By Bob Roehr
The quest for a single-pill once-a-day treatment for HIV became a reality when the FDA approved Atripla on July 12. It combines the already approved drugs efavirenz (Sustiva), tenofovir (Viread), and emtricitabine (Emtriva), and usually will be used as an initial therapy for those who do not have drug-resistant virus and can tolerate the drug side effects.
"This is a landmark for those suffering with HIV and AIDS," said acting FDA Commissioner Andrew von Eschenbach during a news conference announcing the approval. "Compliance with therapy is as important as the therapy itself for a successful outcome."
The revolution in treating HIV that began in 1996 with the introduction of highly active antiretroviral therapy (HAART) initially came with a high burden of taking multiple pills and often with food restrictions that strung out the dosing over many hours. Both made compliance more difficult. And HIV is a virus that will readily mutate resistance if that regimen is not rigorously maintained.
Second generation drugs eased those restrictions and made triple drug combinations easier to take, reducing a regimen to two pills once or twice a day. So in that sense, Atripla represents more of a symbolic culmination of the process rather than a significant change in the lives of people living with HIV.
It also represents an unprecedented collaboration between two companies, Gilead Sciences, which developed Viread and Emtriva, and Bristol-Myers Squibb, which makes Sustiva. They had to overcome many technical issues in order to formulate the three drugs into the same pill.
The companies have set a wholesale price of $1,150.88 for a 30-day supply. That is the same as they currently charge for the individual components. New drugs and combinations traditionally have been priced higher.
AIDS advocates were pleased with holding the line on pricing.
"Atripla pricing appears to be in line with what advocates fought for," said Bill Arnold, head of TII CANN, the advocacy group that focuses on the AIDS drug assistance programs (ADAP) portion of the federal response to HIV.
The most significant impact of this may be on the wallets of people taking the drug. Many health insurance plans require that a patient make a copayment, often $25, for each month's supply of a drug. A regimen of three separate drugs would mean copayments of $75 a month. A single pill regimen would reduce that out of pocket cost by as much as $600 a year, a significant saving for those with a low income.
The pill will be salmon-colored for sale in the US and the industrialized world, and white for sale in developing countries. Companies often create slightly different versions of a pill when they set different prices for those markets, so as to reduce the risk of diversion from the cheaper to the more expensive market.
This suggests that the companies will steeply discount Atripla for sales where the pandemic is most extensive, as has become common with other HIV drugs. However, those matters are clouded by patent and drug approval issues in some developing countries that first must be resolved.
