Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food
and Drug Administration (FDA) has approved StribildTM
(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir
disoproxil fumarate 300 mg), a complete once-daily single tablet regimen
for HIV-1 infection for treatment-naïve adults. Stribild, referred to as
"Quad" prior to FDA approval, combines four compounds in one daily
tablet: elvitegravir, an integrase inhibitor; cobicistat, a
pharmacoenhancing agent; emtricitabine and tenofovir disoproxil fumarate.
"Over the past decade, co-formulated HIV medicines have simplified
therapy for many patients and have become standard of care," said Paul
Sax, MD, Clinical Director of the Division of Infectious Diseases at
Brigham and Women's Hospital, Boston, Professor of Medicine at Harvard
Medical School, and principal investigator of one of the Stribild
pivotal studies. "Today's approval of Stribild will provide physicians
and their patients an effective new single tablet treatment option for
individuals starting HIV therapy for the first time."
The approval of Stribild is supported by 48-week data from two pivotal
Phase 3 studies in which the single tablet regimen met its primary
objective of non-inferiority compared to Atripla® (efavirenz
600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) (Study
102) and to a regimen containing ritonavir-boosted atazanavir plus
Truvada® (emtricitabine/tenofovir disoproxil fumarate) (Study
103). Today's approval is also supported by Chemistry, Manufacturing and
Controls (CMC) information on the individual components of Stribild and
the co-formulated single tablet regimen.
"For much of the company's 25-year history, Gilead has focused on the
development of improved treatments and simplified regimens for HIV,"
said John C. Martin, PhD, Chairman and Chief Executive Officer, Gilead
Sciences. "Therapies that address the individual needs of patients are
critical to enhancing adherence and increasing the potential for
treatment success, and we are proud to introduce a new single tablet
regimen for the healthcare and patient communities."
Stribild is the third single tablet HIV regimen developed by Gilead. The
first, Atripla, was approved in 2006 and is marketed by Gilead and
Bristol-Myers Squibb in the United States. The second single tablet
regimen, Complera® (emtricitabine/rilpivirine/tenofovir
disoproxil fumarate), which combines Gilead's Truvada and Janssen R&D
Ireland's rilpivirine, was approved in 2011.
In all studies of Stribild, most adverse events were mild to moderate.
Stribild has Boxed Warnings of lactic acidosis/severe hepatomegaly with
steatosis and post treatment acute exacerbation of hepatitis B; see
below for important safety information.
Applications for marketing approval of Stribild are also 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.