Up To 92% Sustained Virologic Response In Phase II Dose-Ranging Study Of Treatment-Naïve Hepatitis C Patients Acheived

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Up To 92% Sustained Virologic Response In Phase II Dose-Ranging

Study Of Treatment-Naïve Hepatitis C Patients Acheived

Main Category: Liver

Disease / Hepatitis

Also Included In: Infectious

Diseases / Bacteria / Viruses

Article Date: 01 Apr 2011 - 0:00 PDT

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Bristol-Myers Squibb Company (NYSE: BMY) today announced results

from a Phase II clinical trial in which treatment with the

investigational direct-acting antiviral (DAA) BMS-790052, an NS5A

replication complex inhibitor, in combination with PEG-Interferon

alfa and ribavirin (RBV), achieved sustained virologic response 12

weeks post-treatment (SVR12) in up to 92% of treatment-naïve

patients chronically infected with hepatitis

C (HCV) genotype 1 (10 mg dose arm, n=12). Adverse events and

serious adverse events were consistent with those reported in the

PEG-Interferon alfa and ribavirin arm and were comparable across all

doses of BMS-790052. These data were reported today for the first

time in a late-breaker poster session at the International Liver

Congress, the 46th annual meeting of the European Association for

the Study of the Liver (EASL) in Berlin, Germany.

"There currently exists a medical need for new medicines or new

combinations of medicines for hepatitis C patients as many hepatitis

C patients have limited success on the currently available

treatments," said Stanislas Pol, MD, PhD, Professor of Hepatology at

Université Paris V (René Descartes), Paris, France and head of the

Hepatology unit at Cochin Hospital, Paris, France. "The results of

this study warrant further clinical investigation of adding

Bristol-Myers Squibb's investigational compound BMS-790052 to the

current medicines to evaluate its potential to address this unmet

treatment need."

Study Results

The primary endpoint of the study was the proportion of patients

with extended rapid virologic response (eRVR) defined as

undetectable viral load (HCV RNA < 10 IU/mL) at both Weeks 4 and

12. BMS-790052 plus PEG-interferon alfa and ribavirin achieved

higher rates of SVR12 compared to PEG-interferon alfa and ribavirin

alone, across all BMS-790052 treatment groups [bMS-790052: 60 mg:

83% (10/12 patients), 10 mg: 92% (11/12 patients), 3 mg: 42% (5/12

patients); PEG-interferon alfa/RBV: 25% (3/12 patients)].

Adverse events (AEs) and serious adverse events (SAEs) were

comparable across study arms and were consistent with the safety

profile of PEG-Interferon alfa and ribavirin therapy. Four patients

discontinued due to AEs in the BMS-790052 60 mg group for a diverse

set of adverse events. All four patients had undetectable viral load

at the time of study discontinuation and three of these patients

achieved SVR12. No new on-treatment SAEs were reported beyond study

week 24.

Grade 3 to 4 adverse events for BMS-790052 treatment groups and

placebo were BMS-790052: 60 mg: 33.3%, 10 mg: 25%, 3 mg: 8.3%;

PEG-interferon alfa/RBV: 41.7%. Two patients (one receiving 3 mg

BMS-790052 and one receiving 60 mg BMS-790052) experienced anemia (hemoglobin

<9 g/dL). Erythropoietin use was comparable between BMS-790052

treatment groups (one to three patients per arm) and the placebo

treatment group (two patients). The use of filgrastim (G-CSF) in the

study groups was: BMS-790052: 60 mg: 0%, 10 mg: 25%, 3 mg: 16.7%;

PEG-interferon alfa/RBV: 16.7%. Other adverse events, occurring in

at least four patients (33.3%) in any cohort include: fatigue

(BMS-790052: 60 mg: 50%,10 mg: 50%, 3 mg: 58.3%; placebo: 75%),

neutropenia (BMS-790052: 60 mg: 16.7%,10 mg: 33.3%, 3 mg: 25%;

placebo: 41.7%), nausea (BMS-790052: 60 mg: 33.3%,10 mg: 33.3%, 3

mg: 41.7%; placebo: 50%), vomiting (BMS-790052 60 mg: 33.3%, 10 mg:

8.3%, 3 mg: 16.7%; placebo: 0%), and headache

(BMS-790052: 60 mg: 25%, 10 mg: 75%, 3 mg: 58.3%; placebo: 25%).

--

Bill Eastman

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