Comparison · NCT01866930-sae
Cohort A: HCV GT-2 or GT-3 vs Cohort B: HCV GT-1 or GT-4: 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. Cohort A: HCV GT-2 or GT-3 vs Cohort B: HCV GT-1 or GT-4: serious adverse events. Trial comparisons, record NCT01866930-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01866930-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 | 0.0577 | 0.0267 | 0.12 | wilson | |
| Risk in group 2 | 0.0612 | 0.0354 | 0.104 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00353 | -0.0563 | 0.0641 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.942 | 0.364 | 2.44 | log | |
| Odds ratio, group 1 over group 2 | 0.939 | 0.342 | 2.58 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Cohort A: HCV GT-2 or GT-3 than on Cohort B: HCV GT-1 or GT-4 | 283 | 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 | Cohort A: HCV GT-2 or GT-3 | Participants with HCV (Genotype 2 or 3) and HIV co-infection were treated with Lambda/RBV/DCV for 12 weeks followed by Lambda/RBV for 12 weeks, for a total treatment duration of 24 weeks. Participants received 180μg of Lambda via subcutaneous injection, once weekly, 800 mg/day Ribavirin tablets, orally, twice daily, for a planned duration of 24 weeks. Participants were administered 30 mg Daclatasvir tablets, orally, once daily, for a maximum of 12 weeks. The total daily dose was 30, 60 or 90 mg depending on the HIV concomitant regimen. Participants were followed up for a duration of 24 weeks after 24 weeks of treatment. | 6 | 104 | EG000 |
| Group 2 | Cohort B: HCV GT-1 or GT-4 | Participants with HCV (Genotype 1 or 4) and HIV co-infection were treated with Lambda/RBV/DCV for 12 weeks followed by Lambda/RBV for either 12 or 36 weeks. Participants were administered 180μg of Lambda via subcutaneous injection, once weekly, for a maximum of 48 weeks; body weight stratified dose of Ribavirin tablets, orally, twice daily, for maximum duration of 48 weeks (\<75 kg, total dose was 1000 mg/day, weighing \>=75 kg, total dose was 1200 mg/day); and 30 mg Daclatasvir tablets, orally, once daily, for a maximum of 12 weeks. The total daily dose was 30, 60 or 90 mg depending on the HIV concomitant regimen. Participants who achieved an extended rapid virologic response (eRVR) during initial 12 weeks were treated with Lambda/RBV for 12 weeks for total of 24 weeks. Participants who did not achieve eRVR during initial 12 weeks were treated with Lambda/RBV for 36 weeks for total of 48 weeks. Participants were followed up for a duration of 24 weeks after 24 or 48 weeks of treatment. | 12 | 196 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day 1 to end of treatment; up to week 24 or week 48, SAE: within 30 days of discontinuation of dosing
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of Pegylated Interferon Lambda-1a With Ribavirin and Daclatasvir, to Treat naïve Subjects With Chronic HCV Genotypes 1, 2, 3, and 4 Who Are Co-infected With HIV
- NCT number
- NCT01866930
- Phases
- PHASE3
- Conditions
- Chronic Hepatitis C Infection
- Interventions
- Pegylated Interferon Lambda-1a, Daclatasvir (DCV), Ribasphere (RBV)
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2023-06-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01866930?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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