Hepatitis C, HIV
Conditions
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
Interventions
DRUGGrazoprevir 100 mg/d 8 weeks
Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
DRUGElbasvir 50 mg/d 8 weeks
Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
DRUGGrazoprevir 100 mg/d 12 weeks
Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
DRUGElbasvir 50 mg/d 12 weeks
Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained virological response. | 24 weeks | Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed