Study of Oral Treatments for Hepatitis C

• Status: Completed
• Trial end date: 2020-09-02
• Target enrollment: 0
• Participant gender: All

Summary

Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.

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

Details

• Lead Sponsor: University of Florida
• Collaborators: AbbVie; Merck Sharp & Dohme Corp.; Patient-Centered Outcomes Research Institute
• Treatments: Grazoprevir; Ledipasvir; Ribavirin; Ritonavir; Sofosbuvir

Criteria

Inclusion Criteria:

• HCV Genotype 1a or 1b

• Adult patients (age 18 years or older)

• Patients being prescribed HCV treatment who can begin treatment with any of the three HCV treatments being studied (Harvoni (SOF/LDV), Viekira Pak (PrOD) (Phase 1 only), or Zepatier (EBR/GZR))

Exclusion Criteria:

• Inability to provide written informed consent

• HARVONI® is not a covered drug on benefits formulary

• Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites)

• Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)

• Pregnant or breastfeeding women