Bristol-Myers Squibb Company
(NYSE: BMY) today announced data from a three-year cohort (ETV-022/901,
n=119), which showed BARACLUDE(R) (entecavir) suppressed viral load to
undetectable levels in 90 percent of nucleoside-naive chronic hepatitis B
e-antigen (HBeAg) positive patients at week 144 who continued on-treatment
from week 96. In this cohort, undetectable HBV DNA levels were defined as
less than 300 copies per mL of blood as measured by polymerase chain
reaction (PCR). Suppression of viral load to undetectable levels is one of
several measures of antiviral treatment response; a sustained, undetectable
viral load is an important goal of chronic hepatitis B treatment. The
results of this three-year cohort were presented today at the 57th Annual
Meeting of the American Association for the Study of Liver Diseases
(AASLD).
"The response of most patients in this cohort to undetectable levels of
viral load at three years is encouraging and these data provide important
information about BARACLUDE for healthcare professionals," said Hugo
Cheinquer, M.D., Universidade Federal Do Rio Grande Do Sul, Porto Alegre,
Brazil.
Patients in this cohort had previously been treated for 96 weeks in the
BARACLUDE arm of study ETV-022, which compared the efficacy and safety of
0.5 mg of BARACLUDE vs. lamivudine in nucleoside-naive chronic
HBeAg-positive patients. In this three-year cohort of patients,
normalization of alanine aminotransferase (ALT) was noted in 80 percent of
patients at week 144 of BARACLUDE treatment. All patients in this cohort
were HBeAg-positive at the end of their treatment in study ETV-022: 33
percent of them lost HBeAg and 16 percent achieved HBeAg seroconversion by
week 144. Serologic testing was conducted by a central laboratory up to
week 96 and by local laboratories in the third year.
Safety events were consistent with prior experience. During the third
year of treatment in this cohort, eight percent of patients experienced a
serious adverse event and 89 percent of patients had any adverse event in
the third year. Grade 3-4 adverse events were reported in 11 percent of
patients at week 144. There were no discontinuations due to adverse events
in this cohort during this third year of treatment. The most common adverse
events occurring in greater than or equal to 10 percent of patients were:
upper respiratory tract infection (30 percent), headache (22 percent),
cough (18 percent), diarrhea (18 percent), influenza (16 percent),
nasopharyngitis (14 percent) and upper abdominal pain (10 percent). Two
patients in this cohort died, but these deaths were not attributed to
BARACLUDE(R) (entecavir). No patients experienced on-treatment ALT flares
during the third year.
About the Nucleoside-Naive HBeAg-Positive Three-Year BARACLUDE Cohort
This cohort evaluated the long-term efficacy and safety of BARACLUDE in
nucleoside-naive chronic HBeAg-positive patients who received three years
of BARACLUDE treatment. The three-year cohort consisted of 119 patients who
met the following criteria:
-- Completed study ETV-022, and at 96 weeks had HBV DNA < 0.7 MEq/mL and
remained HBeAg-positive
-- Completed study ETV-022 and enrolled in study ETV-901 without an
intervening gap greater than 35 days
Had HBV DNA tested by PCR at week 144
Data results of the three-year cohort
At week 144, 90 percent (n=107/119) of nucleoside-naive chronic HBeAg-positive patients in this cohort achieved undetectable vira load (HBV DNA