Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PegIntron (PEG), PegIntron (peginterferon alfa-2b), SCH 054031, peginterferon alfa-2b, SCH 54031
PEG-Intron · 7 trials · 8 indications
Hepatitis C Virus ribonucleic acid (HCV-RNA) levels in plasma were measured using the Roche COBAS®AmpliPrep/COBAS® TaqMan® HCV Test, v2.0 on blood samples drawn from each participant. SVR12 was defined as HCV RNA below the lower limit of quantification (\<LLOQ) at 12 weeks after the end of all study therapy. The primary efficacy hypothesis for this study was that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was non-inferior to the percentage in the SOF plus PR arm. A secondary statistical analysis was performed to determine whether the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir arm was superior to the percentage in the SOF plus PR arm.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who experienced at least one AE was reported for each treatment arm.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants who discontinued study treatment due to an AE was reported for each treatment arm. Participants that discontinued study drug treatment due to an AE may have still continued on trial.
SVR rate is the percentage of participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at the end of the 24-week post-treatment follow-up.
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 |
|---|---|---|
| Grazoprevir + Elbasvir | EXPERIMENTAL | Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up. |
| SOF + PR | ACTIVE_COMPARATOR | Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up. |
| PegIntron 1.5 ug/kg/wk plus REBETOL | EXPERIMENTAL | PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| PegIntron 1.0 ug/kg/wk plus REBETOL | EXPERIMENTAL | PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| PEGASYS 180 ug/wk Plus COPEGUS | ACTIVE_COMPARATOR | PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up |
| Overall study population | EXPERIMENTAL | - |
| 0.25 Dose Group | EXPERIMENTAL | PegIntron 0.25 mcg/kg SC QW for 12 weeks |
| 0.5 Dose Group | EXPERIMENTAL | PegIntron 0.5 mcg/kg SC QW for 12 weeks |
| 1.0 Dose Group | EXPERIMENTAL | PegIntron 1.0 mcg/kg SC QW for 12 weeks |
| No-treatment Control | NO_INTERVENTION | No treatment (no placebo) |
| 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 |
|---|---|---|
| Sofosbuvir | DRUG | 400 mg tablets, taken orally (PO) every day (QD) for 12 weeks. |
| PegIntron | BIOLOGICAL | PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks. |
| Ribavirin | DRUG | Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks. |
| Grazoprevir/Elbasvir (100 mg/50 mg) FDC | DRUG | Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks. |
| PegIntron (peginterferon alfa-2b; SCH 54031) | BIOLOGICAL | 1.5 ug/kg/week subcutaneously (SC) for 48 weeks |
| REBETOL (ribavirin; SCH 18908) | DRUG | weight based dose 800-1400 mg/day orally (PO) for 48 weeks |
| PEGASYS (peginterferon alfa-2a) | BIOLOGICAL | 180 ug/week SC administered for 48 weeks |
| COPEGUS (ribavirin) | DRUG | 1000-1200 mg/day PO for 48 weeks |
| PEG-Intron | DRUG | - |
| PegIntron (peginterferon alfa-2b) | BIOLOGICAL | PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks |
| 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: * Weigh ≥40 kg and ≤125 kg * documented chronic HCV GT1, GT4, or GT6 infection * cirrhosis/absence of cirrhosis defined by liver biopsy, Fibroscan, or FibroSure® * either treatment naïve or PR Null Responder, PR Partial Responder, or PR Prior Relapser * participant and partner b...
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PEG-Intron is used in the treatment of hepatitis C, including chronic hepatitis C, and has also been studied in HIV infections and melanoma. It is a pegylated interferon therapy developed by Merck & Company, Inc. under the ticker MRK, and it has been evaluated across multiple clinical trials in these infectious disease and oncology settings.
PEG-Intron is made by Merck & Company, Inc., which trades under the ticker MRK. Merck is the developer associated with the drug, and the clinical program includes studies such as MK-4031-016 and MK-5172-077 that evaluate PEG-Intron in hepatitis C and related indications.
PEG-Intron has been studied in Phase 3 clinical development, with additional Phase 1 and Phase 2 trials also completed. The program includes a total of four listed trials, all of which are completed, and no trials are currently active. The Phase 3 study NCT02358044 evaluated a combination regimen including pegylated interferon in hepatitis C.
PEG-Intron has been evaluated in completed trials including NCT03537274, a Phase 2 study in chronic hepatitis C with 1,224 participants; NCT02358044, a Phase 3 study in hepatitis C genotypes 1, 4, or 6 with 257 participants; NCT00787371, a Phase 2 study in chronic hepatitis C with 69 participants; and NCT00457418, a Phase 1 pharmacokinetic study in melanoma with 32 participants.
Yes, PEG-Intron is the same as PegIntron, PegIntron (PEG), PegIntron (peginterferon alfa-2b), and PegIntron (peginterferon alfa-2b; SCH 54031). These are alternative names for the same drug, so searches using any of these terms refer to the same Merck product studied in hepatitis C, HIV infections, and melanoma.