An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.
The use of a highly potent IFN-sparing drug combination in the setting of recently acquired 1 HCV infection is hypothesised to result in the vast majority of patients achieving SVR. In this setting, it is anticipated that therapy can be shortened relative to that used in established chronic infection. A short course IFN-free strategy is likely to be highly attractive to both patients and clinicians and if proven may further encourage early HCV testing and diagnosis. In this pilot study, the investigators plan to explore the safety, efficacy and feasibility of the IFN-sparing combination for treatment of recently acquired HCV infection. Cohort One: paritaprevir/ritonavir/ombitasvir, dasabuvir with/without ribavirin (HCV genotype 1 only) Cohort Two (and Three): glecaprevir/pibrentasvir (HCV genotypes 1-6)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
83
St Vincent's Hospital
Sydney, New South Wales, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Proportion of treated subjects (intention-to-treat (ITT) population) demonstrating undetectable hepatitis C virus (HCV) RNA at 12 weeks following treatment (SVR 12).
Time frame: 12 weeks post treatment
The proportion of treated subjects overall with ETR, SVR4 and SVR24 defined as undetectable HCV RNA at end of therapy, 4 weeks and 24 weeks post therapy, respectively.
Time frame: End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 24 weeks post treatment
Comparison of ETR, SVR4, SVR12 and SVR24 between those receiving 8 weeks treatment and those receiving 6 weeks treatment.
Time frame: End of treatment- week 6 or week 8 depending on the study arm; 4 weeks post treatment; 12 weeks post treatment; 24 weeks post treatment
Comparison of adherence between those receiving 8 weeks treatment and those receiving 6 weeks treatment
Time frame: Baseline to week 6 or week 8 treatment duration
Proportion with early treatment discontinuation
Time frame: Baseline through to 6 or 8 weeks depending on the study arm
Proportion with adverse events (including serious adverse events)
Time frame: Baseline to week 6 or week 8 treatment duration
Changes in laboratory parameters, including liver function tests (ALT, AST) and haematological indices (haemoglobin, neutrophil count, platelet count)
Time frame: Baseline to week 6 or week 8 treatment duration
Emergence of resistance associated variants (RAVs)
Time frame: Baseline through to 6 or 8 weeks depending on the study arm
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Auckland City Hospital
Auckland, Grafton, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Barts and London
London, United Kingdom
Royal Free Hospital
London, United Kingdom
Guy's and St Thomas' Hospital
London, United Kingdom
Chelsea and Westminster Hospital
London, United Kingdom
St Mary's Hospital
London, United Kingdom
...and 1 more locations
HCV reinfection rate
Time frame: Week 208
Changes in sexual and injecting drug use behaviour at SVR 12 and end of follow up
Time frame: 12 weeks post treatment; week 208
Serum cytokine and ISG expression at baseline and week 4
Time frame: Baseline; week 4 on treatment