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CDC HIV/AIDS/Viral Hepatitis/STD/TB Prevention News Update

UNITED STATES: Setback for Novartis Hepatitis Drug


Wall Street Journal (04.19.12) - Friday, April 20, 2012

On Thursday, the Food and Drug Administration placed the development of an experimental hepatitis C drug on hold after the death of a patient that could be linked to it.

Switzerland-based Novartis AG is developing the drug, known as DEB025 or alisporivir. Rather than targeting hepatitis C virus directly, as other treatments do, it focuses on proteins that are essential for viral replication. Novartis proceeded with late-stage testing after intermediate studies last year showed alisporivir was effective in eliminating HCV.

Novartis said a small number of patients who received DEB025, in addition to pegylated interferon and ribavirin, developed pancreatitis, which is thought to be a contributing factor in the patient's death. This was the only death in the DEB025 program, which has involved about 1,800 patients to date, Novartis said.

David Kaegi, an analyst with Zurich's Bank Sarasin, said the drug's role in the death "remains to be determined. The case is open."


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Information in this article was accurate in April 20, 2012. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.