This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A
The duration of the treatment will be 16 weeks and then will be a security perid with 2 visits (Week 12 post treatment and week 24 post treatment) The study in an open label study with a single arm .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Hospital Univ. La Paz
Madrid, Madri, Spain
Hospital Univ. Gregorio Marañon
Madrid, Spain
Hospital Infanta Leonor
Madrid, Spain
Hospita 12 de octubre
Madrid, Spain
Hospital Univ. La Paz
The rate of patients achieved SVR12
Time frame: Week 12 post treatment
The proportion of subjects infected with HCV genotype 1a with reference VARs NS5A / NS3 who achieved RVS12.
To analyze the impact of VARs NS5A/NS3 on RVS12
Time frame: Week 12 post treatment
The proportion of subjects infected with HCV genotype 1b with reference VARs NS5A / NS3 who achieved RVS12.
Analyze the impact of VARs NS5A/NS3 on RVS12
Time frame: Week 12 post treatment
The proportion of subjects infected with HCV genotype 4 with reference VARs NS5A /NS3 who achieved RVS12.
Analyze the impact of VARs NS5A/NS3 on RVS12
Time frame: Week 12 post treatment
The proportion of subjects infected with HCV genotypes 1.4 with reference VARs NS5A /NS3 who achieved RVS24.
Analyze the impact of VARs NS5A/NS3 on RVS24
Time frame: Week 24 post treatment
The occurrence of Viral resistance variants (VARs) to NS5A or elbasvir, to NS3 or grazoprevir and to NS5B or SOF in patients who did not reach SVR12 after 16 weeks of re-treatment
the occurrence of resistance in patients who did not reach SVR12 after 16 weeks of re-treatment
Time frame: Week 16
The occurrence of resistance variants (VARs) viral to NS5A or elbasvir, to NS3 or grazoprevir, and to NS5B or SOF in HIV patients included
The impact of VARs NS5A/NS3 on RVS12 The proportion of subjects developing HIV-1 virological failure (HIV RNA\> 200 Copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them.
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Madrid, Spain
Time frame: Week 12 post treatment
The proportion of subjects developing HIV-1 virological failure (HIV RNA> 200 Copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them
the impact of treatment with EL / BRA plus SOFT and ribavirin in HIV-1 subjects
Time frame: Week 4, week 8, week 12 and week 16
The proportion of subjects experiencing adverse events of high laboratory values who report as ECI at any time during the study period.
Adverse events
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with at least one adverse experience
Adverse events
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with an adverse experience related to medication
Adverse events
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with a severe adverse experience
Adverse events
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with a serious adverse experience related to medication
Adverse events
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with an adverse experience leading to disruption
Adverse events
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment