Acute hepatitis C (genotypes 1 or 4) MedDRA version: 20.0 Level: PT Classification code 10065051 Term: Acute hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: ZEPATIER
Product Name: ZEPATIER
Product Code: GRAZOPREVIR
Pharmaceutical Form: Tablet
Trade Name: ZEPATIER
Sponsors
IMEA (Institut de Médecine et d’Epidémiologie Appliquée)–Fondation Léon M’Ba
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult =18 years 2. A recent acute HCV infection or reinfection (see definition below) occurred within 6 months prior screening: An acute HCV infection is defined by: a. HCV RNA was detectable within 6 months after a negative HCV RNA or HCV serology test. OR b. Detectable HCV RNA and an acute clinical hepatitis occurred within 5 months prior to the screening visit. Clinical Hepatitis is defined by: - ALT = 250 IU/L with normal ALT within the preceding 8 months, or - ALT = 500 IU/L with either no measured ALT or with abnormal ALT within the preceding 8 months. HCV reinfection is defined by: a. Documented de novo infection after prior clearance after treatment or spontaneously, - After-treatment clearance is defined by one negative HCV RNA = 6 months after end of treatment. - Spontaneous clearance is defined by two negative HCV RNA a minimum of 6 months apart. OR b. Documented infection with a new viral strain, confirmed by phylogenetic or genotypic analysis. 3. Infection with HCV genotype 1 or 4 (confirmed at screening visit or by using a previous biological test performed 1 to 4 weeks before D0) 4. Plasma HCV-RNA = 1000 UI/mL (confirmed at screening visit or by using a previous biological test performed 1 to 4 weeks before D0) 5. Confirmed HIV infection 6. Without HIV treatment or with an acceptable stable HIV treatment for at least two weeks (See section 8.3 of the protocol) 7. Body weight =40 kg and =125 kg 8. Female patients with child-bearing potential and their heterosexual partners must use adequate contraception from the date of screening until 30 days after administration of the last dose of study drug. Male participants must agree to consistently and correctly use a condom, while their female partner must use adequate contraception from the date of screening until 30 days after administration of the last dose of study drug 9. Informed and signed consent 10. Patients with Health insurance (Sécurité Sociale or Couverture Médicale Universelle) 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 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: Current condition 1. Opportunistic infections (stage C), active or occurred within 6 months prior to baseline. 2. Primary HIV infection. 3. Co-infection with Hepatitis B virus (AgHBs +) without appropriate treatment (TDF or TAF) for at least 2 weeks. 4. Confirmed cirrhosis (before acute HCV diagnosis). 5. Any other causes of acute hepatitis. 6. Pregnant or breast-feeding women. 7. Transplant recipients. 8. Evolutive malignancy. 9. Patients with a history of non-adherence, who will be at risk of being unable to respect the study follow-up timetable. 10. Patients participating in another clinical trial (with an experimental treatment) or within an exclusion period of a previous clinical trial at screening. 11. Patients under legal gardianship or incarcerated. Biological criteria 12. Hb < 10 g/dL (female) or < 11g/dL (male). 13. Platelets < 50 000/mm3. 14. Neutrophil count < 750/mm3. Criteria related to study drugs 15. Other antiretroviral drugs than those allowed in the study (please refer to section 8.3 of the protocol). 16. Contra-indications to Grazoprevir and/or Elbasvir or to any of the excipients listed in the summary of the product characteristics. 17. Contra-indicated treatment likely to interfere with the study drugs as listed in the summary of the product characteristics.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the rate of substained virological response (SVR) 12 weeks after 8 weeks of oral treatment with grazoprevir 100mg/elbasvir 50mg (MRK-combo) in patients with acute hepatitis C genotype1 or 4 and co-infected with HIV; Secondary Objective: HCV virological assessment - To describe the HCV virological response at W4, W8, PT4 (=W12) and PT12(=W20) as a whole and according to genotypes (PT = post-treatment visit) - To study the prognostic factors associated with SVR12 (PT 12). - To assess the emergence of resistance in case of virological failure (HCV RNA =12 IU/mL). - To describe treatment adherence and quality of life during the course of the study. - To evaluate the incidence of HCV reinfection at 1 year (W56). - To evaluate the sensitivity of HCV rapid testing (using the Oraquick HCV rapid antibody test) in co-infected patients with HIV and first acute Hepatitis C. HIV virological assessment - To describe the evolution of HIV parameter during treatment (CD4 count and HIV-RNA). Safety assessment - To describe all the clinical events occurred during the study course ;Primary end point(s): SVR rate defined by an undetectable plasma HCV RNA (<12 IU/mL) 12 weeks post-treatment (SVR12).;Timepoint(s) of evaluation of this end point: 12 weeks post end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Please refer to the protocol;Timepoint(s) of evaluation of this end point: Please refer to the protocol | — |
Countries
France
Contacts
Public ContactROUGIER Hayette
IMEA (Institut de Médecine et d’Epidémiologie Appliquée – Fondation Léon M’Ba
Outcome results
None listed