Biotech Values

[DewDiligence]

Here’s the Baraclude PR on 3-year efficacy
based on follow-up of patients who remained
e-positive at 2 years and met certain other
conditions described below. As can be seen
from these data, Baraclude is a fine drug.

http://biz.yahoo.com/prnews/061030/nym043.html?.v=76

>>
BARACLUDE® (Entecavir) Demonstrated Viral Suppression to Undetectable Levels in Most Patients in a Three-Year Cohort

Monday October 30, 3:00 pm ET

90 Percent of Nucleoside-Naive Chronic Hepatitis B E-Antigen (HBeAg) Positive Patients in this Three-Year Cohort Achieved Undetectable Viral Load Levels at 144 Weeks

BOSTON, Oct. 30 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company (NYSE: BMY ) today announced data from a three-year cohort (ETV-022/901, n=119), which showed BARACLUDE® (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 [i.e. this was an entry requirement for the third year]: 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® (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 viral load (HBV DNA <300 copies/mL) and 80 percent (n=95/119) of patients achieved ALT normalization (ALT less than or equal to 1 times the upper limit of normal) at week 144 of BARACLUDE treatment.

* By week 144, 33 percent (n=35/106) of patients lost HBeAg and 16 percent (n=17/105) of patients achieved HBeAg seroconversion by week 144.
<<