Contraindications & DDIs
Established and potentially significant* drug interactions:
(alteration in regimen may be recommended)
Concomitant Drug Class: Drug Name
Coadministration is contraindicated due to the potential for serious and/or life-threatening events associated with dofetilide therapy.
Coadministration with alternative anticonvulsants should be considered.
Coadministration with rifampin is contraindicated due to the effect of rifampin on the BIC component of BIKTARVY.
Coadministration with rifabutin or rifapentine is not recommended.
St. John’s wort§
Coadministration with St. John’s wort is not recommended.
Medications or oral supplements containing polyvalent cations (eg, Mg, Al, Ca, Fe):
Calcium or iron supplements†
Cation-containing antacids or laxatives†
Antacids containing Al/Mg:
BIKTARVY can be taken at least 2 hours before or 6 hours after taking antacids containing Al/Mg.
Routine administration of BIKTARVY together with, or 2 hours after, antacids containing Al/Mg is not recommended.
Supplements or antacids containing Calcium or Iron:
BIKTARVY and supplements or antacids containing calcium or iron can be taken together with food.
Routine administration of BIKTARVY under fasting conditions together with, or 2 hours after, supplements or antacids containing calcium or iron is not recommended.
Refer to the prescribing information of metformin for assessing the benefit and risk of concomitant use of BIKTARVY and metformin.
For an aging patient population, which may have comorbidities, the safety profile and drug-drug interactions of a treatment are important considerations when choosing a therapy2
No known dose adjustments when BIKTARVY is coadministered with these medications1
Drugs with no clinically significant interactions with BIKTARVY
Drug Within Class
Ethinyl estradiol, norgestimate
Selective serotonin reuptake inhibitor
Warnings and Precautions1
Drug interactions: See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.
Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
New onset or worsening renal impairment: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating BIKTARVY and during therapy, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, assess serum phosphorus.
Lactic acidosis and severe hepatomegaly with steatosis: Fatal cases have been reported with the use of nucleoside analogs, including FTC and TDF. Discontinue BIKTARVY if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
*Table is not all-inclusive.
†Drug-drug interaction study was conducted with either BIKTARVY or its components as individual agents.
‡Strong inducer of CYP3A and P-gp, and inducer of UGT1A1.
§The induction potency of St. John’s wort may vary widely based on preparation.
Al, aluminum; Ca, calcium; DDI, drug-drug interaction; Fe, iron; FTC, emtricitabine; HCV, hepatitis C virus; Mg, magnesium; NSAIDs, nonsteroidal anti-inflammatory drugs; TDF, tenofovir disoproxil fumarate.
References: 1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2022. 2. Burgess MJ, Zeuli JD, Kasten MJ. Management of HIV/AIDS in older patients-drug/drug interactions and adherence to antiretroviral therapy. HIV/AIDS (Auckl). 2015;7:251-264.