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| Dear{{customText[ Dr. | |]}}{{accFname}} {{accLname}},
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{{customText[I am happy to announce that BIKTARVY is now available for your patients.|I am excited to talk about the recent FDA approval of BIKTARVY.|It was great catching up with you and getting the chance to discuss BIKTARVY.|Thanks for taking the time to meet with me about the latest treatment from Gilead Sciences.|I'd like to connect with you soon to talk about a new treatment option: BIKTARVY.|I'd like to talk to you about which of your patients BIKTARVY is appropriate for.]}}
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{{customText[I'm including some information about BIKTARVY that I think may be relevant for your practice.|Below you will see some important information about BIKTARVY that I think you will find interesting.|As a continuation of our discussion, I would like to remind you about some of the key attributes of BIKTARVY.|I enjoyed discussing the clinical profile of BIKTARVY with you. Below is a recap of some of the key points we reviewed.|It was great talking with you about BIKTARVY. I wanted to share some more details about this new treatment that I think you may find interesting.|I'm excited to announce the FDA approval of BIKTARVY and would appreciate the opportunity to discuss this new treatment in more detail with you.]}}
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| Please click to view full Prescribing Information for BIKTARVY® and DESCOVY®, including BOXED WARNINGS.
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BIKTARVY® Combines the DESCOVY® (FTC/TAF)* Backbone With Bictegravir, a Novel and Unboosted INSTI1,2
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| INDICATION |
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BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection in adults 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 for ≥3 months with no history of treatment failure and no known resistance to any component of BIKTARVY. |
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| IMPORTANT SAFETY INFORMATION |
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| BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B |
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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.
Please see below for additional Important Safety Information for BIKTARVY. |
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BIKTARVY Has Been Studied in Four Phase 3 Clinical Trials in More Than 1200 Patients1,3-5 |
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Treatment-Naïve Adults
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| STUDY 1489 |
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STUDY 1490 |
BIKTARVY (n=314)
vs
ABC/DTG/3TC
(n=315)
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BIKTARVY (n=320)
vs
FTC/TAF+DTG
(n=325)
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| Virologically Suppressed Adults
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| (HIV-1 RNA <50 copies/mL) |
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| STUDY 1844 |
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STUDY 1878 |
Switched to BIKTARVY
(n=282) or continued on
ABC/DTG/3TC
(n=281)
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Switched to BIKTARVY
(n=290) or stayed on
baseline regimen†
(n=287)
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| BIKTARVY has an extensive clinical trial program with studies in a broad range of patients, including those of various age groups and ethnicities.
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| To learn more about the clinical trial results for treatment-naïve and virologically suppressed adults taking BIKTARVY, visit biktarvyhcp.com. |
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| IMPORTANT SAFETY INFORMATION (cont'd) |
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| Contraindications |
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Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
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Simple Dosing with BIKTARVY1 |
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Once-Daily
STR
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Taken Any
Time of Day
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No Food
Requirement
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No Booster
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| Not actual size. |
| Actual size is 15 mm x 8 mm.5 |
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BIKTARVY is not recommended in patients with severe renal impairment (estimated CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh Class C) |
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| IMPORTANT SAFETY INFORMATION (cont'd) |
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| Warnings and precautions |
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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. |
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Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported. |
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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 BIKTARVY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Do not initiate BIKTARVY 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 BIKTARVY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. |
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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, also assess serum phosphorus. |
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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 |
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Most common adverse reactions (incidence ≥5%; all grades) in clinical studies were diarrhea (6%), nausea (5%), and headache (5%). |
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| Drug interactions |
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Prescribing information: Consult the full prescribing information for BIKTARVY for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. |
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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. |
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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 |
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Dosage: 1 tablet taken once daily with or without food. |
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Renal impairment: Not recommended in patients with CrCl <30 mL/min. |
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Hepatic impairment: Not recommended in patients with severe hepatic impairment. |
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Prior to or when initiating: Test patients for HBV infection. |
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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 |
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Pregnancy: There is insufficient human data on the use of BIKTARVY during pregnancy. 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. |
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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 and DESCOVY, including BOXED WARNINGS. |
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{{customText[BIKTARVY is a novel treatment option for your appropriate patients. I look forward to discussing it with you further.|I hope this has captured your interest! Please feel free to reach out if you have any questions before we meet.|I am happy we were able to connect. Let me know if I can provide any additional information about BIKTARVY.|Please reach out if you have questions or would like more information about BIKTARVY.|I hope we can meet soon to discuss the approval of BIKTARVY. Please reach out to set up an appointment.|I look forward to connecting with you soon and having a conversation about BIKTARVY.]}}
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{{customText[Best,|Best regards,|Regards,|Sincerely,|Thanks,|Thank you,|Cheers,]}}
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*emtricitabine 200 mg/tenofovir alafenamide 25 mg.
†ABC/3TC or FTC/TDF + boosted ATV or DRV regimen (cobicistat or ritonavir).
3TC, lamivudine; ABC, abacavir; ATV, atazanavir; CrCl, creatinine clearance; DRV, darunavir; DTG, dolutegravir; FTC, emtricitabine; INSTI, integrase strand transfer inhibitor; STR, single-tablet regimen; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
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References: 1. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2018. 2. 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. 3. Gallant J, Lazzarin A, Mills A, et al. Bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection (GS-US-380-1489): a double-blind, multicentre, phase 3, randomised controlled non-inferiority trial. Lancet. 2017;390(10107):2063-2072. 4. Sax PE, Pozniak A, Montes ML, et al. Coformulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection (GS-US-380-1490): a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet. 2017;390(10107):2073-2082. 5. Data on file. Gilead Sciences, Inc.
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