Early Chronic Hepatitis C in HIV/HCV co-infected patients MedDRA version: 19.0 Level: LLT Classification code 10065949 Term: HCV coinfection System Organ Class: 100000004862 MedDRA version: 19.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Zepatier(Tablets: 50 mg elbasvir and 100 mg grazoprevir)
Product Name: zepatier tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Elbasvir
Other descriptive name: ELBASVIR
Concentra
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • =18 years of age • Patients with early chronic hepatitis C (Genotype 1 or 4) which is defined as chronic hepatitis C with known episode of AHC within the last 4 years including those who failed to PEG/RBV or those who never received therapy for AHC. AHC infection is diagnosed on the basis of documented HCV-RNA positivity (> 10.000 IU/mL) and anti-HCV seroconversion. • No history of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease • Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result =65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: • 8kPa • Not be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load. • Due to known or suspected drug-drug interactions, for the purpose of this study, the use of Non Nucleoside Reverse Transcriptase Inhibitors, boosted Integrase Inhibitors or Protease Inhibitors against HIV will be not allow.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1.- Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir + Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients 2. Evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients;Secondary Objective: 1.- Evaluate the reinfection rate during 1 year of follow-up 2. - Evaluate the emergence of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742.;Primary end point(s): 1.- Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir + Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients with Viral load hepatitis c (HCV) post treatment 2. Evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients;Timepoint(s) of evaluation of this end point: 1- with Viral load hepatitis c (HCV) post treatment 2- Susars, SAEs , death | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.- Evaluate the reinfection rate during 1 year of follow-up (viral load VHC (w 4, 8,12,24,48 post tratment) 2. -Evaluate the emergence of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742.;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Spain
Contacts
Public ContactFarmacologia clinica
CTU CLINIC (Clinical Trial Unit)
Outcome results
None listed