BOSTON, Oct. 30 /PRNewswire-FirstCall/ -- Bristol-Myers Squibb Company today announced results of an open-label, randomized study of 65 antiviral naive chronic hepatitis B e-antigen (HBeAg) positive patients, showing that patients receiving the oral antiviral therapy BARACLUDE(R) (entecavir) demonstrated greater viral load reduction at weeks 12 (primary endpoint) and 24 than patients treated with adefovir. Specifically, 45 percent of BARACLUDE-treated patients and 13 percent of adefovir-treated patients achieved undetectable viral load at 24 weeks. In this study, undetectable levels were defined as HBV DNA less than 300 copies/mL as measured by a common assay-polymerase chain reaction, or PCR. The 24-week results were presented today at the 57th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD).
“In treating chronic hepatitis B, the goal of healthcare professionals is to suppress viral load to undetectable levels with antiviral therapy,” said Nancy Leung, M.D., of the Alice Ho Miu Ling Nethersole Hospital, Hong Kong, China. “In this study, the first comparing the antiviral treatments BARACLUDE and adefovir, treatment with BARACLUDE led to greater viral load reductions at both 12 and 24 weeks.”
Safety was comparable between the treatment groups, with similar incidence of serious adverse events [three percent with BARACLUDE (n=1), nine percent with adefovir (n=3)] and any adverse event [69 percent with BARACLUDE (n=25), 79 percent with adefovir (n=26)].
Reported Grade 3-4 adverse events were six percent with BARACLUDE (n=2) and 15 percent with adefovir (n=5). There were no discontinuations due to adverse events in patients treated with BARACLUDE. One patient treated with adefovir discontinued due to adverse events. No deaths were observed in either treatment group.
About the Study
Study ETV-079 was a randomized, open-label, comparative study of antiviral naive chronic HBeAg-positive patients evaluating antiviral efficacy as measured by mean reduction in serum HBV DNA levels at week 12. Patients received 0.5 mg of BARACLUDE(R) (entecavir) once daily (n=33) or adefovir 10 mg once daily (n=32).
* At week 12, patients in the BARACLUDE treatment group demonstrated a mean change in viral load of -6.23 log(10) copies/mL, compared to a mean change in viral load of -4.42 log(10) copies/mL with the adefovir group (p < 0.0001). * After 24 weeks, 45 percent of patients treated with BARACLUDE achieved undetectable HBV DNA (<300 copies/mL by PCR) versus 13 percent of patients treated with adefovir. * At week 24, patients in the BARACLUDE treatment group demonstrated a mean change in viral load of -6.97 log(10) copies/mL, compared to a mean change in viral load of -4.48 log(10) copies/mL with the adefovir group (95 percent Confidence Interval -2.51, -1.20). * At week 24, three percent of BARACLUDE-treated patients versus 50 percent of patients treated with adefovir had HBV DNA > 10^5 copies/mL. About BARACLUDE
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 around the world.
Important Information About BARACLUDE 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(R) (entecavir) 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 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(R) (entecavir) 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 and for Full Prescribing Information, including boxed WARNINGS, please visit http://www.bms.com.
Bristol-Myers Squibb is a global pharmaceutical and related healthcare products company whose mission is to extend and enhance human life.
BARACLUDE(R) (entecavir) is a trademark of Bristol-Myers Squibb Company.
Full prescribing information for BARACLUDE, including boxed WARNINGS, is available at http://www.bms.com.
Bristol-Myers Squibb Company
CONTACT: Ken Dominski, Communications, On-site: +1-609-273-9656, Office:+1-609-252-5251, ken.dominski@bms.com, or John Elicker, Investor Relations,+1-212-546-3775, john.elicker@bms.com
Web site: http://www.bms.com/
