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| ID | Type | Description | Link |
|---|---|---|---|
| PCORI-1503-27891 | Other Identifier | PCORI | |
| IRB201501162 | Other Identifier | New UF IRB-01 |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
| Merck Sharp & Dohme LLC | INDUSTRY |
| AbbVie | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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) |
|
| 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. |
|
| 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) |
|
| PrOD (Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir) with RBV (Phase 1 only) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Non-Adherence Probability Estimates | The Voils Medication Adherence Survey (VMAS) was used to evaluate medication adherence during HCV treatment. Participants responded to three questions about the extent of adherence during the past seven days of treatment (during early and late on-treatment occasions). Participants responded using a five-point ordinal scale of missed dosing from 1 (none of the time) to 5 (all of the time). On each occasion participants were coded as being "Non-adherent" if any response was > 1, otherwise they were coded as "Adherent". Probability estimates of percentage of patients reporting non-adherence were calculated per HCV treatment (Direct Acting Antiviral-DAA) regimen: 1)EBR/GZV (elbasvir/grazoprevir, 2)SOF/LDV (sofosbuvir/ledipasvir), 3)PrOD |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David R Nelson, MD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver Wellness Center | Little Rock | Arkansas | 72205 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35657133 | Derived | 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. | |
| 35182741 |
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This study initially (Phase 1) randomized subjects to receive 1 of 3 HCV DAA regimens (EBR/GZR +/- RBV, LDV/SOF +/- RBV, or PrOD +/-RBV). In phase 2 of this study, randomization to PrOD regimen was discontinued and newly enrolled subjects were randomized to either EBR/GZR +/- RBV or LDV/SOF +/- RBV. Efficacy data was analyzed via original 'randomization' and as subjects were 'actually treated (regimen actually received)' while safety analysis was evaluated by actual treatment received.
Participants were consented at 34 US centers Between June 2016 and March 2018. Patients' insurance was screened for inclusion of SOF/LDV on formulary (the HCV regimen not provided by the study). However, following randomization, participants who were unable to obtain SOF/LDV through insurance received 1 of 2 Direct Acting Antiviral (DAA) HCV Treatment regimens 1)EBR/GZR or 2)PrOD during Phase 1 and received EBR/GZR during Phase 2.
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| ID | Title | Description |
|---|---|---|
| FG000 | EBR/GZR With RBV | Patients received EBR/GZR (elbasvir/grazoprevir) (Zepatierâ„¢) orally once daily with RBV for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food and with RBV: Ribavirin (200 mg pill) 1-3 pills/day, once or twice daily. Total daily dosage ranged from 200 to 1200 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| As Randomized |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2018 |
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| 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. |
|
| 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) |
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| 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) |
|
|
| 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 |
|
|
| Ribavirin | Drug | 200 mg pills (1-3 pills, 1-2 times per day) |
|
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| 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 |
| 12-16 weeks of HCV treatment |
| Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation | Change in HCV-associated symptoms was calculated as the mean differences of mean scores from multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)-- Fatigue, nausea, belly pain, sleep disturbance, and diarrhea) and functional status (well-being) when comparing baseline to early post-treatment and late post treatment surveys. Mean change scores were calculated by comparing baseline to early post-treatment (1 yr) and late post-treatment (approximately 3 years) surveys. 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.Negative numbers suggest better symptoms (improvement in HCV-associated symptoms). 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.HCV-PRO positive estimates suggest baseline functional well-being improvement. | 1 year post treatment discontinuation (Early post-tx) |
| Post-treatment Progression/Regression of Liver Disease-Fib-4 | Mean change (delta) in FIB-4, an indirect non-invasive measure of liver fibrosis, calculated as baseline median -long term follow up median, following SVR after any of the study treatment regimens. Change in FIB-4 where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change. FIB-4 = age (years) * AST(IU/L)/Platelets (10^3/L) * ALT^.5(IU/L). In general, Score of 0-1.29 is low risk for advanced fibrosis, 1.30-1.67: intermediate risk for advanced liver fibrosis, >2.67: high risk for advanced fibrosis. | Baseline to up to 3 years post treatment discontinuation |
| Change in Functional Status (HCV-PRO) Within Treatment | HCV-PRO score, a validated PROMIS survey used to evaluate overall functioning and well-being in HCV patients, was utilized to compare long-term 'within treatment' changes of 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 estimate (Post treatment to baseline) suggests baseline functional well-being improvement. Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered. | Treatment start date up to 2 years post-treatment |
| Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF | The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen) | Treatment start date through treatment completion (up to 24 weeks) |
| HCV SVR Durability -No Cirrhosis | Number/Percentage of patients with persistence of viral cure, SVR (SVR = Sustained Virologic Response)- defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. | 24 weeks post-end of treatment up to 153 weeks |
| HCV SVR Durability-Patients With Cirrhosis | Percentage of Cirrhotic patients with persistence of viral cure, SVR, (SVR= Sustained Virologic Response) defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. | Up to 132 weeks post HCV treatment |
| Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2 | Number of participants who achieved SVR (sustained virologic response), defined as undetectable HCV RNA 12 weeks post-treatment with RASs (Resistant Associated Substitutions) after treatment with EBR/GZR or SOF/LDV regimen | 12 weeks post HCV treatment |
| Palo Alto |
| California |
| 94304 |
| United States |
| UCSD Medical Center | San Diego | California | 92103 | United States |
| UCSF/Zuckerberg San Francisco General Hospital and Trauma Center | San Francisco | California | 94110 | United States |
| Univ of California, San Francisco | San Francisco | California | 94143 | United States |
| Yale University Digestive Diseases | New Haven | Connecticut | 06520 | United States |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | United States |
| Howard University | Washington D.C. | District of Columbia | 20060 | United States |
| University of Florida | Gainesville | Florida | 32610-0272 | United States |
| University of Florida, Jacksonville | Jacksonville | Florida | 32209 | United States |
| University of Miami/Schiff Center for Liver Diseases | Miami | Florida | 33136 | United States |
| Orlando Immunology Center | Orlando | Florida | 32803 | United States |
| Internal Medicine Associates of Wellstar Atlanta Medical Center | Atlanta | Georgia | 30312 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Northwestern University | Chicago | Illinois | 60647 | United States |
| Indiana University Medical Center | Indianapolis | Indiana | 46202 | United States |
| John Hopkins University | Lutherville | Maryland | 21093 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| GI Associates & Endoscopy Center | Flowood | Mississippi | 39232 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| University of Nebraska Medical Ctr | Omaha | Nebraska | 68198 | United States |
| Southwest CARE Center | Santa Fe | New Mexico | 87505 | United States |
| Mt. Sinai Beth Israel | New York | New York | 10003 | United States |
| New York Langone Medical Center | New York | New York | 10016 | United States |
| Weill Cornell Medical College | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Mountain View Medical Center | Valatie | New York | 12184 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| University of Cincinnati | Cincinnati | Ohio | 45267 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Research Specialist of Texas | Houston | Texas | 77030 | United States |
| Bon Secours St. Mary 's Hospital of Richmond (Liver Institute of Virginia) | Richmond | Virginia | 23226 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23284 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| 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. |
| 34255381 | 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. |
| FG001 |
| EBR/GZR |
Patients received EBR/GZR (elbasvir/grazoprevir) (Zepatierâ„¢) orally once daily (without RBV) for 12 to 16 weeks EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks. Duration of treatment according to HCV treatment provider. |
| FG002 | SOF/LDV With RBV | Patients received SOF/LDV(sofosbuvir/ledipasvir) (Harvoni®) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV/sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) 1 tablet daily for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider) RBV (200 mg pill): 1-3 pills, once or twice daily (dosing per discretion of HCV provider). Total daily dosage ranged from 200 to 1200 mg. |
| FG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) (Harvoni®) orally once daily with or without food 12 to 24 weeks SOF/LDV: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider) |
| FG004 | PrOD/RBV(Phase 1 Only) | PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir (Viekira) once or twice daily with a meal for 12 to 24 weeks + RBV (provider discretion). Randomization to PrOD discontinued January 2017. ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks with food (treatment duration and use of ribavirin as per HCV provider) Dasabuvir: 250 mg twice daily for 12 to 24 weeks with a meal RBV: Ribavirin 200 to 600 mg once or twice daily |
| FG005 | PrOD (Phase 1 Only) | Randomization to Prod discontinued January 2017 (defining end of Phase 1) PrOD: Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir: 250 mg daily for 12 to 24 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| As Treated |
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Study participants as randomized to HCV treatment
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | EBR/GZR With RBV | Patients received EBR/GZR (elbasvir/grazoprevir) tablet tablet once daily with RBV for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir 50/100mg tablet) once daily with or without food with or without RBV for 12 to 16 weeks (with RBV) |
| BG001 | EBR/GZR | Patients received EBR/GZR (elbasvir/grazoprevir) tablet tablet once daily without RBV for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir 50/100mg tablet): 1 tablet once daily with or without food with or without RBV for 12 to 16 weeks (without RBV) |
| BG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks with Ribavirin (RBV) (treatment duration and use of ribavirin is per discretion of HCV provider) |
| BG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (per discretion of provider) SOF/LDV: Sofosbuvir/Ledipasvir (400/90 mg tablet ) 1 tablet orally once daily for approximately 12 to 24 weeks |
| BG004 | PROD With RBV (Phase 1 Only) | Phase 1 only - Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks +/- RBV (provider discretion) ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir: 250 mg daily for 12 to 24 weeks |
| BG005 | PROD (Phase 1 Only) | Phase 1 only - Two ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks Dasabuvir: 250 mg daily for 12 to 24 weeks |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| HCV RNA | Mean | Standard Deviation | 10^6 units IU/mL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | 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. | mITT with imputation, Missing SVR data = Failure. Numbers represent participants according to arm randomized (Period 1). Population excludes participants who did not start any HCV treatment. | Posted | Count of Participants | Participants | 12 weeks post-treatment |
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| Primary | 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. | All mITT without imputation (missing data excluded). Includes only number of participants for whom SVR12 data is available and based on study drug as randomized (Period 1). Participants for whom SVR 12 is not available are excluded from this table. | Posted | Count of Participants | Participants | 12-24 weeks post HCV treatment |
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| Primary | 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. | mITT with imputation, Missing SVR data =failure. Numbers represent participants according to arm randomized (period 1). Population excludes participants who did not start any HCV treatment. | Posted | Count of Participants | Participants | 12 weeks post-treatment |
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| Primary | 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. | Participants analyzed based on HCV treatment as assigned by randomization. | Posted | Count of Participants | Participants | 12 -24 weeks post-treatment |
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| Primary | 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. | Analysis limited to patients who completed a baseline and on-treatment PRO and as treated (Period 2) during Phase 1 only. | Posted | Mean | Standard Deviation | units on a scale | Baseline to On-Treatment |
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| Primary | 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 | Analysis limited to participants who completed both baseline and end of treatment PRO | Posted | Mean | Standard Deviation | units on a scale | Baseline to On-Treatment |
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| Primary | 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 | Analysis limited to patients randomized up to last patient randomized to PrOD and participants who completed baseline and on-treatment survey. | Posted | Median | Full Range | units on a scale | 12 weeks (Baseline and Average On-treatment Score) |
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| Primary | 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 | Analysis limited to patients randomized to EBR/GZR regimen or SOF/LDV regimen and participants who completed both baseline and on treatment survey. | Posted | Median | Full Range | units on a scale | Baseline -on Treatment (12-16 weeks) |
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| Primary | 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. | Analysis is limited to patients who completed at least one baseline and one end of treatment PRO survey during Phase 1 (end date corresponds to last PrOD patient start date) | Posted | Mean | Standard Deviation | units on a scale | Baseline to On-Treatment |
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| Primary | 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. | Patients with Baseline PROMIS Nausea/vomiting score who started treatment by arm as treated and completed baseline and on-treatment survey. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Average On-Treatment Score |
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| Primary | 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. | Analysis limited to patients who completed baseline and on treatment Nausea short form during Phase 1 (up to last PrOD randomized) as treated. | Posted | Median | Full Range | units on a scale | Baseline to end of treatment |
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| Primary | 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. | Posted | Median | Full Range | score on a scale | Baseline- On Treatment (up to 16 weeks) |
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| Primary | 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. | Analysis limited to patients who completed baseline and at least one on-treatment Fatigue PRO survey during phase 1 as treated. | Posted | Mean | Standard Deviation | units on a scale | Baseline to On-treatment |
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| Primary | 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. | Patients with Baseline PROMIS Fatigue score who started treatment by arm as treated (Period 2) | Posted | Mean | Standard Deviation | score on a scale | Baseline and Average On-Treatment Score |
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| Primary | 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. | Analysis is limited to patients who completed baseline and on-treatment fatigue PRO during Phase 1 (last PrOD patient started). Safety profiles of the evaluated regimens in PRIORITIZE are by actual treatment received. | Posted | Median | Full Range | units on a scale | Baseline to End of Treatment |
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| Primary | 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. | Analysis limited to Period 2 -as treated, participants who completed baseline and on-treatment surveys. | Posted | Median | Full Range | units on a scale | Baseline-On Treatment (up to 16 weeks) |
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| Primary | 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. | Analysis limited to patients who completed baseline and at least one on treatment Fatigue Short form. Evaluation is based on actual HCV regimen received. | Posted | Mean | Standard Deviation | units on a scale | Baseline to End of Treatment |
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| Primary | 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. | Analysis limited to patients who completed baseline and at least one survey while on treatment up to end of treatment. Evaluation was based on actual regimen received versus regimen to which patient was randomized. | Posted | Median | Full Range | score on a scale | Baseline to End of Treatment |
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| Primary | 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. | Patients with completed Baseline and End of Treatment HCV-PRO survey who started treatment by arm as treated (Period 2) | Posted | Mean | Standard Deviation | score on a scale | End of Treatment - Baseline |
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| Primary | 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. | All Genotype 1a patients who started treatment by arm randomized (Elbasvir/Grazobevir) with Baseline RAS at any location (28, 30, 31, or 93) | Posted | Count of Participants | Participants | 12 weeks post treatment |
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| Secondary | Treatment Non-Adherence Probability Estimates | The Voils Medication Adherence Survey (VMAS) was used to evaluate medication adherence during HCV treatment. Participants responded to three questions about the extent of adherence during the past seven days of treatment (during early and late on-treatment occasions). Participants responded using a five-point ordinal scale of missed dosing from 1 (none of the time) to 5 (all of the time). On each occasion participants were coded as being "Non-adherent" if any response was > 1, otherwise they were coded as "Adherent". Probability estimates of percentage of patients reporting non-adherence were calculated per HCV treatment (Direct Acting Antiviral-DAA) regimen: 1)EBR/GZV (elbasvir/grazoprevir, 2)SOF/LDV (sofosbuvir/ledipasvir), 3)PrOD | Analysis is limited to participants to patients who started treatment prior to January 2017 (last day patient started on PrOD treatment) | Posted | Number | 95% Confidence Interval | percentage of patients | 12-16 weeks of HCV treatment |
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| Secondary | Change in HCV-associated Symptoms (PROMIS Measures) After HCV Treatment Initiation | Change in HCV-associated symptoms was calculated as the mean differences of mean scores from multiple surveys from the NIH Patient-Reported Outcomes Measurement Information System (PROMIS)-- Fatigue, nausea, belly pain, sleep disturbance, and diarrhea) and functional status (well-being) when comparing baseline to early post-treatment and late post treatment surveys. Mean change scores were calculated by comparing baseline to early post-treatment (1 yr) and late post-treatment (approximately 3 years) surveys. 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.Negative numbers suggest better symptoms (improvement in HCV-associated symptoms). 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.HCV-PRO positive estimates suggest baseline functional well-being improvement. | Analysis includes all patients who started treatment on either EBR/GZR or SOF/LDV regimen and is limited to patients who completed surveys. Analysis does not decipher between RBV usage given RBV usage was based on HCV provider selection and not study randomization | Posted | Mean | 95% Confidence Interval | units on a scale | 1 year post treatment discontinuation (Early post-tx) |
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| Secondary | Post-treatment Progression/Regression of Liver Disease-Fib-4 | Mean change (delta) in FIB-4, an indirect non-invasive measure of liver fibrosis, calculated as baseline median -long term follow up median, following SVR after any of the study treatment regimens. Change in FIB-4 where negative values indicate improvement in liver fibrosis score and positive values indicate worsening of fibrosis score. There is no upper or lower limit for change. FIB-4 = age (years) * AST(IU/L)/Platelets (10^3/L) * ALT^.5(IU/L). In general, Score of 0-1.29 is low risk for advanced fibrosis, 1.30-1.67: intermediate risk for advanced liver fibrosis, >2.67: high risk for advanced fibrosis. | Population analyzed limited to cirrhotic patients who had two separate FIB-4 values collected as part of standard care and achieved SVR (defined as undetectable HCV 24 weeks post treatment). Given pragmatic trial design, availability of fibrosis markers is limited thereby restricting analysis (substantially limited sample size) to difference in fibrosis markers following SVR with any HCV treatment used in study. | Posted | Median | Full Range | score on a scale | Baseline to up to 3 years post treatment discontinuation |
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| Secondary | Change in Functional Status (HCV-PRO) Within Treatment | HCV-PRO score, a validated PROMIS survey used to evaluate overall functioning and well-being in HCV patients, was utilized to compare long-term 'within treatment' changes of 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 estimate (Post treatment to baseline) suggests baseline functional well-being improvement. Total score = (SUM-N)/(4*N)*100, where N is the number of questions answered. | Analysis limited to patients who completed HCV-PRO assessments during post-treatment. For this safety analysis, regimen is based on treatment received versus treatment to which patient was randomized. Arms with and without RBV are combined in consideration that usage of RBV was decided by HCV provider and not part of study randomization. | Posted | Mean | 95% Confidence Interval | score on a scale | Treatment start date up to 2 years post-treatment |
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| Secondary | Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF | The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen) | As randomized and treated population during Phase 1 and 2 (See Period 1). Analysis based on HCV DAA regimen randomization per study. Differentiation between RBV usage was not included in analysis given that RBV was not part of study randomization but rather decided by HCV provider. | Posted | Count of Participants | Participants | Treatment start date through treatment completion (up to 24 weeks) |
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| Secondary | HCV SVR Durability -No Cirrhosis | Number/Percentage of patients with persistence of viral cure, SVR (SVR = Sustained Virologic Response)- defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. | Analysis limited to patients who have HCV RNA result at least 24 weeks after end of treatment regimen as per period 1 (As randomized). | Posted | Count of Participants | Participants | 24 weeks post-end of treatment up to 153 weeks |
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| Secondary | HCV SVR Durability-Patients With Cirrhosis | Percentage of Cirrhotic patients with persistence of viral cure, SVR, (SVR= Sustained Virologic Response) defined as undetectable HCV RNA at least 24 weeks following HCV Treatment. | Analysis limited to patients who had HCV viral load result at least 24 weeks after treatment and analyzed as per randomized (Period 1) | Posted | Count of Participants | Participants | Up to 132 weeks post HCV treatment |
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| Secondary | Impact of Baseline NS5A RASs on Treatment Outcomes-Phase 2 | Number of participants who achieved SVR (sustained virologic response), defined as undetectable HCV RNA 12 weeks post-treatment with RASs (Resistant Associated Substitutions) after treatment with EBR/GZR or SOF/LDV regimen | Analysis is based on as assigned by randomization and patients with available RAS data. Exploratory RAS analysis is grouped by DAA regimen with or without RBV given 1)RBV usage was decided by HCV provider and not part of study randomization and small sample size (limited number of RAS in regimens with RBV) | Posted | Count of Participants | Participants | 12 weeks post HCV treatment |
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28 weeks. Adverse events collected up until final viral outcome is determined (approximately 12 weeks after HCV treatment completion).
An adverse event (AE) is any untoward medical occurrence abstracted from the submitted patient medical records. In order to evaluate the safety profiles of the evaluated regimens, all safety analyses were performed based on 'actual treatment received' (as described in Period 2) rather than treatment to which subject was 'randomized'
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EBR/GZR | Patients received EBR/GZR (elbasvir/grazoprevir) tablet once daily without RBV for 12 to 16 weeks (provider discretion) EBR/GZR: Elbasvir/grazoprevir (50/100mg tablet) 1 tablet once daily with or without food | 6 | 664 | 30 | 664 | 298 | 664 |
| EG001 | EBR/GZR With RBV | Patients received EBR/GZR (elbasvir/grazoprevir tablet) tablet once daily with Ribavirin (RBV) for 12 to 16 weeks (provider discretion) EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food with RBV (200 to 600 mg once or twice daily) for 12 to 16 weeks | 0 | 56 | 2 | 56 | 46 | 56 |
| EG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (Sofosbuvir/Ledipasvir) (400/90 mg tablet) 1 tablet taken daily for approximately 12 to 24 weeks with RBV (Ribavirin) 200 mg: 1-3 pills, one to two times daily (dosage at discretion of HCV provider). Total daily dosage ranged fro 200 to 1200 mg. | 0 | 15 | 0 | 15 | 8 | 15 |
| EG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks (treatment duration per discretion of provider) SOF/LDV (Sofosbuvir/Ledipasvir )(400/90 mg tablet) 1 tablet orally taken daily for approximately 12 to 24 weeks | 4 | 394 | 6 | 394 | 184 | 394 |
| EG004 | PrOD With RBV | PrOD (ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) (treatment at duration provider discretion) ombitasvir/paritaprevir/ritonavir: 2 tablets orally once daily (12.5/75/50mg) for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet orally once or twice daily for 12 to 24 weeks Ribavirin (200 mg pill): 200 to 600 mg once or twice daily (dosage at provider discretion). Total daily dosage ranged from 200 to 1200 mg. | 1 | 99 | 5 | 99 | 74 | 99 |
| EG005 | PrOD | Patients received PrOD orally (ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV) (provider discretion) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg): 2 tablets taken once orally daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks | 0 | 47 | 0 | 47 | 32 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Adjustment Disorder | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Alcohol withdrawal Syndrome | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Arteriovenous fistula | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDra | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Chest Pain | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDra | Systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Drug Abuse | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Drug Detoxification | Surgical and medical procedures | MedDRA (15.1) | Systematic Assessment |
| |
| Drug Withdrawal Syndrome | General disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Femoral hernia, obstructive | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment | Gastric ulcer perforation |
|
| Gastroenteritis viral | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Gun shot wound | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hepatitis B | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Mania | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Mental status change | Psychiatric disorders | MedDra | Systematic Assessment |
| |
| Neuroendocrine carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Self-injurious ideation | Psychiatric disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Spinal Hematoma | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (15.1) | Systematic Assessment | Anemia |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment | Dyspnea |
|
| Fatigue | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Insomnia | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Influenza like illness | Infections and infestations | MedDRA (15.1) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Chest Pain | Cardiac disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Decreased Appetite | Gastrointestinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (15.1) | Systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Oedema Peripheral | Vascular disorders | MedDRA (15.1) | Systematic Assessment | Peripheral edema Edema Peripheral |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (15.1) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (15.1) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (15.1) | Systematic Assessment |
|
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.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lauren Morelli | UF Hepatology Research at CTRB | 352-273-9508 | lauren.morelli@medicine.ufl.edu |
| Mar 6, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C586541 | ledipasvir |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| D019362 | Cytochrome P-450 CYP2B1 |
| C586094 | ombitasvir |
| C588260 | dasabuvir |
| C000607373 | Viekira Pak |
| C000589335 | elbasvir |
| C578009 | grazoprevir |
| C000611265 | elbasvir-grazoprevir drug combination |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D001189 | Aryl Hydrocarbon Hydroxylases |
| D003577 | Cytochrome P-450 Enzyme System |
| D003580 | Cytochromes |
| D045762 | Enzymes and Coenzymes |
| D000072467 | Cytochrome P450 Family 2 |
| D006899 | Mixed Function Oxygenases |
| D010105 | Oxygenases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D006420 | Hemeproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
Not provided
Not provided
| Death |
|
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Non-compliance with study drug |
|
| Lost insurance |
|
| Withdrawal by Subject |
|
| Incarceration |
|
| Opiate dependency relapse |
|
| Drugs stolen from patient |
|
| Advised to stop tx after loss of meds |
|
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (treatment duration per discretion of provider) sofosbuvir/ledipasvir: 1 Sofosbuvir/Ledipasvir (400/90 mg) tablet once daily with or without food for approximately 12 to 24 weeks Ribavirin (200 mg pill): 200 to 600 mg once or twice daily (treatment duration and dosage of ribavirin as per discretion of HCV provider) |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily for 12 to 24 weeks (treatment duration as per discretion of HCV treatment provider) SOF/LDV (400/90 MG TABLET): 1 tablet orally once daily for 12 to 24 weeks |
|
|
Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
| OG004 | PrOD With RBV | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider) |
| OG005 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks |
|
|
Patients received SOF/LDV (sofosbuvir/ledipasvir) tablet orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) 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) RBV: At discretion of provider, 200 mg pill, 1-3 pills/day, 1-2 times/day (daily dosing ranging from 200mg to 1200 mg daily) added to HCV treatment regimen |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider) SOF/LDV (Sofosbuvir/Ledipasvir 400/90 mg tablet): 1 tablet daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider) |
| OG004 | PrOD With RBV | Patients received PrOD (ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily) for 12 to 24 weeks with Ribavirin (RBV) (use and dosage at provider discretion) ombitasvir/paritaprevir/ritonavir (Phase 1 only): (Phase 1 only) Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet ) 2 tablets daily for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir: 500 mg tablet once or twice daily (morning and evening) RBV: At discretion of provider, 200 mg pill, 1-3 pills/day, 1-2 times/day (daily dosing ranging from 200mg to 1200 mg daily) added to HCV treatment regimen |
| OG005 | PrOD (Phase 1 Only) | Patients received ProD (ombitasvir/paritaprevir/ritonavir once daily and dasabuvir twice daily) for 12 to 24 weeks without Ribavirin (at provider discretion) ombitasvir/paritaprevir/ritonavir (Phase 1 only): Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir: 250 mg tablet twice daily for 12 to 24 weeks |
|
|
| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with ribavirin (RBV) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without ribavirin (RBV) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
| OG004 | PrOD With RBV Regimen | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg pill): 1-3 pills once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider) |
| OG005 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). Treatment duration as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) |
|
|
|
| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
|
|
|
| OG002 | 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) (duration and usage of RBV at discretion of provider). SOF/LDV (sofosbuvir/ledipasvir): Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks Ribavirin (RBV): 200 mg/tablet(capsule), 1-3 pills/day, 1-2 times/day. |
| OG003 | 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) SOF/LDV (sofosbuvir/ledipasvir): Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration at discretion of HCV provider) |
| OG004 | 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. |
| OG005 | 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) 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) |
|
|
| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without RBV SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
|
|
|
Patients received EBR/GZR (elbasvir/grazoprevir ) once daily for 12 to 16 weeks (duration of treatment per provider discretion) without Ribavirin (RBV) (per provider discretion) EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks |
| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
| OG004 | PrOD With RBV | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG005 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) |
|
|
|
| OG002 | SOF/LDV With RBV | Patients received 1 tablet SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage 200 mg- 1200 mg. |
| OG003 | SOF/LDV | Patients received 1 tablet SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) without ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
|
|
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| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider) RBV(Ribavirin) (200mg tablet): 1 - 3 tablets,1-2 times per day (dosage and duration per discretion of provider) |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider) SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration as per discretion of HCV provider) |
| OG004 | PrOD With RBV | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) RBV(Ribavirin) (200mg tablet): 1 - 3 tablets,1-2 times per day (dosage and duration per discretion of provider) |
| OG005 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) |
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Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider)
SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: RBV(Ribavirin) (200mg tablet): 1 - 3 tablets,1-2 times per day (dosage and duration per discretion of provider)
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily (with or without food) for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
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| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider) RBV (Ribavirin) 200mg tablet: 1 to 3 tablets, once or twice daily at discretion of provider. Total daily dosage ranged from 200 to 1200 mg. |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider) SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
| OG004 | PrOD With RBV | Patients received PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets, 1-2 times per day, daily for 12 to 24 weeks (dosage and duration at discretion of provider) |
| OG005 | PrOD | Patients received PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) |
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| OG002 | SOF/LDV With RBV | Patients received sofosbuvir/ledipasvir orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food, daily for 12 - 24 weeks (use of RBV and dosage at discretion of provider) |
| OG003 | SOF/LDV | Patients received sofosbuvir/ledipasvir orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
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Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) without Ribavirin (RBV) (per provider discretion)
EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks
| OG002 | SOF/LDV With RBV | Patients received sofosbuvir/ledipasvir orally once daily with or without food 12 to 24 weeks with or without ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG003 | SOF/LDV | Patients received sofosbuvir/ledipasvir orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
| OG004 | PrOD Regimen With RBV | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG005 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) |
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| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (treatment duration per discretion of provider) sofosbuvir/ledipasvir: 1 Sofosbuvir/Ledipasvir (400/90 mg) tablet once daily with or without food for approximately 12 to 24 weeks Ribavirin (200 mg tablet): 1-3 tablets, once or twice daily (treatment duration and dosage of ribavirin as per discretion of HCV provider). |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily for 12 to 24 weeks (treatment duration as per discretion of HCV treatment provider) SOF/LDV (400/90 MG TABLET): 1 tablet orally once daily for 12 to 24 weeks |
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| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider) RBV (Ribavirin) 200mg tablet: 1 to 3 tablets, once or twice daily at discretion of provider. Total daily dosage ranged from 200 to 1200 mg. |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider) SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider) |
| OG004 | PrOD With RBV | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets, once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider). |
| OG005 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). Treatment duration as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) |
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Subjects will take EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) without Ribavirin (RBV) (per provider discretion)
EBR/GZR (Elbasvir/grazoprevir) 50/100mg tablet: 1 tablet once daily with or without food for 12 to 16 weeks
| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider) RBV (Ribavirin) 200mg tablet: 1 to 3 tablets, once or twice daily at discretion of provider. Total daily dosage ranged from 200 to 1200 mg. |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily with or without food 12 to 24 weeks without ribavirin (RBV) (per discretion of provider) SOF/LDV 400/90 mg tablet: 1 tablet once daily for approximately 12 to 24 weeks (treatment duration as HCV provider discretion) |
| OG004 | PrOD With RBV | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV). Treatment duration and use of ribavirin as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage ranging from 200 - 1200 mg. |
| OG005 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks without Ribavirin (RBV). Treatment duration as per HCV provider ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks (dosage at discretion of provider) |
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| EBR/GZR |
Patients received EBR/GZR (elbasvir/grazoprevir) once daily without RBV (at discretion of provider) for 12 to 16 weeks EBR/GZR (50/100mg tablet): 1 tablet orally once daily with or without food for 12 to 16 weeks (duration per provider discretion) |
| OG002 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage ranged from 200 to 1200 mg. |
| OG003 | SOF/LDV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks without ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) |
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Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with or without ribavirin (RBV) (per discretion of provider)
SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider)
| OG002 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with or without Ribavirin ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider) |
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| OG001 | SOF/LDV Regimen | Patients received 1 tablet SOF/LDV(sofosbuvir/ledipasvir) orally once daily with or without ribavirin (RBV) (per discretion of provider) with or without food 12 to 24 weeks SOF/LDV/sofosbuvir/ledipasvir: Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration is per discretion of HCV provider) RBV: Ribavirin (200mg pill) 1-3 pills, once or twice/day -dosage at discretion of provider. Total daily dosage ranged from 200 to 1200 mg. |
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| OG001 |
| SOF/LDV Regimen |
Subjects will take 1 tablet SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks (per discretion of provider) with or without ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
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| OG003 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets, once or twice daily orally with food (use of RBV and dosage at discretion of provider). Total daily dosage ranged from 200 to 1200 mg. |
| OG004 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks |
| OG005 | PrOD With RBV | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider) |
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| OG003 | SOF/LDV With RBV | Patients received SOF/LDV (sofosbuvir/ledipasvir) orally once daily 12 to 24 weeks with ribavirin (RBV) (per discretion of provider) SOF/LDV (400/90 mg tablet): 1 tablet once daily with or without food for approximately 12 to 24 weeks (treatment duration per discretion of HCV provider) Ribavirin (RBV) 200 mg tablet: 1 to 3 tablets once or twice daily orally with food (use of RBV and dosage at discretion of provider) |
| OG004 | PrOD | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily for 12 to 24 weeks (treatment duration as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily for 12 to 24 weeks |
| OG005 | PrOD With RBV | PrOD -(ombitasvir/paritaprevir/ritonavir and dasabuvir) daily for 12 to 24 weeks with Ribavirin (RBV) ombitasvir/paritaprevir/ritonavir (12.5/75/50mg tablet): 2 tablets once daily with food for 12 to 24 weeks (treatment duration and use of ribavirin as per HCV provider) Dasabuvir (250 mg tablet): 1 tablet once or twice daily with food for 12 to 24 weeks (dosage at discretion of provider) RBV (200 mg tablet): 1-3 tablets once or twice daily for 12 to 24 weeks (dosage and duration at discretion of provider) |
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