Bictegravir/Emtricitabine/Tenofovir alafenamide

Dosing

1 tab PO once daily

1 tab = Bictegravir 50mg/ Emtricitabine 200 mg/ Tenofovir alafenamide 25 mg

BW ≥25 kg 1 tab PO once daily

1 tab = Bictegravir 50mg/ Emtricitabine 200 mg/ Tenofovir alafenamide 25 mg

Mild to moderate hepatic impairment No dose adjustment

Severe hepatic impairment Not recommended

CrCl ≥30CrCl <30HD (CrCl <15; previous history of ART)HD (CrCl <15; no history of ART)No dose adjustmentNot recommendedAdminister daily dose after completion of hemodialysis treatmentNot recommended

General Information

Treatment of HIV infection.

Black Box Warning: Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and hepatitis B virus (HBV) and have discontinued products containing emtricitabine and/or tenofovir disoproxil fumarate. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue this drug.

Monitor viral load and CD4 cell counts at baseline and with modification of ARV treatment.

Perform hepatitis C antibody testing prior to initiation or modification of ARV treatment.

Test for hepatitis B virus (HBV) infection prior to or during initiation as severe acute exacerbation may occur upon therapy discontinuation.

Monitor ALT, AST, total bilirubin, and urinalysis at baseline and with modification of ARV treatment.

Obtain fasting blood glucose or HbA1C, fasting lipid profile, and CBC with a differential.

Obtain estimate CrCl, serum phosphorus, and urinalysis.

Obtain basic chemistry including serum sodium, potassium, bicarbonate, chloride, BUN, creatinine, and creatinine-based estimated glomerular filtration rate.

Common

  • Diarrhea

  • Nausea

  • Headache

Serious

  • Lactic acidosis

  • Hepatitis B exacerbation

  • Hepatomegaly with steatosis

  • Immune reconstitution syndrome

  • Fanconi syndrome

  • Renal impairment

  • Acute renal failure

Contraindications:

  • Carbamazepine

  • St. John's wort

  • Phenytoin

  • Phenobarbital

  • Rifampin

  • Dofetilide

Major drug-drug interactions:

  • Horsetail

  • CYP3A4 substrates

  • CYP3A inducers

  • Polyvalent cations containing products

  • P-gp and BCRP substrates

  • Cabotegravir

  • Anticonvulsants

  • Rifapentine

  • Orlistat

  • Tipranavir

  • Rifabutin

  • Select antimycrobials

Antimicrobial class: Antiretroviral, Integrase strand transfer inhibitor, Nucleoside reverse transcriptase inhibitor

Average serum half life: 17.3 hours (Bictegravir), 10.4 hours (Emtricitabine), 0.51 hours (Tenofovir alafenamide)

Precautions: Monitoring recommended and anti-hepatitis B therapy may be warranted upon discontinuation, especially in patients with advanced liver disease or cirrhosis.

Suspend treatment if pronounced hepatotoxicity or lactic acidosis develops.

Not recommended in patients with severe renal impairment or with ESRD who are not receiving hemodialysis, or patients with no ARV treatment history and ESRD who are receiving chronic HD.

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