Interaksi Biktegravir, emtrisitabin, dan tenofovir alafenamid dan Rifabutin

Antimycobacterials: rifabutin Drug-drug interaction study was conducted for components of BIXLENVO dosed as individual agents (BIC or LEN). rifampin rifapentine ↓ lenacapavir ↓ bictegravir Concomitant administration with rifampin is contraindicated [see Contraindications (4) ] .

Concomitant administration with rifabutin or rifapentine is not recommended.

Concomitant administration of BIXLENVO is contraindicated with: dofetilide due to the potential for increased dofetilide plasma concentrations and associated serious and/or life-threatening events. strong CYP3A inducers due to decreased plasma concentrations of BIC and LEN, which may result in the loss of therapeutic effect and development of resistance to BIXLENVO.

Concomitant administration of BIXLENVO is contraindicated with: Dofetilide Strong CYP3A inducers.

Concomitant administration of BIXLENVO with strong CYP3A inducers is contraindicated [see Contraindications (4) ] .

Bictegravir 75 mg once a day 300 mg once a day (fasted) Healthy subjects ND ↓ AUC 38% ↓ C min 56% ↓ C max 20% Co-administration of rifabutin with Biktarvy (bictegravir/emtricitabine/ tenofovir alafenamide) is not recommended due to an expected decrease in tenofovir alafenamide in addition to the reported reduction in bictegravir.

ND ↓ AUC by 42% ↓ C min by 48% ↓ C max by 31% Co-administration of rifabutin with Odefsey (rilpivirine/tenofovir alafenamide/emtricitabine) is not recommended, due to an expected decrease in tenofovir alafenamide in addition to the reported reduction in rilpivirine.

Therefore, co-administration with antiretroviral and anti-HCV drugs metabolized by CYP3A is not recommended or there may be a need to increase the dose of antiretroviral or anti-HCV drugs (see PRECAUTIONS-Drug Interactions ).

The concomitant use of protease inhibitors may require at least a 50% reduction in rifabutin dose, and depending on the protease inhibitor, an adjustment of the antiretroviral drug dose.

Co-administration with antiretroviral drugs metabolized by CYP3A, including but not limited to products containing bictegravir, elvitegravir, oral rilpivirine, or doravirine and anti-HCV drugs including but not limited to sofosbuvir (alone or in combination) may decrease plasma concentrations of those drugs, which may lead to loss of virologic response and possible…