San Francisco Chronicle - July 13, 2006
Sabin Russell, srussell@sfchronicle.com.

A combination of two AIDS drugs made by Gilead Sciences Inc. of Foster City and a third antiviral medicine from rival Bristol-Myers Squibb Co. of New York, the new three-in-one pills should be ready for sale within a week.

They will be sold under the name Atripla, and the two companies said they will sell the new pill at the same price that its three components together cost today: $1,051 for a 30-day supply.

"It's great news,'' said Mark Cloutier, executive director of the San Francisco AIDS Foundation. "These are the most commonly recommended drugs in triple therapy today."

The announcement is a milestone in the history of AIDS treatment. When researchers first discovered in 1996 that combinations of three drugs could save lives, it was not uncommon for an AIDS patient to take 30 pills a day.

Such a regimen is very difficult to keep consistently, so patients would forget to take pills, and the virus would quickly develop mutations that rendered the medicines less effective.

In the 10 years since, the drugs have become easier to take, with fewer pills needed each day, but the newest pill is the simplest regimen ever devised. There are currently more than 400,000 Americans living with an AIDS diagnosis.

The three drugs combined into one include:

-- Efavirenz -- originally approved in 1998 and sold by Bristol-Myers under the name Sustiva.

-- Tenofovir -- approved in 2001 and sold by Gilead under the name Viread.

-- Emtricitabine -- approved in 2003 and sold by Gilead under the name Emtriva.

Since 2004, Gilead has been selling tenofovir and emtricitabine in a double combination called Truvada.

Combining Truvada and Sustiva into one pill will not only make it easier for patients to be sure not to miss a dose, it will save them money. "It is one less co-pay, one less deductible, every time you have a prescription filled," Cloutier said.

According to Gilead research and development Vice President Norbert Bischofberger, about 13 percent of AIDS patients in the United States take Truvada and Sustiva today, and the combination is prescribed to 60 percent of those in this country who are taking antiviral medications for HIV for the first time.

All three drugs have potentially serious side effects, but the three are each considered to be among the safest and most easily tolerated AIDS medications available today.

Although the new drug is the first once-a-day AIDS treatment, Indian drugmakers were the first to come up with the idea of combining three drugs into a single pill. In 2003, the World Health Organization endorsed Cipla's Triomune -- a combination of generic copies of three older AIDS medications -- as an easy to administer treatment for people in poor countries. Two Triomune pills are required per day.

"Ironically, the generic companies have created a new wave of innovation," Cloutier said.

Last week, the FDA approved its first twice-a-day, three-in-one pill for sale to President Bush's $15 billion overseas AIDS initiative, which has refused to purchase the low-cost Cipla drug. The newly approved pill, produced by Indian drugmaker Aurobindo Pharma, is deemed safer than Triomune.

"We absolutely think it was worth waiting for," said Dr. Mark Dybul, the acting Global AIDS coordinator in charge of the administration's program.

The FDA also approved a version of Atripla for sale to developing countries. The pill will be produced in a white color, instead of the salmon color of those to be sold in wealthier markets. Gilead plans to sell the new white pill at cost, but the price has not been announced pending negotiations with Merck & Co., which holds rights to efavirenz in many poor countries.

Martin Delaney, founder of Project Inform in San Francisco, said that the latest approval of Atripla is important because, for the first time, U.S. drugmakers are cooperating on a better AIDS treatment. It took an Indian drug maker to produce Triomune, because it ignored the fact that the ingredients found in its pill were patented by different, competing companies.

"The fact that two American companies have collaborated here is a good model for the future," Delaney said.

060713
SC060707

Always watch for outdated information. This article first appeared in 2006. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2006. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content. .