The FINANCIAL — Bristol-Myers Squibb Company (NYSE:BMY) on November 2 announced data from two separate cohort evaluations, in which long-term treatment with BARACLUDE (entecavir) was associated with improved liver histology, including improvement in fibrosis, in chronic hepatitis B patients.
The histology data were presented today at the 59th Annual Meeting of the American Association for the Study of Liver Diseases.
"New long-term histology results were presented from a cohort of 57 nucleoside-naive patients from rollover study ETV-901. ETV-901 provided long-term treatment with BARACLUDE 1 mg for patients who completed phase 2-3 studies. Patients followed in this cohort received BARACLUDE for a median of six years across the studies (ETV-022, -027 and -901) and had evaluable baseline and long-term liver biopsies. Of the 57 patients, 96 percent (55/57) experienced improvement in liver histology (improvement in how the liver tissue looks under a microscope). Improvement in liver histology was defined as greater than or equal to a two-point decrease in Knodell necroinflammatory score and no worsening of Knodell fibrosis score. Additionally, 88 percent of patients (50/57) experienced a reduction in liver fibrosis, defined as improvement in Ishak fibrosis score (greater than or equal to a one-point decrease). Fibrosis occurs when excessive fibrous connective tissue builds up in the liver in response to chronic inflammation, which can be caused by chronic hepatitis B infection." Bristol-Myers Squibb reports.
Control of viral replication is an important goal of chronic hepatitis B treatment. At the time of the ETV-901 long-term biopsy, 100 percent of subjects with evaluable liver biopsies (57/57) had undetectable viral load [HBV DNA less than 300 copies/mL by polymerase chain reaction (PCR)].
Histology results were also presented from the open-label rollover study ETV-060, which evaluated Japanese patients with chronic hepatitis B. This cohort included 37 treatment-naive patients and 27 patients resistant to treatment with lamivudine from two Phase 2 studies (ETV-053, ETV-052) who had liver biopsies after receiving at least three years of treatment with BARACLUDE. Of these 64 patients, 100 percent (37/37) of treatment-naive patients and 89 percent (23/26) of lamivudine-refractory patients experienced improvement in liver histology (measured by a greater than or equal to a two-point decrease in Knodell necroinflammatory score), and 47 percent (17/36†) of treatment-naive and 32 percent (8/25‡) of lamivudine-refractory patients experienced an improvement in liver fibrosis (greater than or equal to a one-point decrease in Knodell fibrosis score).
“These data suggest that long-term treatment with BARACLUDE has the potential to stop liver damage and may even improve liver fibrosis caused by chronic hepatitis B infection,” said Professor Yun-Fan Liaw, lead investigator for the Long-term Histology Cohort (subset of ETV-901), from Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taipei, Taiwan. “The ability to provide effective long-term treatment with a potent antiviral with minimal resistance represents a positive step forward.”