Evaluation of the Efficacy and Safety of the Fixed-dose Combination Sofosdac® 400mg/60mg in Patients With Chronic Hepatitis C (HCV)

Study Overview
=================
Brief Summary
-----------------
A multicentric, observational, open-design study conducted to evaluate the efficacy and safety of Sofosdac® 400mg/60mg tablets treatment in 100 patients with chronic hepatitis C (HCV)

Detailed Description
-----------------
BEKER laboratories developed the generic drug Sofosdac® 400 mg/60 mg Tablets as fixed dose combination that contains two direct antiviral agents (400 mg Sofosbuvir and 60 mg Daclatasvir) known to be pangenotypic in order to fulfill WHO plan to eradicate HCV by 2030. BEKER conducted an observational clinical trial to evaluate the efficacy and safety of FDC Sofosdac® 400 mg/60 mg treatment in Algerian patients with chronic hepatitis C (HCV).

Official Title
-----------------
Observational, Open Label Study With Direct Individual Benefit Assessing the Efficacy and Safety of Sofosdac® 400mg/60mg Tablets (400 mg Sofosbuvir and 60 mg of Daclatasvir) Treatment in Patients With Chronic Hepatitis C (HCV)

Conditions
-----------------
Chronic Hepatitis c

Intervention / Treatment
-----------------
* Combination Product: Sofosdac®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women age of 18 years old and older. HCV chronic Infection, genotype 1 or 2 or 3 or 4 or 5 or 6 Naive Bi-therapy failure, Tri-therapy 1st generation Telaprévir and Boceprevir, Sofosbuvir - pegIFN - RBV failure Evaluation of fibrosis by non-invasive methods (Fibroscan, Fib 4, APRI) performed during the pre-inclusion period (of at least one month) or A Liver biopsy puncture of at least 24 months before the inclusion visit. Fibrosis according to Metavir score: F0, F1, F2, F3, F4. Compensated Cirrhosis Child-Pugh A or Decompensated Cirrhosis (This point is applicable for patients who have cirrhosis) Exclusion Criteria: Patient under amiodarone Hepatocellular carcinoma HCC Haemodialysis Creatinine Clearance < 30ml/min Breastfeeding Impossibility of using effective masculine or feminine contraception during the study and 6 months after treatment cessation. Medications triggering conduction disturbances with long QT, 30 days prior to inclusion QT prolongation > 450 ms Personal or familial history of torsade de pointes Allergies to nucleosi(ti)des analogues. Advanced cardiopulmonary pathology Malignant neoplasia The intake of anticonvulsants: Carbamazepine, eslicarbazepine, fosphenytoin, phenytoin, oxcarbazepine, pentobarbital, phenobarbital, primidone or the antimycobacterial agents: Rifabutin, rifampin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-cirrhotic<br>Non-cirrhotic HCV patients; 12 weeks treatment | Combination Product: Sofosdac®<br>* Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir<br>|
| Cirrhotic<br>Cirrhotic HCV patients; 24 weeks treatment | Combination Product: Sofosdac®<br>* Once daily fixed-dose combination of 400 mg Sofosbuvir and 60 mg Daclatasvir<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of RNA HCV 12 weeks after treatment cessation by acceptable quantification assay | A quantification assay is performed to all patients to detect RNA HCV in order to determine the proportion of patients who achieve SVR12 (Sustained Viral Response) defined as: RNA HCV < LLOQ (Lower Limit of Quantification) 12 weeks after treatment cessation. | 12 weeks after treatment cessation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of reported adverse events | Assessment of observed adverse events / adverse effects and serious adverse events related or not related to Sofosdac® treatment. | During treatment duration defined as: 24 weeks for cirrhotics, and 12 weeks for non-cirrhotic patients | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HCV, Cirrhotic, non-cirrhotic, sofosdac, sofosbuvir, daclatasvir, fixed-dose combination, FDC, hepatitis C, pangenotypic, genotype