Acute HCV infection MedDRA version: 20.1 Level: LLT Classification code 10047457 Term: Viral hepatitis C System Organ Class: 100000004862
Conditions
Interventions
Trade Name: MAVIRET n.AIC 045445018/E
Product Name: Glecaprevir/Pibrentasvir
Product Code: [Glecaprevir/Pibrentasvir]
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: MAVIRET
Other descri
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO “PAOLO GIACCONE” DI PALERMO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria will be: - Adult patients (=18 years); - Presenting acute HCV infection (all genotypes); - With or without HIV co-infection; - Active or inactive drug users Diagnosis of AHC: Acute HCV infection was defined as either a documented seroconversion to HCV antibody positivity within the 4 months before screening, or known or suspected exposure to HCV within the 4 months before screening with raised alanine aminotransferase concentration more than ten times the upper limit of normal at screening or within a 4-week period before screening. 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: - Patients fulfilling the criteria for acute liver failure (evidence of coagulation abnormality, INR > 1.5, and any degree of encephalopathy) (6). - HBV co-infection; - Patients with previous HCV infection cured by DAA regimens who were reinfected after HCV clearance - Patients with chronic liver disease of any other etiology (NASH, ASH, autoimmune, metabolic); - Concomitant use with atazanavir and rifampicin; - Hypersensitivity to the active substances or to any of the excipients; - Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Only few data are available on the management of acute HCV infection in the DAAs era. Therefore the optimal regimen and treatment duration of acute HCV infection require evaluation. The aim of the study is evaluate the efficacy and safety of the combinations of glecaprevir/pibrentasvir in the treatment of HCV acute hepatitis. ;Secondary Objective: Secondary endpoints included the following: - safety and tolerability of glecaprevir plus pibrentasvir in this population - virological responses after 2 weeks of treatment (very rapid virological response; vRVR), after 4 weeks of treatment (rapid virological response; RVR), at the end of treatment (end-of-treatment virological response; ETR), ALT level normalization at the end of treatment and at 12 weeks post- treatment follow-up; - factors associated with SVR (genotype, baseline viral load, adherence…);Primary end point(s): The protocol-defined primary endpoint was SVR, defined as s undetectable HCV RNA at 12 weeks after the end of treatment; Patients who discontinued the study for any reason before the 12-weeks follow-up visit will be considered as drop-out. ;Timepoint(s) of evaluation of this end point: 12° weeks after end of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints included the following: - safety and tolerability of glecaprevir plus pibrentasvir in this population - virological responses after 2 weeks of treatment (very rapid virological response; vRVR), after 4 weeks of treatment (rapid virological response; RVR), at the end of treatment (end-of-treatment virological response; ETR), ALT level normalization at the end of treatment and at 12 weeks post- treatment follow-up; - factors associated with SVR (genotype, baseline viral load, adherence…);Timepoint(s) of evaluation of this end point: 2, 4, 5 weeks of therapy; 12 weeks of follow up | — |
Countries
Italy
Contacts
Public ContactServizio Informazione sulla Sperime
Policlinico Paolo Giaccone
Outcome results
None listed