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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.”
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
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