[{"_1":2,"_67":-5,"_68":-5},"loaderData",{"_3":4,"_12":13},"root",{"_5":-5,"_6":7,"_8":9,"_10":11},"user","recaptchaSiteKey","6Ler9Q4rAAAAAIntb4jBhAbPRXMJSQVneAzxg5M8","sentryTrace","43ffcd9d2ac20e5f654530181398c4b8-cbec595746be1a50-0","sentryBaggage","sentry-environment=production,sentry-public_key=fbef35ac88c344bffa6f98009cf3736c,sentry-trace_id=43ffcd9d2ac20e5f654530181398c4b8,sentry-org_id=4505908219871232,sentry-sampled=false,sentry-sample_rand=0.7040519429746175,sentry-sample_rate=0.5","routes/domain.$domainId",{"_14":15,"_63":64,"_5":-5,"_65":66},"domain",{"_16":17,"_14":18,"_19":20,"_21":22,"_23":24,"_25":26,"_27":28,"_29":-5,"_30":-5,"_31":-5,"_32":33,"_43":44,"_49":50,"_61":62},"id","cmhb5dj78000vl502tasfjwsm","www.biktarvyhcp.com","screenshotPath","sites/www.biktarvyhcp.com/screenshot.jpg","htmlPath","sites/www.biktarvyhcp.com/index.html","metaDescription","Find HCP info about BIKTARVY® (bictegravir, emtricitabine, tenofovir alafenamide). View full Prescribing Information, including BOXED WARNING.","importantText","BIKTARVY® Official HCP Website from Gilead | BIKTARVY® HCP \n\nSorry, your browser does not support JavaScript.\n\n[](#main-container)\n\n[Skip to main content](#main-bkv-content)\n\nThis information is intended for US healthcare professionals.\n\nContinue\n\n[Visit the patient site](https://www.biktarvy.com/)\n\n* [BIKTARVY Prescribing Information](https://www.gilead.com/~/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.pdf)\n* [DESCOVY Prescribing Information](https://www.gilead.com/~/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf?la=en)\n* [Important Safety Information](/important-safety-information)\n* [Patient Site](https://www.biktarvy.com/)\n* [Gilead Medical Information](https://www.askgileadmedical.com/)\n* [Register for Updates](/information-updates/)\n\n[Expert Insights](https://expertinsights.biktarvyhcp.com)\n\n[![BIKTARVY (bictegravir, emtricitabine, and tenofovir alafenamide) logo.](/img/biktarvy-logo.png)](/)\n\n* [Efficacy & Resistance](#)\n * [Treatment-Naïve Patients](/efficacy-resistance/treatment-naive)\n * [Virologically Suppressed Patients](/efficacy-resistance/virologically-suppressed)\n * [Clinical Trial Experience](/efficacy-resistance/clinical-trial-experience)\n * [Resistance Summary](/efficacy-resistance/resistance-summary)\n* [Safety & Tolerability](#)\n * [Adverse Reactions & Discontinuations](/safety-tolerability/treatment-naive)\n * [Contraindications & DDIs](/safety-tolerability/contraindications-ddis)\n * [Warnings & Precautions](/safety-tolerability/contraindications-ddis#warnings-precautions)\n* [About BIKTARVY](#)\n * [Dosing & Administration](/dosing-administration/dosing)\n * [Early Treatment Initiation](/about-biktarvy/early-treatment)\n * [Components & MOA](/about-biktarvy/components-moa)\n* [HIV Considerations](#)\n * [Risk of Resistance](/treatment-considerations/barrier-to-resistance)\n * [HIV and Aging](/treatment-considerations/aging-plwh)\n * [Starting HIV Treatment Early](/treatment-considerations/hiv-treatment)\n * [Optimizing Treatment](/treatment-considerations/optimizing-regimens)\n * [Adherence Considerations](/treatment-considerations/adherence-considerations)\n* [Access](/support/cost-assistance)\n\nClose\n\n* [DESCOVY Prescribing Information](https://www.gilead.com/~/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf?la=en)\n* [Visit Patient Site](https://www.biktarvy.com/)\n* [Gilead Medical Information](https://www.askgileadmedical.com)\n* [Register for Updates](/information-updates/)\n* [Expert Insights](https://expertinsights.biktarvyhcp.com)\n\n ![Theron holding 2 dogs.](/img/carousel/mobile/theron-holding-dogs.png)\n\nTHERON, 66 \nUNDETECTABLE \n4 YEARSONBIKTARVY®\n\nFor today, tomorrow, and the days to come\n=========================================\n\nPeople featured are compensated by Gilead.\n\n ![Zach is holding a baby.](/img/carousel/mobile/zach-holding-baby.png)\n\nZACH, 37 \nUNDETECTABLE \n5 YEARSONBIKTARVY®\n\nFor today, tomorrow, and the days to come\n=========================================\n\nPeople featured are compensated by Gilead.\n\n ![Elias is staring behind and smiling.](/img/carousel/mobile/elias-staring-smiling.png)\n\nELIAS, 42 \nUNDETECTABLE \n6 YEARSONBIKTARVY®\n\nFor today, tomorrow, and the days to come\n=========================================\n\nPeople featured are compensated by Gilead.\n\n ![Tamera and a man are smiling at one another.](/img/carousel/mobile/tamera-man-smiling.png)\n\nTAMERA, 32 \nUNDETECTABLE \n6 YEARSONBIKTARVY®\n\nFor today, tomorrow, and the days to come\n=========================================\n\nPeople featured are compensated by Gilead.\n\nResistance Data Across 9 Clinical Trials\n\n[Explore the BIKTARVY resistance overview](/efficacy-resistance/resistance-summary)\n\nLong-Term Treatment-Naïve Efficacy Data\n\n[Discover BIKTARVY 5-year efficacy data](/efficacy-resistance/treatment-naive)\n\n5-Year Long-Term Safety and Tolerability Profile\n\n[Explore BIKTARVY safety data](/safety-tolerability/treatment-naive)\n\n### Learn More About Key Patient Populations\n\nReal-World Data in Treatment-Naïve and Treatment-Experienced Adults, Including Individuals With ART History and Not Virologically Suppressed\n\n[Explore the BICSTaR Study](/documents/hiv-treatment-real-world-study.pdf)\n\nPeople With HIV Aged 50 and Older\n\n[Explore BIKTARVY clinical trial data](/documents/eng_pwh_50_hcp_brochure.pdf)\n\n### 6 YEARS AS THE #1 PRESCRIBED REGIMEN FOR PEOPLE STARTING AND SWITCHING HIV-1 TREATMENT\n\nFueled by the power of bictegravir1\n\nSOURCE: _IQVIA LAAD,_ July 2018 through July 2024\\*\n\n![Real conversations logo.](/img/home/real-conversations-logo.png)\n\nHear from key opinion leaders, **Joel E. Gallant**, **MD**, **MPH**, and **Calvin J. Cohen**, **MD**, **MSc**, as they discuss the events that shaped the way providers approach HIV treatment. Dr. Cohen is an employee of Gilead. Dr. Gallant is a former employee of Gilead.\n\n Your browser does not support the video tag.\n\n### See Dr. Joel Gallant and Dr. Calvin Cohen discuss more HIV topics:\n\n [![The Threat of Resistance video play button.](/img/home/video-callouts/resistance-play-video-button.png) ![](/img/icons/play-button.svg)\n\nResistance](/treatment-considerations/barrier-to-resistance#resistance)\n\n [![Initiating HIV Treatment Early video play button.](/img/home/video-callouts/initiating-treatment-early-play-video-button.png) ![](/img/icons/play-button.svg)\n\nEarly Treatment Initiation](/treatment-considerations/hiv-treatment#initiating-treatment-early)\n\n [![HIV Treatment Optimization video play button.](/img/home/video-callouts/hiv-treatment-optimization-play-video-button.png) ![](/img/icons/play-button.svg)\n\nTreatment Optimization](/treatment-considerations/optimizing-regimens#treatment-optimization)\n\n [![The Importance of Viral Suppression video play button.](/img/home/video-callouts/viral-suppression-play-video-button.png) ![](/img/icons/play-button.svg)\n\nDurable Viral Suppression](/treatment-considerations/aging-plwh#aging)\n\n\\*This information is an estimate derived from the use of information under license from the following IQVIA information service: _IQVIA LAAD,_ for the period of July 2018 through July 2024. IQVIA expressly reserves all rights, including rights of copying, distribution, and republication.\n\n**Reference: 1.** Data on file. Gilead Sciences, Inc.\n\nINDICATION\n----------\n\nBIKTARVY® 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.\n\nTap for Important Safety Information, including **BOXED WARNING** for post treatment acute exacerbation of hepatitis B infection.\n\nINDICATION\n----------\n\nBIKTARVY® 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.\n\nImportant Safety Information\n----------------------------\n\nBOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B\n---------------------------------------------------------------\n\n* **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.**\n\nContraindications\n-----------------\n\n* **Coadministration:** Do not use BIKTARVY with dofetilide or rifampin.\n\nWarnings and precautions\n------------------------\n\n* **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.\n* **Immune reconstitution syndrome,** including the occurrence of autoimmune disorders with variable time to onset, has been reported.\n* **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. \n _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.\n* **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.\n\nAdverse reactions\n-----------------\n\n* **Most common adverse reactions** (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).\n\nDrug interactions\n-----------------\n\n* **Prescribing information:** Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.\n* **Enzymes/transporters:** 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.\n* **Drugs affecting renal function:** 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.\n\nDosage and administration\n-------------------------\n\n* **Dosage:** Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 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.\n* **Renal impairment:** 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.\n* **Hepatic impairment:** Not recommended in patients with severe hepatic impairment.\n* **Prior to or when initiating:** Test patients for HBV infection.\n* **Prior to or when initiating, and during treatment:** As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.\n\nPregnancy and lactation\n-----------------------\n\n* **Pregnancy:** 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.\n* **Lactation:** Individuals with HIV-1 should be informed of the potential risks of breastfeeding.\n\nPlease see full Prescribing Information for [BIKTARVY®](https://www.gilead.com/~/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.pdf) and [DESCOVY®](https://www.gilead.com/~/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf?la=en), including **BOXED WARNINGS**.\n\nINDICATION\n----------\n\nBIKTARVY® 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.\n\nImportant Safety Information\n----------------------------\n\nBOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B\n---------------------------------------------------------------\n\n* **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.**\n\nContraindications\n-----------------\n\n* **Coadministration:** Do not use BIKTARVY with dofetilide or rifampin.\n\nWarnings and precautions\n------------------------\n\n* **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.\n* **Immune reconstitution syndrome,** including the occurrence of autoimmune disorders with variable time to onset, has been reported.\n* **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. \n _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.\n* **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.\n\nAdverse reactions\n-----------------\n\n* **Most common adverse reactions** (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).\n\nDrug interactions\n-----------------\n\n* **Prescribing information:** Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.\n* **Enzymes/transporters:** 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.\n* **Drugs affecting renal function:** 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.\n\nDosage and administration\n-------------------------\n\n* **Dosage:** Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 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.\n* **Renal impairment:** 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.\n* **Hepatic impairment:** Not recommended in patients with severe hepatic impairment.\n* **Prior to or when initiating:** Test patients for HBV infection.\n* **Prior to or when initiating, and during treatment:** As clinically appropriate, assess serum creatinine, CrCl, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, assess serum phosphorus.\n\nPregnancy and lactation\n-----------------------\n\n* **Pregnancy:** 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.\n* **Lactation:** Individuals with HIV-1 should be informed of the potential risks of breastfeeding.\n\nPlease see full Prescribing Information for [BIKTARVY®](https://www.gilead.com/~/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.pdf) and [DESCOVY®](https://www.gilead.com/~/media/files/pdfs/medicines/hiv/descovy/descovy_pi.pdf?la=en), including **BOXED WARNINGS**.\n\n* [Privacy Policy](https://www.gilead.com/privacy-statements)\n* [Consumer Health Data Privacy Policy](https://www.gilead.com/privacy-statements/consumer-health-data-privacy-policy)\n* [Terms of Use](https://www.gilead.com/terms-of-use)\n* [Contact Us](https://www.gilead.com/utility/contact)\n* [Site Map](/sitemap)\n\n[![Gilead logo.](/img/gilead-logo.svg)](https://www.gilead.com)\n\nThe information contained on this site is intended for healthcare provider audiences in the United States only. The content on this site may not apply to non-US audiences as regulatory control, legal requirements, and/or medical practices may vary in other countries.\n\nBIKTARVY, BIKTARVY ANYWHERE, the BIKTARVY Logo, the BIKTARVY Tablet, BIKTARVY TODAY, ADVANCING ACCESS, DESCOVY, FOR TODAY, TOMORROW, AND THE DAYS TO COME, GILEAD, the GILEAD Logo, GSI, and 9883 are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.\n\n© 2025 Gilead Sciences, Inc. All rights reserved. US-BVYP-1341 10/25\n\nYou are leaving the BIKTARVY® website.\n\n[Leave site](#) [Go back](#)\n\nYou are leaving the BIKTARVY® website. \nA new window is opening.\n\n[Continue](#) [Go back](#)\n\nFDA\n\n![](/img/home/approved.png)\n\nwith an **expanded Indication**\n\n[Learn more](/efficacy-resistance/virologically-suppressed)\n\nPlease see the full Prescribing Information for BIKTARVY®, including the **BOXED WARNING**.\n\n![](/img/biktarvy-logo.png)\n\n[Learn more](#)\n\nNow FDA Approved With An\n\n![Expanded Indication](/img/home/expanded@2x.png)\n\nExplore if more of your patients may be appropriate for BIKTARVY®.\n\n[Learn more](/documents/eng_expanded_indication_hcp_flashcard.pdf)\n\nPlease click for the full [Prescribing Information](https://www.gilead.com/~/media/files/pdfs/medicines/hiv/biktarvy/biktarvy_pi.pdf) for BIKTARVY®, including the **BOXED WARNING**.\n\n![](/img/biktarvy-logo.png)\n\n \n\n ![](https://px.deepintent.com/pixel.gif?id=a31a505a9b) \n\nWe may utilize tracking technologies such as cookies and pixels to process personal data in order to enhance your experience on our site and to analyze performance and traffic. 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www.biktarvyhcp.com

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