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<h4>IMPORTANT SAFETY INFORMATION</h4>
<h4>BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B</h4>
<ul class="li-inline-start">
<li><span class='bold'>Severe acute exacerbations of hepatitis B have been reported in patients with HIV‑1 and HBV who have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of BIKTARVY. Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months in patients with HIV‑1 and HBV who discontinue BIKTARVY. If appropriate, anti‑hepatitis B therapy may be warranted.</span>
</li>
</ul>
<h4>Contraindications</h4>
<ul>
<li>
<span class='bold'>Coadministration:</span> Do not use BIKTARVY with dofetilide or rifampin.
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</ul>
<h4>Warnings and precautions</h4>
<ul>
<li>
<span class='bold'>Drug interactions:</span> See Contraindications and Drug Interactions sections. Consider the potential for drug interactions prior to and during BIKTARVY therapy and monitor for adverse reactions.</li>
<li>
<span class='bold'>Immune reconstitution syndrome,</span> including the occurrence of autoimmune disorders with variable time to onset, has been reported.
</li>
<li>
<span class='bold'>New onset or worsening renal impairment:</span> 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.<br><span class='italic'>Renal monitoring:</span> 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.
</li>
<li>
<span class='bold'>Lactic acidosis and severe hepatomegaly with steatosis:</span> 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.
</li>
</ul>
<h4>Adverse reactions</h4>
<ul>
<li>
<span class='bold'>Most common adverse reactions</span> (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
</li>
</ul>
<h4>Drug interactions</h4>
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<li>
<span class='bold'>Prescribing information:</span> Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.</li>
<li>
<span class='bold'>Enzymes/transporters:</span> Drugs that induce P-gp or induce both CYP3A and UGT1A1 can substantially decrease the concentration of components of BIKTARVY. Drugs that inhibit P-gp, BCRP, or inhibit both CYP3A and UGT1A1 may significantly increase the concentrations of components of BIKTARVY. BIKTARVY can increase the concentration of drugs that are substrates of OCT2 or MATE1.
</li>
<li>
<span class='bold'>Drugs affecting renal function:</span> Coadministration of BIKTARVY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of FTC and tenofovir and the risk of adverse reactions. </li>
</ul>
<h4>Dosage and administration</h4>
<ul>
<li>
<span class='bold'>Dosage:</span> <span class='underline'>Adult and pediatric patients weighing ≥25 kg:</span> 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. <span class='underline'>Pediatric patients weighing ≥14 kg to <25 kg:</span> 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For these pediatric patients, who are unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.</li>
<li>
<span class='bold'>Renal impairment:</span> For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, not recommended in patients with CrCl <30 mL/min.
</li>
<li>
<span class='bold'>Hepatic impairment:</span> Not recommended in patients with severe hepatic impairment.
</li>
<li>
<span class='bold'>Prior to or when initiating:</span> Test patients for HBV infection.
</li>
<li>
<span class='bold'>Prior to or when initiating, and during treatment:</span> As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.
</li>
</ul>
<h4>Pregnancy and lactation</h4>
<ul>
<li>
<span class='bold'>Pregnancy:</span> BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population.</li>
<li>
<span class='bold'>Lactation:</span> Individuals with HIV‑1 should be informed of the potential risks of breastfeeding.
</li>
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<h4>INDICATION</h4>
<p>BIKTARVY<sup>®</sup> is indicated as a complete regimen for the treatment of HIV‑1 infection in adult and pediatric patients weighing ≥14 kg with no antiretroviral (ARV) treatment history; or with an ARV treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir; or to replace the current ARV regimen in those who are virologically suppressed (HIV‑1 RNA <50 copies per mL) on a stable ARV regimen with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.</p>
<p><span class='bold'>Please see full Prescribing Information for BIKTARVY, including BOXED WARNING, available at BiktarvyHCP.com.</span>
</p>
<p>ART, antiretroviral therapy; DHHS, US Department of Health and Human Services; FDA, US Food and Drug Administration; PWH, people with HIV; STR, single-tablet regimen.</p>
<p><span class='bold'>References: 1.</span> BIKTARVY. Prescribing Information. Gilead Sciences, Inc.; 2025. <span class='bold'>2.</span> Panel on antiretroviral guidelines for adults and adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Updated September 12, 2024. Accessed March 1, 2025. https://clinicalinfo.hiv.gov/<br>sites/default/files/guidelines/<br>documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf <span class='bold'>3.</span> Panel on antiretroviral therapy and medical management of children living with HIV. Guidelines for the use of antiretroviral agents in pediatric HIV infection. Department of Health and Human Services. Updated December 19, 2024. Accessed March 18, 2025. https://clinicalinfo.hiv.gov/<br>sites/default/files/guidelines/<br>documents/pediatric‑arv/<br>guidelines-pediatric-arv.pdf</p>
<p>BIKTARVY, the BIKTARVY Logo, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.</p>
<p>© 2025 Gilead Sciences, Inc.<br>All rights reserved. US‑BVYP‑1190 05/25</p>
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