Best Evidence Analyses and Commentary

FDA Grants Approval for HIV Combination Pill
Sara Ingargiola, PharmD Candidate - LECOM Point
Stephanie Peshek, PharmD
October 2012

The Food and Drug Administration (FDA) announced approval for Stribild on Monday August 27, 2012. Stribild is a once daily anti-HIV treatment developed by Gilead Sciences. Stribild is indicated and approved to treat HIV-1 infections in treatment naïve adults. Stribild is a combination product that contains emtricitabine (FTC) (200mg), tenofovir disoproxil fumarate (TDF) (300mg), elvitegravir (EVG) (150mg) and cobicistat (COBI) (150mg). FTC and TDF have prior FDA approval and are sold in combination under the brand name Truvada (FTC/TDF).

 

FTC and TDF are nucleoside reverse transcriptase inhibitors that interfere with the HIV viral RNA dependent DNA polymerase inhibiting viral replication. EVG inhibits the catalytic activity of HIV-integrase, thus preventing the proviral gene from integrating into human DNA. COBI inhibits enzymes of the CYP3A subfamily and enhances systemic exposure to EVG.

Stribild (EVG/COBI/FTC/TDF) was approved based on the results of two randomized, double blind, phase three noninferiority clinical trials. 707 patients were randomly assigned to Stribild or to Atripla (efavirenz (EFV)/FTC/TDF)) once daily in the first trial and 715 patients were randomly assigned to Stribild or Truvada plus atazanavir (ATV) and ritonavir (RTV) once daily in the second trial. The studies measured the percentage of patients who had an undetectable level of HIV RNA in their blood at 48 weeks. In both trials Stribild was found to be non-inferior to the comparators. Common side effects include nausea and diarrhea. Stribild does carry the same Boxed Warning as Truvada, for lactic acidosis and hepatomegaly with steatosis.

 References

 

1. Food and Drug Administration. Stribild. FDA approves new combination pill for HIV treatment for some patients. Retrieved from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm317004.htm.

2. Gilead Sciences Inc. (2012) Stribild® (elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate) tablet, film coated: Prescribing Information. Retrieved from: http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=74ae2a93-b267-444c-8f0f-a2a6522260ee

3. Sax PE,  DeJesus E, Mills A, et al. Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir: a randomized, double blind, phase 3 trial, analysis of results after 48 weeks. Lancet. 2012; 379: 2439-48.


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