The results of a Phase II clinical trial of 48 treatment-naive genotype 1 hepatitis C infected patients in which treatment with BMS-790052, an NS5A replication complex inhibitor, in combination with Peginterferon alfa and Ribavirin ( pegIFNalfa/RBV ) maintained undetectable viral load at 24 weeks post-treatment ( SVR24 ) in 83% (60 mg), 83% (10 mg) and 42% (3 mg) of patients, compared with 25% of patients in the pegIFNalfa/RBV control group after 48 weeks of combination therapy, have been reported.
In this study, serious adverse events were reported in one patient ( 8.3% ) from each of the BMS-790052 treatment groups and in zero patients from the control group.

BMS-790052 plus pegIFNalfa/RBV achieved higher rates of SVR24 compared to pegIFNalfa/RBV alone across all BMS-790052 treatment groups [ BMS-790052: 60 mg: 83% ( n=10/12 ), 10 mg: 83% ( n=10/12 ), 3 mg: 42% ( n=5/12 ); control: 25% ( n=3/12 ) ].

Adverse events leading to discontinuation with BMS-790052 plus pegINFalfa/RBV were comparable with treatment with pegIFNalfa/RBV plus placebo. One patient ( 8.3% ) in each of the 3 mg and 10 mg groups and four patients ( 33.3% ) in the 60 mg group discontinued due to adverse events, compared with two patients ( 16.7% ) in the control group. Reasons for discontinuation were a diverse set of adverse events sometimes associated with the use of pegIFNalfa/RBV.

Serious adverse events and overall adverse events were comparable across study arms. The addition of BMS-790052 to pegIFNalfa/RBV therapy did not result in any apparent incremental hematologic, hepatic or dermatologic adverse events. One patient ( 8.3% ) in each of the BMS-790052 treatment groups experienced a serious adverse events during therapy compared with zero patients in the control group.
On-treatment Grade 3-4 adverse events were: BMS-790052 60 mg: 33.0%, 10 mg: 25.0%, 3 mg: 8.3%; control: 41.7%. One patient ( 8.3% ) in each of the BMS-790052 3 mg and 60 mg groups experienced hemoglobin less than 10 g/dL, compared with zero patients in the 10 mg and control groups.

Erythropoietin use was comparable across all study arms. Three patients ( 25.0% ) in each of the BMS-790052 10 mg and 60 mg groups and one patient ( 8.3% ) in the 3 mg group required Erythropoietin, compared with two patients ( 16.7% ) in the control group.
The use of Filgrastim ( G-CSF ) in the study groups was: BMS-790052 60 mg: 0%, 10 mg: 25.0%, 3 mg: 16.7%; control: 16.7%.

Source: 51st Interscience Conference on Antimicrobial Agents and Chemotherapy ( ICAAC ), 2011

XagenaMedicine2011


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