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news.Bristol-Myers Squibb Company has announced positive data from two separate cohort evaluations, in which long-term treatment with Baraclude was associated with improved liver histology, including improvement in fibrosis, in chronic hepatitis B patients.
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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 1mg for patients who have completed Phase II-III 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% 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% of patients experienced a reduction in liver fibrosis, defined as improvement in Ishak fibrosis score (greater than or equal to a one-point decrease).
Control of viral replication is an important goal of chronic hepatitis B treatment. At the time of the ETV-901 long-term biopsy, 100% of subjects with evaluable liver biopsies 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 II studies (ETV-053, ETV-052) who had liver biopsies after receiving at least three years of treatment with Baraclude.
Of these 64 patients, 100% of treatment-naive patients and 89% 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% of treatment-naive and 32% of lamivudine-refractory patients experienced an improvement in liver fibrosis (greater than or equal to a one-point decrease in Knodell fibrosis score).
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, said: “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. The ability to provide effective long-term treatment with a potent antiviral with minimal resistance represents a positive step forward.”