1. Details from the clinical trials
2. See the results for virologically suppressed adults

See the clinical trial data

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

^#1	PRESCRIBED HIV-1 TREATMENT FOR ADULTS SWITCHING REGIMENS Source: Ipsos Healthcare US HIV Therapy Monitor & Scope Study Q2 2018.

INDICATION

BIKTARVY is indicated as a complete regimen for the treatment of HIV-1 infection to replace the current ARV regimen in adults 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. I'm excited to talk to you about BIKTARVY.
2. I'm looking forward to talking to you about BIKTARVY and providing a more detailed look at its clinical profile.
3. I'd like to discuss BIKTARVY and its data in virologically suppressed adults.
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 would like to follow up with you about what we discussed.
7. BIKTARVY is a triple therapy STR with a novel and unboosted INSTI from Gilead Sciences.
8. 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.
9. I would like to take this opportunity to share some details about BIKTARVY.

1. Before we meet, I would like 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 some of the results of the clinical trials of BIKTARVY among virologically suppressed adults.
4. Below you will find 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 of the clinical trials among virologically suppressed adults.
7. I enjoyed discussing the results of the BIKTARVY clinical trials with you. Below is a recap of some of the data we reviewed.
8. It was great talking with you about BIKTARVY. Based on our conversation, I would like to share some details I think may be useful.

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

Powerful Efficacy in Virologically Suppressed Adults^1,3-6

≥92% of adults who switched to BIKTARVY maintained virologic suppression at Week 48

Virologic Response: Study 1844

Virologic Response in Study 1844

Virologic Response: Study 1878

Virologic Response in Study 1878


^†	95% confidence interval.
^‡	ABC/3TC or FTC/TDF + boosted ATV or DRV regimen (cobicistat or ritonavir).

BIKTARVY was also studied in an additional phase 3 clinical trial comprised of adult women

Virologic Response: Study 1961

Virologic Response in Study 1961


^†	95% confidence interval.
^§	E/C/F/TAF or E/C/F/TDF or ATV+RTV+FTC/TDF.

	In all studies, treatment outcomes were similar across subgroups by age, sex, race, and region

Adverse Reactions Through Week 48

	In Studies 1844 and 1878, the most common adverse reactions (incidence ≥2%; all grades) reported in virologically suppressed adults who switched to BIKTARVY were headache, flatulence, nausea, and diarrhea

	The most common adverse reactions (incidence ≥5%; all grades) in clinical trials of treatment-naïve adults who received BIKTARVY were diarrhea, nausea, and headache

	Overall, the safety profile of BIKTARVY in virologically suppressed adults from Studies 1844 and 1878 was similar to that of treatment-naïve adults

	In Study 1961, the most common adverse reactions (incidence ≥0.5%; all grades) reported in virologically suppressed adult women who switched to BIKTARVY were iron deficiency anemia, nausea, and vomiting

Study design: The efficacy and safety of switching to BIKTARVY for virologically-suppressed adults were evaluated in Study 1844, Study 1878, and Study 1961. In Study 1844, a phase 3, randomized, double-blind, active-controlled study, virologically-suppressed adults (HIV-1 RNA <50 copies/mL for ≥3 months) with an eGFR ≥50 mL/min were randomized in a 1:1 ratio to either switch to BIKTARVY (n=282) or continue on their baseline regimen of ABC/DTG/3TC (n=281). In Study 1878, a phase 3, randomized, open-label, active-controlled study, virologically-suppressed adults (HIV-1 RNA <50 copies/mL for ≥6 months) with an eGFR ≥50 mL/min were randomized in a 1:1 ratio to either switch to BIKTARVY (n=290) or stay on their baseline regimen of either ABC/3TC or FTC/TDF plus boosted ATV or DRV (cobicistat or ritonavir) (n=287). In Study 1961, a phase 3, randomized, open-label, active-controlled study, virologically-suppressed adult women (HIV-1 RNA <50 copies/mL for ≥3 months) with an eGFR ≥50 mL/min were randomized in a 1:1 ratio to either switch to BIKTARVY (n=234) or stay on their baseline regimen of E/C/F/TAF, E/C/F/TDF or ATV+RTV+FTC/TDF (n=236). The primary endpoint for all three trials was the proportion of adults with HIV-1 RNA ≥50 copies/mL at Week 48 using the FDA snapshot algorithm.

No Treatment-Emergent Resistance Associated With BIKTARVY^1,4-7

In three large phase 3 clinical trials in virologically suppressed adults through Week 48

	Among 572 virologically suppressed adults in Studies 1844 and 1878, 2 virologic rebound subjects had genotypic and phenotypic data (1 for RT, 1 for IN and RT) and no virologically suppressed subjects had treatment-emergent genotypic or phenotypic resistance to BIKTARVY

	Among 234 virologically suppressed adult women in Study 1961, 1 participant met the criteria for resistance testing, was tested, and no amino acid substitutions emerged that were associated with BIKTARVY resistance

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 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 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. I look forward to discussing BIKTARVY's clinical trial data in virologically suppressed adults.
2. 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.
3. I look forward to connecting with you soon and sharing more information about BIKTARVY.
4. I hope this 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. Please let me know when a good time would be.
7. Please reach out if you have any questions, or if there's any other information about BIKTARVY that I can provide.

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See the possibilities at biktarvyhcp.com

Find more information about Advancing Access^®

emtricitabine 200 mg/tenofovir alafenamide 25 mg.

3TC, lamivudine; ABC, abacavir; ATV, atazanavir; C, cobicistat; DRV, darunavir; DTG, dolutegravir; E, elvitegravir; F, emtricitabine; FTC, emtricitabine; IN, integrase; INSTI, integrase strand transfer inhibitor; PI, protease inhibitor; RT, reverse transcriptase; RTV, ritonavir; STR, single-tablet regimen; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

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. Daar ES, DeJesus E, Ruane P, et al‌. Phase 3 randomized, controlled trial of switching to fixed-dose bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) from boosted protease inhibitor-based regimens in virologically suppressed adults: week 48 results. Oral presentation at: IDWeek; October 4-8, 2017; San Diego, CA. 4. Data on file. Gilead Sciences, Inc. 5. Molina JM, Ward D, Brar I, et al. Switch to bictegravir/F/TAF from DTG and ABC/3TC. Oral presentation at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston, MA. 6. 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. 7. Andreatta K, Willkom M, Martin R, et al. Resistance analyses of bictegravir/emtricitabine/tenofovir alafenamide switch studies. Poster presented at: Conference on Retroviruses and Opportunistic Infections; March 4-7, 2018; Boston, MA.