AEGiS-Reuters: DuPont Says FDA OKs One-Dose-A-Day HIV Drug

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DuPont Says FDA OKs One-Dose-A-Day HIV Drug

Reuters NewMedia, Inc.; Friday September 18, 1998


WILMINGTON, Del. (Reuters) - DuPont Pharmaceuticals said Friday the U.S. Food and Drug Administration approved Sustiva, a one-dose-a-day drug to treat the virus that causes AIDS.

Although in recent years new HIV drugs have helped reduce the disease from a certain death sentence into a chronic condition, the number of pills patients have to swallow daily has been considered a major obstacle to treatment.

The drug was designed to be taken as part of a triple-combination therapy, commonly a three-drug daily treatment regimen. However, DuPont said that early clinical trials show the drug was effective in two-drug combinations.

Patients on existing "cocktails" of three different medications sometimes take dozens of pills a day, a complication that causes many patients to skip their medication routines.

By failing to comply with their regimens, significant percentages of patients develop resistance to their drugs as the AIDS virus mutates in the absence of proper medical control of its replication. The Holy Grail of many doctors is to simplify medication regimens in order to keep patients on track.

Sustiva is the only drug for which the FDA has specifically approved a once-daily dosage, unlike other drugs, which are typically taken at multiple times during the day. DuPont said patients can take three Sustiva pills together at any time of day, with or without meals. Sustiva, which will be in pharmacies in the next few days, costs $10.95 per day, DuPont said.
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