None listed
Conditions
Brief summary
Hepatitis C virus (HCV) leads to cirrhosis and/or hepatocellular carcinoma in 20-40% of those infected after 30 years. It is unclear whether the remaining 60-80% of those with HCV derive an objective physical health benefit from the treatment and cure of HCV infection. HCV infection appears to be associated with increased cardiovascular risk, however this is controversial, and it is unclear whether the mechanism is through HCV-induced metabolic syndrome and diabetes, or through chronic inflammation and endothelial dysfunction. The aim of this study if to determine feasibility of using RH-PAT to measure change in endothelial function over time during HCV treatment, to refine assumptions and to seek a signal of effect. These data will then be used to determine if a larger multicentre trial is justifiable and to inform its design.
Interventions
Before and after study. All patients will be assessed at baseline, week 2 and week 4 on no HCV treatment. They will then receive 12 weeks of active treatment with the “Abbvie 3D regimen” which is as follows: paritaprevir/ritonavir/ombitasvir (150/100/25 mg once daily by mouth), dasabuvir (250 mg twice daily by mouth) and weight-based RBV dosed twice daily by mouth(1000 mg daily if body weight < 75 kg, 1200 mg daily if body weight >= 75 kg). Ribavirin will be given to GT1a patients but not to GT1
Before and after study. All patients will be assessed at baseline, week 2 and week 4 on no HCV treatment. They will then receive 12 weeks of active treatment with the “Abbvie 3D regimen” which is as follows: paritaprevir/ritonavir/ombitasvir (150/100/25 mg once daily by mouth), dasabuvir (250 mg twice daily by mouth) and weight-based RBV dosed twice daily by mouth(1000 mg daily if body weight < 75 kg, 1200 mg daily if body weight >= 75 kg). Ribavirin will be given to GT1a patients but not to GT1b patients
Sponsors
John Hunter Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age >= 18 years 2. Chronic HCV infection (HCV PCR positive for at least 6 months) 3. HCV Genotype 1a or 1b 4. HCV viral load at screening of >=10,000 IU/ml 5. Absence of advanced fibrosis as defined by fibroscan within 12months prior to randomisation of < 9.6 kPa 6. Females who are potentially fertile must agree to use 2 forms of reliable contraception
Exclusion criteria
1. Cirrhosis as defined by any one of a. Fibroscan in past 12 months >=12kPa b. Liver biopsy in past 5 years showing F4 fibrosis c. Clinical or radiological evidence of portal hypertension (any of varices, splenomegaly, reversal of flow in portal vein, ascites, encephalopathy) 2. Receiving prescribed medication which has a significant interaction with the AbbVie 3D+R regimen which cannot be ceased or substituted 3. Previous treatment with HCV protease-inhibitor based therapy. (Previous treatment with interferon +/- ribavirin, including both relapsers and null responders is allowed). 4. Screening laboratory values showing any of: a. ALT or AST > 10x ULN b. eGFR <60ml/min c. Albumin <=30 g/dL d. INR >1.3 e. Haemaglobin <110 g/dL f. Platelet count<140 cells/mm3 g. Total serum bilirubin >2 x ULN 5. Known latex allergy 6. Receiving nitrates that cannot be ceased (isosorbide mononitrate, GTN patch)
Outcome results
None listed