Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
peginterferon alfa 2b · 7 trials · 3 indications
Previously untreated adults with CHC genotype 1 were treated with the assigned study medication. Participants who had undetectable plasma HCV-RNA at FW 24 had achieved SVR. SVR rate is the percent of participants achieving SVR. HCV-RNA was detected by a nucleic acid amplification test and the limit of detection for this assay is 9.3 IU/mL. If a participant was missing data at FW 24 after having had undetectable HCV-RNA at FW 12, the participant was to be considered to have SVR.
Relapse was defined as Hepatitis C Virus ribonucleic acid (HCV-RNA) that was above the lower limit of quantitation at Year 5 of the LTFU.
To determine long-term effects of the Part 1 treatment on height, changes in height during the Part 2 LTFU were evaluated using height percentiles based on 2000 Center For Disease Control growth charts for the general population.
To determine long-term effects of the Part 1 treatment on weight, changes in weight during the Part 2 LTFU were evaluated using weight percentiles based on 2000 Center For Disease Control growth charts for the general population.
To determine long-term effects of the Part 1 treatment on BMI, changes in BMI during the Part 2 LTFU were evaluated using BMI percentiles based on 2000 Center For Disease Control growth charts for the general population.
The Tanner Stage (TS) defines physical measurements of sexual development based on external primary and secondary sex characteristics. Female participants are evaluated for breast development and pubic hair distribution and male participants are evaluated for genital development and pubic hair distribution, based on a 5-stage ordinal scale ranging from TS 1 (prepubertal/preadolescent characteristics) to TS 5 (mature or adult characteristics). Mean ages for attaining each TS in the normal population have been previously established based on measuring correlating reproductive hormone levels, and are expressed in years as follows for females (F) and males (M): TS 1= 7.1 (F+M); TS 2= 10.5 (F), 12.1 (M); TS 3= 11.6 (F), 13.6 (M); TS 4=, 12.3 (F), 15.1 (M); TS 5= 14.5 (F), 18 (M). To assess sexual maturation at the end of the LTFU (last observation), females and males were staged and the mean age at each TS attained was reported.
Serum HCV-RNA was qualitatively measured by reverse transcriptase polymerase chain reaction (RT-PCR)
SVR is defined as undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks post-treatment
A sustained virologic response is defined as undetectable hepatitis C virus ribonucleic acid \[HCV-RNA\] 24 weeks post-treatment. Serum HCV-RNA is measured by HCV-PCR in local laboratories. HCV-RNA below the limit of detection is considered undetectable.
| Arm | Type | Description |
|---|---|---|
| 1. Placebo + PEG + RBV | PLACEBO_COMPARATOR | PegIntron (PEG) 1.5 μg/kg + Ribavirin (RBV) (weight-based dosing \[WBD\]) for 4 weeks (lead in treatment) followed by placebo + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. |
| 2. Boceprevir + PEG + RBV - 24 Weeks (RGT) | EXPERIMENTAL | PEG 1.5 μg/kg + RBV (WBD) for 4 weeks (lead in treatment) followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 24 weeks. Participants were offered a response guided therapy (RGT) at treatment week 28. * At the Treatment Week 28 visit, participants whose HCV-RNA was undetectable from Treatment Weeks 8 to Treatment Week 24, will proceed to the 44-week follow-up. * At the Treatment Week 28 visit, participants with detectable HCV-RNA at Treatment Week 8 or at any subsequent assays will continue on therapy with placebo + PEG 1.5 μg/kg + RBV (WBD) for an additional 20 weeks, to complete a total of 48 weeks on treatment with 24 weeks post-treatment follow-up. |
| 3. Boceprevir + PEG + RBV - 44 Weeks | EXPERIMENTAL | PEG 1.5 μg/kg + RBV (WBD) for 4 weeks (lead in treatment) followed by boceprevir + PEG 1.5 μg/kg + RBV (WBD) for 44 weeks with 24 weeks post-treatment follow-up. |
| PEG-IFN + RBV: LTFU | OTHER | Pediatric participants who completed treatment with peginterferon alfa-2b (PEG-IFN) plus ribavirin (RBV) in P02538 Part 1 of this study (NCT00104052) were enrolled in a 5-year Long Term Follow-Up (LTFU) during P02538 Part 2 (NCT00761735). No study treatment was administered in Part 2. |
| Peginterferon alfa-2b + Ribavirin | EXPERIMENTAL | - |
| PEG-Intron alfa 2b (PEG2b) plus REBETOL (RBV) | EXPERIMENTAL | PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) and RBV 400-1200 mg/day by mouth divided in 2 daily doses (administered twice daily with food, dosed 12 hours apart) for 48 weeks. Subjects treated up to 48 weeks and followed for additional 24 weeks after the end of treatment (total of 72 weeks study participation). |
| PEG2b 1.5/R (24 weeks) | ACTIVE_COMPARATOR | PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks |
| PEG 2b 1.0/R (24 weeks) | EXPERIMENTAL | PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks |
| PEG2b 1.5/R (16 weeks) | EXPERIMENTAL | PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks |
| Standard of Care | ACTIVE_COMPARATOR | PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily for 48 weeks. * Subjects with \>= 1 log decrease from baseline in HCV-RNA levels after 12 weeks, but still above the lower limit of quantitation, have the option of crossing over to PegIntron, ribavirin plus SCH 900518 400 mg and ritonavir 100 mg daily for 12 weeks. This is followed by standard of care, PegIntron and ribavirin, for a total treatment duration of up to 48 weeks. |
| 2 | EXPERIMENTAL | PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily plus SCH 900518 200 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 12 or 36 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks. |
| 3 | EXPERIMENTAL | PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily plus SCH 900518 400 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 12 or 36 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks. |
| 4 | EXPERIMENTAL | 4 week lead-in with PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily followed by PegIntron plus ribavirin plus SCH 900518 200 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 8 or 32 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks. |
| 5 | EXPERIMENTAL | 4 week lead-in with PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily followed by PegIntron plus ribavirin plus SCH 900518 400 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 8 or 32 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks. |
| 6 | EXPERIMENTAL | PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily plus SCH 900518 100 mg twice daily plus ritonavir 100 mg twice daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 12 or 36 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks. |
| 7 | EXPERIMENTAL | 4 week lead-in with PegIntron 1.5 mcg/kg SC weekly plus ribavirin 600 to 1400 mg daily (weight-based) by mouth twice daily followed by PegIntron plus ribavirin plus SCH 900518 600 mg daily plus ritonavir 100 mg daily for 12 weeks. Depending on HCV-RNA levels after 4 weeks of SCH 900518, patients will receive an additional 8 or 32 weeks of PegIntron/ribavirin. Total treatment duration will be 24 or 48 weeks. |
| Randomised PegIFN alfa 2b + ribavirin (RBV) arm | EXPERIMENTAL | Combination of ribavirin capsules 200 mg, weight-based daily dose ( \<75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36 |
| Randomised PegIFN alfa 2b + ribavirin-placebo arm | PLACEBO_COMPARATOR | Combination of ribavirin-placebo capsules 200 mg, weight-based daily dose ( \<75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), and low-dose PegIFN alfa 2b by subcutaneous injection 0.5 μg / kg / week, from day 0 to M36 |
| Name | Type | Description |
|---|---|---|
| Peginterferon alfa-2b (PEG) | BIOLOGICAL | Peginterferon alfa-2b 1.5 μg/kg/week subcutaneously (SC) |
| Ribavirin (RBV) | DRUG | Ribavirin weight-based dosing (WBD) 600 mg/day to 1400 mg/day administered orally, divided twice daily (BID). |
| Placebo | DRUG | Placebo to boceprevir, 800 mg (4 x 200mg capsules) administered orally three times a day (TID). |
| Boceprevir | DRUG | Boceprevir, 800 mg (4 x 200 mg capsules) administered orally TID. |
| Peginterferon alfa-2b | BIOLOGICAL | In the previous treatment protocol (P02538 Part 1), peginterferon alfa-2b was administered at a dose of 60 μg/m\^2 by subcutaneous injection weekly for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2). |
| Ribavirin | DRUG | In the previous treatment protocol (P02538 Part 1), ribavirin was administered at a dose of 15 mg/kg/day orally in two divided doses for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2). |
| peginterferon alfa-2b (PEG2b) (SCH 54031) | BIOLOGICAL | PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks. |
| ribavirin (SCH 18908) | DRUG | 15 mg/kg/day for up to 48 weeks |
| peginterferon alfa-2b (SCH 54031) | BIOLOGICAL | 1.5 mcg/kg QW SC for 24 weeks |
| peginterferon alfa 2b | BIOLOGICAL | 1.5 mcg/kg subcutaneously weekly for up to 24 or 48 weeks |
| SCH 900518 | DRUG | SCH 900518 100 mg tablets taken as 200 mg PO QD, 100 mg PO BID, 400 mg PO QD, or 600 mg PO QD for 12 weeks. |
| ritonavir | DRUG | Ritonavir 100 mg capsules taken as 100 mg PO QD or 100 mg PO BID for 12 weeks. |
| Ribavirin-Placebo | DRUG | Ribavirin-placebo in addition to PegIFN alfa 2b, from day 0 to M36 |
Inclusion Criteria: * Participant must have previously documented CHC genotype 1 infection. * Participant must have a liver biopsy with histology consistent with CHC and no other etiology. * Participants with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Vi...
PEG Interferon Alfa-2b is being studied for use in neoplasms, chronic hepatitis C, chronic hepatitis D, hepatocellular carcinoma, and chronic hepatitis C with liver fibrosis. It is an investigational therapy in clinical development and has not been approved for these uses.
PEG Interferon Alfa-2b is developed by Merck & Company, Inc., which is listed on the stock exchange under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various conditions.
PEG Interferon Alfa-2b is in Phase 1 clinical development. While some completed trials were Phase 3, the current development stage is Phase 1, and the drug remains investigational and not approved by regulatory authorities.
PEG Interferon Alfa-2b has been studied in several completed trials, including NCT00049842 for chronic hepatitis C with liver fibrosis, NCT00686790 for hepatitis B and D co-infection, NCT00759109 for hepatocellular carcinoma, and NCT03554005 for solid tumors.
Yes, PEG Interferon Alfa-2b is also referred to as Peginterferon Alfa-2b. Clinical trial titles use both names interchangeably, such as in NCT00686790, which mentions Peginterferon Alfa-2b, and NCT03554005, which uses PEG Interferon Alfa-2b.