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

Fundacion Clinic per a la Recerca Biomédica

Status and phase: Unknown; Phase 3

Conditions: Hepatitis C; HIV

Treatments: Drug: Grazoprevir 100 mg/d 12 weeks; Drug: Elbasvir 50 mg/d 8 weeks; Drug: Elbasvir 50 mg/d 12 weeks; Drug: Grazoprevir 100 mg/d 8 weeks

Study type: Interventional

Funder types: Other

Identifiers

NCT02897596

EARLY-HEP-C

Details and patient eligibility

About

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.

Full description

Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir

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

Enrollment: 62 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Genotype 1b

Experimental group

Description:

Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.

Treatment:

Drug: Grazoprevir 100 mg/d 8 weeks

Drug: Elbasvir 50 mg/d 8 weeks

Genotype 1a and 4

Experimental group

Description:

Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.

Treatment:

Drug: Elbasvir 50 mg/d 12 weeks

Drug: Grazoprevir 100 mg/d 12 weeks