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BIKTARVY (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets)
#1 prescribed regimen for HIV-1 treatment. Source: Ipsos Healthcare US HIV Therapy Monitor & Scope Study May-July 2019.
 
 Reduce pill burden with BIKTARVY® 
 
 
BIKTARVY - 30 pills per month vs FTC/TAF+DTG - 60 pills per month
 
 
 Pills are not actual size. 
 
 These charts do not include the complete prescribing and dosing considerations, use in specific populations, or laboratory monitoring requirements for using these medications. Please refer to the full Prescribing Information for each medication. Comparison of agents does not imply comparable clinical effectiveness, safety, or tolerability. 
 
 
 Dear {{customText[Dr.|Mr.|Mrs.|Ms.|]}} {{accFname}} {{accLname}}, {{customText[MD,|DO,|PharmD,|PA,|NP,|]}} 
 
 {{customText[I’m looking forward to discussing how your patients could benefit from BIKTARVY.|I’m excited to have the chance to talk to you about BIKTARVY.|Thanks for taking the time to meet with me.|I’m glad we had the opportunity to discuss BIKTARVY.|I’d like to discuss how BIKTARVY may help your patients.|I hope to schedule some time to talk about BIKTARVY with you.]}} 
 
 {{customText[Please take a look at the information below ahead of our meeting.|To get started, I’ve included some important points about how BIKTARVY, with once-­daily dosing, may reduce your patients’ pill burden.|To continue our discussion, I’d like you to consider how the triple-­therapy STR, BIKTARVY, may reduce your patients’ pill burden.|I wanted to follow up with some key points about simple dosing with BIKTARVY.|Below you will find some information about BIKTARVY that I think will be helpful for your patients.|I’m eager to share information about simple dosing with BIKTARVY.]}} 
 
 BIKTARVY is a powerful triple-therapy STR packed in a small pill that combines the DESCOVY (FTC/TAF)* backbone with bictegravir, a novel and unboosted INSTI.1,2,5 
 
 Simple Dosing With BIKTARVY1 
 
 
Once-Daily STRNo Food Requirement
Taken Any Time of DayNo Booster
 
 
 *emtricitabine 200 mg/tenofovir alafenamide 25 mg 
 
 Counseling Patients1 
 
 
‣BIKTARVY is not recommended in patients with severe renal impairment (estimated CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh Class C)
 
‣Prior to or when initiating BIKTARVY, test patients for HBV infection
 
‣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
 
 
 
 
One prescription,
one co-pay†
 
†Individual coverage may vary.
 
 
 What could simple dosing mean
for your patients?
 
 
 INDICATIONS 
 
 BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥25 kg who have no antiretroviral (ARV) treatment history 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 history of treatment failure and no known resistance to any component of BIKTARVY. 
 
 DESCOVY®, a component of BIKTARVY, is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in patients weighing at least 35 kg. 
 
 IMPORTANT SAFETY INFORMATION FOR BIKTARVY AND DESCOVY 
 
 BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B 
 
 
‣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 or DESCOVY. 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 or DESCOVY. If appropriate, anti-hepatitis B therapy may be warranted.
 
 
 Contraindications 
 
 Contraindications for BIKTARVY: 
 
 
‣Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
 
 
 Warnings and precautions 
 
 Warnings and precautions for BIKTARVY and DESCOVY: 
 
 
‣Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
 
 
 Please see below for additional Important Safety Information for BIKTARVY and DESCOVY. 
 
 
 IMPORTANT SAFETY INFORMATION FOR BIKTARVY AND DESCOVY (cont’d) 
 
 Warnings and precautions (cont’d) 
 
 Warnings and precautions for BIKTARVY and DESCOVY (cont’d): 
 
 
‣New onset or worsening renal impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of emtricitabine and tenofovir alafenamide (TAF) with other ARVs, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate in patients with estimated creatinine clearance (CrCl) <30 mL/min. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Prior to or when initiating 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 if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.
 
 
 Additional warnings and precautions for BIKTARVY: 
 
 
‣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.
 
 
 Adverse reactions 
 
 Adverse reactions for BIKTARVY: 
 
 
‣Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%).
 
 
 Adverse reactions for DESCOVY: 
 
 
‣Most common adverse reaction (incidence ≥10%; all grades) in clinical studies was nausea (10%).
 
 
 Drug interactions 
 
 Drug interactions for BIKTARVY and DESCOVY: 
 
 
‣Prescribing information: Consult the full prescribing information for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments.
 
 
‣Drugs affecting renal function: Coadministration 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.
 
 
 Additional drug interactions for BIKTARVY: 
 
 
‣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.
 
 
 Additional drug interactions for DESCOVY: 
 
 
‣Metabolism: Drugs that inhibit P-gp can increase the concentrations of components of DESCOVY. Drugs that induce P-gp can decrease the concentrations of components of DESCOVY, which may lead to loss of efficacy and development of resistance.
 
 
 Dosage and administration 
 
 Information for BIKTARVY: 
 
 
‣Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food.
 
 
 Information for DESCOVY: 
 
 
‣Dosage: Patients weighing ≥35kg: 1 tablet taken once daily with or without food.
 
 
 Information for BIKTARVY and DESCOVY: 
 
 
‣Renal impairment: Not recommended in patients with CrCl <30 mL/min.
‣Prior to or when initiating: Test patients for HBV infection.
‣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.
 
 
 Additional information for BIKTARVY: 
 
 
‣Hepatic impairment: Not recommended in patients with severe hepatic impairment.
 
 Pregnancy and lactation 
 
 Information for BIKTARVY and DESCOVY: 
 
 
‣Pregnancy: There is insufficient human data on use during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for FTC shows no difference in the rates of birth defects compared with a US reference population.
‣Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission.
 
 
 Please click to view full Prescribing Information for BIKTARVY and DESCOVY, including BOXED WARNINGS. 
 
 {{customText[Please let me know if you would like any additional materials about BIKTARVY before we meet.|Looking forward to our upcoming conversation about BIKTARVY. Please feel free to reach out if you have any questions.|It was great to see you. Let me know if I can provide any additional information about BIKTARVY.|There's much more to discuss about BIKTARVY—please let me know when a good time would be to continue the conversation.|I hope we can meet in the near future. Please let me know when we can connect at your earliest convenience.|Please reach out if you have any questions, or if there's other information about BIKTARVY that I can provide.]}} 
 
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BIKTARVY TODAY iconA free trial of BIKTARVY may be available for your appropriate patients. Talk to your Gilead Sales Representative for more information, including important steps to getting started with BIKTARVY TODAY™ 
 
 
 DTG, dolutegravir; FTC, emtricitabine; HBV, hepatitis B virus; INSTI, integrase strand transfer inhibitor; STR, single-tablet regimen; TAF, tenofovir alafenamide. 
 
 References: 1. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2019. 2. Data on file. Gilead Sciences, Inc. 3. DESCOVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017. 4. TIVICAY [package insert]. Research Triangle Park, NC: ViiV Healthcare group of companies; 2019. 5. Tsiang M, Jones GS, Goldsmith J, et al. Antiviral activity of bictegravir (GS-9883), a novel potent HIV-1 integrase strand transfer inhibitor with an improved resistance profile. Antimicrob Agents Chemother. 2016;60(12):7086-7097.  
 
 BIKTARVY (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg tablets) 
 
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BIKTARVY, the BIKTARVY Logo, BIKTARVY TODAY, DESCOVY, GSI, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks referenced herein are the property of their respective owners. 
 
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