HCV infection
Conditions
Interventions
Trade Name: Zepatier
Pharmaceutical Form: Tablet
INN or Proposed INN: ELBASVIR
CAS Number: 1370468-36-2
Other descriptive name: ELBASVIR
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
Fundación SEIMC-GESIDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Adults with chronic HCV genotype 1, 4 infection with or without HIV infection aged 18 years or above - Concentration of HCV RNA plasma of at least 1000 IU / mL - Subjects previously treated with NS5A-based regimens for at least 8 weeks. - Patients with HCV relapse after receiving a complete treatment with NS5A-based AAD regimen for at least 8 weeks and becoming undetectable at the end of treatment. Relapse is defined as a confirmed HCV RNA detectable upon completion of NS5A-based AAD therapy against HCV. - Subjects with compensated hepatic cirrhosis (Child A) could be included. - For patients with HIV coinfection: - Being infected with HIV-1, documented by any HIV rapid test with the corresponding license and confirmed by a Western blot or second antibody test using a method other than the initial rapid HIV method and / or E / CIA or By HIV-1 p24 antigen or viral load of HIV-1 RNA plasma. - Be on stable HIV antiretroviral therapy (ART) for at least 4 weeks prior to entry into the study using a dual ITN backbone of tenofovir or abacavir and emtricitabine or lamivudine PLUS raltegravir or dolutegravir or rilpivirine (with CD4 + > 100 cells / mm 3 and undetectable HIV-1 RNA at baseline. Results from prior analysis will be accepted within 24 weeks prior to study entry). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Subjects with hepatitis other than C or steatosis. - Subjects previously treated less than 8 weeks with regimens based on NS5A. - Evidence of previous hepatocellular carcinoma although it has criteria of cure - Subjects with past or current decompensated liver disease; Only decompensated patients who have received a liver transplant and have not decompensated after transplantation will be included. - Subjects suspected of clinical or genotypic reinfection of HCV. - Subject with HCV response regrowth while receiving NS5A-based ADA therapy against HCV. Said regrowth is defined as a confirmation of detectable HCV RNA after achieving undetectable HCV RNA during NS5A-based ADA therapy against HCV. - Recent history of drug or alcohol abuse. - Important comorbidities. - Pregnant women, breastfeeding, or women who do not use contraceptive methods, if they are women of childbearing age. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months. - Subjects with a glomerular filtration rate lower than 30 ml / min.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy, in terms of the rate of patients achieving SVR12, of ELB / GRA retreatment plus SOF and ribavirin for 16 weeks in patients infected with hepatitis C virus genotypes 1, 4 who have failed treatment with regimens based In NS5A;Secondary Objective: -Analyze the impact of VARs NS5A on RVS12 that is achieved with ELB / GRA plus SOF and ribavirin in patients with HCV genotype 1a, genotype 1b, genotype 4, for whom treatment with NS5A based regimens failed. - Analyze the impact of VARs NS5A on RVS24 that is achieved with ELB / GRA plus SOF and ribavirin in patients with HCV genotypes 1, 4 who have failed treatment with regimens based on NS5A. - Analyze the occurrence of resistance in patients who do not reach SVR12 after 16 weeks of re-treatment with ELB / GRA plus SOF and ribavirin. - Analyze the impact of VARs NS5A on RVS12 that is achieved with ELB / GRA plus SOF and ribavirin in HIV-1 patients - Analyze the impact of ELB / GRA retreatment plus SOF and ribavirin in HIV-1 subjects Develop HIV-1 virological failure. - Evaluate the safety profile of the treatment combination formed by ELB / GRA plus SOF and ribavirin. ;Primary end point(s): - Rate of patients achieving SVR12.;Timepoint(s) of evaluation of this end point: Week 12 post treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The proportion of subjects infected with HCV genotype 1a with reference VARsNS5A that achieve RVS12. - The proportion of subjects infected with HCV genotype 1b with reference VARsNS5A that achieve RVS12. - The proportion of subjects infected with HCV genotype 4 with reference to NS5A VARs that achieved RVS12. - The proportion of subjects infected with HCV genotype 1a with reference VARsNS3 that achieve RVS12. - The proportion of subjects infected with HCV genotype 1b with reference to NS3 VARs that achieved RVS12. - The proportion of subjects infected with HCV genotype 4 with reference to NS3 VARs that achieved RVS12. - The proportion of subjects infected with HCV genotypes 1.4 with reference VARs NS5A who achieved RVS24. - Viral resistance variants (VARs) will be analyzed for NS5A or elbasvir, NS3 or grazoprevir and NS5B or SOF at any time in the study. - The proportion of subjects who develop HIV-1 virological failure (HIV RNA> 200 copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them. The secondary security variables are: - The proportion of subjects experiencing adverse events of high laboratory values ??who report as ECI at any time during the study period. - The proportion of subjects with adverse experiences: 1. At least one adverse experience 2. Adverse experience related to medication 3. Severe adverse experience 4. A serious adverse experience related to medication 5. An adverse experience leading to disruption;Timepoint(s) of evaluation of this end point: - Week 12 post treatment, week 24 post treatment. - At any time during the study | — |
Countries
Spain
Contacts
Public ContactMaria Yllescas
Fundacion SEIMC-GESIDA
Outcome results
None listed