Hepatitis C
Conditions
Interventions
Product Name: ledipasvir/sofosbuvir (Harvoni)
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Ledipasvir
CAS Number: 1256388-51-8
Other descriptive name: LEDIPASVIR
Concentration unit: mg mill
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. =18 years 2. Chronic HCV genotype 4 infection according to definition mentioned below 3. F0-3 with biopsy or fibroscan result (stiffness =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. HCV viral load >10 million IU/ml 2. Fibroscan >12.5 Kpa or F4 on liver biopsy or signs of portal hypertension or liver cirrhosis on imaging ** 3. Disallowed co-medication that cannot be stopped or replaced: Therefore ALL co-medication, including over-the-counter drugs should be checked for potential drug-drug interactions using the summary of product characteristics (appendix A). When in doubt about drug-drug interactions, contact the coordinating investigator. 4. eGFR < 30 ml/min 5. Previous therapy with any DAA for current HCV genotype 4 infection **In case the HCV infection is <24 months old (=documented negative HCV IgG or negative HCV RNA < 24 months) and there is no HBV infection currently active or a history of alcohol abuse, then a fibroscan is not mandatory.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotype 4 patients without cirrhosis. ;Secondary Objective: To document that 8 weeks of treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotyp 4 patients without cirrhosis, with and without HIV, with and without high viral load.;Primary end point(s): Sustained viral response 12 weeks after the end of therapy (SVR12) in on-treatment study population with HCV RNA 10 million IU/mL at baseline, should extent therapy to 12 weeks and will leave the study as soon as the baseline HCV RNA load has become available. ;Timepoint(s) of evaluation of this end point: 12 weeks after therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): SVR12 in ITT study population SVR12 in the population with < 6 million IU/ml HCV RNA SVR12 in the population with HCV RNA < limit of detection at week 4 of therapy SVR12 in HIV negative population compared to SVR12 in HIV positive population ;Timepoint(s) of evaluation of this end point: All 12 weeks after therapy | — |
Countries
Belgium, Netherlands
Contacts
Public ContactPrincipal investigator
Erasmus MC
Outcome results
None listed