J05AR06 · Anti-infectives for systemic use
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva
Indications
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva prior to initiation of their first antiretroviral treatment regimen.
The demonstration of the benefit of the combination efavirenz/emtricitabine/tenofovir disoproxil is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to efavirenz/emtricitabine/tenofovir disoproxil. No data are currently available from clinical studies with combination efavirenz/emtricitabine/tenofovir disoproxil in treatment-naïve or in heavily pretreated patients.
No data are available to support the combination of efavirenz/emtricitabine/tenofovir disoproxil and other antiretroviral agents.
Composition
- Active substance
- efavirenz, emtricitabine, tenofovir disoproxil phosphate
- International name (INN)
- efavirenz;emtricitabine;tenofovir disoproxil
Official product information
The European public assessment report holds the summary of product characteristics and the package leaflet in every EU language.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.