Clinical Trial Experience

D’Eva and others are looking at flowers.

Broad Experience in Clinical Trials and Proven Results^1-7

The efficacy and safety profile of BIKTARVY is backed by robust clinical trial experience in a diverse range of people^1-7

Over 3600 participants and up to 5 years of follow-up in clinical trials^1-4,6-9

BIKTARVY has been extensively studied across^1,5,7,10,11:

Treatment Naïve Adults, including

Various races and ethnicities*
High baseline viral loads
(HIV RNA >100k copies/mL)
Low CD4 counts
(CD4 cell count <200 cells/μL)

Virologically Suppressed PWH,
including

Adults with known or suspected M184V/I resistance mutation
Various races and ethnicities*
Black American Adults
Adults assigned female at birth^†
Adults ≥65 years
Children and adolescents

Additional Understudied Populations

Virologically suppressed pregnant adult women
Virologically suppressed adults with ESRD receiving chronic hemodialysis^‡
Mild to moderate renal impairment (estimated CrCl ≥30 mL/min)

People featured are real patients who take BIKTARVY and are compensated by Gilead; they did not participate in clinical trials.

*Including Black, White, Hispanic/Latino, and Asian populations.

^†Including adults, adolescents, and children.

^‡In Trial 1825, an open-label, single-arm trial, virologically suppressed adults with ESRD (estimated CrCl <15 mL/min) on chronic hemodialysis were given FTC/TAF in combination with elvitegravir and cobicistat for 96 weeks (N=55). In a 48-week extension, 10 study participants switched to BIKTARVY.

182 virologically suppressed study participants across 6 clinical trials with preexisting M184V/I resistance mutation, including¹²:

20% (n=47/238) of participants who had M184V/I resistance mutation at baseline in Study 4030¹³

Of the participants with known M184V/I:

47%

were identified through
historical genotype

74%

were identified through
proviral DNA

BIKTARVY was studied across 9 phase 3 clinical trials in treatment-naïve and virologically suppressed study participants^1,6,7

Treatment-Naïve Studies

Study 1489
Adults

BIKTARVY (n=314) vs
ABC/DTG/3TC (n=315)

(n=254) switched to BIKTARVY at Week 144

View Study 1489

Study 1490
Adults

BIKTARVY (n=320) vs
DTG+FTC/TAF (n=325)

(n=265) switched to BIKTARVY at Week 144

View Study 1490

Virologically Suppressed Studies

Study 1844
Adults

Switched to BIKTARVY (n=282) or continued on ABC/DTG/3TC
(n=281)

(n=265) switched to BIKTARVY at Week 48

View Study 1844

Study 1878
Adults

Switched to BIKTARVY (n=290) or stayed on baseline regimen^‡ (n=287)

(n=244) switched to BIKTARVY at Week 48

View Study 1878

Study 4030
Adults, Including Those
With Known or Suspected
Preexisting M184V/I
Resistance Mutation

Switched to BIKTARVY (n=284) or continued on
DTG+FTC/TAF (n=281)

View Study 4030

Study 1961
Adult Women

Switched to BIKTARVY (n=234) or stayed on baseline regimen^§ (n=236)

(n=228) switched to BIKTARVY at Week 48

View Study 1961

Study 4449
Adults Aged ≥65

Switched to BIKTARVY
(N=86)^||

View Study 4449

Study 1474
Children & Adolescents

Switched to BIKTARVY
(N=122)^¶

View Study 1474

BRAAVE
Black American Adults

Switched to BIKTARVY (n=330)
or stayed on stable baseline regimen (n=165) with delayed switch to BIKTARVY at Week 24 (n=163)

View BRAAVE

Study 5310
A Phase 1 Trial in Virologically Suppressed Pregnant Adult Women

Switched to BIKTARVY
(n=33)

View the Prescribing Information

BIKTARVY is being studied in additional clinical trials, including:

BICSTaR: Ongoing multicountry, multicenter, prospective observational cohort study aimed to evaluate the effectiveness and safety of treatment with BIKTARVY with enrollment of over 2300 people living with HIV.^16,17

Select BIKTARVY DHHS guidelines recommendations:

BIKTARVY is DHHS guidelines–recommended^14,15

As an initial regimen for most people living with HIV
In virologically suppressed people with M184V/I resistance mutation (BIII)*
As a preferred initial regimen for children ≥2 years old (≥14 kg)
BIKTARVY is DHHS guidelines–recommended for PWH with adherence challenges¹⁴
- Other considerations include side effects, out-of-pocket costs, convenience, and patient preferences¹⁴
- Continue to counsel your patients to take BIKTARVY once daily.¹

*Rating of recommendation: B=Moderate. Rating of evidence: III=Expert opinion.

Treatment Naïve Patients

Resistance Summary

Please see full Prescribing Information for BIKTARVY^® and DESCOVY^®, including BOXED WARNINGS.

^‡ABC/3TC or FTC/TDF + boosted ATV or DRV regimen (cobicistat or ritonavir).
^§E/C/F/TAF or E/C/F/TDF or ATV+RTV+FTC/TDF.
^||Switched from E/C/F/TAF or F/TDF + a third agent.
^¶Open-label, single-arm trial included virologically suppressed adolescents, aged ≥12 to <18 years weighing at least 35 kg (n=50), virologically suppressed children aged ≥6 to <12 years weighing at least 25 kg (n=50), and virologically suppressed children, aged ≥2 years and weighing at least 14 kg (n=22).¹

3TC, lamivudine; ABC, abacavir; ATV, atazanavir; BICSTaR, bictegravir single-tablet regimen; C, cobicistat; CD4, cluster of differentiation 4; DRV, darunavir; DTG, dolutegravir; E, elvitegravir; FTC, emtricitabine; RNA, ribonucleic acid; RTV, ritonavir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.

References: 1. BIKTARVY. Prescribing information. Gilead Sciences, Inc.; 2024. 2. Wohl DA, Pozniak A, Workowski K, et al. B/F/TAF five-year outcomes in treatment-naïve adults. Poster presented at: Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022; Virtual. Poster 494. 3. Brar I, Ruane P, Ward D, et al. Long-term follow-up after a switch to bictegravir, emtricitabine, and tenofovir alafenamide from dolutegravir, abacavir, and lamivudine. Poster presented at: IDWeek; October 21-25, 2020; Virtual. Poster 1028. 4. Rockstroh J, Molina J-M, Post F, et al. Long-term follow-up after a switch to bictegravir, emtricitabine, tenofovir alafenamide (B/F/TAF) from a boosted protease inhibitor-based regimen. Poster presented at: HIV Drug Therapy Glasgow 2020; October 5-8, 2020; Virtual. Poster P036. 5. Kityo C, Hagins D, Koenig E, et al. Switching to fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in virologically suppressed HIV-1 infected women: a randomized, open-label, multicenter, active-controlled, Phase 3, noninferiority trial. J Acquir Immune Defic Syndr. 2019;82(3):321-328. 6. Kityo C, Hagins D, Koenig E, et al. Longer-term (96-week) efficacy and safety of switching to bictegravir, emtricitabine, and tenofovir alafenamide (B/F/TAF) in women. Oral presentation at: International AIDS Society Conference on HIV Science 2019; July 21-24, 2019; Mexico City, Mexico. Abstract MOAB0106. 7. Kumar P, Stephens JL, Wurapa AK, et al. Week 72 outcomes and COVID-19 impact from the BRAAVE 2020 study: a randomized switch to B/F/TAF in Black American adults with HIV. Poster presented at: International AIDS Society Conference on HIV Science; July 18-21, 2021; Virtual. Poster PEB161. 8. Maggiolo F, Rizzardini G, Molina J-M, et al. Bictegravir/emtricitabine/tenofovir alafenamide in virologically suppressed people with HIV aged ≥65 years: week 48 results of a Phase 3b, open-label trial. Infect Dis Ther. 2021;10(2):775-788. 9. Natukunda E, Rodriguez CA, McGrath EJ, et al. B/F/TAF in virologically suppressed adolescents and children: two-year outcomes in 6 to <18 year olds and six-month outcomes in toddlers. Abstract presented at: International Workshop on HIV & Pediatrics. July 16-17, 2021; Virtual. Abstract 2. 10. 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. 11. 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. 12. Sax PE, Andreatta K, Molina J-M, et al. High efficacy of switching to bictegravir/emtricitabine/tenofovir alafenamide in people with suppressed HIV and preexisting M184V/I. AIDS. 2022;36(11):1511-1520. 13. Acosta RK, Willkom M, Andreatta K, et al. Switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) from dolutegravir (DTG)+F/TAF or DTG+F/tenofovir disoproxil fumarate (TDF) in the presence of pre-existing NRTI resistance. J Acquir Immune Defic Syndr. 2020;85(3):363-371. 14. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Updated September 12, 2024. Accessed September 24, 2024. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-arv/guidelines-adult-adolescent-arv.pdf 15. Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Department of Health and Human Services. Updated June 27, 2024. Accessed September 24, 2024. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/pediatric-arv/guidelines-pediatric-arv.pdf 16. Spinner CD, Stoehr A, Wong A, et al. Starting or switching to bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in clinical practice: pooled 12-month results from the global BICSTaR study. Poster presented at: HIV Glasgow 2020; October 5-8, 2020; Glasgow, UK. Poster P046K. 17. Trottier B, Antinori A, De Wet J, et al. Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) for the treatment of people living with HIV: 24-month analyses by age, race, sex, adherence and late diagnosis in a multi-country cohort study. Poster presented at: HIV Glasgow 2022; October 23-26, 2022; Glasgow, UK. Poster P067.

INDICATION

BIKTARVY® is indicated as a complete regimen for the treatment of HIV-1 infection in adult and pediatric patients weighing ≥14 kg 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 with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.

INDICATION

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: Postmarketing cases of renal impairment, including acute renal failure, proximal renal tubulopathy (PRT), and Fanconi syndrome have been reported with tenofovir alafenamide (TAF)–containing products. Do not initiate BIKTARVY in patients with estimated creatinine clearance (CrCl) <30 mL/min except in virologically suppressed adults <15 mL/min who are receiving chronic hemodialysis. 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, 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 144 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: Adult and pediatric patients weighing ≥25 kg: 1 tablet containing 50 mg bictegravir (BIC), 200 mg emtricitabine (FTC), and 25 mg tenofovir alafenamide (TAF) taken once daily with or without food. Pediatric patients weighing ≥14 kg to <25 kg: 1 tablet containing 30 mg BIC, 120 mg FTC, and 15 mg TAF taken once daily with or without food. For these pediatric patients, who are unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes.
Renal impairment: For patients weighing ≥25 kg, not recommended in patients with CrCl 15 to <30 mL/min, or <15 mL/min who are not receiving chronic hemodialysis, or <15 mL/min who are receiving chronic hemodialysis and have no antiretroviral treatment history. For patients weighing ≥14 kg to <25 kg, 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: BIKTARVY is recommended in pregnant individuals who are virologically suppressed on a stable ARV regimen with no known substitutions associated with resistance to any of the individual components of BIKTARVY. Lower plasma exposures of BIKTARVY were observed during pregnancy; therefore, viral load should be monitored closely during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Available data from the APR for BIC, FTC, or TAF show no difference in the rates of birth defects compared with a US reference population.
Lactation: Individuals infected with HIV-1 should be informed of the potential risks of breastfeeding.

Please see full Prescribing Information for BIKTARVY^® and DESCOVY^®, including BOXED WARNINGS.

The information contained on this site is intended for healthcare provider audiences in the United States only. The content on this site may not apply to non-US audiences as regulatory control, legal requirements, and/or medical practices may vary in other countries.

BIKTARVY, BIKTARVY ANYWHERE, the BIKTARVY Logo, the BIKTARVY Tablet, BIKTARVY TODAY, ADVANCING ACCESS, DESCOVY, FOR TODAY, TOMORROW, AND THE DAYS TO COME, GILEAD, the GILEAD Logo, GSI, and 9883 are trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners.

Clinical Trial Experience

Broad Experience in Clinical Trials and Proven Results1-7

The efficacy and safety profile of BIKTARVY is backed by robust clinical trial experience in a diverse range of people1-7

BIKTARVY has been extensively studied across1,5,7,10,11:

182 virologically suppressed study participants across 6 clinical trials with preexisting M184V/I resistance mutation, including12:

BIKTARVY was studied across 9 phase 3 clinical trials in treatment-naïve and virologically suppressed study participants1,6,7

BIKTARVY is being studied in additional clinical trials, including:

Select BIKTARVY DHHS guidelines recommendations:

BIKTARVY is DHHS guidelines–recommended14,15

INDICATION

INDICATION

Important Safety Information

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pregnancy and lactation

INDICATION

Important Safety Information

BOXED WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Contraindications

Warnings and precautions

Adverse reactions

Drug interactions

Dosage and administration

Pregnancy and lactation

Broad Experience in Clinical Trials and Proven Results^1-7

The efficacy and safety profile of BIKTARVY is backed by robust clinical trial experience in a diverse range of people^1-7

BIKTARVY has been extensively studied across^1,5,7,10,11:

182 virologically suppressed study participants across 6 clinical trials with preexisting M184V/I resistance mutation, including¹²:

BIKTARVY was studied across 9 phase 3 clinical trials in treatment-naïve and virologically suppressed study participants^1,6,7

BIKTARVY is DHHS guidelines–recommended^14,15