Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PegIFN-2b · 2 trials · 4 indications
SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
| Arm | Type | Description |
|---|---|---|
| PegIFN-2b + RBV | PLACEBO_COMPARATOR | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. |
| PegIFN-2b + RBV + Boceprevir | ACTIVE_COMPARATOR | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. |
| Healthy Participants | ACTIVE_COMPARATOR | Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| Participants with Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| Participants with Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| Name | Type | Description |
|---|---|---|
| PegIFN-2b | DRUG | PegIFN-2b (1.5 μg/kg/week subcutaneously) |
| RBV | DRUG | Ribavirin (600-1400 mg/day, orally, divided into two daily doses) |
| Placebo to Boceprevir | DRUG | Placebo to boceprevir (orally, three times per day) |
| Boceprevir | DRUG | Boceprevir (800 mg, orally, three times per day) |
| PegIFN-2b (Sylatron®) | DRUG | Single 4.5 μg/kg dose |
Inclusion Criteria: * \>=18 and \<=65 years of age * Body weight \>=40 and \<=125 kg * Documented history of HIV infection for greater than 6 months prior to Day 1 * On an optimized anti-retroviral treatment regimen (OTR) with stable HIV disease with CD4 \>=200 cells/µL and HIV-1 RNA viral load \<5...
Top 20 of 28 competitors
PegIFN-2b is an investigational drug being studied for use in renal insufficiency and HIV infections. It is a pegylated form of interferon alfa-2b, which is being evaluated for its potential to treat conditions related to these indications. The drug is currently in clinical development and has not been approved for any use.
PegIFN-2b is being developed by Merck & Company, Inc., which is publicly traded under the ticker symbol MRK. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for renal insufficiency and HIV infections.
PegIFN-2b is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for its potential use in renal insufficiency and HIV infections, with clinical trials currently ongoing or completed.
PegIFN-2b has been studied in two completed clinical trials. One trial, NCT00959699, was a Phase 2b study in patients coinfected with HIV and hepatitis C, with 99 participants. Another trial, NCT01432535, was a Phase 1 study in participants with moderate and severe renal impairment, with 25 participants.
Yes, PegIFN-2b is the same as peginterferon alfa-2b. The drug is a pegylated form of interferon alfa-2b, and the name PegIFN-2b is a shortened version of the full chemical name. It is being developed by Merck & Company, Inc. for potential use in renal insufficiency and HIV infections.