FDA Approves Stribild, the “Quad” Combination Pill
People starting HIV treatment for the first time have a new simplified treatment option: The U.S. Food and Drug Administration (FDA) yesterday approved Gilead Sciences’ combination pill Stribild, formerly known as the “Quad” pill.
Like Atripla and Complera before it, Stribild offers a complete HIV treatment regimen in a single pill taken once daily. It combines the new integrase inhibitor elvitegravir and the “boosting” agent cobicistat with the previously approved HIV meds tenofovir and emtricitabine (the drugs already combined in Truvada and recommended as part of a “preferred” treatment regimen).
The new combination pill comes with safety warnings about lactic acidosis (buildup of lactic acid in the blood) and kidney and liver complications experienced by some people taking tenofovir, as well as warnings against use of Stribild by people coinfected with hepatitis B virus. (Click here to view the full prescribing information and safety warnings.) However, clinical trials of the combination pill found it to be generally well tolerated. (A succinct review of recent study results is available here.)
With a price tag upwards of $28,000 a year, Stribild may be out of reach to many who would otherwise benefit from it. Gilead is reportedly working out discounts for state AIDS Drug Assistance Programs (ADAPs) to help ADAP users access the new combination pill. The company’s Advancing Access patient assistance program also offers help to people who are uninsured or otherwise need assistance paying for their meds (call 1-800-226-2056 between 9 a.m. and 8 p.m. Eastern time for more information).
Gilead’s press release announcing the FDA approval of Stribild is excerpted below.
U.S. FDA Approves Gilead’s Stribild™, a Complete Once-Daily Single Tablet Regimen for Treatment-Naïve Adults with HIV-1 Infection
FOSTER CITY, Calif.–(BUSINESS WIRE)–Aug. 27, 2012– 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….
Reilly O’Neal is the editor of BETA.