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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
Phase 3 trial testing Pegylated Interferon Lambda-1a in Chronic Hepatitis C Infection in 453 participants. Terminated before completion.
| Lead sponsor | Bristol-Myers Squibb |
|---|---|
| Phase | Phase 3 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 453 |
| Start date | 11 July 2013 |
| Primary completion | 27 August 2015 |
| Estimated completion | 27 August 2015 |
| Sites | 63 locations across France, Italy, Russia, Belgium, United Kingdom, Germany, Poland, Mexico |
Bristol-Myers Squibb — full company profile →
18 and older, any sex, with Chronic Hepatitis C Infection. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
SVR12 was defined as HCV RNA less than lower limit of quantification (\< LLOQ) (25 IU/mL; target detected or not detected) at follow-up week 12.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 88 | |
| Cohort B: HCV GT-1 or GT-4 | 149 |
RVR is defined as HCV RNA \< LLOQ target not detected at Week 4 and eRVR defined as HCV RNA \< LLOQ target not detected at Weeks 4 and 12
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 82 | |
| Cohort B: HCV GT-1 or GT-4 | 149 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 80 | |
| Cohort B: HCV GT-1 or GT-4 | 138 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 4 | |
| Cohort B: HCV GT-1 or GT-4 | 15 |
All treated participants were monitored for IFN-associated Flu-like and Musculoskeletal symptoms. Flu-like symptoms were defined as pyrexia, chills, or pain. Musculoskeletal symptoms were defined as arthralgia, myalgia, or back pain. Subjects were monitored throughout the treatment period during the treatment period (After day 1 up to week 24, or After day 1 up to week 48 for subjects requiring those visits).
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 6 | |
| Cohort B: HCV GT-1 or GT-4 | 21 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 6 | |
| Cohort B: HCV GT-1 or GT-4 | 19 |
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that. at any dose, results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 0 | |
| Cohort B: HCV GT-1 or GT-4 | 3 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 6 | |
| Cohort B: HCV GT-1 or GT-4 | 12 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 4 | |
| Cohort B: HCV GT-1 or GT-4 | 19 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 4 | |
| Cohort B: HCV GT-1 or GT-4 | 13 |
Grade 3/4 treatment-emergent lab abnormalities that occurred in \>=5% of subjects in either cohort are reported. The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4= Potentially Life-threatening or disabling. AST = Aspartate aminotransferase, ALT = Alanine aminotransferase.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 26 | |
| Cohort B: HCV GT-1 or GT-4 | 63 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 10 | |
| Cohort B: HCV GT-1 or GT-4 | 13 |
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 2 | |
| Cohort B: HCV GT-1 or GT-4 | 10 |
All treated participants were monitored for change in Absolute CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | -42.4 | -85.86 – 1.09 |
| Cohort B: HCV GT-1 or GT-4 | -104.9 | -128.74 – -81.04 |
All treated participants were monitored for percent change in CD4 T Lymphocyte count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | -4.0 | -10.32 – 2.24 |
| Cohort B: HCV GT-1 or GT-4 | -13.4 | -18.91 – -7.98 |
All treated participants were monitored for change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants is reported in Cells/µL.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | -0.38 | -0.50 – -0.25 |
| Cohort B: HCV GT-1 or GT-4 | -0.50 | -0.56 – -0.43 |
All treated participants were monitored for percent change in Total Lymphocyte Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | -15.33 | -20.46 – -10.19 |
| Cohort B: HCV GT-1 or GT-4 | -22.95 | -26.04 – -19.86 |
All treated participants were monitored for change in Platelet Count from Baseline to the end of the treatment period. The mean change in each arm for all evaluable participants (units of measurement = x10\^9 cells/L).
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 32.7 | 24.62 – 40.84 |
| Cohort B: HCV GT-1 or GT-4 | 33.3 | 27.10 – 39.57 |
All treated participants were monitored for percent change in Platelet Count from Baseline to the end of the treatment period. The mean percent change in each arm is presented for all evaluable participants.
| Group | Value | 95% CI |
|---|---|---|
| Cohort A: HCV GT-2 or GT-3 | 16.9 | 12.53 – 21.20 |
| Cohort B: HCV GT-1 or GT-4 | 20.1 | 16.10 – 24.16 |
Time frame: Day 1 to end of treatment; up to week 24 or week 48, SAE: within 30 days of discontinuation of dosing. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cohort A: HCV GT-2 or GT-3 | Cohort B: HCV GT-1 or GT-4 |
|---|---|---|---|
| Sudden death | General disorders | — | — |
| Jaundice | Hepatobiliary disorders | — | — |
| Accidental overdose | Injury, poisoning and procedural complications | — | — |
| Ankle fracture | Injury, poisoning and procedural complications | — | — |
| Overdose | Injury, poisoning and procedural complications | — | — |
| Facial bones fracture | Injury, poisoning and procedural complications | — | — |
| Alanine aminotransferase increased | Investigations | — | — |
| International normalised ratio increased | Investigations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Multi-Organ failure | General disorders | — | — |
| Dysthymic disorde | Psychiatric disorders | — | — |
| Psychotic disorder | Psychiatric disorders | — | — |
| Small intestinal haemorrhage | Gastrointestinal disorders | — | — |
| Renal failure | Renal and urinary disorders | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — |
| Liver injury | Hepatobiliary disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — | — |
| Bronchopulmonary aspergillosis | Infections and infestations | — | — |
| Secondary syphilis | Infections and infestations | — | — |
| Device related infection | Infections and infestations | — | — |
| Reaction | System | Cohort A: HCV GT-2 or GT-3 | Cohort B: HCV GT-1 or GT-4 |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Asthenia | General disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Irritability | Psychiatric disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Depressed mood | Psychiatric disorders | — | — |
| Pyrexia | General disorders | — | — |
| Injection site erythema | General disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — |
| Weight decreased | Investigations | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Jaundice | Hepatobiliary disorders | — | — |
| Aspartate aminotransferase increased | Investigations | — | — |
| Influenza like illness | General disorders | — | — |
Most-reported serious reactions: Sudden death, Jaundice, Accidental overdose, Ankle fracture, Overdose, Facial bones fracture, Alanine aminotransferase increased, International normalised ratio increased.
Data from ClinicalTrials.gov NCT01866930 adverse events section.
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1
5 peer-reviewed publications reference this trial (live from Europe PMC):
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