FDA approves additional drug in fight against AIDS

By Randolph E. Schmid The Associated Press
Tuesday October 30, 2001

WASHINGTON — A new anti-viral drug is being added to the arsenal of anti-AIDS medications. 

The Food and Drug Administration said Monday it has approved Viread for use in combination with other drugs in fighting HIV, the virus that causes AIDS. 

The drug blocks reproduction of the virus, the agency said. Its technical name is tenofovir disoproxil fumarate. 

AIDS survival rates have increased in recent years as combinations of drugs are used to battle the virus. 

FDA noted that the virus mutates rapidly, however, and often develops resistance to drugs. That makes development of new medications necessary. 

The FDA said it approved the new pill after two clinical trials on more than 700 people who showed increased HIV despite treatment with other drugs. They showed significant reductions in the amount of HIV in their blood during the trials, the agency said. 

The new drug is taken as a single pill once a day. Supplies should be available by the end of this week, according to the manufacturer, Gilead Sciences of Foster City, Calif. 

Gilead spokeswoman Amy Flood said a year’s supply of Viread would cost $4,135, but added that much of that probably would be covered by insurance. 

In clinical trials the most common side effects of Viread were moderate diarrhea, nausea, vomiting and flatulence. Viread is a type of drug known as a nucleotide analog. Its action is similar to nucleoside analogs, which the FDA said have been connected to some serious liver conditions.