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

Primary Purpose

Hepatitis C, Chronic

Status

Completed

Phase

Phase 3

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Elbasvir, Grazoprevir 50-100Mg Oral Tablet

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C Virus, Chronic Hepatitis C, Genotype 4, Treatment-naive, Non-cirrhotic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age above 18 years.
Chronically infected with HCV genotype 4.
Treatment naïve.
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.
Not expected to leave the country for six months after the end of the intervention.

Exclusion Criteria:

Incapability of providing an informed consent to participate in the study.
Advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4).
HIV or HBV co-infection
Organ transplant recipients.
Type 2 or 3 cryoglobulinemia with end-organ manifestations.
Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis
Patients with a higher risk of transmitting the disease (Dialysis patients, incarcerated individuals, and intravenous drug abusers).
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.
Pregnancy.
History of hepatocellular carcinoma.

Sites / Locations

King Fahad Medical City

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment arm

Arm Description

Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Outcomes

Primary Outcome Measures

Sustained virologic response at 12 weeks after the end of intervention (SVR-12).

Viral RNA below the level of detection at 12 weeks after the end of the intervention. (Hepatitis C viral load evaluated by polymerase chain reaction (PCR) with a cutoff of 20 IU/mL for detectability.)

Secondary Outcome Measures

Sustained virological response at 4 weeks after the end of intervention (SVR-4).

Hepatitis C viral RNA below the level of detection at 4 weeks after the end of the intervention.

Serious and treatment-related adverse events.

Number of patients with serious and treatment-related adverse events based on the common terminology criteria (CTCAE 4.03), or death during the follow-up period.

Changes in the quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)

To assess this outcome, a self-administered questionnaire called the "Hepatitis Quality of Life Questionnaire" (HQLQ) will be used. The HQLQ is composed of 7 domains; the physical and mental components (PCS and MCS, respectively), a self-evaluated health transition item (SET), and four hepatitis-related items. The latter include general health distress (HD), psychological well-being (PWB), hepatitis-specific functional limitations (HLIM), and hepatitis-specific health distress (HHD) sub-scales. Higher numbers on each component/scale represent better results (e.g., better physical, emotional, and psychological functioning, and little to no limitations in these aspects). Higher scores on the self-evaluated transition item, however, represent less favorable results. These assessments will take place over three occasions. The first will be upon initiating the treatment, the second will be during/by the end of treatment, and the last will take place 12 weeks after the end of treatment.

Full Information

NCT ID

NCT03578640

First Posted

June 6, 2018

Last Updated

November 18, 2020

Sponsor

King Fahad Medical City

1. Study Identification

Unique Protocol Identification Number

NCT03578640

Brief Title

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

Acronym

ELEGANT-4

Official Title

The Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, Non-Cirrhotic, HCV GT4-Infected Patients: A Single-Center, Single-Arm, Open-Label, Phase III Trial

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

King Fahad Medical City

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

Open-label

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Intervention Type

Drug

Intervention Name(s)

Elbasvir, Grazoprevir 50-100Mg Oral Tablet

Other Intervention Name(s)

Elbasvir / Grazoprevir Oral Tablet (Zepatier)

Intervention Description

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

Primary Outcome Measure Information:

Title

Sustained virologic response at 12 weeks after the end of intervention (SVR-12).

Description

Time Frame

At 12 weeks after the end of intervention.

Secondary Outcome Measure Information:

Title

Sustained virological response at 4 weeks after the end of intervention (SVR-4).

Description

Hepatitis C viral RNA below the level of detection at 4 weeks after the end of the intervention.

Time Frame

At 4 weeks after the end of intervention.

Title

Serious and treatment-related adverse events.

Description

Number of patients with serious and treatment-related adverse events based on the common terminology criteria (CTCAE 4.03), or death during the follow-up period.

Time Frame

From the first day of intervention until the end of week 4 after the intervention is finished.

Title

Changes in the quality of life: Hepatitis Quality of Life Questionnaire (HQLQ)

Description

Time Frame

Quality of life evaluations will take place over three occasions. The first will be at baseline (upon treatment initiation), the second will be during treatment/at the end of treatment, and the last will be 12 weeks after the end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age above 18 years. Chronically infected with HCV genotype 4. Treatment naïve. 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. Not expected to leave the country for six months after the end of the intervention. Exclusion Criteria: Incapability of providing an informed consent to participate in the study. Advanced fibrosis (Metavir F3) or cirrhosis (Metavir F4). HIV or HBV co-infection Organ transplant recipients. Type 2 or 3 cryoglobulinemia with end-organ manifestations. Proteinuria, nephrotic syndrome, or membranoproliferative glomerulonephritis Patients with a higher risk of transmitting the disease (Dialysis patients, incarcerated individuals, and intravenous drug abusers). 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. Pregnancy. History of hepatocellular carcinoma.

Facility Information:

Facility Name

King Fahad Medical City

City

Riyadh

ZIP/Postal Code

11525

Country

Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD

Citations:

Citation

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.

Results Reference

result

Citation

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.

Results Reference

result

PubMed Identifier

27770561

Citation

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.

Results Reference

result

PubMed Identifier

28193518

Citation

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.

Results Reference

result

PubMed Identifier

35142658

Citation

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.

Results Reference

derived

Links:

URL

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

Description

C-WORTHY trial

URL

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

Description

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.

URL

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

Description

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

Learn more about this trial

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

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