Clinical trial NCT02897596: Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
Official title: Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatitis C
HIV
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir

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

Eligibility 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 \<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.

Primary outcomes:
measure: Sustained virological response.
timeFrame: 24 weeks
Secondary outcomes:
measure: Reinfection rate
timeFrame: 1 year
measure: Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.
timeFrame: 2 years
measure: Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.
timeFrame: 2 years
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clínico y provincial de Barcelona
Study officials:
References: