Clinical trial NCT02646111: Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Protease-Inhibitors ("PI") Failures
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis C
Keywords: "Hepatitis C Virus"
"Triple Therapy"
"PI Failure"
"Genotype 1"
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-01-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: "SVR" (sustained virologic response) rates
timeFrame: 12 weeks after end of treatment
Secondary outcomes:
measure: "SF" (short-form)-36 health survey
timeFrame: Day 1, weeks 4, 12, 24, 36.
measure: WPAI Hep C v2.0 questionnaire
timeFrame: Day 1, weeks 4, 12, 24, 36.
Other outcomes:
Locations:
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Oren Shibolet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deutsch L, Houri I, Ben-Ari Z, Shlomai A, Veitsman E, Cohen-Ezra O, Issachar A, Mor O, Gozlan Y, Bruck R, Menachem Y, Zelber-Sagi S, Katchman H, Shibolet O. Ombitasvir/paritaprevir/ritonavir & dasabuvir +/- ribavirin following protease inhibitors failure - a prospective multi-centre trial. BMC Infect Dis. 2020 Apr 3;20(1):264. doi: 10.1186/s12879-020-4921-3.