NCT02646111

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

An Open-label, Multi-center Study to Evaluate Sustained Virologic Response With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Genotype 1 Chronic Hepatitis C Virus Infected Patients With Past PI Failure

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Tel-Aviv Sourasky Medical Center · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie adults with chronic hepatitis C virus ("HCV"), who have not responded to prior treatment with protease inhibitors. The "Triple therapy" of AbbVie attacks various sites of the viral genome, thus increasing the potential efficacy of the treatment, especially for patients who have failed PI treatment.

Detailed description

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 cirrhosis - 12 weeks of treatment * Group C - genotype 1a without cirrhosis - 12 weeks of treatment * Group D - genotype 1a with cirrhosis - 24 weeks of treatment (\* Only this group will not get Ribavirin) During the treatment period, participants will be asked to describe the treatment's tolerability (in terms of side effects) using self-administered questionnaires: SF-36, and WPAI Hep C v2.0. The follow up will also include physical assessments, side effects documentation, blood tests, abdominal Ultrasound and Fibroscan.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	12 weeks without Ribavirin	12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.
DRUG	12 weeks with Ribavirin	12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight \<75 kg, 1,200 mg weight\> 75 kg.
DRUG	24 weeks with Ribavirin	24 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight \<75 kg, 1,200 mg weight\> 75 kg.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-01-01
• Completion: 2019-01-01
• First posted: 2016-01-05
• Last updated: 2016-01-05