—

1. A closer look at a new treatment from Gilead Sciences

2. See the results for treatment-naïve adults

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

1. I'd like to connect with you soon to talk about BIKTARVY—the latest treatment from Gilead Sciences.

2. I'd like to talk to you about BIKTARVY and what makes this new treatment different.

3. I'm looking forward to talking to you about BIKTARVY, and providing a more detailed look at its clinical profile.

4. It was great catching up with you and getting the chance to discuss BIKTARVY.

5. Thanks for taking the time to meet with me.

6. I'm glad we got a chance to talk about BIKTARVY, and wanted to follow up with you about what we discussed.

7. I'm excited to introduce BIKTARVY—the latest treatment from Gilead Sciences.

8. Since we haven't yet had a chance to meet, I wanted to share some information on BIKTARVY, which received FDA approval on February 7th, 2018.

9. BIKTARVY is now available! I wanted to take this opportunity to share some details about this new treatment.

1. Before we meet, I wanted to share some of the results from the BIKTARVY clinical trials.

2. I'm including some information about BIKTARVY that I think you may find interesting.

3. Below, you'll find the results of the clinical trials of BIKTARVY in treatment-naïve adults.

4. Below you will see some information about BIKTARVY that I think will be relevant for your patients.

5. I'd like to share some of the results from the BIKTARVY clinical trials.

6. As a continuation of our discussion, I would like to share some of the results from the clinical trials in treatment-naïve adults.

7. I enjoyed discussing the results of the BIKTARVY clinical trials with you. Below is a recap of some of the data that we reviewed.

8. It was great talking with you about BIKTARVY. Based on our conversation, I wanted to share some details that I think may be useful.

Please click to view full Prescribing Information for BIKTARVY^®, including BOXED WARNING.

DHHS RECOMMENDED AS AN INITIAL REGIMEN FOR ADULTS WITH HIV-1¹

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.

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.

Please see below for additional Important Safety Information for BIKTARVY.

Powerful Efficacy in Treatment-Naïve Adults^2-6

Results noninferior to comparators at Week 48

Powerful Efficacy in Treatment-Naïve Adults With Noninferior Results vs Comparators at Week 48

Treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4+ cell count

Adults with HIV RNA ≥50 copies/mL include those who were not virologically suppressed at Week 48, and those who were not virologically suppressed when they discontinued early due to lack/loss of efficacy, or reasons other than AEs, death, or lack/loss of efficacy

•	In Study 1489, 0 adults in either group had missing post-baseline virologic data

•	In Study 1490, 6 adults in the BIKTARVY group and 0 adults in the FTC/TAF+DTG group had missing post-baseline virologic data

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

Study design: 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 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 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 studies was the proportion of adults with HIV-1 RNA <50 copies/mL at Week 48 using the FDA snapshot algorithm.

IMPORTANT SAFETY INFORMATION (cont'd)

Contraindications

Coadministration: Do not use BIKTARVY with dofetilide or rifampin.

No Treatment-Emergent Resistance Associated With BIKTARVY^2-4

In two large phase 3 clinical trials in treatment-naïve adults through Week 48

Among 634 treatment-naïve adults, 8 treatment-failure subjects were tested and no amino acid substitutions emerged that were associated with BIKTARVY resistance

IMPORTANT SAFETY INFORMATION (cont'd)

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.
	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, including BOXED WARNING.

1. BIKTARVY represents a novel treatment option for your appropriate patients. I look forward to discussing it with you further.

2. There's much more to discuss about BIKTARVY—please let me know what information would be relevant for your practice, and when a good time would be to continue the conversation.

3. I look forward to connecting with you soon and having a conversation about BIKTARVY.

4. I hope this information has been helpful. Please feel free to reach out if you have any questions before we meet.

5. 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.

6. I hope we can meet soon to discuss BIKTARVY. Please let me know when a good time would be.

7. Please reach out if you have any questions, or if there's other information about BIKTARVY that you're interested in.

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

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Find more information about Advancing Access^®

Learn more about BIKTARVY for your treatment-naïve patients at b‍iktarvyhcp.c‍om

95% confidence interval.

3TC, lamivudine; ABC, abacavir; AEs, adverse events; DTG, dolutegravir; FTC, emtricitabine; TAF, tenofovir alafenamide.

References: 1. 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. 2. BIKTARVY [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2018. 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. 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 [supplementary appendix]. Lancet. 2017;390(10107):2073-2082.

BIKTARVY, the BIKTARVY Logo, ADVANCING ACCESS, GILEAD, and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. All other marks referenced herein are the property of their respective owners.

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