Atripla: New, Convenient HIV Medication Receives FDA Approval

July 17, 2006: The FDA approved a new HIV drug Wednesday, July 12, 2006, which could significantly decrease the inconvenience and confusion of people currently combining medications in HIV drug cocktails. Atripla, the first once-a-day HIV medication, combines three of the most frequently utilized drugs prescribed to people living with the virus.

Atripla contains a combination of the medications Sustiva (Bristol-Myers Squibb), Viread and Emtriva (both produced by Gilead) in one pill. These three medications represent the most frequently prescribed drug combo for HIV patients in the United States. This new medication can be taken once daily, alleviating the cumbersome process of taking several medications at different intervals.

One of the benefits expected of Atripla is a decrease in occurrence of missed a doses or medication errors that many people living with HIV experience with the current multiple drug, multiple dose HIV medication cocktails.

In a statement to reporters, U.S. FDA Deputy Commissioner Murray Lumpkin said, "it's one thing to have medicine available, but it will only be effective when people can indeed take it as they are supposed to."

If effective, Atripla should help to provide a simpler method of treating the virus. The convenience of the one a day, three medication single pill offered in Atripla is a far cry from the earlier HIV cocktails, many of which involved the taking of dozens of pills at varying times of the day, some with food and some on an empty stomach.

According to Norbert Bischofberger, the executive vice president in charge of research and development for Gilead, Atripla "is a really nice advance. You can't make it any simpler."

According to Biscofberger, other possible drug combination pills are in the works, as well.

Atripla is not a breakthrough in HIV or AIDS management. Currently, there is no medication that can cure HIV or AIDS, but there are medications that are effective in suppressing the virus, often for many years. The three drugs found in Atripla block the production of an enzyme that HIV requires in order to replicate, thereby depressing the virus' ability to convert to full blown AIDS.

Now that Atripla has received FDA approval, it should be available within seven business days, the drug makers say. The cost for Atripla will be $1,150.88 per patient for a thirty-day supply.

Expectations for the success Atripla are high enough to inspire a market report, released by the Prudential Equity Group announcing the FDA approval. In a statement by Ron Ellis, an analyst with Prudential, the pricing of Atripla is consistent with the equity firm's expectations.

"There is a high level of interest in the triple co-formulation for two main reasons - lower prescription co-payments and dosing convenience," Ellis wrote in a client note. "We would not underestimate the importance of paying for only one pill versus two or three even though the cumulative cost is the same."

Ellis continued, "based on these considerations, physicians with whom we speak believe that the triple co-formulation drug could become the choice of therapy in treatment-naive HIV patients."

People taking Atripla may find that they are unable to stay on the three in one medication permanently if they develop tolerance to the drug. This is a common problem with HIV and AIDS medications, making it necessary for patients to change to different medications once resistance to a drug renders it less effective.

Source: Reuters, Forbes