In the news ... 2006 archive

First “One Pill, Once a Day” Regimen Approved

July 18, 2006

On July 13, the US Food and Drug Administration announced the approval of an unusual new product, called Atripla, for treating HIV. Atripla is unique in a number of ways. It is not actually a new drug, but rather a combination of three well-proven drugs in a single pill. The three component drugs, Sustiva (efavirenz), Viread (tenofovir) and Emtriva (emtricitabine) make up one of the most common and well regarded combinations for treating HIV. A second unique property is that Atripla reduces the entire regimen to a single pill that is taken only once daily. This simplifies treatment and is likely to improve users’ ability to adhere to the regimen. Better adherence results in better durability of the regimen, along with reduced risk of HIV becoming resistant to the drugs. Combined, these advantages make Atripla a major advance in the treatment of HIV disease.

Atripla is one of a category of drugs called “fixed dose combinations.” The first such combination was Combivir from GlaxoSmithKline (GSK), which contained Retrovir (zidovudine /AZT) and Epivir (lamivudine /3TC). GSK also offers fixed dose combinations of Ziagen (abacavir) and Epivir, called Epzicom and a three-drug combination of Retrovir, Epivir and Ziagen, called Trizivir. Although Trizivir is a three-drug combination like Atripla, many researchers believe it isn’t sufficiently powerful to serve as a person’s full anti-HIV regimen. Gilead Sciences also offers a fixed dose combination of their two anti-HIV drugs Viread and Emtriva in a single pill called Truvada.

Bringing together the three drugs in Atripla required that two competing drug companies, Bristol-Myers Squibb (BMS) and Gilead, put aside their normal competitive posture and work together. Their example, which has clearly been successful, will hopefully serve as a model for other companies. Other possible fixed dose combinations come to mind that would simplify or strengthen other combinations. Some immediate possibilities include Kaletra (lopinavir + ritonavir) + Truvada (tenofovir + emtricitabine) or Combivir (zidovudine + lamivudine); Prezista (darunavir) + Truvada or Combivir; Lexiva (fosamprenavir) + Truvada or Combivir, and many others. All that stands in the way is the willingness of the parent companies to learn to work together.

There is already evidence that other drug companies are taking note. GSK and Boehringer Ingelheim are reported to be working on a fixed dose combination of Combivir + Viramune (nevirapine).

A final salute must be given to both BMS and Gilead for holding the line on pricing with the new product. The wholesale cost of Atripla is the same as the combined cost of the component drugs, with no added premium for the new formulation. This is exactly what the Fair Pricing Coalition requested of the two companies before the launch of the new product. (The Fair Pricing Coalition is a nationwide association of activists working to contain drug prices.)

It would not have been unusual for the companies to charge a substantial premium, arguing that they had to recover the costs of developing the new formulation. In this case, the first two efforts to create Atripla ended in failure before the third succeeded. Nonetheless, the companies recognized the current crisis in drug pricing and agreed not to make things worse by raising the price. This is the second time in a month that drug companies have acted responsibly on pricing (see A Drug Pricing Victory!). For some people living with HIV, this new fixed dose combination will result in lowered cost of their HIV drugs, as they will be responsible for one less co-pay.

Important as it is in the United States, Atripla will also be very important in resource poor countries, where its simplicity and ease of use will be extremely important. It could not have come at a more important time. Most people receiving treatment in developing nations are receiving a drug regimen that is considered less than ideal in the US and Europe. The availability of Atripla will make a high quality, well-regarded regimen readily available throughout the world. The next great challenge will be to get the drug approved in the many resource poor countries so that it may be purchased under government, private foundation, and other international programs. Since one key component of Atripla, efavirenz, is already distributed by Merck internationally (under the name Stocrin), rather than BMS or Gilead, discussions are underway that might make Merck responsible for distribution of Atripla internationally.

Project Inform salutes BMS and Gilead for having the courage and foresight to collaborate on this important advance and urges other companies to follow suit.