Alejandro Freixes
Nov 9, 2011

No significant difference between Baraclude and Baraclude+


Over the course of 96 weeks, a Phase 3 clinical study trial was conducted to test the safety and efficacy of BARACLUDE monotherapy and BARACLUDE plus tenofovir for treatment-naive adult patients with HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB) with compensated liver disease.
The results of the study were recently revealed by Bristol Meyers Squibbs at the 62nd annual meeting for the American Association of the Study of Liver Disease in San Francisco, California. Results indicate that there is no clinical or statistical difference between the two treatments. Both groups that received the treatment in the study expressed similar desired effects and serious adverse effects.

HBeAg (Hepatitis B e Antigen), infecting approximately 350 million people around the globe, is a viral protein that is secreted by cells infected with hepatitis B. It is associated with chronic hepatitis B infections and is used as a marker to indicate the severity of the ability to infect others.  A positive result indicates the person has high levels of the virus and greater ability to infect others with the disease. A negative result indicates relatively low to zero levels of the virus in the blood, categorizing the person as being less infectious.
The instructions for creating the hepatitis virus is carried in HBV DNA. The amount of HBV DNA present in a sample of blood is indicative of how quickly the disease is being reproduced in the liver. The higher the level that is found in the blood, the more infectious a person is considered to be to others.

The drug BARACLUDE is intended to treat chronic hepatitis B virus. Its function is to reduce the amount of HBV that is present in the body and lower the ability of the virus to reproduce and infect new liver cells as well as improve the current state of the liver.

In the study, the two treatments were shown to have approximately the same percentage yield in terms of their results. Baraclude and  Baraclude+ showed primary efficacy endpoints of 76.4 percent and 83.2 percent, respectively, at 96 weeks.

The two treatments were similar in their safety as well, with only 6.6 percent of patients experiencing serious adverse effects in the arm receiving Baraclude and 7.1 percent experiencing serious adverse effects in the arm receiving Baraclude+. Some of the effects included a bile duct tumor, a late on-set exacerbation of hepatitis, cardiac arrest, and even death in three of the patients.

Dr. Anna Lok, Director of Clinical Hepatology and professor in the Department of Internal Medicine at the University of Michigan Medical School, stated,  “In these 96-week data comparing entecavir monotherapy to combination of entecavir plus tenofovir, we found that combination therapy did not result in statistically significant difference in virologic response compared to entecavir monotherapy. The BE-LOW study data confirmed the results of previous studies showing limited or no benefit of combination therapy compared to monotherapy for treatment-naïve patients with chronic hepatitis B”.

Overall both treatments varied slightly in terms of their respective percentages of efficacy.