Comparison · NCT02707601-sae
E/C/F/TAF + LDV/SOF vs F/R/TAF + LDV/SOF: serious adverse events
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. E/C/F/TAF + LDV/SOF vs F/R/TAF + LDV/SOF: serious adverse events. Trial comparisons, record NCT02707601-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02707601-sae
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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 | 0.0946 | 0.0466 | 0.183 | wilson | |
| Risk in group 2 | 0.162 | 0.0953 | 0.262 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0676 | -0.179 | 0.043 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.583 | 0.243 | 1.4 | log | |
| Odds ratio, group 1 over group 2 | 0.54 | 0.2 | 1.46 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on E/C/F/TAF + LDV/SOF than on F/R/TAF + LDV/SOF | 14.8 | 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 | E/C/F/TAF + LDV/SOF | Part 1: Participants received E/C/F/TAF 150/150/200/10 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to E/C/F/TAF and maintained HIV-1 RNA \< 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving E/C/F/TAF 150/150/200/10 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). | 7 | 74 | EG000 |
| Group 2 | F/R/TAF + LDV/SOF | Part 1: Participants received F/R/TAF 200/25/25 mg orally once daily with food for 8 weeks. At Week 8, participants who tolerated the switch to F/R/TAF and maintained HIV-1 RNA \< 50 copies/mL continued to Part 2 of the study.~Part 2: Participants continued receiving F/R/TAF 200/25/25 mg orally once daily with food until the end of the study and received LDV/SOF 90/400 mg orally once daily with or without food for 12 weeks (until Week 20). | 12 | 74 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Up to 32 weeks plus 30 days
Source ClinicalTrials.gov
Trial
- Title
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
- NCT number
- NCT02707601
- Phases
- PHASE3
- Conditions
- HIV-1 Infection, HCV Infection
- Interventions
- E/C/F/TAF, F/R/TAF, LDV/SOF
- Lead sponsor
- Gilead Sciences
- Results first posted
- 2018-10-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02707601?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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