subgroups: all RAVs, different classes of RAVs)

Secondary Analysis

Time frame: 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

Time frame: 12 weeks after last treatment

Evaluate patient adherence (subgroups: those who achieve SVR12 and those who do not)

Secondary Analysis

Time frame: 12 weeks after last treatment

Data from ClinicalTrials.gov

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