New FDA Approved HIV Drug, Stribild Gives Gilead Unrestricted Pricing Power

New HIV medication containing four different drugs combined in one pill has been approved for sale and distribution by the FDA (Food and Drug Administration). The FDA said Stribild provides a complete treatment regimen for HIV infection; that’s the good news.

The not so good news or rather bad news is that the manufacturer of the drug plans to charge approximately $28,500 a year’s supply of Stribild; talk about high medical cost. Ultimately, Gilead will have unrestricted pricing power.

“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, 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.

Clearly, Gilead’s FDA approval will give them an almost  monopoly in the treatment of HIV, with them owning all the ingredients to manufacture the drug. This means they control the price and from the looks of it, are not interested in pricing their product appropriately.

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.”

Stribild’s approval is the latest HIV/AIDS-related action taken by the FDA this year. Other actions include approval of the first over-the-counter home-use rapid HIV test; approval of the first drug for pre-exposure prophylaxis in combination with safer sex practices to reduce the risk of sexually acquired HIV infection in adults at high risk; and commemoration of the full or tentative approvals of more than 150 antiretroviral products for the President’s Emergency Plan for AIDS Relief (PEPFAR) to treat those in countries most affected by the HIV/AIDS epidemic.

Like labels of many other drugs used to treat HIV, Stribild’s label carries a Boxed Warning alerting patients and health care professionals that the drug can cause a build up of lactic acid in the blood and severe liver problems, both of which can be fatal. The Boxed Warning also states that Stribild is not approved to treat chronic hepatitis B virus infection.

Common side effects observed in clinical trials include nausea and diarrhea. Serious side effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system (immune reconstitution syndrome).  Stribild’s label gives advice to health care providers on how to monitor patients for kidney or bone side effects.

Aside from the these small details compared to what the product will cost an aids patient, Gilead says it would provide discounts to state AIDS Drug Assistance Programs, and would also offer various programs to help privately insured patients obtain the drug. Gilead further added that it had also granted rights to certain companies in India to make generic versions of Stribild for distribution in poor countries.

What can be gathered from their rhetoric is that the price is the price and a thing can be done about it.

 

Contributor D. Chandler

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