Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PegIFN-2b (Sylatron®), SCH 054031, MK-4031, Pegylated interferon alfa-2b, Peginterferon alfa-2b
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 19 of 30 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Pfizer Inc. | PFE | 7 | PHASE3 | VLA15, Prevenar 20, 13vPnC, ATM-AVI, PG4 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE3 | PCV21 |
| GSK plc Sponsored ADR | GSK | 4 | PHASE2 | Penmenvy, iNTS-TCV, Strep A vaccine, Pan-Salmonella vaccine |
| Grifols, S.A. Sponsored ADR Class B | GRFS | 1 | PHASE3 | Xembify |
| CorMedix Inc. | CRMD | 1 | PHASE3 | DefenCath |
| Sinovac Biotech Ltd. | SVA | 4 | PHASE3 | Sinovac PCV24, Group ACYW135X Meningococcal Conjugate Vaccine, Group ACYW135 Meningococcal Conjugate Vaccine |
| Novartis AG Sponsored ADR | NVS | 2 | PHASE2 | EDI048 |
| Innoviva, Inc. | INVA | 3 | PHASE2 | Eravacycline, Sulbactam-durlobactam |
| BiomX Inc. | PHGE | 1 | PHASE2 | BX004 |
| Hoffmann-La Roche | RHHBY | 1 | PHASE3 | Baloxavir Marboxil |
| Merck & Co., Inc. | MRK | 2 | PHASE1 | V118C |
| AstraZeneca PLC | AZN | 1 | PHASE1 | AZD7760 |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT163 |
| 60 Degrees Pharmaceuticals, Inc. | SXTP | 1 | PHASE2 | Tafenoquine |
| Tarsus Pharmaceuticals, Inc. | TARS | 1 | PHASE2 | TP-05 |
| Moderna, Inc. | MRNA | 1 | PHASE2 | mRNA-1982 |
| AN2 Therapeutics, Inc. | ANTX | 1 | PHASE2 | Epetraborole |
| Emergent BioSolutions Inc. | EBS | 4 | - | AIGIV/kg |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | - | Vonoprazan |
PegIFN-2b is an investigational pegylated interferon therapy developed by Merck & Company, Inc. (MRK). It has been studied in HIV Infections and Renal Insufficiency. The drug is in Phase 2 clinical development and has not been approved by the FDA.
PegIFN-2b has been studied for the treatment of HIV Infections and Renal Insufficiency. It is an investigational agent and is not approved for any indication. Clinical testing has included patients with HIV and hepatitis C coinfection as well as individuals with renal impairment.
PegIFN-2b is developed by Merck & Company, Inc., which trades on the New York Stock Exchange under the ticker symbol MRK. Merck is the sponsor of the clinical trials evaluating this investigational therapy.
PegIFN-2b is in Phase 2 clinical development. It has not been approved by the FDA and remains investigational. The Phase 2 study has been completed, and no active trials are currently listed for this drug.
PegIFN-2b has been evaluated in two completed clinical trials. NCT00959699 was a Phase 2b safety and efficacy study in patients coinfected with HIV and hepatitis C, enrolling 99 participants. NCT01432535 was a Phase 1 pharmacokinetic study in participants with moderate and severe renal impairment, enrolling 25 participants.
PegIFN-2b is also known as Sylatron. Both names refer to the same pegylated interferon alfa-2b product developed by Merck & Company, Inc. (MRK).