Comparison · NCT02786537-031f87d3
EBR/GZR Regimen vs SOF/LDV Regimen: Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. EBR/GZR Regimen vs SOF/LDV Regimen: Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF. Trial comparisons, record NCT02786537-031f87d3. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02786537-031f87d3
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0171 | 0.00983 | 0.0297 | wilson | |
| Risk in group 2 | 0.00935 | 0.00364 | 0.0238 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0078 | -0.00838 | 0.0216 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.83 | 0.595 | 5.65 | log | |
| Odds ratio, group 1 over group 2 | 1.85 | 0.592 | 5.77 | log | |
| Number needed to treat, for one more participant with the outcome on EBR/GZR Regimen than on SOF/LDV Regimen | 128 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | EBR/GZR Regimen | Patients received EBR/GZR (elbasvir/grazoprevir ) tablet once daily for 12 to 16 weeks (duration of treatment per provider discretion) with or 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~RBV(Ribavirin) (200mg to 600mg pill): 1 to 3 pill once or twice daily (dosage and duration per discretion of provider) | 12 | 700 | OG000 |
| Group 2 | SOF/LDV Regimen | Patients received 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 pill: 1 to 3 pills 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. | 4 | 428 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Adverse Events That Caused Treatment Discontinuation-EBR/GZR vs. LDV/SOF
- Description
- The number of participants with adverse events that led to early treatment discontinuation (defined as duration less than originally prescribed treatment regimen)
- Time frame
- Treatment start date through treatment completion (up to 24 weeks)
- Population
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.
Source ClinicalTrials.gov
Trial
- Title
- Study of Oral Treatments for Hepatitis C
- NCT number
- NCT02786537
- Phases
- PHASE4
- Conditions
- Chronic Hepatitis C
- Interventions
- SOF/LDV (sofosbuvir/ledipasvir), PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only), EBR/GZR (elbasvir/grazoprevir), Ribavirin
- Lead sponsor
- University of Florida
- Results first posted
- 2020-11-24
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02786537?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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