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Comparison · NCT01866930-a93ec624

Cohort A: HCV GT-2 or GT-3 vs Cohort B: HCV GT-1 or GT-4: Number of Participants With Treatment Emergent Cytopenic Abnormalities

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Cohort A: HCV GT-2 or GT-3 vs Cohort B: HCV GT-1 or GT-4: Number of Participants With Treatment Emergent Cytopenic Abnormalities. Trial comparisons, record NCT01866930-a93ec624. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01866930-a93ec624

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.03850.01510.0947wilson
Risk in group 20.07650.04690.122wilson
Risk difference, group 1 minus group 2-0.0381-0.08960.0255newcombe hybrid score
Risk ratio, group 1 over group 20.5030.1711.48log
Odds ratio, group 1 over group 20.4830.1561.49log
Number needed to treat, for one fewer participant with the outcome on Cohort A: HCV GT-2 or GT-3 than on Cohort B: HCV GT-1 or GT-426.3from the risk difference intervalthe interval includes no difference

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Cohort 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.
4104OG000
Group 2Cohort 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.
15196OG001

Outcome

Type
SECONDARY
Title
Number of Participants With Treatment Emergent Cytopenic Abnormalities
Description
All treated participants were monitored for treatment emergent cytopenic abnormalities (anemia as defined by hemoglobin (Hb) \< 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) \< 750 mm3 and/or thrombocytopenia as defined by platelets \< 50,000/mm3) during the treatment period (Weeks 1, 2, 4, 6, 8, 12, 20, and 24, and at Weeks 28, 32, 36, 40, 44, and 48 for subjects requiring those visits).
Time frame
After Day 1 to end of treatment; up to Weeks 24 or 48
Population
Analysis was performed in all treated participants.

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

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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