Label Changes for:
Atripla (efavirenz/emtricitabine/tenofovir disoproxil fumarate) Tablets
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
NS5A inhibitor/NS5B polymerase inhibitor: ledipasvir/sofosbuvir
- Patients receiving ATRIPLA and HARVONI (ledipasvir/sofosbuvir) concomitantly should be monitored for adverse reactions associated with tenofovir
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