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Two New Fixed-Dose Combinations Approved

August 2, 2004

FDA announced approval today, August 2, 2004, of two fixed-dose combination (FDC) antiretroviral drug products for use with other antiretroviral agents for the treatment of HIV-1 infection. The FDCs are GlaxoSmithKline's EPZICOMTM (abacavir/lamivudine) and Gilead Sciences, Inc.'s TRUVADATM (tenofovir disoproxil/emtricitabine).

These FDC approvals are important because they provide simplified dosing regimens -- one pill, once daily, for the component of multi-drug therapy represented by these FDCs.


TRUVADATM (Tenofovir Disoproxil/Emtricitabine) -- Gilead Sciences, Inc.

  • TRUVADA is a fixed-dose combination (FDC) of the antiretroviral drugs tenofovir disoproxil fumarate 300 mg (TDF) and emtricitabine 200 mg (FTC), both of which are approved individually under the brand names of VIREADTM (tenofovir disoproxil fumarate) and EMTRIVATM (emtricitabine).

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  • The approval of TRUVADA is based on bioequivalence studies demonstrating similar pharmacokinetic parameters of the combination product and the individual products, safety and efficacy data that exist for both components individually, and efficacy results from studies using the combination of TDF and lamivudine (3TC), [lamivudine is an approved product with many similarities to FTC] are being extrapolated to support the use of the TDF/FTC combination.

  • TRUVADA should be considered as an alternative to TDF and 3TC for treatment naive patients who might benefit from a once-a-day regimen.


EPZICOMTM (Abacavir/Lamivudine) -- GlaxoSmithKline

  • EPZICOM is a fixed-dose combination (FDC) of the antiretroviral drugs abacavir sulfate 600 mg and lamivudine 300 mg, both of which are approved individually under the brand names of ZIAGENTM (abacavir sulfate) and EPIVIRTM (lamivudine).

  • EPZICOM is being approved based on a large well-controlled clinical study which showed that abacavir dosed once daily had similar antiviral effect as abacavir dosed twice daily both in conjunction with lamivudine and efavirenz.

The important safety issue regarding abacavir-containing products, including EPZICOM, is abacavir hypersensitivity reaction (a serious allergic reaction). Previous clinical trials showed that there is a possibility of this hypersensitivity reaction occurring in approximately 8% of the patients. EPZICOM should be discontinued a soon as a hypersensitivity reaction is suspected. EPZICOM or other abacavir-containing products must not be restarted following a hypersensitivity reaction because more severe symptoms can occur within hours and may include life-threatening hypotension and death. Information on this serious allergic reaction has been updated in the EPZICOM package insert as well as the patient Medguide/Warning Card.



  
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This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
 
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