F.D.A. Approves Once-a-Day Pill for H.I.V.

F.D.A. Approves Once-a-Day Pill for H.I.V.

By ANDREW POLLACK
Published: August 27, 2012

The Food and Drug Administration approved a new once-a-day H.I.V. treatment from Gilead Sciences that contains four different drugs in one pill.

But the price Gilead plans to charge for the new drug — about $28,500 a year — was criticized as excessive by one AIDS activist, who said it would put additional pressure on the already strained public health programs that pay for the majority of H.I.V. medications.

“That’s shockingly irresponsible,” said the activist, Michael Weinstein, the president of the AIDS Healthcare Foundation, which treats more than 100,000 infected individuals around the world. “It’s just unsustainable at these levels.”

Gilead said the price was in line with that of some other regimens for treating H.I.V.

The new drug, which will be called Stribild, is the third once-a-day pill for H.I.V. brought to market by Gilead, after Atripla in 2006 and Complera in 2011. In the late 1990s, when cocktails of drugs began to be used to successfully treat the infection, patients sometimes had to take two dozen pills, at various times of the day and night.

Stribild, which was previously known as the Quad, does not appear to represent a huge leap medically.

In the clinical trials that led to its approval, Stribild was roughly equivalent to Atripla and to another combination, though it avoids some psychiatric side effects of Atripla. About 88 to 90 percent of those who took Stribild had undetectable amounts of H.I.V. in their blood after 48 weeks, compared to 84 percent treated with Atripla and 87 percent treated with the combination of Gilead’s Truvada, Bristol-Myers Squibb’s Reyataz and Abbott’s Norvir.

But Stribild could be important commercially for Gilead because the company owns all the ingredients. By contrast, Atripla contains a drug from Bristol-Myers Squibb and Complera contains a drug from Johnson & Johnson, so Gilead must split profits.

Geoffrey Meacham, an analyst for J.P. Morgan Chase, estimated Stribild’s worldwide sales could reach $2.5 billion annually by 2015. “Given similar efficacy with an improved safety profile, we expect the Quad to take share from Atripla,” he wrote in a note Monday.

Two of the ingredients in Stribild — emtricitabine and tenofovir — are also in Atripla and Complera and are sold as a dual combination known as Truvada.

The other two drugs in Stribild are elvitegravir, which is a type of drug known as an integrase inhibitor, and cobicistat, which enhances the effect of elvitegravir. Neither of those drugs has been approved yet for use independently.

The wholesale acquisition of Stribild is about one-third more than that of Atripla, which costs about $21,000 a year. “If that is not true excess, I don’t know what is, for something that is not a true advance,” Mr. Weinstein said.

Erin Rau, a spokeswoman for Gilead, said in an e-mail that the price of Stribild “reflects a reasonable return on our product development investment.”

She said the company would provide discounts to state AIDS Drug Assistance Programs, and would also offer various programs to help privately insured patients obtain the drug. Gilead said it had also granted rights to certain companies in India to make generic versions of Stribild for distribution in poor countries.

A version of this article appeared in print on August 28, 2012, on page B4 of the New York edition with the headline: F.D.A. Approves Once-a-Day Pill for H.I.V..