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Qvir KIT is indicated for the treatment of HIV-1 infection in adults and adolescents weighing at least 40 kg and aged12 years and above.
The following points should be considered when initiating therapy with Qvir KIT:
- In Study AI424-045, atazanavir/ritonavir and lopinavir/ritonavir were similar for the primary efficacy outcome measure of time-averaged difference in change from baseline in HIV RNA level. This study was not large enough to reach a definitive conclusion that atazanavir/ritonavir and lopinavir/ritonavir are equivalent on the secondary efficacy outcome measure of proportions below the HIV RNA lower limit of detection.
- The number of baseline primary protease inhibitor mutations affects the virological response to atazanavir/ritonavir.
- It is not recommended that emtricitabine/tenofovir DF be used as a component of a triple nucleoside regimen.
- Emtricitabine/tenofovir DF should not be coadministered with emtricitabine/tenofovir DF/efavirenz, emtricitabine, tenofovir DF or lamivudine-containing products (see WARNINGS AND PRECAUTIONS).
- In treatment experienced patients, the use of emtricitabine/tenofovir DF should be guided by laboratory testing and treatment history.