Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Protease-Inhibitors ("PI") Failures

Launched by TEL-AVIV SOURASKY MEDICAL CENTER · Jan 4, 2016

Keywords

ClinConnect Summary

Patients with genotype 1 HCV, who underwent past triple therapy (Telaprevir, Boceprevir or Simeprevir with Pegylated interferon / Ribavirin) and are non-responders, partial responders or in relapse - will be screened in all research centers up to 30 days before the first treatment.

At the end of the initial assessment - the recruited participants will be allocated to different treatment groups in accordance with the hepatitis virus subtype 1a, 1b and presence of cirrhosis, as follows:

* Group A - genotype 1b without cirrhosis - 12 weeks of treatment \*
* Group B - genotype 1b with cirrhos...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of hepatitis C, genotype 1A or 1B.
• • Documentation of PI failure of treatment at least 12 months prior to study entry.
• • Patients with cirrhosis - (only patients with cirrhosis Child A with only 5 points).
• Exclusion Criteria:
• • Inability to stay in the study for 36 weeks.
• • Diagnosis of cross-contamination by HIV or Hepatitis B virus.
• • Renal disfunction (creatinine clearance \<30 ml / min).
• • Evidence of hepatic carcinoma.
• • Another serious disease, which may interfere with the study.
• • Pregnant / breast-feeding women.
• • Men with pregnant partners.
• • Drug or alcohol abuse in the six months preceding the study.
• • Chronic liver disease other than hepatitis C (such as Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis).
• • Current other treatment for HCV.
• • Past PI Failure due to adverse events.
• • Patients with cirrhosis Child B.
• • Patients with cirrhosis, who were at child B and improved to child A after treatment.