| {{customText[Find out about co-pay support and how it may help your patients|Provide information about available co-pay support]}} | {{customText[Find out about co-pay support and how it may help your patients|Provide information about available co-pay support]}} |
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| | | Reliable Access for Your Patients | | |
| | | | | | | {{customText[Dear|Hello,|Hi,|Good morning,|Good afternoon,|Good evening,]}} {{customText[Dr.|Mr.|Mrs.|Ms.|Prof.|]}} {{accFname}} {{accLname}}, {{customText[MD:|PharmD:|PA:|NP:|DO:|]}} | | {{customText[I'm looking forward to providing an overview of Gilead's Advancing Access co-pay support program.|I would like to discuss the co-pay support options available that help eligible patients access BIKTARVY.|I’m glad we had a chance to talk about how the Advancing Access co-pay support program helps eligible patients access BIKTARVY.|Thank you for taking the time to discuss the co-pay support program that may help cover BIKTARVY for your eligible patients.|Hope to connect with you in the near future to discuss the co-pay support option available to help eligible patients access BIKTARVY.|I would like to schedule some time to meet with you and discuss the co-pay support program available to eligible patients.]}} | | {{customText[To get started, I’ve included some information below.|Here is some key information I would like to share ahead of our meeting.|To further our conversation, I would like to provide an overview of the co-pay support program.|As a follow-up, I wanted to highlight some of the key points from our meeting.|Here are some key points about the Advancing Access program's co-pay support that may be helpful to your practice.|Below is an outline of the co-pay support program that helps ensure broad access to BIKTARVY.]}} |  | | | | Cost should never be a barrier to access. Whether they're insured or not insured, BIKTARVY could cost as little as $0 for your eligible patients with Gilead's Advancing Access program. | | | | | | | ~95% of commercially insured enrolled patients pay $0 with our BIKTARVY Copay Coupon Assistance |
| | | | | | | Two options for getting patients started: | | | | | |  | Appropriate patients can get a free trial of BIKTARVY through the BIKTARVY TODAY® sampling program |
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| | | | | | INDICATION | | 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. |
| IMPORTANT SAFETY INFORMATION |
| 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. 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. |
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| Contraindications | | Coadministration: Do not use BIKTARVY with dofetilide or rifampin. |
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| Warnings and precautions | | 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. |
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| | | | | | | Please see below for additional Important Safety Information for BIKTARVY. |
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| | | | Reliable Access for Your Patients | | |
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| | | | | | INDICATION | | 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. |
| IMPORTANT SAFETY INFORMATION |
| 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. 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. |
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| | | | | | | Please see below for additional Important Safety Information for BIKTARVY. |
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| | | | | | | | | | | {{customText[Dear|Hello,|Hi,|Good morning,|Good afternoon,|Good evening,]}} {{customText[Dr.|Mr.|Mrs.|Ms.|Prof.|]}} {{accFname}} {{accLname}}, {{customText[MD:|PharmD:|PA:|NP:|DO:|]}} | | {{customText[I'm looking forward to providing an overview of Gilead's Advancing Access co-pay support program.|I would like to discuss the co-pay support options available that help eligible patients access BIKTARVY.|I’m glad we had a chance to talk about how the Advancing Access co-pay support program helps eligible patients access BIKTARVY.|Thank you for taking the time to discuss the co-pay support program that may help cover BIKTARVY for your eligible patients.|Hope to connect with you in the near future to discuss the co-pay support option available to help eligible patients access BIKTARVY.|I would like to schedule some time to meet with you and discuss the co-pay support program available to eligible patients.]}} | | {{customText[To get started, I’ve included some information below.|Here is some key information I would like to share ahead of our meeting.|To further our conversation, I would like to provide an overview of the co-pay support program.|As a follow-up, I wanted to highlight some of the key points from our meeting.|Here are some key points about the Advancing Access program's co-pay support that may be helpful to your practice.|Below is an outline of the co-pay support program that helps ensure broad access to BIKTARVY.]}} | | | | | Cost should never be a barrier to access. Whether they're insured or not insured, BIKTARVY could cost as little as $0 for your eligible patients with Gilead's Advancing Access program. | | | | | | | ~95% of commercially insured enrolled patients pay $0 with our BIKTARVY Copay Coupon Assistance |
| | | | | | | Two options for getting patients started: | | | | | | | Appropriate patients can get a free trial of BIKTARVY through the BIKTARVY TODAY® sampling program |
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| | | | | | IMPORTANT SAFETY INFORMATION (cont’d) |
| | Contraindications | | Coadministration: Do not use BIKTARVY with dofetilide or rifampin. |
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| | Warnings and precautions (cont’d) | | 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. |
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| Warnings and precautions | | 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. |
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| | Adverse reactions | | Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). |
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| | Drug interactions | | Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. | | 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. | | 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. |
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| | Dosage and administration | | Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food. | | Renal impairment: 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. | | Hepatic impairment: Not recommended in patients with severe hepatic impairment. | | 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. |
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| | Pregnancy and lactation | | Pregnancy: There is insufficient human data on the use of BIKTARVY 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. |
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| | Please click to view full Prescribing Information for BIKTARVY, including BOXED WARNING. | | {{customText[I hope this information has been helpful. Please feel free to reach out if you have any questions before we meet.|Looking forward to our upcoming conversation about BIKTARVY and the Advancing Access co-pay support program.|It was great to see you. Let me know if I can provide any additional information about BIKTARVY and co-pay support for your patients.|Let’s connect again soon. In the meantime, please reach out if you have any questions about co-pay support.|Looking forward to discussing the co-pay support options available to help eligible patients with coverage of BIKTARVY.|I hope to talk with you soon about how the Advancing Access co-pay support program helps provide broad access to BIKTARVY.]}} | | {{customText[Best regards,|Sincerely,|Thank you,|Thanks again,|Talk with you soon,]}} | | {{userName}} | | {{userEmailAddress}} | | {{customText(25)}} | | {{customText(25)}} | | | |  | Learn more about the Advancing Access® program |  |
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