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

Beker Laboratories

Status: Completed

Conditions: Chronic Hepatitis c

Treatments: Combination Product: Sofosdac®

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05138523

DASO2018/PRO-00

Details and patient eligibility

About

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)

Full 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).

Enrollment: 99 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

99 participants in 2 patient groups

Non-cirrhotic

Description:

Non-cirrhotic HCV patients; 12 weeks treatment

Treatment:

Combination Product: Sofosdac®

Cirrhotic

Description:

Cirrhotic HCV patients; 24 weeks treatment

Treatment:

Combination Product: Sofosdac®