Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic H... (l the incidence of serious adverse event...)

HOME >> MEDICINE >> TECHNOLOGY

Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic Hepatitis C

Date:11/24/2008

l, the incidence of serious adverse events was 17% in the PEGINTRON/REBETOL groups compared to 14% in the INTRON A/ REBETOL group. The incidence of severe adverse events in the PEGINTRON/REBETOL combination therapy trial was 23% in the INTRON A/REBETOL group and 31-34% in the PEGINTRON/REBETOL groups. Dose reductions due to adverse reactions occurred in 42% of patients receiving PEGINTRON (1.5 mcg/kg)/REBETOL and in 34% of those receiving INTRON A/REBETOL.

In a study with weight-based ribavirin, there was a higher rate of anemia among patients in the weight-based dosing group (29%) compared to the flat-dosing group (19%). The majority of these cases were mild and responded to dose reductions. Serious adverse events were similar between the two groups (12%), and discontinuations for adverse events (15% in weight-based dosing and 14% in flat dosing) were also similar. Dose modifications due to adverse events occurred more frequently in the weight-based dosing group (29%) compared to the flat-dosing (23%) group.

Additional Safety Information

Relapse of drug addiction/overdose has occurred in patients on PEGINTRON therapy. Aggressive behavior sometimes directed towards others has occurred in patients with and without a previous psychiatric disorder during PEGINTRON and/or INTRON A treatment and follow-up. If patients develop psychiatric problems, including clinical depression, it is recommended that patients be carefully monitored during treatment and in the 6-month follow-up period. If psychiatric symptoms persist or worsen, or suicidal ideation or aggressive behavior towards others is identified, it is recommended that treatment with PEGINTRON and/or INTRON A be discontinued, and the patient be carefully followed with psychiatric intervention, as appropriate. Cases of encephalopathy have been observed in some patients, usually elderly, treated with higher doses of PEGINTRON and/or INTRON A. Isch
'/>"/>

1

GOOD

Page: 1 2 3 4 5 6 7 8 9
Related medicine technology :

1. Schering-Plough Unveils Top-Line Study Results for SAPHRIS(TM) (asenapine) Demonstrating Efficacy in Long-Term Schizophrenia Relapse Prevention
2. Schering-Plough Reports Preladenant Meets Primary Endpoint in Phase II Dose-Finding Trial for Parkinsons Disease
3. Schering-Plough Announces European Launch of BRIDION(R) (Sugammadex)
4. Schering-Plough Announces Phase III Data for Sustained Follicle Stimulant
5. About 60 Clinical Studies Regarding Schering-Ploughs Oncology Compounds Will be Presented at ASCO
6. Schering-Plough To Initiate Phase III Studies With HCV Protease Inhibitor Boceprevir in Previously Untreated Hepatitis C Patients and Those Who Failed Prior Treatment
7. Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Hepatitis C Data Presentations at Digestive Disease Week (DDW) Annual Meeting
8. Schering-Plough Highlights PEGINTRON(TM) and Boceprevir Data Presentations at European Association for the Study of the Liver (EASL) Annual Meeting
9. Schering-Plough Announces Imperfect Contraceptive Use Impacts Womens Emotional Well-Being
10. Schering-Plough Initiates Phase II Study With Vicriviroc in Treatment-Naive HIV-Infected Patients
11. Parker Waichman Alonso LLP and Affiliated Lawfirms Have Filed a Class Action Lawsuit in the United States District Court for the Eastern District of New York Against Merck & Co., Inc. and Schering-Plough Corporation

Post Your Comments:

Schering-Plough Provides Update on Boceprevir Clinical Development and Introduces Potent Next-Generation Oral HCV Protease Inhibitor for Treating Patients With Chronic H...(l the incidence of serious adverse event...),Health