In the news ... 2006 archive

Project Inform Endorses FDA Approval
of New HIV/AIDS Drug

June 26, 2006

Project Inform, one of the nation’s best known HIV treatment and health care information and advocacy organizations, today announced its enthusiastic support of the Food & Drug Administration’s (FDA) approval of Prezista, a new anti-HIV drug from Tibotec Therapeutics. Prezista will initially be used in the treatment of people with advanced HIV disease who are resistant to most other therapies.

“Based on the evidence we seen so far,” said Paul Dalton of Project Inform, “this is very likely the most successful drug yet for treating people with high levels of resistance. That makes it a very important step forward.”

Project Inform Founding Director Martin Delaney added, “This is a victory for everyone involved. The FDA recognized the drug’s potential early on and cleared the way for a rapid approval. The company listened well to its investigators and the community, resulting in well designed and rapidly filled clinical trials. Finally, the company met extensively with activists involved in the Fair Pricing Coalition and ultimately made a wise choice in its pricing of the drug. This is a balanced pricing model for the whole industry.”

Prezista has shown high levels of activity in people who are resistant to most other protease inhibitors. For the first time, a large percentage of highly resistant patients are able to achieve “undetectable” levels of virus. Reaching “undetectable” viral load is considered the key step to successful treatment.

Previously, many HIV-infected people eventually became resistant to nearly all medications and ran out of options. “The new drug opens the door to a future for many people who were otherwise running out of hope,” said Delaney. To be most effective in such patients, Prezista will need to be combined with a second drug that is still active. Many patients in need of salvage therapy have been delaying their use of some other recently released drugs until they were able to use them in combination with Prezista. Others are planning to use Prezista with two other new drugs that will soon be available.

Later in the year, Tibotec itself will offer expanded access to a second new therapy to better support the use of Prezista. Additionally, Merck is expected to make a drug from a new class, called integrase inhibitors, available later this summer. “Taken together, the approval of Prezista combined with access to recently approved and soon-to-be available new drugs marks a major step forward for people with advanced disease. The result should be that very few people will be “out of options” any longer,” said Brenda Lein, a veteran AIDS treatment activist and long-term Project Inform staff member.

Ryan Clary, from the health care advocacy department of Project Inform, added, “From a health care perspective, what’s really good about this is not only that the drug works well but that the company has reversed the upward spiral of prices for new anti-HIV drugs. This is the first drug in a long time that didn’t come with a price tag that leapfrogged the last approved drug of its type. This company seems to understand that a new drug means little if people can’t afford it, or if public health care programs aren’t able to provide it. While we’d like to see the price go even lower, this is at least a big step in the right direction.”