Viral infections:
Indications for: BIKTARVY
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.
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:
Concomitant dofetilide, rifampin.
Boxed Warning:
Post-treatment acute exacerbation of hepatitis B.
BIKTARVY 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 Classification:
HIV-1 integrase strand transfer inhibitor (INSTI) + nucleoside analog reverse transcriptase inhibitors (NRTIs).
BIKTARVY 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).
Adverse Reactions:
Diarrhea, nausea, headache; HBV exacerbation, new onset or worsening renal impairment, immune reconstitution syndrome, lactic acidosis, hepatomegaly.
Note:
Register pregnant patients in the Antiretroviral Pregnancy Registry (APR) by calling (800) 258-4263.
Generic Drug Availability:
NO
How Supplied:
Tabs—30
