1. DHHS Recommendations Update
2. Stay Up to Date With a DHHS-Recommended STR

Discover more about BIKTARVY

BIKTARVY^® is a powerful STR that combines the DESCOVY^® (FTC/TAF)* backbone with bictegravir, a novel and unboosted INSTI^1,2

DHHS RECOMMENDED
AS AN INITIAL REGIMEN FOR ADULTS WITH HIV-1³

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.

Dear {{customText[Dr.|Mr.|Mrs.|Ms.|]}} {{accFname}} {{accLname}}, {{customText[MD,|DO,|PharmD,|PA,|
NP,|]}}

1. Looking forward to speaking with you this week.
2. Happy we were able to schedule time to meet.
3. Hope this message finds you well.
4. Glad we were able to connect this week.
5. I really appreciated you taking time out of your day to talk with me.
6. We had a great dialogue about BIKTARVY.
7. I would like to set up some time to meet with you.
8. Hope to connect with you in the near future.
9. Excited to share a DHHS recommendations update.

1. I'm excited to discuss the inclusion of BIKTARVY in the DHHS guidelines.
2. Before we connect, I'm eager to share some information about BIKTARVY.
3. I have some exciting news about the updated DHHS guidelines, which now recommend BIKTARVY.
4. To expand upon our conversation, I would like to share some additional information about BIKTARVY--specifically, its inclusion in the updated DHHS guidelines.
5. As a follow-up to our meeting, I am sending you highlights of our discussion regarding BIKTARVY.
6. Below, you will find some of the information about BIKTARVY that we discussed.
7. The following information about BIKTARVY may be of interest.
8. BIKTARVY, a once-daily STR, is now recommended by DHHS.

Please click to view full Prescribing Information for BIKTARVY^® and DESCOVY^®, including BOXED WARNINGS.

DHHS Guidelines Recommendations³

BIKTARVY: DHHS Recommended as an Initial Regimen for Adults With HIV-1

All recommended initial regimens for most adults with HIV are three ARV components consisting of a dual NRTI plus an INSTI

DHHS Guidelines Support Treatment Initiation As Soon As Possible

ARV therapy should be initiated as soon as possible in patients diagnosed with HIV, regardless of CD4+ cell count

When initiating therapy, it is important to educate patients on the benefits and considerations of treatment and adherence

On a case-by-case basis, ARV therapy may be deferred because of clinical and/or psychosocial factors

Testing with BIKTARVY¹

Prior to or when initiating BIKTARVY, and during treatment, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients as clinically appropriate. In patients with chronic kidney disease, also assess serum phosphorus

Prior to or when initiating BIKTARVY, test for hepatitis B virus infection

No HLA-B*5701 testing required

Simple Dosing With BIKTARVY^1,4

Once-Daily STR		No Food Requirement

Taken Any Time of Day		No Booster


Not actual size. Actual size is 15mm x 8mm.		BIKTARVY combines the DESCOVY^® (FTC/TAF)* backbone with bictegravir, in a small and powerful unboosted STR

BIKTARVY is not recommended in patients with severe renal impairment (estimated CrCl <30 mL/min) or severe hepatic impairment (Child-Pugh Class C)

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.

Contraindications

	Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

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: 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.
Please see below for additional Important Safety Information for BIKTARVY.

IMPORTANT SAFETY INFORMATION (cont'd)

Warnings and precautions (cont'd)
	Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported.
	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.
	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

Most common adverse reactions (incidence ≥5%; all grades) in clinical studies were diarrhea (6%), nausea (5%), and headache (5%).

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.

Dosage and administration

Dosage: 1 tablet taken once daily with or without food.

Renal impairment: Not recommended in patients with CrCl <30 mL/min.

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.

Pregnancy and lactation

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.

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 once-daily STR option for your appropriate patients. I look forward to discussing it with you further.
2. Please let me know if I can send you additional information about BIKTARVY ahead of our meeting.
3. If you have any questions before our call, feel free to reach out. I look forward to seeing you soon.
4. I am happy we were able to connect. Let me know if I can provide any additional information about BIKTARVY.
5. It was great seeing you again. I look forward to our next discussion.
6. Feel free to contact me if you have any questions or would like additional information. Let's meet again soon.
7. I look forward to connecting with you soon and having a conversation about BIKTARVY.
8. If you are interested in additional materials about BIKTARVY, please don't hesitate to contact me.
9. Please reach out if you have any questions. Let's schedule some time to meet at your earliest convenience.

{{customText[Best,|Best regards,|Regards,|Sincerely,|Thanks,|Thank you,|Cheers,]}}

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See the possibilities at biktarvyhcp.com

Find more information about Advancing Access^®

emtricitabine 200 mg/tenofovir alafenamide 25 mg.

ARV, antiretroviral; CrCl, creatinine clearance; FTC, emtricitabine; HLA, human leukocyte antigen; INSTI, integrase strand transfer inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; STR, single-tablet regimen; TAF, tenofovir alafenamide.

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:/‌/aidsi‌nfo.nih.gov/Content‌Files/lvguidelines/AdultandAdolesc‌entGL.pdf. Updated Mar‌ch 27, 20‌18. Accessed Ma‌rch 27, 20‌18. 4. Data on file. Gilead Sciences, Inc.