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Also known as BMS-914143
Peginterferon Lambda-1a · 4 trials · 5 indications
* ANC = Absolute Neutrophil Count * Hb = Hemoglobin
eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).
SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).
An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization.
| Arm | Type | Description |
|---|---|---|
| Peginterferon Lambda-1a + Ribavirin | EXPERIMENTAL | Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks |
| Peginterferon alfa-2a + Ribavirin | ACTIVE_COMPARATOR | Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks |
| Peginterferon Lambda-1a + Ribavirin + Daclatasvir | EXPERIMENTAL | Peginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks Ribavirin 200 mg tablets \[1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects \< 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food\] by mouth, twice daily, for 24 weeks Daclatasvir 60 mg tablets by mouth, once a day for 12 weeks |
| Peginterferon Alfa-2a + Ribavirin + Telaprevir | EXPERIMENTAL | Peginterferon Alfa-2a 180 µg solution for subcutaneous injection, once a week for 24 to 48 weeks depending on response Ribavirin 200 mg tablets \[1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects \< 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food\] by mouth, twice daily, for 24 to 48 weeks depending on response Telaprevir 375 mg tablets \[2250 mg total daily dose: subjects should take 750 mg (two 375 mg tablets) orally three times a day, approximately 7-9 hours apart) for 12 weeks |
| Part A: Peginterferon Lambda-1a + RBV + TVR | EXPERIMENTAL | - |
| Part B (Arm 1): Peginterferon Lambda-1a + RBV + TVR | EXPERIMENTAL | - |
| Part B (Arm 2): Peginterferon Lambda-2a + RBV + TVR | EXPERIMENTAL | - |
| Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2 |
| Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with mild renal dysfunction with eGFR 60 to 79 mL/min/1.73 m2 |
| Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with moderate renal dysfunction with eGFR 30 to 59 mL/min/1.73 m2 |
| Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with severe renal dysfunction with eGFR 15 to 29 mL/min/1.73 m2 |
| Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with end-stage renal dysfunction with eGFR \< 15 mL/min/1.73 m2 (on hemodialysis \[HD\] or non-HD) |
| Name | Type | Description |
|---|---|---|
| Peginterferon Lambda-1a | BIOLOGICAL | - |
| Ribavirin | DRUG | - |
| Peginterferon alfa-2a | BIOLOGICAL | - |
| Daclatasvir | DRUG | - |
| Telaprevir | DRUG | - |
| BMS-914143 (Peginterferon Lambda-1a) | BIOLOGICAL | - |
Inclusion Criteria: * Chronic hepatitis C, Genotype 1 * HCV RNA ≥100,000 IU/mL at screening * Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease * Naïve to prior anti-HCV t...
Top 1 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir |
Peginterferon Lambda-1a is an investigational interferon therapy developed by Bristol-Myers Squibb for the treatment of hepatitis C virus infection. It is a type III interferon designed as an alternative to peginterferon alfa, and it has been studied in Phase 3 clinical trials in combination with ribavirin and direct-acting antivirals.
Peginterferon Lambda-1a is being studied for the treatment of chronic hepatitis C virus infection. Phase 3 trials evaluated it in combination with ribavirin, and in some studies with daclatasvir or telaprevir, in patients with genotype 1 HCV, including treatment-naive patients and prior relapsers to peginterferon alfa plus ribavirin.
Peginterferon Lambda-1a targets the IFNAR1 and IFNAR2 receptor subunits, acting as an agonist. By binding these receptors it activates type III interferon signaling, which is intended to produce antiviral activity against hepatitis C virus while potentially limiting the broader receptor distribution associated with type I interferons.
Peginterferon Lambda-1a is developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the Phase 3 clinical program evaluating the drug in hepatitis C virus infection.
Peginterferon Lambda-1a is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trials in hepatitis C have been completed, and no trials are currently active.
Three Phase 3 trials of Peginterferon Lambda-1a have been completed: NCT01754974, which compared it with peginterferon alfa-2a plus ribavirin in genotype 1 HCV; NCT01718158, which tested it with ribavirin and daclatasvir; and NCT01598090, which studied it with ribavirin and telaprevir.