FDA Approved Drugs » 2012
Medical Areas: Immunology | Family Medicine | Infections and Infectious Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Approval Status: Approved August 2012
Treatment Area: HIV-1 infection
Stribild is a once daily, fixed-dose single-tablet regimen of four drugs. Three of the four medications are active against HIV: the integrase inhibitor elvitegravir and the nucleotide/nucleoside reverse transcriptase inhibitors Viread (tenofovir) and Emtriva (emtricitabine). The fourth medication is cobicistat, a drug that has no activity against HIV, but is needed to boost the blood levels and effectiveness of elvitegravir.
Stribild is specifically indicated as a complete regimen for the treatment of HIV-1 infection in adults who are antiretroviral treatment-naïve.
Stribild is supplied as a tablet containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate. It is designed for oral administration. The recommended dose of Stribild is one tablet taken orally once daily with food.
FDA ApprovalThe FDA approval of Stribild was based on 48 week data from two randomized, double-blind, active-controlled trials, Study 102 and Study 103, in treatment-naive, HIV-1 infected subjects (N=1408). In Study 102, subjects were randomized to receive either Stribild once daily or Atripla (efavirenz 600 mg/emtricitabine 200 mg/tenofovir DF 300 mg) once daily. In Study 103, subjects were randomized to receive either Stribild once daily or atazanavir 300 mg + ritonavir 100 mg (ATV+RTV) + Truvada (emtricitabine 200 mg/tenofovir DF 300 mg) once daily. In both studies, subjects were stratified by baseline HIV-1 RNA. The primary endpoint was Virologic Success (HIV-1 RNA < 50 copies/mL) at 48 weeks.Study 102: Virologic success was reached by 88% in the Stribild arm and 84% in the Atripla arm. In Study 102, the mean increase from baseline in CD4+ cell count at Week 48 was 230 cells per mm3 in the Stribild-treated subjects and 193 cells per mm3 in the Atripla-treated subjects.Study 103: Virologic success was reached by 90% in the Stribild arm and 87% in the ATV + RTV + Truvada arm. In Study 103, the mean increase from baseline in CD4+ cell count at Week 48 was 202 cells per mm3 in the Stribild-treated subjects and 201 cells per mm3 in the ATV + RTV + Truvada-treated subjects.
Adverse events associated with the use of Stribild may include, but are not limited to, the following:
Stribild is a once daily, fixed-dose single-tablet regimen of four drugs: elvitegravir (an HIV-1 integrase strand transfer inhibitor), cobicistat (a mechanism-based inhibitor of cytochrome P450 (CYP) enzymes of the CYP3A family), emtricitabine (a synthetic nucleoside analog of cytidine) and tenofovir disoproxil fumarate (an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate).
Sax PE, DeJesus E, Mills A, Zolopa A, Cohen C, Wohl D, Gallant JE, Liu HC, Zhong L, Yale K, White K, Kearney BP, Szwarcberg J, Quirk E, Cheng AK; GS-US-236-0102 study team 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. Lancet 2012 Jun 30;379(9835):2439-48
DeJesus E, Rockstroh JK, Henry K, Molina JM, Gathe J, Ramanathan S, Wei X, Yale K, Szwarcberg J, White K, Cheng AK, Kearney BP; GS-236-0103 Study Team 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. Lancet 2012 Jun 30;379(9835):2429-38
For additional information regarding Stribild or HIV, please visit the Stribild web page.