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Drug Name:


Generic Name and Formulations:
Bictegravir 50mg, emtricitabine 200mg, tenofovir alafenamide 25mg; tabs.

Gilead Sciences, Inc.

Therapeutic Use:

Indications for BIKTARVY:

A complete regimen for the treatment of HIV-1 infection in adults 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 regimen for ≥3 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.


Test for HBV infection prior to initiation. 1 tab once daily.


<18yrs: not established.


Concomitant dofetilide, rifampin.

Boxed Warning:

Post-treatment acute exacerbation of hepatitis B.


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 hepatotoxicity (eg, hepatomegaly, steatosis) occurs. Monitor serum creatinine, CrCl, urine glucose, urine protein, and serum phosphorus (in patients at risk for chronic renal disease); discontinue if significant renal dysfunction or Fanconi syndrome occurs. Severe renal impairment (CrCl <30mL/min): not recommended. Severe hepatic impairment (Child-Pugh Class C): not recommended. Pregnancy. Nursing mothers: not recommended.

Pharmacological Class:

HIV-1 integrase strand transfer inhibitor (INSTI) + nucleoside analog reverse transcriptase inhibitors (NRTIs).


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 cation-containing antacids, laxatives, sucralfate, and buffered drugs: give Biktarvy 2hrs before. Concomitant oral iron/calcium supplements: may take together with food. Routine coadministration with, or 2hrs after, cation-containing antacids or oral iron/calcium supplements: not recommended. May potentiate metformin (refer to metformin labeling).

Adverse Reactions:

Diarrhea, nausea, headache; HBV exacerbation, new onset or worsening renal impairment, immune reconstitution syndrome, lactic acidosis, hepatomegaly.


Register pregnant patients in the Antiretroviral Pregnancy Registry (APR) by calling (800) 258-4263.

Generic Availability:


How Supplied:


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