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

NCT ID: NCT03578640

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2020-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis C, Chronic

Keywords

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Hepatitis C Virus Chronic Hepatitis C Genotype 4 Treatment-naive Non-cirrhotic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

An interventional, single-center, single-arm study among 30 patients who are treatment naïve, have no advanced fibrosis and mono-infected with HCV-GT4.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open-label

Study Groups

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Treatment arm

Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Group Type EXPERIMENTAL

Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Intervention Type DRUG

Daily, fixed-dose combination of Elbasvir 50 mg and Grazoprevir 100 mg given in a single oral tablet for 8 weeks.

Interventions

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Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Daily, fixed-dose combination of Elbasvir 50 mg and Grazoprevir 100 mg given in a single oral tablet for 8 weeks.

Intervention Type DRUG

Other Intervention Names

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Elbasvir / Grazoprevir Oral Tablet (Zepatier)

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Fahad Medical City

OTHER_GOV

Sponsor Role lead

Responsible Party

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Ahmad A AlEid, MD

Staff Physician, Department of Gastroenterology and Hepatology, Consultant Advanced Hepatology and Liver Transplantation, Principal Investigator of the ELEGANT-4 trial

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Fahad Medical City

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Serfaty L, Zeuzem S, Vierling JM, et al. High efficacy of the combination HCV regimen grazoprevir and elbasvir for 8 or 12 weeks with or without ribavirin in treatment-naive, noncirrhotic HCV GT1b-infected patients: an integrated analysis. Program and abstracts of the 2015 Annual Meeting of the American Association for the Study of Liver Diseases; November 13-17, 2015; San Francisco, California. Abstract 701.

Reference Type RESULT

STREAGER Interim Analysis: High Rate of SVR With 8 Weeks of Elbasvir/Grazoprevir in Treatment-Naive Patients With Genotype 1b HCV Infection and F0-F2 Fibrosis; 2017 Annual Meeting of the American Association for the Study of Liver Diseases; Washington DC; Posted online October 27, 2017.

Reference Type RESULT

Lawitz E, Poordad F, Gutierrez JA, Wells JT, Landaverde CE, Evans B, Howe A, Huang HC, Li JJ, Hwang P, Dutko FJ, Robertson M, Wahl J, Barr E, Haber B. Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial. Hepatology. 2017 Feb;65(2):439-450. doi: 10.1002/hep.28877. Epub 2016 Dec 19.

Reference Type RESULT
PMID: 27770561 (View on PubMed)

Jacobson IM, Lawitz E, Kwo PY, Hezode C, Peng CY, Howe AYM, Hwang P, Wahl J, Robertson M, Barr E, Haber BA. Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis. Gastroenterology. 2017 May;152(6):1372-1382.e2. doi: 10.1053/j.gastro.2017.01.050. Epub 2017 Feb 11.

Reference Type RESULT
PMID: 28193518 (View on PubMed)

AlEid A, Al Balkhi A, Qutub A, Abbarh S, AlLehibi A, Almtawa A, Al Otaibi N, AlGhamdi A, AlGhamdi A, Alamr A, Ahmad S, Al Sayari K, Al Ibrahim B, AlKhathlan A. The efficacy of Elbasvir/Grazoprevir fixed-dose combination for 8 weeks in HCV treatment and health-related quality of life (HRQoL) in treatment-naive, non-cirrhotic, genotype 4-infected patients (ELEGANT-4): A single-center, single-arm, open-label, phase 3 trial. Saudi J Gastroenterol. 2022 May-Jun;28(3):225-232. doi: 10.4103/sjg.sjg_374_21.

Reference Type DERIVED
PMID: 35142658 (View on PubMed)

Related Links

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http://www.natap.org/2015/AASLD/AASLD_169.htm

C-WORTHY trial

https://www.ncbi.nlm.nih.gov/pubmed/27770561

Short-duration treatment with elbasvir/grazoprevir and sofosbuvir for hepatitis C: A randomized trial. Hepatology. 2017 Feb;65(2):439-450. doi: 10.1002/hep.28877. Epub 2016 Dec 19.

https://www.ncbi.nlm.nih.gov/pubmed/28193518

Safety and Efficacy of Elbasvir/Grazoprevir in Patients With Hepatitis C Virus Infection and Compensated Cirrhosis: An Integrated Analysis.

Other Identifiers

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18-226

Identifier Type: -

Identifier Source: org_study_id