Posts
Stribild, the once-daily four-in-one
fixed-dose combination (FDC) tablet formerly known as the “Quad,” has been
approved for people living with HIV initiating antiretroviral (ARV) therapy for
the first time, according to announcements by Gilead Sciences and the U.S. Food
and Drug Administration released on Monday, August 27.
The tablet contains two new
antiretrovirals—the integrase inhibitor elvitegravir and the novel
pharmacokinetics enhancer cobicistat (needed to boost blood levels of
elvitegravir)—as well as the nucleotide/nucleoside analog pair Truvada
(tenofovir and emtrictabine).
The approval of Stribild is
supported by 48-week data from two Phase III clinical trials (Studies 102 and
103) in which the single-tablet regimen was found comparable to Atripla and
Norvir (ritonavir)-boosted Reyataz plus Truvada.
Like labels of many other ARVs,
Stribild’s package insert carries a Boxed Warning alerting people living with
HIV and their health care providers 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.
Stribild's per-patient annual
wholesale acquisition cost (WAC) is $28,500, according to a Gilead
spokesperson. The per-patient WAC for Atripla (efavirenz plus tenofovir and
emtricitabine), Gilead’s current leading once-daily FDC tablet, is $21,000.
A patient assistance
program—Gilead’s U.S. Advancing Access initiative—will provide assistance to
people living with HIV who do not have insurance or who need financial
assistance to pay for their ARVs, including Stribild. Patients may contact Advancing Access at
1-800-226-2056 between 9:00 AM and 8:00 PM (Eastern Time) to see if they are
eligible for the program.
For people living with HIV who have
private insurance, Gilead’s co-pay program provides assistance with
out-of-pocket expenses for Gilead’s HIV medications, including Stribild,
starting at the first dollar.
Additionally, Gilead is working closely with the ADAP Crisis Task Force,
as the company has done for each of its other HIV medications, to provide
discounts to state AIDS Drug Assistance Programs (ADAPs) that will help ensure
access to Stribild for people living with HIV who receive medications through
these programs.
Applications for marketing approval
of Stribild are pending in Australia, Canada and the European Union.
In the developing world, Gilead has
granted multiple Indian manufacturing partners and the Medicines Patent Pool
the right to develop generic versions of Stribild and distribute them to 100
developing countries. These agreements
include a complete technology transfer of the manufacturing process for the
single tablet regimen.
Source: POZ
The Friends of AIDS Foundation is
dedicated to enhancing the quality of life for HIV positive individuals and
empowering people to make healthy choices to prevent the spread of the HIV
virus. To learn more about The Friends of AIDS Foundation, please visit: http://www.friendsofaids.org.
TOGETHER WE REMAIN STRONG!
