Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients

Overview

Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 28, 2019

Detailed Description

Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir

Interventions

  • Drug: Grazoprevir 100 mg/d 8 weeks
    • Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
  • Drug: Elbasvir 50 mg/d 8 weeks
    • Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
  • Drug: Grazoprevir 100 mg/d 12 weeks
    • Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
  • Drug: Elbasvir 50 mg/d 12 weeks
    • Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.

Arms, Groups and Cohorts

  • Experimental: Genotype 1b
    • Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.
  • Experimental: Genotype 1a and 4
    • Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.

Clinical Trial Outcome Measures

Primary Measures

  • Sustained virological response.
    • Time Frame: 24 weeks
    • Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.

Secondary Measures

  • Reinfection rate
    • Time Frame: 1 year
    • Evaluate the reinfection rate during 1 year of follow-up Sustained virological response defined as HCV-RNA undetectable at post-treatment.
  • Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.
    • Time Frame: 2 years
    • number of adverse events treatment-related assess in 62 patients.
  • Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.
    • Time Frame: 2 years
    • In case of viral failure confirmation during the follow up, viral resistence-associated variants will be assess by samples genotyping HCV protease and NS5A gene at baseline and after the viral failure.

Participating in This Clinical Trial

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 <8 kPa – 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. – Be on stable HIV Antiretroviral Therapy (ART) for at least 8 weeks prior to study entry using a dual NRTI backbone of tenofovir or abacavir Exclusion Criteria:

  • < 18 years of age – Patients with chronic hepatitis C genotypes other than 1 or 4. – 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 > 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, Inhibitors or Protease Inhibitors against HIV will be not allow.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundacion Clinic per a la Recerca Biomédica
  • Provider of Information About this Clinical Study
    • Principal Investigator: Anna Cruceta, Project manager – Fundacion Clinic per a la Recerca Biomédica

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