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Register for a webinar to learn more. See full Prescribing Information, including BOXED WARNING.","importantText","BIKTARVY® (bictegravir/emtricitabine/tenofovir alafenamide) HCP | Expert Insights \n\n \n\nBIKTARVY® (bictegravir/emtricitabine/tenofovir alafenamide) HCP | Expert Insights\n=================================================================================\n\n[Skip to main content](#mainBody)\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](https://www.biktarvyhcp.com/important-safety-information)\n* [Patient Site](https://www.biktarvy.com/)\n* [Gilead Medical Information](https://www.askgileadmedical.com/)\n* [Register for Updates](https://www.biktarvyhcp.com/information-updates/)\n\n[Expert Insights](/)\n\n[![BIKTARVY® (bictegravir, emtricitabine, and tenofovir alafenamide) tablets.](/-/media/project/p2phub/p2pbiktarvyhcp/header/biktarvy-bictegravir-emtricitabine-and-tenofovir-alafenamide-logo.png?iar=0&hash=30F0172AF3C3C6C8D434C76BEC19AB3C)](https://www.biktarvyhcp.com/)\n\n* [Efficacy & Resistance](#)\n * [Treatment-Naïve Patients](https://www.biktarvyhcp.com/efficacy-resistance/treatment-naive)\n * [Virologically Suppressed Patients](https://www.biktarvyhcp.com/efficacy-resistance/virologically-suppressed)\n * [Clinical Trial Experience](https://www.biktarvyhcp.com/efficacy-resistance/clinical-trial-experience)\n * [Resistance Summary](https://www.biktarvyhcp.com/efficacy-resistance/resistance-summary)\n* [Safety & Tolerability](#)\n * [Adverse Reactions & Discontinuations](https://www.biktarvyhcp.com/safety-tolerability/treatment-naive)\n * [Contraindications & DDIs](https://www.biktarvyhcp.com/safety-tolerability/contraindications-ddis)\n * [Warnings & Precautions](https://www.biktarvyhcp.com/safety-tolerability/contraindications-ddis#warnings-precautions)\n* [About BIKTARVY](#)\n * [Dosing & Administration](https://www.biktarvyhcp.com/dosing-administration/dosing)\n * [Early Treatment Initiation](https://www.biktarvyhcp.com/about-biktarvy/early-treatment)\n * [Components & MOA](https://www.biktarvyhcp.com/about-biktarvy/components-moa)\n* [HIV Considerations](#)\n * [HIV Treatment Considerations](https://www.biktarvyhcp.com/treatment-considerations/hiv-treatment)\n * [Optimizing Treatment](https://www.biktarvyhcp.com/treatment-considerations/optimizing-regimens)\n * [HIV and Aging](https://www.biktarvyhcp.com/treatment-considerations/aging-plwh)\n* [Access](https://www.biktarvyhcp.com/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](https://www.biktarvyhcp.com/information-updates/)\n* [Expert Insights](/)\n\nExpert Insights\n===============\n\nA BIKTARVY® Information Exchange: \nTopics About HIV Treatment\n\nThe treatment of HIV has been continually evolving over the past decades. Join leading HIV clinicians as they discuss crucial insights to HIV treatment and review the clinical data for BIKTARVY. Register for a webinar below to learn more about their experiences and strategies to help support patients.\n\n### Upcoming BIKTARVY Webinars\n\nKey Insights From the BICSTaR Study: Real-World Data Featuring BIKTARVY® Data in Treatment-Naïve and Treatment-Experienced Adults, Including Individuals With ART History Who Were Not Virologically Suppressed\n\nJoseph Gathe, FACP, MD, FIDSA Thursday, December 4, 2025, 12:00 PM CT\n\n![Register for Live Virtual Event](https://custom.cvent.com/4ABEC95C0FDD44DE8139166872AE9CF5/files/event/fda7ee0c4277485587ce0ed3ce1cd177/60c2e38a40a142759b646a559f6ab46c.png)\n\nStaying engaged in care can be challenging for many adults with HIV. This webinar reviews real-world data for BIKTARVY from the BICSTaR study in treatment-naïve and treatment-experienced adults, including those with prior ART history who were not virologically suppressed, and highlights data on effectiveness, safety, resistance, and patient-reported outcomes.\n\n[Register](/register?event_id=LJhQ2p/QoueV0QPZ5rZvIbm9HT1IcnAF51305/NG+1u0YEg07wG/jzlNgRRwWNKm)\n\nThese non-CME educational programs and speakers are sponsored by Gilead Sciences, Inc.\n\n### Digital Library\n\n![Real conversations logo.](/-/media/project/p2phub/p2pbiktarvyhcp/video/real-conversations.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, and Dr. Gallant is a former employee of Gilead.\n\nContents\n--------\n\n(0:04)\n\n### Introduction\n\n(0:23)\n\n### HIV Impact\n\n(0:50)\n\n### Dr. Gallant’s Story\n\n(1:20)\n\n### Antiretrovirals\n\nTranscript\n----------\n\n##### Introduction \\[0:04\\]\n\nI was a medical student, starting school in, here in San Francisco at UCSF in 1981. I recall being in medical school in the early ’80s just about the beginning of when we started to hear this bad news grumbling about this mysterious illness that was killing young men.\n\n \n\n##### HIV Impact \\[0:23\\]\n\nYou saw people on the streets who were emaciated covered with Kaposi sarcoma lesions with walkers. Death was everywhere. We had no idea what we were up against, we had no idea the size or shape of it if this was going to be temporary for a few months or what it obviously turned out to be.\n\n \n\n##### Dr. Gallant’s Story \\[0:50\\]\n\nFor me as a, as a gay man who had been at risk and was untested, every day was terrifying. And, and so many of my patients were just reminders that they were no different than I was. In the early ‘90s, patients became friends, friends became patients, and...sometimes I don’t remember which, in which order that happened. But all of us had those patients.\n\n \n\n##### Antiretrovirals \\[1:20\\]\n\nIt was the summer of 1996 and we were at yet another international AIDS conference this one in beautiful Vancouver, Canada. At that meeting, a few studies were presented to us that showed us something that the field hadn’t seen before, which was durable suppression of HIV for 48 weeks on a combination of three antivirals and at least acceptable toxicities. 1996 was a landmark year. We could now measure viral load and we could measure resistance. Instead of HIV winning and creating resistance to everything we threw at it, the antivirals were winning, we were winning. And we were able to stop HIV from growing and it wasn’t just for weeks, it was for a year. And it was exhilarating. I remember the first patient whose viral load came back undetectable. I had just gotten back from the Vancouver AIDS Conference. I remember getting that viral load report back, along with all my other stack of labs and it was the first time I had ever seen an undetectable viral load. And this guy was, he was a friend as well as a patient. I called him up and I said, “You’re not going to believe this, your viral load is undetectable.” And he started crying at work and then I started crying in my office and it was just tears of joy of course. And he’s still doing well to this day.\n\n### See Dr. Joel Gallant and Dr. Calvin Cohen discuss more HIV topics:\n\n![Watch Dr. Joel Gallant discuss the importance of remembering the basic principles of preventing resistance from early years of HIV treatment.](/-/media/project/p2phub/p2pbiktarvyhcp/cards/the-threat-of-resistance.png?h=432&iar=0&w=768&hash=94B2F028E6835A38241FFCE1B0023F3F)\n\n“Once you develop resistance, it’s there forever.” **Dr. Joel Gallant** comments on the importance of remembering the basic principles of preventing resistance from early years of HIV treatment.\n\n[The Threat of Resistance](https://www.biktarvyhcp.com/treatment-considerations/hiv-treatment#resistance)\n\n![Watch Dr. Joel Gallant and Dr. Calvin Cohen discuss clinical, social, and community-level factors that influence the achievement of durable viral suppression.](/-/media/project/p2phub/p2pbiktarvyhcp/cards/the-importance-of-viral-suppression.png?h=432&iar=0&w=768&hash=70CF01B3281A1D2A31C7F88B62D63CBA)\n\n**Dr. Joel Gallant** and **Dr. Calvin Cohen** discuss clinical, social, and community-level factors that influence the achievement of durable viral suppression. [The Importance of Viral Suppression](https://www.biktarvyhcp.com/treatment-considerations/hiv-treatment#durable-viralsuppresion)\n\n![Listen to Dr. Joel Gallant and Dr. Calvin Cohen as they reflect on the importance of early treatment initation and how it changed the conversation with their patients. ](/-/media/project/p2phub/p2pbiktarvyhcp/cards/initiating-treament-early.png?h=394&iar=0&w=701&hash=2D8A48E2406351E2A8F7DF5D11B94F57)\n\nListen to Dr. Joel Gallant and Dr. Calvin Cohen as they reflect on the importance of early treatment initiation and how it changed the conversation with their patients. [Early Treatment Initiation](https://www.biktarvyhcp.com/treatment-considerations/hiv-treatment#initiating-treatment-early)\n\n![Watch how having conversations around treatment optimization can help providers and patients who are assessing their options.](/-/media/project/p2phub/p2pbiktarvyhcp/cards/discussing-treatment-optimization-with-your-patients.png?h=394&iar=0&w=700&hash=C671B5D68E7EB9E4013928908747D426)\n\nHaving conversations around optimizing regimens can help providers and patients who are assessing their options. [Treatment Optimization](https://www.biktarvyhcp.com/treatment-considerations/optimizing-regimens#treatment-optimization)\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&hash=C7A061BEEFC8F2C0B176303D02DA1D95), 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 who are coinfected with HIV-1 and HBV and 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 who are coinfected with HIV-1 and HBV and 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&hash=C7A061BEEFC8F2C0B176303D02DA1D95), 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](https://www.biktarvyhcp.com/sitemap)\n\n[![Gilead Logo](/-/media/project/p2phub/p2pbiktarvyhcp/footer/gilead-logo.svg?iar=0&hash=6FD303F08BF154476ED2A9787057E2D5)](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. 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