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Study of Oral Treatments for Hepatitis C

NCT ID: NCT02786537

Last Updated: 2021-12-06

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1275 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-09-02

Brief Summary

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Phase 1 of this study compared the effectiveness of 3 approved DAA (direct-acting antiviral) HCV treatment regimens to learn whether they worked equally well under real-world conditions. Phase 2 of this study began early 2017 with removal of 1 DAA regimen, limiting randomization to just 2 FDA approved DAA regimens. Patients receiving HCV therapy in community and academic clinics were offered the opportunity to consent to be randomly assigned to one of three (phase 1) or one of two (phase 2) regimens and observed for outcomes. Once randomized, all medical care, laboratory testing, and any disease or side effect management were assumed by usual care conditions, and patient-reported outcomes were collected outside clinic in keeping with pragmatic design principles.

Detailed Description

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In Phase 1 of this study, consented patients were randomized to 1 of the following 3 HCV DAA treatments: 1) Harvoni® (SOF/LDV) 2) Viekira Pak™ (PrOD) 3) Zepatier™ (EBR/GZR) with the optional addition of Ribavirin (RBV) and the length of treatment determined by the individual provider.

In Phase 2 of this study, consented patients were randomized to 1 of 2 FDA approved HCV treatments: Harvoni® or Zepatier™. Both Phase 1 and Phase 2 subjects had up to 1 tablespoon of blood drawn for HCV resistance testing and future biorepository testing (following appropriate additional consent). The results of testing determined whether a genotype 1a subject randomized to Zepatier would be provided 12 or 16 wks of Zepatier.

Following enrollment/randomization, participants completed patient reported outcome questionnaires (PROs) via electronic device or telephone. Following baseline/randomization, participants were asked to complete surveys again at Wk 4 of treatment, End of Treatment, 1 and 3 year post treatment. Patients continued standard medical care throughout study. Data was abstracted from test results and medical records throughout treatment and for up to 3 years post treatment.

Conditions

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Chronic Hepatitis C

Keywords

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Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EBR/GZR (elbasvir/grazoprevir) with RBV

Patients received 1 EBR/GZR (elbasvir/grazoprevir) (Zepatier) tablet (50/100mg) once daily for 12 to 16 weeks (provider discretion) with Ribavirin (RBV) 200 mg/tablet, 1-3/day, taken 1-2 times per day (dosage at discretion of provider).

Group Type ACTIVE_COMPARATOR

EBR/GZR (elbasvir/grazoprevir)

Intervention Type DRUG

Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks

Ribavirin

Intervention Type DRUG

200 mg pills (1-3 pills, 1-2 times per day)

EBR/GZR (elbasvir/grazoprevir)

Patients received 1 EBR/GZR (elbasvir/grazoprevir) tablet (50/100 mg) once daily for 12 to 16 weeks (provider discretion) (without Ribavirin)

Group Type ACTIVE_COMPARATOR

EBR/GZR (elbasvir/grazoprevir)

Intervention Type DRUG

Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks

SOF/LDV (sofosbuvir/ledipasvir) with RBV

Patients received 1 SOF/LDV (sofosbuvir/ledipasvir) (Harvoni) tablet (400/90 mg) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (at discretion of provider). RBV taken as 200 mg/tablet(capsule), 1-3 pills/day, 1-2 times/day.

Group Type ACTIVE_COMPARATOR

SOF/LDV (sofosbuvir/ledipasvir)

Intervention Type DRUG

Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)

Ribavirin

Intervention Type DRUG

200 mg pills (1-3 pills, 1-2 times per day)

SOF/LDV (sofosbuvir/ledipasvir)

Patients received 1 SOF/LDV (sofosbuvir/ledipasvir) tablet (400/90 mg) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider)

Group Type ACTIVE_COMPARATOR

SOF/LDV (sofosbuvir/ledipasvir)

Intervention Type DRUG

Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)

PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) with RBV (Phase 1 only)

Patients received Pr0D (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) orally daily with food for 12 to 24 weeks with RBV (Ribavirin). Ombitasvir/Paritaprevir/Ritonavir (12.5/75/50 mg/tablet) -2 tablets once daily with food for 12 to 24 weeks and 1 dasabuvir tablet (250 mg) twice daily with food for 12 to 24 weeks.

RBV (200 mg/pill) 1-3 pills/day, 1-2 times/day (use and dosage at provider discretion). Total daily RBV dosage ranged from 200 to 1200 mg.

Group Type ACTIVE_COMPARATOR

PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only)

Intervention Type DRUG

Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) (2 tablets taken orally) and Dasabuvir (250 mg tablet) (1 tablet twice daily) with food for 12 to 24 weeks (treatment duration as per HCV provider)

PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir)

Patients received 2 ombitasvir/paritaprevir/ritonavir tablets (12.5/75/50 mg) once daily and 1 dasabuvir (250 mg) tablet twice daily with food for 12 to 24 weeks without Ribavirin (as per provider instructions)

Group Type ACTIVE_COMPARATOR

PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only)

Intervention Type DRUG

Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) (2 tablets taken orally) and Dasabuvir (250 mg tablet) (1 tablet twice daily) with food for 12 to 24 weeks (treatment duration as per HCV provider)

Ribavirin

Intervention Type DRUG

200 mg pills (1-3 pills, 1-2 times per day)

Interventions

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SOF/LDV (sofosbuvir/ledipasvir)

Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)

Intervention Type DRUG

PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only)

Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) (2 tablets taken orally) and Dasabuvir (250 mg tablet) (1 tablet twice daily) with food for 12 to 24 weeks (treatment duration as per HCV provider)

Intervention Type DRUG

EBR/GZR (elbasvir/grazoprevir)

Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks

Intervention Type DRUG

Ribavirin

200 mg pills (1-3 pills, 1-2 times per day)

Intervention Type DRUG

Other Intervention Names

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Harvoni® (sofosbuvir/ledipasvir) Viekira Pak/Viekira Zepatier RBV

Eligibility Criteria

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Inclusion Criteria

* HCV Genotype 1a or 1b
* Adult patients (age 18 years or older)
* Patients being prescribed HCV treatment who can begin treatment with any of the three HCV treatments being studied (Harvoni (SOF/LDV), Viekira Pak (PrOD) (Phase 1 only), or Zepatier (EBR/GZR))

Exclusion Criteria

* Inability to provide written informed consent
* HARVONI® is not a covered drug on benefits formulary
* Current or historical evidence of hepatic decompensation (variceal bleeding, hepatic encephalopathy, or ascites)
* Child Pugh (CTP) B or C Cirrhosis (documented CTP calculation is required)
* Pregnant or breastfeeding women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David R Nelson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Liver Wellness Center

Little Rock, Arkansas, United States

Site Status

Stanford University

Palo Alto, California, United States

Site Status

UCSD Medical Center

San Diego, California, United States

Site Status

UCSF/Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, United States

Site Status

Univ of California, San Francisco

San Francisco, California, United States

Site Status

Yale University Digestive Diseases

New Haven, Connecticut, United States

Site Status

Georgetown University

Washington D.C., District of Columbia, United States

Site Status

Howard University

Washington D.C., District of Columbia, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

University of Florida, Jacksonville

Jacksonville, Florida, United States

Site Status

University of Miami/Schiff Center for Liver Diseases

Miami, Florida, United States

Site Status

Orlando Immunology Center

Orlando, Florida, United States

Site Status

Internal Medicine Associates of Wellstar Atlanta Medical Center

Atlanta, Georgia, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Indiana University Medical Center

Indianapolis, Indiana, United States

Site Status

John Hopkins University

Lutherville, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

GI Associates & Endoscopy Center

Flowood, Mississippi, United States

Site Status

Saint Louis University

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Ctr

Omaha, Nebraska, United States

Site Status

Southwest CARE Center

Santa Fe, New Mexico, United States

Site Status

Mt. Sinai Beth Israel

New York, New York, United States

Site Status

New York Langone Medical Center

New York, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Columbia University Medical Center

New York, New York, United States

Site Status

Mountain View Medical Center

Valatie, New York, United States

Site Status

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Cincinnati

Cincinnati, Ohio, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Research Specialist of Texas

Houston, Texas, United States

Site Status

Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia)

Richmond, Virginia, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Evon DM, Dong M, Reeve BB, Peter J, Michael L, Lok AS, Nelson DR, Stewart PW. Sustainable and equivalent improvements in symptoms and functional well-being following viral cure from ledipasvir/sofosbuvir versus elbasvir/grazoprevir for chronic hepatitis C infection: Findings from the randomized PRIORITIZE trial. J Viral Hepat. 2022 Sep;29(9):795-806. doi: 10.1111/jvh.13716. Epub 2022 Jun 15.

Reference Type DERIVED
PMID: 35657133 (View on PubMed)

Lok AS, Moon J, Sherman KE, Khalili M, Fishbein D, Reddy KR; PRIORITIZE Study Team. Long-term Follow-up of Hepatitis C Patients Who Achieved Sustained Virologic Response in the Pragmatic PRIORITIZE Study. Clin Gastroenterol Hepatol. 2023 Feb;21(2):546-548.e4. doi: 10.1016/j.cgh.2022.01.059. Epub 2022 Feb 17.

Reference Type DERIVED
PMID: 35182741 (View on PubMed)

Sulkowski MS, Moon JS, Sherman KE, Morelli G, Darling JM, Muir AJ, Khalili M, Fishbein DA, Hinestrosa F, Shiffman ML, Di Bisceglie A, Rajender Reddy K, Pearlman B, Lok AS, Fried MW, Stewart PW, Peter J, Wadsworth S, Kixmiller S, Sloan A, Vainorius M, Horne PM, Michael L, Dong M, Evon DM, Segal JB, Nelson DR; PRIORITIZE Study Team. A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study. Hepatology. 2021 Dec;74(6):2952-2964. doi: 10.1002/hep.32053. Epub 2021 Aug 26.

Reference Type DERIVED
PMID: 34255381 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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PCORI-1503-27891

Identifier Type: OTHER

Identifier Source: secondary_id

IRB201501162

Identifier Type: OTHER

Identifier Source: secondary_id

16-1234

Identifier Type: -

Identifier Source: org_study_id