Phase 4
Completed N=1,275
Study of Oral Treatments for Hepatitis C
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02786537 ↗
Enrolled (actual)
1,275
Serious AEs
3.4%
Results posted
Nov 2020
Primary outcomePrimary: Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV — 40; 516; 14; 335 Participants
◆ Published Evidence
Emerging
12citations · ~2 / year
A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study.
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.
Linked Publications (3)
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A Pragmatic, Randomized Controlled Trial of Oral Antivirals for the Treatment of Chronic Hepatitis C: The PRIORITIZE Study.
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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.
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Long-term Follow-up of Hepatitis C Patients Who Achieved Sustained Virologic Response in the Pragmatic PRIORITIZE Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response (SVR12) mITT With Imputation-Phase 1 and 2 EBR/GZR, SOF/LDV |
40; 516; 14; 335 | — |
| PRIMARY Phase 1/2 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) |
40; 516; 14; 335 | — |
| PRIMARY Phase 1-Sustained Virologic Response (SVR12) mITT With Imputation |
9; 108; 6; 88; 77; 42 | — |
| PRIMARY Phase 1 Number of Participants With Sustained Virologic Response (SVR12-mITT Without Imputation) |
9; 108; 6; 88; 77; 42 | — |
| PRIMARY Mean Change in Headache-PRO Scores -Phase 1 |
0.0; -0.8; -0.7; -0.5; -0.2; -2.2 | — |
| PRIMARY Mean Change in Headache-EBR/GZR and SOF/LDV |
-0.8; -0.7; 0.4; -0.8 | — |
| PRIMARY Median Change in Headache -Phase 1 |
0.0; 0.0; -2.0; -1.0; 0.0; -1.0 | — |
| PRIMARY Median Change in Headache-Phase 2 |
-1.0; 0.0; 0.5; -0.5 | — |
| PRIMARY Mean Change in Nausea/Vomiting PRO Score -Phase 1 |
1.3; -1.4; -3.9; -0.7; 2.5; 0.7 | — |
| PRIMARY Mean Change in Nausea/Vomiting PROMIS Score -EBR/GZR vs. LDV/SOF |
-0.3; -0.6; -1.6; -0.4 | — |
| PRIMARY Median Change in Nausea PRO Score -Phase 1 |
0.4; 0.0; -6.1; 0.0; 0.0; 0.0 | — |
| PRIMARY Median Change in Nausea PROMIS Score-EBR/GZR SOF/LDV |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Mean Change in Fatigue PRO Score -Phase 1 |
1.5; -1.2; -7.2; -2.0; -1.9; -3.0 | — |
| PRIMARY Mean Change in Fatigue PRO -EBR/GZR vs SOF/LDV |
-1.0; -2.1; -3.7; -2.2 | — |
| PRIMARY Median Change in Fatigue -Phase 1 |
2.2; -0.9; -10.2; -3.4; -0.2; -4.1 | — |
| PRIMARY Median Change in Fatigue-Phase 2 |
-1.3; -1.2; -2.4; -1.4 | — |
| PRIMARY Mean Change in HCV- PRO- Phase 1 |
-0.9; 5.6; 2.5; 6.9; 3.2; 9.9 | — |
| PRIMARY Median Change in HCV-PRO (Overall Well Being) -Phase 1 |
0.0; 4.3; 4.7; 4.7; 3.1; 8.6 | — |
| PRIMARY Mean Change in HCV-PRO (Functional Well-being) EBR/GZR vs. SOF/LDV Score-Phase 2 |
3.2; 6.1; 6.3; 6.8 | — |
| PRIMARY 16 Wk EBR/GZR With RBV Efficacy on Patients With HCV RASs |
34 | — |
| SECONDARY Treatment Non-Adherence Probability Estimates |
23; 19; 26 | — |
| SECONDARY Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation |
0.00; -4.99; -0.82; -6.47; -1.12; -5.77 | — |
| SECONDARY Post-treatment Progression/Regression of Liver Disease-Fib-4 |
-1.36 | — |
| SECONDARY Change in Functional Status (HCV-PRO) Within Treatment |
8.02; 9.90; 9.87; 11.54 | — |
| SECONDARY Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF |
12; 4 | — |
| SECONDARY HCV SVR Durability -No Cirrhosis |
255; 17; 146; 2; 14; 36 | — |
| SECONDARY HCV SVR Durability-Patients With Cirrhosis |
43; 7; 35; 7; 6; 7 | — |
| SECONDARY Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2 |
47; 42; 485; 286 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02786537) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.