Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Peginterferon Lambda-1a · 3 trials · 3 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 | - |
| Name | Type | Description |
|---|---|---|
| Peginterferon Lambda-1a | BIOLOGICAL | - |
| Ribavirin | DRUG | - |
| Peginterferon alfa-2a | BIOLOGICAL | - |
| Daclatasvir | DRUG | - |
| Telaprevir | DRUG | - |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Atea Pharmaceuticals, Inc. | AVIR | 2 | PHASE3 | Bemnifosbuvir-Ruzasvir, Sofosbuvir-Velpatasvir |
| Abbott Laboratories | ABT | 2 | - | Undisclosed |
| AbbVie, Inc. | ABBV | 1 | - | Undisclosed |
Peginterferon Lambda-1a is an investigational drug being studied for the treatment of Hepatitis C Virus (HCV) infection. It is a pegylated form of interferon lambda-1a that was evaluated in Phase 3 clinical trials for chronic hepatitis C, including in combination with ribavirin and other antiviral agents.
Peginterferon Lambda-1a is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the New York Stock Exchange. The company sponsored Phase 3 clinical trials of the drug for the treatment of hepatitis C virus infection.
Peginterferon Lambda-1a has completed Phase 3 clinical trials for hepatitis C virus infection. The drug is investigational and has not been approved by regulatory authorities. All three Phase 3 trials listed for the drug have been completed, with no active trials currently ongoing.
Peginterferon Lambda-1a has been studied in three completed Phase 3 clinical trials. NCT01598090 evaluated the drug with ribavirin and telaprevir in 881 patients with hepatitis C. NCT01718158 studied it with ribavirin and daclatasvir in 444 patients with HCV genotype 1b. NCT01754974 compared it to peginterferon alfa-2a with ribavirin in 40 patients with genotype 1 hepatitis C.
Peginterferon Lambda-1a is a pegylated form of interferon lambda-1a, a cytokine that binds to the interferon lambda receptor to stimulate antiviral immune responses. By activating this receptor, the drug triggers intracellular signaling pathways that inhibit viral replication and enhance the body's immune clearance of hepatitis C virus.