Healthcare Industry News: BARACLUDE
News Release - October 30, 2006
BARACLUDE(R) (Entecavir) Demonstrated Viral Suppression to Undetectable Levels in Most Patients in a Three-Year Cohort90 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 (HSMN NewsFeed) -- 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).
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® (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.
About BARACLUDE® (entecavir)
Discovered at Bristol-Myers Squibb, BARACLUDE is a nucleoside analogue indicated for the treatment of chronic hepatitis B virus infection in adults with evidence of active viral replication with either evidence of persistent elevations in serum aminotransferases (ALT or AST) or histologically active disease. In addition to the United States, BARACLUDE has been approved in more than 50 countries and regions around the world.
Important Information About BARACLUDE (entecavir) Tablets
BARACLUDE is a prescription medicine used for chronic infection with hepatitis B virus (HBV) in adults where the virus is multiplying and damaging the liver. BARACLUDE does not cure HBV or stop the spread of HBV to others. People should not take BARACLUDE if they are allergic to it or any of its ingredients. BARACLUDE has not been studied in children and is not recommended for anyone less than 16 years of age.
People taking BARACLUDE should tell their healthcare provider right away if they feel very weak or tired, have unusual muscle pain, have trouble breathing, have stomach pain with nausea and vomiting, feel cold -- especially in their arms and legs, feel dizzy or lightheaded, or have a fast or irregular heartbeat, as they may be signs of a serious condition called lactic acidosis (buildup of an acid in the blood). Lactic acidosis is a medical emergency and must be treated in the hospital. Some people who have taken medicines like BARACLUDE have developed serious liver problems called hepatotoxicity. This may occur with liver enlargement (hepatomegaly) and fat in the liver (steatosis). People should call their healthcare provider right away if they get any of the following signs of liver problems: yellowing (jaundice) of the skin or the white part of the eyes, darkening of the urine, lightening in the color of bowel movements (stools), not feeling like eating food for several days or longer, feeling sick to the stomach (nausea), or having lower stomach pain. Lactic acidosis and hepatotoxicity have happened in some people taking medicines like BARACLUDE.
In some people, hepatitis B symptoms may get worse or become very serious when they stop taking BARACLUDE. People should not stop BARACLUDE without talking to their healthcare provider. Healthcare providers will need to follow their patients and do blood tests to check the liver when BARACLUDE is stopped. People should tell their healthcare provider if they have or develop kidney problems because their healthcare provider may want to do tests to see if a lower dose is needed.
Because BARACLUDE® (entecavir) is removed from the body through the kidneys, a lower dose may be required. Healthcare providers may want to perform tests to determine whether a patient needs a lower dose.
It is not known if BARACLUDE is safe to use during pregnancy. It is not known if BARACLUDE helps to prevent a pregnant mother from passing HBV to her baby. A pregnant woman and her healthcare provider will need to decide if BARACLUDE is right for her. A woman should not breastfeed if she is taking BARACLUDE.
People should discuss with their healthcare provider all prescription and non-prescription medicines, vitamins, herbal supplements, and other health preparations they are taking or plan to take. BARACLUDE may interact with medicines that leave the body through the kidneys. The most common side effects of BARACLUDE in clinical studies were headache, tiredness, dizziness, and nausea.
This list of side effects is not complete at this time because BARACLUDE is still under study. People should report any new or continuing symptom to their healthcare provider. BARACLUDE should be taken once daily on an empty stomach (at least two hours after a meal and two hours before the next meal). To learn more about BARACLUDE (entecavir) and for Full Prescribing Information, including boxed WARNINGS, please visit www.bms.com. Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
BARACLUDE® (entecavir) is a trademark of Bristol-Myers Squibb Company.
Full prescribing information, including boxed WARNINGS for BARACLUDE is available at www.bms.com.
Source: Bristol-Myers Squibb
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.