Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PEG-Intron · 3 trials · 4 indications
The number of participants achieving responder status at 24 weeks of treatment was assessed. A participant was classified as a responder if, at 24 weeks of treatment, they met both of the following criteria: 1) HCV-Ribonucleic Acid (RNA) negative (defined as \<100 copies/mL serum by quantitative polymerase chain reaction \[qPCR\] assay); and 2) alanine transaminase (ALT) level normal.
The number of participants achieving sustained responder status at 24 weeks of follow-up was assessed. A participant was classified as a sustained responder if, at 24 weeks of follow-up, they met both of the following criteria: 1) HCV-RNA negative (defined as \<100 copies/mL serum by qPCR assay); and 2) ALT level normal.
AUC was defined as the actual body exposure to drug after administration of a dose of the drug.
Cmax was defined as observed maximum plasma concentration.
Cavg was defined as average plasma concentration.
Cmin was defined as observed minimum plasma concentration.
Tmax was defined as time of maximum plasma concentration.
CL/F was defined apparent clearance - the volume of plasma in the vascular compartment cleared of drug per unit of time and per kilogram of body weight by the processes of metabolism and excretion.
| Arm | Type | Description |
|---|---|---|
| PEG-Intron, 0.5 mg/kg | EXPERIMENTAL | PEG-Intron administered once weekly (QW) for 48 weeks at 0.5 mg/kg by subcutaneous (SC) injection. |
| PEG-Intron, 1.0 mg/kg | EXPERIMENTAL | PEG-Intron administered QW for 48 weeks at 1.0 mg/kg by SC injection. |
| PEG-Intron, 1.5 mg/kg | EXPERIMENTAL | PEG-Intron administered QW for 48 weeks at 1.5 mg/kg by SC injection. |
| Interferon Alfa-2b | ACTIVE_COMPARATOR | Interferon Alfa-2b administered three times per week (TIW) for 48 weeks at 3 million international units (MIU) by SC injection. |
| PEG-Intron | EXPERIMENTAL | 6 ug/kg/week, SC (first 8 weeks) 3 ug/kg/week, SC (252 weeks \[weeks 9-260\], maintenance) |
| Name | Type | Description |
|---|---|---|
| PEG-Intron | DRUG | - |
| Interferon Alfa-2B | BIOLOGICAL | Interferon alfa-2b is administered TIW for 48 weeks by SC injection at 3 MIU regardless of participant body weight. |
Inclusion Criteria: * HIV positive * History of virologic failure on at least 2 antiretroviral regimens including exposure to at least one NRTI, one NNRTI and one PI * HIV RNA \>400-\<50,000 copies/mL * Laboratory parameters: platelet count (75,000u/L, hemoglobin \>9gm/dl, absolute neutrophil count...
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PEG-Intron is used for HIV infections, hepatitis, melanoma, and hepatitis C, including chronic hepatitis C. It is an investigational small molecule being developed by Merck & Company, Inc. (MRK) for these infectious disease and oncology indications.
PEG-Intron is a pegylated form of interferon alfa-2b, which targets the immune system to fight viral infections and certain cancers. It is being studied in HIV infections, hepatitis, melanoma, and chronic hepatitis C.
PEG-Intron is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company is conducting clinical trials for this investigational drug in infectious disease and oncology indications.
PEG-Intron has completed Phase 3 clinical trials for HIV infections and chronic hepatitis C. It is an investigational drug that has not been approved by the FDA, and it remains in clinical development for these indications.
PEG-Intron has been studied in several clinical trials, including NCT00035360 for HIV infections, NCT00039871 for chronic hepatitis C, NCT00457418 for melanoma, and NCT03537274 for hepatitis C. All trials have been completed.
Yes, PEG-Intron is also known as SCH 54031. In clinical trials, it has been referred to as polyethylene glycol-interferon alfa-2b (PEG-Intron, SCH 54031).