Gilead Sciences have shelved the development of their novel HIV inhibitor adefovir dipivoxil (Preveon) for the treatment of HIV disease in the US. This follows the recent decision of the US regulatory authorities to refuse Gilead's application for marketing approval for adefovir (see Previous news stories). Gilead say they will continue to pursue the development of the drug for the treatment of hepatitis B.
Gilead applied for adefovir's approval within the European Union this past September, and their Director of Clinical Research, Sally Van Doren, told aidsmap that the company anticipates an initial decision from the drug approval agency, the Committee for Proprietary Medicinal Products (CPMP) by the end of December. Gilead's plans for adefovir within Europe are dependent on that decision. At present however, they plan to open an expanded use programme in Europe early in the New Year. This is expected to provide the drug on a rollover basis to participants in the ADHOC study, which recently closed to recruitment. At this time, it is not expected that this scheme will provide adefovir to people who have not used it previously.