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

• Status: Completed
• Trial end date: 2017-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American Research Corporation
• Collaborator: AbbVie
• Treatments: Ribavirin; Ritonavir

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