AEGiS-AFP News: US-AIDS: FDA approves Zerit, Videx as first line drugs for HIV treatment agence france-presse
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US-AIDS: FDA approves Zerit, Videx as first line drugs for HIV treatment

Agence France-Presse - September 8, 1999

WASHINGTON, Sept 8 (AFP) - The US government has approved the drugs Zerit and Videx for first-line treatment of people infected with HIV, the drug's manufacturers said Wednesday.

The decision by the Food and Drug Administration gives the official stamp of approval for doctors to prescribe the drugs as part of a first-line antiretroviral combination therapy, Bristol-Myers Squibb said.

The move brings the FDA into line with common best practice, as Videx and Zerit are already widely prescribed by physicians as part of the standard HIV combination therapy regime, according to Bristol-Myers Squibb spokesman Mark Short.

The National Association of People with AIDS hailed the move, stressing the importance of simplifying prescription guidelines to ensure people with the Human Immunodeficiency Virus got the best treatment.

"The FDA must do everything possible to ensure that labeling mirrors the standard of care. This approval will make it possible for doctors, even for those who care for only a few HIV patients to provide the best care," A. Cornelius Baker, Executive Director of NAPWA, said in a statement.

"Getting the right treatment is a challenge for many patients," Baker added.

FDA labeling was critical, the association argued, in light of recent studies showing that some 25 percent of patients, especially women and minorities, were not receiving the appropriate standard of care.

Videx and Zerit, both nucleoside analogues, have been on the market since 1991 and 1994 respectively, although they had not been approved for first-line treatment.

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