Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

February 2016

Summary View


NS5A inhibitor/NS5B polymerase inhibitor: ledipasvir/sofosbuvir
  • Patients receiving ATRIPLA and HARVONI (ledipasvir/sofosbuvir) concomitantly should be monitored for adverse reactions associated with tenofovir 


January 2010

Summary View 


Clinical Trials Experience
  • In Study 073, subjects with stable, virologic suppression on antiretroviral therapy and no history of virologic failure were randomized to receive ATRIPLA or to stay on their baseline regimen.  The adverse reactions observed in Study 073 were generally consistent with those seen in Study 934* and those seen with the individual components of Atirpla when each was administered in combination with other antiretroviral agents


Page Last Updated: 03/14/2016
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