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{{customText[Details from the clinical trials|See the results for treatment-naïve adults]}}
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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. |
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| IMPORTANT SAFETY INFORMATION |
| 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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{{customText[Dear|Hello,|Hi,|Good morning,|Good afternoon,|Good evening,]}} {{customText[Dr.|Mr.|Mrs.|Ms.|Prof.|]}} {{accFname}} {{accLname}}, {{customText[MD,|DO,|PharmD,|PA,|NP,|]}} |
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{{customText[I'm excited to tell you about BIKTARVY 144-week data.|I'd like to discuss BIKTARVY and its long-term 144-week data in treatment-naïve adults.|I'm looking forward to talking to you about BIKTARVY and providing a more detailed look at its clinical profile.|It was great catching up with you and getting a chance to discuss BIKTARVY long-term 144-week data.|Thanks for taking the time to meet with me about the exciting BIKTARVY results.|I'm glad we got a chance to talk about BIKTARVY, and I would like to follow up with you about what we discussed.|BIKTARVY is a triple therapy single-tablet regimen with a novel and unboosted INSTI from Gilead Sciences, Inc.|Since we haven't yet had a chance to meet, I would like to share some information about BIKTARVY, a single-tablet regimen for the treatment of HIV-1 from Gilead Sciences, Inc.|I would like to take this opportunity to share some details about BIKTARVY.]}}
{{customText[See below for the long-term 144-week data from the BIKTARVY treatment-naïve clinical trials.|I'm including some information about BIKTARVY that I think you may find interesting.|I'd like to share some of the results from the BIKTARVY treatment-naïve clinical trials at 144 weeks, below.|To continue our last conversation, I'd like to share the long-term 144-week data from our clinical trials among treatment-naïve adults.|I enjoyed discussing the results of the BIKTARVY clinical trials with you. Below is a recap of some of the data we reviewed.|It was great talking with you about BIKTARVY. Based on our conversation, I would like to share some details I think may be useful.|I enjoyed discussing the long-term 144-week data from the BIKTARVY clinical trials in treatment-naïve adults. Below is a recap of some of the data we reviewed.|Below, you'll find some of the results of the clinical trials of BIKTARVY among treatment-naïve adults.|Below, you will find some information about BIKTARVY that I think could be relevant for your patients.]}}
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Durability You Can Trust. |
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Durable Viral Suppression: Long‑Term Efficacy in Treatment‑Naïve Adults at Week 1441-7 |
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BIKTARVY was noninferior to ABC/DTG/3TC |
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BIKTARVY was noninferior to FTC/TAF+DTG |
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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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In both studies, treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4 cell count
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Established Safety Profile. |
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Demonstrated Long-Term Safety and Tolerability Profile in Treatment-Naïve Adults Through Week 1444 |
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| Contraindications |
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Coadministration: Do not use BIKTARVY with dofetilide or rifampin. |
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Study design1-6: The efficacy and safety of BIKTARVY for treatment-naïve adults were evaluated in Study 1489 and Study 1490. In Study 1489, a phase 3, randomized, double-blind, active-controlled study, treatment-naïve adults with an eGFR ≥50 mL/min were randomized in a 1:1 ratio to receive either BIKTARVY (n=314) or ABC/DTG/3TC (n=315) once daily. In Study 1490, a phase 3, randomized, double-blind, active-controlled study, treatment-naïve adults with an eGFR ≥30 mL/min were randomized in a 1:1 ratio to receive either BIKTARVY (n=320) or FTC/TAF+DTG (n=325) once daily. The primary endpoint for both trials was the proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot algorithm. Secondary endpoints included efficacy, safety, and tolerability through Weeks 96 and 144. |
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Zero Resistance in
Clinical Trials. |
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In two large studies of treatment-naïve adults through Week 1441,3-5,7 |
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Among 634 treatment-naïve adults in Studies 1489 and 1490, 8 treatment-failure subjects were tested and no amino acid substitutions emerged that were associated with BIKTARVY resistance through Week 144 |
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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. |
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| Contraindications |
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Coadministration: Do not use BIKTARVY with dofetilide or rifampin. |
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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: 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. |
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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 through week 144 were diarrhea (6%), nausea (6%), 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: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food. |
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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.
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Please see below for additional Important Safety Information for BIKTARVY. |
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| IMPORTANT SAFETY INFORMATION (cont'd) |
| Contraindications |
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Coadministration: Do not use BIKTARVY with dofetilide or rifampin. |
| 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: 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.. |
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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. |
| Adverse reactions |
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Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 144 were diarrhea (6%), nausea (6%), and headache (5%). |
| 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 (cont'd) |
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Dosage: Patients weighing ≥25 kg: 1 tablet taken once daily with or without food. |
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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. |
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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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| Dosage and administration |
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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. 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. |
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Lactation: Women infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission. |
Please see full Prescribing Information for BIKTARVY, including BOXED WARNING.
{{customText[There's much more to discuss about BIKTARVY—please let me know what information would be relevant to your practice and when would be a good time to continue the conversation.|I look forward to connecting with you soon and sharing more information about BIKTARVY.|I hope this has been helpful. Please feel free to reach out if you have any questions before we meet.|Thank you for taking the time to discuss BIKTARVY's clinical trial data in treatment-naïve adults.|I am happy we were able to connect. Let me know if I can provide any additional information about BIKTARVY, and I look forward to seeing you soon.|I hope we can meet soon. Please let me know when a good time would be.|Please reach out if you have any questions or if there’s any other information about BIKTARVY that I can provide.|Please reach out if you have any questions about BIKTARVY's long-term 144-week data.]}}
{{customText[Best regards,|Sincerely,|Thank you,|Thanks again,]}}
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| 3TC, lamivudine; ABC, abacavir; DTG, dolutegravir; eGFR, estimated glomerular filtration rate; FTC, emtricitabine; INSTI, integrase strand transfer inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; TAF, tenofovir alafenamide. |
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| References: 1. BIKTARVY. Package insert. Gilead Sciences, Inc.; 2021. 2. 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. 3. Wohl DA, Yazdanpanah Y, Baumgarten A, et al. Bictegravir combined with emtricitabine and tenofovir alafenamide versus dolutegravir, abacavir, and lamivudine for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e355-e363. 4. Data on file. Gilead Sciences, Inc. 5. Stellbrink HJ, Arribas JR, Stephens JL, et al. Co-formulated bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir with emtricitabine and tenofovir alafenamide for initial treatment of HIV-1 infection: week 96 results from a randomised, double-blind, multicentre, phase 3, non-inferiority trial. Lancet HIV. 2019;6(6):e364-e372. 6. 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. 7. Orkin C, DeJesus E, Sax PE, et al. Fixed-dose combination bictegravir, emtricitabine, and tenofovir alafenamide versus dolutegravir-containing regimens for initial treatment of HIV-1 infection: week 144 results from two randomised, double-blind, multicentre, phase 3, non-inferiority trials. Lancet HIV. 2020;7(6):e389-e400.
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