Chronic hepatitis C virus genotype 1 infection MedDRA version: 19.0 Level: LLT Classification code 10072844 Term: Hepatitis C virus genotype 1a positive System Organ Class: 100000004848 MedDRA version: 19.0 Level: LLT Classification code 10072845 Term: Hepatitis C virus genotype 1b positive System Organ Class: 100000004848
Conditions
Interventions
Trade Name: VIEKIRAX (ombitasvir/paritaprevir/ritonavir)
Pharmaceutical Form: Tablet
Trade Name: EXVIERA (dasabuvir)
Pharmaceutical Form: Tablet
Sponsors
The Kirby Institute - UNSW Australia
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older. 2. Detectable HCV RNA in plasma (>1,000 IU/ml). 3. Evidence of positive HCV antibody >6 months prior to screening. 4. HCV genotype 1 infection. 5. Recent injecting drug use (previous 6 months) or receiving opioid substitution therapy. 6. Participant has never received treatment for hepatitis C virus infection. 7. Compensated liver disease. Enrolment of patients with cirrhosis (FibroScan >14.6 kPa or FIB-4 > 3.25) will be capped to 60% of the total enrolment (maximum 3 per site). 8. Participants with FibroScan > 12KPa or AFP >50 ng/mL must have an abdominal ultrasound or CT scan without evidence of hepatocellular carcinoma within 2 months prior to screening. 9. Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. 10. All fertile males and females must be using effective contraception during treatment and during 7 months after treatment end (patients treated with ribavirin) or during 30 days after treatment end (patients not treated with ribavirin). 11. Participants have voluntarily signed the informed consent form. 12. Participants to be covered by medical insurance. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug. 2. Any investigational drug ?6 weeks prior to the first dose of study drug. 3. HIV infection. 4. History or other evidence of decompensated liver disease. 5. Neutrophil count 1.5 x upper limit of normal at screening. 7. Ongoing severe psychiatric disease as judged by the treating physician. 8. Frequent injecting drug use that is judged by the treating physician to compromise treatment safety. 9. Inability or unwillingness to provide informed consent or abide by the requirements of the study. 10. Haemoglobin 1.5; i. Patients with a known inherited blood disorder and INR > 1.5 may be enrolled after discussion with the Principal Investigator b. Serum albumin 1.8 x upper limit of normal (ULN), unless isolated in subjects with Gilbert’s syndrome. 14. Subject shows evidence of significant liver disease in addition to hepatitis C, which may include but is not limited to drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson’s disease, non-alcoholic steatohepatitis (NASH), or primary biliary cirrhosis. 15. Subject has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma). 16. History of chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, malignancy, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study. 17. Poorly controlled diabetes mellitus as evidenced by haemoglobin A1c (HbA1c) =8.5%. 18. Positive test at screening for anti-HAV IgM Ab, anti-HBc IgM Ab or HBsAg. 19. Confirmed presence of hepatocellular carcinoma indicated on imaging techniques such as computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or on an ultrasound performed at screening (a positive ultrasound result will be confirmed with CT scan or MRI). 20. Subject has history of organ transplant that requires chronic immunosuppression (corneal, skin and hair grafts allowed). 21. History of severe psychiatric disease that in the opinion of the investigator is unstable enough to compromise treatment adherence. 22. Prohibited medications and herbal reme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To evaluate the proportion of participants with undetectable HCV RNA at 2 weeks following the initiation of treatment (vRVR), 4 weeks following the initiation of treatment (RVR), the end of treatment (ETR) and at 24 weeks post-treatment (SVR24); • To evaluate predictors of SVR12 (including drug use, disease stage and HCV genotype); • To evaluate the proportion adherent to therapy (both on-treatment adherence and treatment discontinuation); • To evaluate the association between adherence and response to treatment; • To evaluate predictors of adherence; • To evaluate safety and tolerability; Please refer to the protocole for the complete list ;Main Objective: The primary objective is to evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) in people with chronic HCV genotype 1 infection and recent injection drug use or receiving opiate substitution therapy.; Primary end point(s): SVR12 defined as the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (week 24). ;Timepoint(s) of evaluation of this end point: 12 weeks post end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Please refer to the protocol;Timepoint(s) of evaluation of this end point: Please refer to the protocol | — |
Countries
Australia, Canada, France, New Zealand, Norway, Switzerland
Contacts
Public ContactGIRARD Pierre-Marie
IMEA (Institut de Médecine et d’Epidémiologie Appliquée)
Outcome results
None listed