1. An overview of the clinical trials and dosing of an STR
2. Details about a triple therapy STR with a novel and unboosted INSTI
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BIKTARVY® is a powerful STR that combines the DESCOVY® (FTC/TAF)* backbone with bictegravir, a novel and unboosted INSTI1,2
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DHHS RECOMMENDED
AS AN INITIAL REGIMEN FOR ADULTS WITH HIV-13
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| INDICATION |
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 |
| 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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Dear {{customText[Dr.|Mr.|Mrs.|Ms.|]}} {{accFname}} {{accLname}}, {{customText[MD,|DO,|PharmD,|PA,|
NP,|]}} |
1. I'm excited to have a discussion about a triple therapy STR with a novel and unboosted INSTI.
2. I'm looking forward to providing a more detailed look at a triple therapy.
3. I'd like to discuss BIKTARVY and what makes this treatment different.
4. It was great catching up with you.
5. Thanks for taking the time to meet with me.
6. Glad we had a chance to talk about BIKTARVY.
7. Hoping to schedule some time to meet with you.
8. Would love to connect about BIKTARVY--a triple therapy STR with a novel and unboosted INSTI from Gilead Sciences.
9. I would like to take this opportunity to introduce myself.
1. Below you will find some information about BIKTARVY that may be of interest.
2. Here is some information about BIKTARVY ahead of our meeting.
3. To get started, I have provided some materials on the clinical trials and dosing of BIKTARVY.
4. I'm writing to follow up on what we discussed. Below are some highlights of our conversation.
5. As a continuation of our discussion, I would like to share details about the clinical trials and dosing of BIKTARVY.
6. To further our conversation, I would like to provide some additional details about BIKTARVY that may interest you.
7. I have included some information about BIKTARVY that I think will be relevant to your practice.
8. I'm eager to share some information about the clinical trials of BIKTARVY and its dosing.
9. Since we haven't had a chance to meet yet, I would like to share some information about BIKTARVY, a triple therapy STR from Gilead Sciences.
Please click to view full Prescribing Information for BIKTARVY® and DESCOVY®, including BOXED WARNINGS.
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| IMPORTANT SAFETY INFORMATION (cont'd) |
| Contraindications |
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Coadministration: Do not use BIKTARVY with dofetilide or rifampin.
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| BIKTARVY Clinical Trials1,4-7 |
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| BIKTARVY was approved based on data from four phase 3 clinical trials, including more than 1200 patients |
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Treatment-Naïve Adults
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STUDY 1489
BIKTARVY (n=314)
vs
ABC/DTG/3TC
(n=315)
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Study 1490
BIKTARVY (n=320)
vs
FTC/TAF+DTG
(n=325)
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| Virologically Suppressed Adults |
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Study 1844
Switched to BIKTARVY
(n=282) or continued
on ABC/DTG/3TC
(n=281)
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STUDY 1878
Switched to BIKTARVY
(n=290) or stayed on
baseline regimen†
(n=287)
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| †ABC/3TC or FTC/TDF + boosted ATV or DRV regimen (cobicistat or ritonavir). |
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| BIKTARVY was studied in an additional phase 3 clinical trial comprised of adult women |
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| Virologically Suppressed Adult Women |
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Study 1961
Switched to BIKTARVY (n=234) or
stayed on baseline regimen‡
(n=236) |
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| ‡E/C/F/TAF or E/C/F/TDF or ATV+RTV+FTC/TDF. |
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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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IMPORTANT SAFETY INFORMATION (cont'd) |
| 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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| BIKTARVY is a Triple Therapy STR That Combines the DESCOVY (FTC/TAF)* Backbone with Bictegravir, a Novel and Unboosted INSTI1,2 |
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| Pharmacokinetics |
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Bictegravir has a long plasma half-life of 17.3 hours1,6 |
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IMPORTANT SAFETY INFORMATION (cont'd) |
| Warnings and precautions (cont'd) |
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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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| Simple Dosing With BIKTARVY1,6 |
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Once-Daily
STR
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No Food
Requirement
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Taken Any
Time of Day
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No Booster
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Not actual size.
Actual size is 15mm x 8mm.
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BIKTARVY combines the DESCOVY® (FTC/TAF)* backbone with bictegravir, in a small and powerful unboosted STR
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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 |
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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: 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.
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. |
Please see below for additional Important Safety Information for BIKTARVY. |
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IMPORTANT SAFETY INFORMATION (cont'd) |
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| Warnings and precautions (cont'd) |
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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.
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. |
| 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%). |
| 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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| Drug interactions (cont'd) |
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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. |
Please click to view full Prescribing Information for BIKTARVY and DESCOVY, including BOXED WARNINGS.
1. BIKTARVY is a triple therapy STR option for your appropriate patients. I look forward to discussing it with you further.
2. I hope this information has been helpful. Please feel free to reach out if you have any questions before we meet.
3. Looking forward to our upcoming conversation about BIKTARVY.
4. It was great to see you. Let me know if I can provide any additional information about BIKTARVY.
5. If you are interested in additional materials about BIKTARVY, please feel free to contact me.
6. Let's connect again soon. In the meantime, please reach out if you have any questions about BIKTARVY.
7. I hope we can meet in the near future. Please let me know when we can connect at your earliest convenience.
8. Please reach out if you have any questions, or if there's other information about BIKTARVY that I can provide.
9. There's much more to discuss about BIKTARVY--please let me know when a good time would be to continue the conversation.
1. Best,
2. Best regards,
3. Regards,
4. Sincerely,
5. Thanks,
6. Thank you,
7. Cheers,
{{userName}}
{{userEmailAddress}}
{{Rep office number}}
{{Rep cell number}}
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emtricitabine 200 mg/tenofovir alafenamide 25 mg.
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3TC, lamivudine; ABC, abacavir; ATV, atazanavir; C, cobicistat; CrCl, creatinine clearance; DRV, darunavir; DTG, dolutegravir; E, elvitegravir; F, emtricitabine; FTC, emtricitabine; INSTI, integrase strand transfer inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; RTV, ritonavir; 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. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV. Department of Health and Human Services. http://aids.info.nih.gov/ContentFiles/lvguidelines/AdultandAdolescentGL.pdf. Updated March 27, 2018. Accessed March 27, 2018. 4. 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. 5. 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. 6. Data on file. Gilead Sciences, Inc. 7. Kityo C, Hagins D, Koenig E, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide in women. Poster presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston, MA.
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