Bristol Myers Squibb presents new hepatitis B drug data

A new study based on two trials from Bristol-Myers Squibb has found that its nucleoside antiviral drug, Baraclude, suppresses the viral load levels of the hepatitis B virus to “undetectable levels”.

The two phase III trials involved comparisons with lamivudine over 96 weeks of use. In the first trial, 94 per cent of chronically-infected patients with the HBeAg-negative variant of the virus using Baraclude reduced their hepatitis B viral load levels to an undetectable state after 96 weeks of use, compared with 77 per cent using lamivudine. According to the company, there was no evidence of any resistance to Baraclude.

Additionally, 30 per cent of patients with HBeAg-positive hepatitis B patients who were using lamivudine but then switched to Baraclude achieved the reduction of their viral load to an undectectable state. This is in contrast to the one per cent of lamivudine patients who achieved the same outcome, using only lamivudine.

Lamivuldine was approved for use by the FDA in 1995 and it has been licensed to GlaxoSmithKline.

Morris Sherman, one of the study investigators and associate professor of medicine at the University of Toronto, said: “It is increasingly recognised that hepatitis B viral load is an important evaluation tool for physicians when assessing, monitoring, and managing patients.”

Although hepatitis B is preventable by the use of vaccines, the British Liver Trust estimates that one in 1,000 people in the UK are infected with the virus. It says in inner-city areas, as many as one in 50 pregnant women may be infected with the virus which is commonly transferred by having unprotected sex. It is also transferred through the blood by drug users sharing contaminated equipment.

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