[Ip-health] F.D.A Approves Once-a-Day Pill for HIV

Stephanie Rosenberg steph.rosenberg at gmail.com
Wed Aug 29 10:54:26 PDT 2012


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


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

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.

Stephanie Rosenberg, M.A.
Public Citizen
Global Access to Medicines Campaign
(773) 620-3968--cell

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