FDA approves new combination tablet for HIV treatment in some patients

August 29, 2012

FDA has approved elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Stribild, Gilead Sciences), a complete once-daily single tablet regimen for HIV-1 infection for treatment-naïve adults.

FDA has approved elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (Stribild, Gilead Sciences), 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 4 compounds in 1 daily tablet: elvitegravir, an integrase inhibitor; cobicistat, a pharmacoenhancing agent; emtricitabine; and tenofovir disoproxil fumarate.

Stribild is the third once-a-day pill for HIV brought to market 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.

“Over the past decade, co-formulated HIV medicines have simplified therapy for many patients and have become standard of care,” 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, said in a press release. “. . . 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.”

According to F. Randy Vogenberg, PhD, RPh, principal, Institute for Integrated Healthcare, Stribild is “a line extension targeted at enhancing patient compliance or ease of use but not necessarily advancing the basic clinical outcomes performance in patients.

“From a plan sponsor perspective, there is some value in these kinds of products as long the incremental cost of convenience is not out of bounds with the improvement level of patient outcomes,” Vogenberg told Formulary. “HIV/AIDS remains primarily a Medicaid/Ryan White issue, but could change as preventive use of this category of medications expands due to health reform driven policy change. This will remain an important area of clinical care to watch in addition to the economic ramifications of various biologic based combinations of drugs.”

The approval of Stribild is supported by 48-week data from 2 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). The approval is also supported by Chemistry, Manufacturing, and Controls (CMC) information on the individual components of Stribild and the co-formulated single-tablet regimen.

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.

Applications for marketing approval of Stribild are also pending in Australia, Canada, and the European Union.