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cobicistat/elvitegravir/emtricitabine/tenofovir (Quad, Stribild, Genvoya)

FDA-approved August 2012 [3] Indications: - treatment of HIV1 (treatment-naive adults) - treatment of HIV1 in adults, patients >= 12 years at least 77 lbs (35 kg) in weight [5] Contraindications: - severe renal failure [5] Dosage: - PO QD Storage: - keep in original container - original container has a desiccant [4] Monitor: - renal function Adverse effects: - hypercholesterolemia, increased total serum cholesterol & LDL cholesterol - lactic acidosis - hepatotoxicity Laboratory: - cobicistat inhibits tubular secretion of creatinine that may increase serum creatinine levels (< 0.4 mg/dL) without effect on glomerular filtration rate [6] Clinical trials: - non-inferior to standard therapy [2] Notes: - novel formulation of tenofovir (tenofovir alafenamide) of Genvoya may reduce renal & bone toxicity associated with other formulations

General

antiretroviral combination

References

  1. Morgan D FDA panel recommends Gilead's Quad for HIV Reuters, May 11, 2012 http://www.reuters.com/article/2012/05/11/us-usa-aids-quad-idUSBRE84A15W20120511 - FDA Advisory Committee Supports Approval of Gilead's Once-Daily - Quad Single Tablet Regimen for HIV Gilead, may 11, 2012 http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle&ID=1695211&highlight= - Journal Watch, Massachussetss Medical Society, May 14, 2012 Quad Pill Poised to Become the Next One-Pill, Once-Daily Treatment for HIV http://aids-clinical-care.jwatch.org/ (subscription required)
  2. DeJesus E et al Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial The Lancet, 379(9835):2429-2438, 30 June 2012 Not yet indexex in PubMed http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60918-0/abstract - Sax PE et al Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir versus co-formulated efavirenz, emtricitabine, and tenofovir for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3 trial, analysis of results after 48 weeks The Lancet, 379(9835):2439-2448, 30 June 2012 Not yet indexex in PubMed http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60917-9/abstract - Schrijvers R and Debyser Z Quad's in it for antiretroviral therapy? The Lancet, 379(9835):2403-2405, 30 June 2012 Not yet indexex in PubMed http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)61029-0/fulltext
  3. Physician's First Watch, Aug 29 2012 Massachusetts Medical Society http://www.jwatch.org - FDA News Release: Aug. 27, 2012 FDA approves new combination pill for HIV treatment for some patients
  4. Prescriber's Letter 21(6): 2014 Oral Meds to Keep in Original Containers Detail-Document#: 300622 (subscription needed) http://www.prescribersletter.com
  5. FDA News Release. November 5, 2015 FDA approves new treatment for HIV http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm471300.htm
  6. Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015

Components

cobicistat (GS-9350, COBI) elvitegravir (GS 9137, EVG/c) emtricitabine (Emtriva, FTC) tenofovir (TDF)