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Biktarvy Generic Name & Formulations
Legal Class
Rx
General Description
Bictegravir, emtricitabine, tenofovir alafenamide; 30mg/120mg/15mg, 50mg/200mg/25mg; tabs.
Pharmacological Class
HIV-1 integrase strand transfer inhibitor (INSTI) + nucleoside analog reverse transcriptase inhibitors (NRTIs).
How Supplied
Tabs—30
Manufacturer
Generic Availability
NO
Biktarvy Indications
Indications
As a complete regimen for HIV-1 infection in patients with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable
antiretroviral with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.
Biktarvy Dosage and Administration
Adults and Children
<14kg: not established. Test for HBV infection prior to initiation. 14kg–<25kg (CrCl ≥30mL/min): 1 tab (30mg/120mg/15mg) once daily. For children unable to swallow: may split tab and each part taken separately, but all must be ingested within ~10mins. ≥25kg (CrCl ≥30mL/min) or virologically suppressed adults on hemodialysis (CrCL <15mL/min): 1 tab (50mg/200mg/25mg) once daily.
Biktarvy Contraindications
Contraindications
Concomitant dofetilide, rifampin.
Biktarvy Boxed Warnings
Boxed Warning
Post-treatment acute exacerbation of hepatitis B.
Biktarvy Warnings/Precautions
Warnings/Precautions
Test for HBV before starting therapy and closely monitor patients co-infected with HBV and HIV for several months after stopping treatment (discontinuing therapy may exacerbate HBV infection); if appropriate, anti-hepatitis B therapy may be warranted (esp. in those with advanced liver disease or cirrhosis). Suspend therapy if lactic acidosis or pronounced hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor serum creatinine, CrCl, urine glucose, urine protein, and serum phosphorus (in chronic kidney disease); discontinue if significant renal dysfunction or Fanconi syndrome occurs. Severe renal impairment (CrCl <30mL/min), ESRD (CrCl <15mL/min) not receiving chronic dialysis, or ESRD with no antiretroviral treatment history and receiving chronic dialysis: not recommended. Severe hepatic impairment (Child-Pugh Class C): not recommended. Pregnancy: increased risk of neural tube defects (due to bictegravir). Nursing mothers: not recommended.
Biktarvy Pharmacokinetics
See Literature
Biktarvy Interactions
Interactions
See Contraindications. Concomitant other antiretrovirals: not recommended. May potentiate concomitant OCT2 and MATE1 substrates (eg, dofetilide). May be affected by drugs that induce or inhibit CYP3A and UGT1A1. Concomitant drugs that strongly affect P-gp and BCRP activity may lead to changes in TAF absorption. May be potentiated by drugs that decrease renal function or compete for active tubular secretion (eg, acyclovir, cidofovir, ganciclovir, valacyclovir, valganciclovir, aminoglycosides, NSAIDs). May be antagonized by anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin); consider alternatives. Concomitant rifabutin, rifapentine, St. John's wort: not recommended. Concomitant antacids (containing Al/Mg): give Biktarvy at least 2hrs before or 6hrs after. Concomitant oral iron/calcium supplements or antacids: can take together with food. Routine coadministration (under fasting conditions) with, or 2hrs after, oral iron/calcium supplements or antacids: not recommended. May potentiate metformin (refer to metformin labeling).
Biktarvy Adverse Reactions
Adverse Reactions
Diarrhea, nausea, headache; HBV exacerbation, new onset or worsening renal impairment, immune reconstitution syndrome, lactic acidosis, hepatomegaly.
Biktarvy Clinical Trials
See Literature
Biktarvy Note
Notes
Register pregnant patients in the Antiretroviral Pregnancy Registry (APR) by calling (800) 258-4263.
Biktarvy Patient Counseling
See Literature
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