Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Reuters NewMedia - Friday September 25, 1998
The biotech company said trials have shown that a higher, twice-daily dosage of Viracept worked as well as the lower three-times-daily dosage.
Agouron told a meeting of the American Society for Microbiology in San Diego that 80 percent of 238 patients taking Viracept twice a day as part of a cocktail of drugs showed almost undetectable levels of the HIV virus. That is as good a response as patients get on a three times a day dose.
Viracept is only approved by U.S. regulators for a three-times-daily dosage. Agouron is hoping to secure approval for a twice-daily dosage because it makes it easier for patients to take their medicine on time, an important factor in protease inhibitors since taking the medicine late can make the treatment less effective and cause complications.
A spokeswoman for Agouron said the company hopes to file an application with regulators by the end of the year to raise the approved dosage to 1,250 mg twice daily, up from a current regimen of 750 mg three times a day.
If approved, the twice-daily dosage is expected to help Agouron take market share from Merck Co., Inc.'s (NYSE:MFW - news) and competing drug Crixivan. HIV patients complain that they have to take many pills a day, some at set times, some with food and some without, and it is hard to keep the regimen up. Patients who fail to take their pills as directed may develop drug-resistant strains of the virus -- which can then be passed on to other people.
But companies are racing to simplify the dosages.
Earlier this month DuPont Pharmaceuticals (NYSE:DD - news) won FDA approval for Sustiva, the first once-a-day drug to treat HIV.
It is a non-nucleoside reverse transcriptase inhibitor (NNRTI), the third class of HIV drugs on the market after reverse transcriptase inhibitors such as Glaxo's (quote from Yahoo! UK & Ireland: GLXO.L) AZT, and the protease inhibitors.
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