Study of Oral Treatments for Hepatitis C

NCT02786537 | Completed Phase 4 Results FDA Drug

• 3 other identifiers: 16-1234PCORI-1503-27891IRB201501162
• Study Type: interventional
• Target: 1,275
• Locations: 1 country
• Sites: 38

Brief Summary

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.

Conditions

Chronic Hepatitis C

Keywords

Hepatitis C

Outcome Measures

Primary Outcomes (20)

• Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV

  SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation at discretion of provider). mITT with imputation (missing=failure). Total number of subjects reflects participants from EBR/GZR with or without RBV and SOF/LDV with or without RBV randomized during Phase 1 and Phase 2.

  12 weeks post-treatment

• Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)

  SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site). Number of subjects reflects participants who started EBR/GZR or SOF/LDV- based treatment (with or without RBV) during Phase 1 and 2.

  12-24 weeks post HCV treatment

• Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation

  SVR (Sustained Virologic Response) 12 will be defined as patients who have undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site). mITT with imputation (missing=failure). Total number of subjects reflects participants from Phase 1 only.

  12 weeks post-treatment

• Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation)

  SVR (Sustained Virologic Response) 12 will be defined as undetectable hepatitis C virus (HCV) RNA at 12 week follow-up visit (12 -24 weeks after HCV treatment discontinuation as dictated by standard of care at each individual site). Number of subjects reflects participants randomized during Phase 1 only.

  12 -24 weeks post-treatment

• Mean Change in Headache-PRO Scores -Phase 1

  Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement in symptom.

  Baseline to On-Treatment

• Mean Change in Headache-EBR/GZR and SOF/LDV

  Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Mean change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD

  Baseline to On-Treatment

• Median Change in Headache -Phase 1

  Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of mean change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD

  12 weeks (Baseline and Average On-treatment Score)

• Median Change in Headache-Phase 2

  Headache was evaluated by the HIT-6 score, a validated, Patient Reported Outcomes survey (PROs) 'PROMIS Headache Impact Test (HIT)' with scores ranging from 36 to 78 with higher score reflecting greater impact. Median change in headache side effect was evaluated using difference between baseline value of HIT-6 score to the highest (worst) score during treatment. Estimates of median change and differences obtained from a constrained longitudinal linear mixed-effects model that treated baseline score as one of outcomes. Negative values for mean change represent improvement, while negative values for 'difference' indicate LDV/SOF performed better than PrOD

  Baseline -on Treatment (12-16 weeks)

• Mean Change in Nausea/Vomiting PRO Score -Phase 1

  Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement. The estimates of mean change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes. The model expressed mean score as a function of DAA regimen, cirrhosis status, HCV genotype, sex, age, race, and previous treatment status.

  Baseline to On-Treatment

• Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF

  Participants completed the Patient Reported Outcomes surveys (PROs) 'PROMIS Nausea/Vomiting -4 Short Form' at baseline and during treatment. Raw scores are converted to standardized T-scores with a range of 45.0-80.1. Higher scores indicate worse nausea/vomiting. Results presented as mean difference from baseline to average of on Treatment Scores (highest/worst) score during treatment. A negative (-) PROMIS change score is suggestive of symptom improvement or lack of drug side effect. Estimates of mean change were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes.

  Baseline and Average On-Treatment Score

• Median Change in Nausea PRO Score -Phase 1

  Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for mean change represent improvement. The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes.

  Baseline to end of treatment

• Median Change in Nausea PROMIS Score-EBR/GZR SOF/LDV

  Patients completed the PROMIS® Nausea Short Form at Baseline (T1) and on-treatment. PROMIS raw scores from each of the completed questionnaires were converted to standardized T-scores. Change was calculated as the difference between baseline and on-treatment score. T-scores for the PROMIS Nausea and Vomiting 4a scale range from 45.0 - 80.1. Higher scores indicate worse nausea. Negative values for change represent improvement. The estimates of change and differences were obtained from a constrained longitudinal linear mixed-effects model that treated the baseline score as one of the outcomes.

  Baseline- On Treatment (up to 16 weeks)

• Mean Change in Fatigue PRO Score -Phase 1

  Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.

  Baseline to On-treatment

• Mean Change in Fatigue PRO -EBR/GZR vs SOF/LDV

  Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.

  Baseline and Average On-Treatment Score

• Median Change in Fatigue -Phase 1

  Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.

  Baseline to End of Treatment

• Median Change in Fatigue-Phase 2

  Fatigue severity collected from validated, Patient Reported Outcomes survey (PROs), 'PROMIS Fatigue Short Form'. PROMIS® T-scores were computated to compare difference between baseline value of PROMIS score to the highest (worst) score during treatment. Results presented as computated t-score from baseline to average of on Treatment Scores. A positive (+) score suggests improvements in functional well-being. A negative (-) PRO change score is suggestive of symptom improvement or lack of drug side effect. PROMIS Fatigue Score scale per question: 1=Never, 2=Rarely, 3=Sometimes, 4=Often, 5=Always with 7 questions for a total maximum score of 35.

  Baseline-On Treatment (up to 16 weeks)

• Mean Change in HCV- PRO- Phase 1

  HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'overall functioning and well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being. Total score = (SUM-N)/(4\*N)\*100, where N is the number of questions answered.

  Baseline to End of Treatment

• Median Change in HCV-PRO (Overall Well Being) -Phase 1

  HCV-PRO, a survey for patients with HCV that measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess 'Overall Functioning and Well-being'. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being. Total score = (SUM-N)/(4\*N)\*100, where N is the number of questions answered.

  Baseline to End of Treatment

• Mean Change in HCV-PRO (Functional Well-being) EBR/GZR vs. SOF/LDV Score-Phase 2

  HCV-PRO, a survey designed to assess functional status of patients with HCV and measures physical, emotional, and social functioning, productivity, intimacy, and perception of quality of life, was used to assess functional well-being. In general, lower score is worst outcome and higher scores indicate greater well-being and functioning. However, for ease of interpretation, HCV-PRO scale has been transformed by using '100 - HCV-PRO' ultimately revising the score to mean 0 (lowest score) is best to 100 (worst outcome). A positive change (End of treatment to baseline) suggests improvements in functional well-being. Total score = (SUM-N)/(4\*N)\*100, where N is the number of questions answered. End of Treatment -Baseline were used to calculate CHANGE in outcome. Number of subjects reflects participants from both Phase 1 and 2.

  End of Treatment - Baseline

• 16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs

  Efficacy of Hepatitis C Virus (HCV) Treatment with Zepatier (Elbasvir/Grazobevir) with Ribavirin (RBV) for 16 weeks when used in Genotype 1a patients with Baseline RASs (NS5a Resistance Associated Substitutions or RAPs -Resistance Associated Polymorphisms). Efficacy defined as HCV RNA undetectable 12 weeks post treatment. Table excludes Genotype 1b patients.

  12 weeks post treatment

Secondary Outcomes (8)

• Treatment Non-Adherence Probability Estimates

  12-16 weeks of HCV treatment

• Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation

  1 year post treatment discontinuation (Early post-tx)

• Post-treatment Progression/Regression of Liver Disease-Fib-4

  Baseline to up to 3 years post treatment discontinuation

• Change in Functional Status (HCV-PRO) Within Treatment

  Treatment start date up to 2 years post-treatment

• Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF

  Treatment start date through treatment completion (up to 24 weeks)

Study Arms (6)

EBR/GZR (elbasvir/grazoprevir) with RBV

ACTIVE COMPARATOR

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).

Drug: EBR/GZR (elbasvir/grazoprevir); Drug: Ribavirin

EBR/GZR (elbasvir/grazoprevir)

ACTIVE COMPARATOR

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

Drug: EBR/GZR (elbasvir/grazoprevir)

SOF/LDV (sofosbuvir/ledipasvir) with RBV

ACTIVE COMPARATOR

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.

Drug: SOF/LDV (sofosbuvir/ledipasvir); Drug: Ribavirin

SOF/LDV (sofosbuvir/ledipasvir)

ACTIVE COMPARATOR

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)

Drug: SOF/LDV (sofosbuvir/ledipasvir)

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

ACTIVE COMPARATOR

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.

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

PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir)

ACTIVE COMPARATOR

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)

Drug: PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only); Drug: Ribavirin

Interventions

SOF/LDV (sofosbuvir/ledipasvir) DRUG

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

Also known as: Harvoni® (sofosbuvir/ledipasvir)

SOF/LDV (sofosbuvir/ledipasvir); SOF/LDV (sofosbuvir/ledipasvir) with RBV

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

Also known as: Viekira Pak/Viekira

PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) with RBV (Phase 1 only); PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir)

EBR/GZR (elbasvir/grazoprevir) DRUG

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

Also known as: Zepatier

EBR/GZR (elbasvir/grazoprevir); EBR/GZR (elbasvir/grazoprevir) with RBV

Ribavirin DRUG

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

Also known as: RBV

EBR/GZR (elbasvir/grazoprevir) with RBV; PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir); SOF/LDV (sofosbuvir/ledipasvir) with RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Florida: lead
• Patient-Centered Outcomes Research Institute: collaborator
• Merck Sharp & Dohme LLC: collaborator
• AbbVie: collaborator

Study Sites (38)

Liver Wellness Center

Little Rock, Arkansas, 72205, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

UCSD Medical Center

San Diego, California, 92103, United States

Location

UCSF/Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

Location

Univ of California, San Francisco

San Francisco, California, 94143, United States

Location

Yale University Digestive Diseases

New Haven, Connecticut, 06520, United States

Location

Georgetown University

Washington D.C., District of Columbia, 20007, United States

Location

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

University of Florida

Gainesville, Florida, 32610-0272, United States

Location

University of Florida, Jacksonville

Jacksonville, Florida, 32209, United States

Location

University of Miami/Schiff Center for Liver Diseases

Miami, Florida, 33136, United States

Location

Orlando Immunology Center

Orlando, Florida, 32803, United States

Location

Internal Medicine Associates of Wellstar Atlanta Medical Center

Atlanta, Georgia, 30312, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Northwestern University

Chicago, Illinois, 60647, United States

Location

Indiana University Medical Center

Indianapolis, Indiana, 46202, United States

Location

John Hopkins University

Lutherville, Maryland, 21093, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

GI Associates & Endoscopy Center

Flowood, Mississippi, 39232, United States

Location

Saint Louis University

St Louis, Missouri, 63104, United States

Location

University of Nebraska Medical Ctr

Omaha, Nebraska, 68198, United States

Location

Southwest CARE Center

Santa Fe, New Mexico, 87505, United States

Location

Mt. Sinai Beth Israel

New York, New York, 10003, United States

Location

New York Langone Medical Center

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Mountain View Medical Center

Valatie, New York, 12184, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Research Specialist of Texas

Houston, Texas, 77030, United States

Location

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

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

Related Publications (3)

• 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.

  PMID: 35657133 DERIVED

• 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.

  PMID: 35182741 DERIVED

• 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.

  PMID: 34255381 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

Sofosbuvir; ledipasvir; ledipasvir, sofosbuvir drug combination; Cytochrome P-450 CYP2B1; ombitasvir; dasabuvir; Viekira Pak; elbasvir; grazoprevir; elbasvir-grazoprevir drug combination; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Aryl Hydrocarbon Hydroxylases; Cytochrome P-450 Enzyme System; Cytochromes; Enzymes and Coenzymes; Cytochrome P450 Family 2; Mixed Function Oxygenases; Oxygenases; Oxidoreductases; Enzymes; Hemeproteins; Proteins; Amino Acids, Peptides, and Proteins; Ribonucleosides; Nucleosides

Limitations and Caveats

This pragmatic trial allowed patients who were randomized to SOF/LDV but unable to obtain SOF/LDV (due to limitations in access from insurance, etc.) to be treated with the accessible, alternative DAA regimens. This contributed to the variance from 'as randomized' population to the 'as treated' population. Rapidly changing HCV landscape led to discontinuation of PrOD treatment regimen and modification of initial analysis plan including reduction of original sample size.

Results Point of Contact

• Title: Lauren Morelli
• Organization: UF Hepatology Research at CTRB

lauren.morelli@medicine.ufl.edu

352-273-9508

Study Officials

• David R Nelson, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: June 1, 2016
• Study Start: June 1, 2016
• Primary Completion: June 13, 2019
• Study Completion: September 2, 2020
• Last Updated: December 6, 2021
• Results First Posted: November 24, 2020

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (38)