Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4

• Status: Completed
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the safety and efficacy of a daily, fixed-dose, 8-week course combination of Elbasvir/Grazoprevir in treatment-naïve, non-cirrhotic patients who are mono-infected with hepatitis C, genotype 4.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Fahad Medical City
• Treatments: Grazoprevir

Criteria

Inclusion Criteria:

1. Age above 18 years.

2. Chronically infected with HCV genotype 4.

3. Treatment naïve.

4. No advanced fibrosis. Defined by the absence of clinical, radiological and laboratory signs of cirrhosis, and fibrosis assessment consistent with fibrosis stage (Metavir F2) or less by liver biopsy or transient elastography.

5. Not expected to leave the country for six months after the end of the intervention.

Exclusion Criteria:

1. Incapability of providing an informed consent to participate in the study.

2. Advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4).

3. HIV or HBV co-infection

4. Organ transplant recipients.

5. Type 2 or 3 cryoglobulinemia with end-organ manifestations.

6. Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis

7. Patients with a higher risk of transmitting the disease (Dialysis patients, incarcerated individuals, and intravenous drug abusers).

8. The use of any medication that has major interactions with Elbasvir or Grazoprevir as defined by the University of Liverpool drug interaction database, and cannot be discontinued or replaced with other alternatives.

9. Pregnancy.

10. History of hepatocellular carcinoma.