Bristol-Myers Squibb: Plan A for Hepatitis B Treatment

A comparative study has shown Bristol-Myers’ Baraclude to be more effective than Gilead Science’s Hespera in treating hepatitis B patients. With Baraclude having compared favorably with lamivudine, the most commonly used antiviral therapy for the disease, in earlier studies, these latest results increase the likelihood of the Bristol-Myers drug becoming the new gold-standard in HBV treatment.

Although a highly effective vaccine for hepatitis B has been available for over two decades, the virus remains a serious global health threat, with approximately 350 million chronically infected individuals worldwide, mostly in Asia and Sub-Saharan Africa.

There are two classes of drugs used to treat chronic infection of hepatitis B, immunomodulators and nucleoside analogues, such as Baraclude (entecavir), Hespera (adefovir) and lamivudine. Immunomodulators help to optimize a patient’s immune system’s response to the viral infection, allowing it to suppress the virus to undetectable levels. Nucleoside analogues, the newest of which is Baraclude, work by interfering with the production of new viruses.

In March of this year the first large phase III clinical trials comparing the effectiveness of chronic hepatitis B treatments found that treating patients with Baraclude demonstrated greater benefits than treating patients with lamivudine, which is currently the most common antiviral therapy for chronic hepatitis B infection. Occurrences of side-effects were similar and no evidence of viral resistance to Baraclude was observed.

In this latest study, Baraclude was tested against Hespera in an open-label, randomized study of 65 antiviral naïve chronically infected hepatitis B patients. As with the lamivudine study, Baraclude was found to produce a greater reduction in viral load than the comparative treatment with no adverse events resulting in termination of treatment.

These compelling trial results raise the possibility of Baraclude establishing itself as the new gold standard of HBV therapy, gradually replacing lamivudine for first-line therapy. However, this is likely to depend on the price, especially in the more cost-constrained European markets such as the UK, Spain and Italy. Peak sales for Baraclude in the US, Europe and the Pacific Rim are estimated by Datamonitor at $320 million.

Despite these positive results, the bigger issue remains that this drug, just like the vaccine, can only truly be considered more effective within the global health community if it is made accessible to patients in the developing world where hepatitis B infection is endemic.