{{customText[Clinical trial details|See the results for treatment-naïve adults]}}

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

^#1	PRESCRIBED FOR ADULTS WITH HIV-1 STARTING AND SWITCHING ARV REGIMENS Source: Ipsos Healthcare US HIV Therapy Monitor & Scope Study Q3 2018.

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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{{customText[I'm excited to tell you about BIKTARVY's new data.|I'd like to discuss BIKTARVY and its new, long-term 96-week data in treatment-naïve adults.|It was great catching up with you and getting a chance to discuss BIKTARVY's long-term 96-week data.|Thanks for taking the time to meet with me about BIKTARVY's exciting, new results.|Since we haven't yet had a chance to meet, I would like to share some information about BIKTARVY, the latest STR from Gilead Sciences.|I would like to take this opportunity to share some details about BIKTARVY.]}}

{{customText[I'd like to share new, long-term 96-week data from the BIKTARVY treatment-naïve clinical trials.|I'm including some information about BIKTARVY that I think you may find interesting.|Below, you'll find some of the long-term 96-week data from clinical trials of BIKTARVY among treatment-naïve adults.|I'd like to share some of the results from the BIKTARVY treatment-naïve clinical trials at 96 weeks.|To continue our last conversation, I'd like to share the new, long-term 96-week data from our clinical trials among treatment-naïve adults.|I enjoyed discussing the long-term 96-week data from the BIKTARVY clinical trials in treatment-naïve adults. Below is a recap of some of the data we reviewed.]}}

Powerful Long-Term Efficacy in Treatment-Naïve Adults at Week 96^1,4-8

Results noninferior to comparators

Study 1489: Virologic Response

^†	95% confidence interval.

1% of adults who received BIKTARVY experienced virologic failure (HIV-1 RNA ≥50 copies/mL) vs 3% with ABC/DTG/3TC at Week 48

1% of adults who received BIKTARVY experienced virologic failure (HIV-1 RNA ≥50 copies/mL) vs 2% with ABC/DTG/3TC at Week 96

Study 1490: Virologic Response


^†	95% confidence interval.

4% of adults who received BIKTARVY experienced virologic failure (HIV-1 RNA ≥50 copies/mL) vs 1% with FTC/TAF+DTG at Week 48

4% of adults who received BIKTARVY experienced virologic failure (HIV-1 RNA ≥50 copies/mL) vs 3% with FTC/TAF+DTG at Week 96

In both studies, treatment outcomes were similar across subgroups, regardless of age, sex, race, baseline viral load, and baseline CD4+ cell count

Adverse Reactions Through Week 96

Most common adverse reactions (incidence ≥5%; all grades) in clinical studies through week 96 were diarrhea (6%), nausea (6%), 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 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 at Week 96.

No Treatment-Emergent Resistance Associated With BIKTARVY^4-8

In two large phase 3 clinical trials in treatment-naïve adults through Week 96

Among 634 treatment-naïve adults in Studies 1489 and 1490, 7 treatment-failure subjects were tested and no amino acid substitutions emerged that were associated with BIKTARVY resistance

See the possibilities at biktarvyhcp.com >

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.
	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 through week 96 were diarrhea (6%), nausea (6%), 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.
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 through week 96 were diarrhea (6%), nausea (6%), 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.

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.

{{customText[There's much more to discuss about BIKTARVY—please let me know what information would be relevant to your practice, and when a good time would be 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.|I am glad 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 new, long-term 96-week data.]}}

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Find more information about Advancing Access^®

emtricitabine 200 mg/tenofovir alafenamide 25 mg.

3TC, lamivudine; ABC, abacavir; AEs, adverse events; DTG, dolutegravir; eGFR, estimated glomerular filtration rate; FTC, emtricitabine; INSTI, integrase strand transfer 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/‌AdultandAdolescentGL.pdf. Updated October 25, 2018. Accessed October 31, 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. Wohl D, Yazdanpanah Y, Baumgarten A, et al. A phase 3, randomized, controlled clinical trial of bictegravir in a fixed-dose combination, B/F/TAF, vs DTG/ABC/3TC in treatment-naïve adults at week 96. Oral presentation at: IDWeek; October 3-7, 2018; San Francisco, CA. 8. Stellbrink HJ, Arribas J, Stephens JL, et al. Phase III randomized, controlled clinical trial of bictegravir coformulated with FTC/TAF in a fixed-dose combination (B/F/TAF) versus dolutegravir (DTG) + F/TAF in treatment-naïve HIV-1 positive adults: week 96. Oral presentation at: HIV Drug Therapy; October 28-31, 2018; Glasgow, UK.