Top-Line Results of Boceprevir Phase II Study Showed High Rate of Sustained Response (SVR) in Genotype 1 Treatment-Naive Hepatitis ...(ine results with boceprevir are very exc...),Health

Date:8/4/2008

ine results with boceprevir are very exciting, especially given that genotype 1 is the most common and hardest to treat form of hepatitis C," said Paul Kwo, M.D., associate professor of medicine and medical director, liver transplantation, Department of Medicine, Division of Gastroenterology/Hepatology, Indiana University School of Medicine, Indianapolis, and lead investigator of the study. "Boceprevir was well tolerated by patients in this study, including those who received 48 weeks of boceprevir in the longer duration treatment arms."

Safety data from the study showed that the most common adverse events reported in the boceprevir arms were fatigue, anemia, nausea and headache. No increase in skin adverse events (rash or pruritus) beyond what was seen in the PEGINTRON and REBETOL control arm was observed. Treatment discontinuations due to adverse events were between 9 and 19 percent for patients in the boceprevir arms, compared to 8 percent for the control arm.

In the study, known as HCV SPRINT-1 (HCV Serine Protease Inhibitor Therapy-1), boceprevir (800 mg TID) was evaluated in three treatment regimens: 4 weeks of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) therapy followed by the addition of boceprevir to the combination for 24 or 44 weeks (totaling 28 or 48 weeks of treatment); boceprevir in combination with PEGINTRON and REBETOL at the doses described above for 28 or 48 weeks; and boceprevir in combination with PEGINTRON and low-dose REBETOL (400-1000 mg daily) for 48 weeks, compared to a control of PEGINTRON (1.5 mcg/kg once weekly) and REBETOL (800-1400 mg daily based on patient weight) alone for 48 weeks (an approved treatment regimen). The primary endpoint of the study is SVR after 24 weeks of follow up (SVR 24). This is an ongoing study and SVR 24 rates are not yet available for patients in the 48-week boceprevir arms or the 48-week control arm of the study.

Sustai
'/>"/>

SOURCE Schering-Plough Corporation Copyright©2008 PR Newswire. All rights reserved

4 GOOD

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

1. Genmab and GlaxoSmithKline Announce Positive Top-Line Results in Ofatumumab Chronic Lymphocytic Leukemia Pivotal Study
2. NicOx Announces Top-Line Results From Naproxcinod 52-Week 301 Safety Extension
3. Medivation Announces Positive Top-Line Results From Phase 2 Dimebon Study in Huntingtons Disease
4. Medivation to Host Conference Call at 5 p.m. EDT Monday to Discuss Top-Line Phase 2 Study Results in Huntingtons Disease
5. Inspires Phase 3 CF Trial, Using PARIs Nebulizer & Compressor, Shows Positive Top-Line Results
6. Cardica Reports Positive Top-Line Results and Submits 510(k) for PAS-Port(R) Proximal Anastomosis System in Cardiac Bypass Surgery
7. Statement From the Lupus Foundation of America Regarding the Release of Top-Line Results From a Study of Rituxan for the Treatment of Lupus
8. InterMune Announces Top-Line Results of Phase 1b Trial of ITMN-191 (R7227) and Provides Program Update
9. Schering-Plough Reports Top-Line Results of the IDEAL Study
10. Exelixis Reports Top-Line Results of the Phase 2 Trial of XL784 in Patients With Proteinuria Associated With Diabetic Nephropathy
11. Top-Line Efficacy Data Presented from Phase 2 Trial of Alemtuzumab in Multiple Sclerosis