Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
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.
Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir

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