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

Phase 3

• Conditions: Hepatitis C; HIV
• Interventions: Drug: Grazoprevir 100 mg/d 8 weeks; Drug: Grazoprevir 100 mg/d 12 weeks; Drug: Elbasvir 50 mg/d 12 weeks; Drug: Elbasvir 50 mg/d 8 weeks

• Registration Number: NCT02897596
• Lead Sponsor: Fundacion Clinic per a la Recerca Biomédica

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

Study Timeline

• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-07
• Study First Posted: 2016-09-13
• Study Start: 2017-04-28
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15
• Primary Completion: 2019-04-28
• Study Completion: 2019-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 62

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Genotype 1b	Grazoprevir 100 mg/d 8 weeks	Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.
Genotype 1a and 4	Grazoprevir 100 mg/d 12 weeks	Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.
Genotype 1a and 4	Elbasvir 50 mg/d 12 weeks	Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.
Genotype 1b	Elbasvir 50 mg/d 8 weeks	Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Reinfection rate	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.	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.	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.

Trial Locations

Locations (1)

Hospital Clínico y provincial de Barcelona; 🇪🇸 Barcelona, Spain