Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4 (ELEGANT-4)

King Fahad Medical City

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03578640

18-226

Details and patient eligibility

About

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.

Full description

The treatment of hepatitis C has gone through significant advances in the last few years with the development of direct-acting antivirals "DAAs." Since 2013, many DAAs have been approved for the treatment of HCV with excellent efficacy and safety profiles. The major hurdle in treating patients on a large scale is the high cost of the current treatment regimens. Multiple approaches have been proposed, among them, a shortened treatment regimen of 6 to 8 weeks rather than the standard 12-week-regimen. The strategy of shortening the treatment will help in reducing the cost by 33% to 50%. Thus, it will increase the availability of the treatment to more patients.

Zepatier is a combination drug of Elbasvir (EBR), an NS5A inhibitor, and Grazoprevir (GZR), a potent NS3/4A inhibitor. This study is being proposed to address two main issues. First, collecting information on the safety and efficacy of a shortened course of zepatier (8 weeks instead of the standard 12 weeks) in patients who are treatment-naïve, non-cirrhotic and mono-infected with HCV. Second, to investigate whether this course provides similar clinical outcomes to the standard regimen in HCV-Genotype 4, which is the most common genotype in Saudi Arabia.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment arm

Experimental group

Description:

Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Treatment:

Drug: Elbasvir, Grazoprevir 50-100Mg Oral Tablet