U.S. Food and Drug Administration Approves Expanded Indication of Gilead’s Biktarvy® for Treatment of HIV-1 in Pediatric Populations

– FDA Approves Low-Dose Tablet for HIV Treatment in Virologically Suppressed Children Weighing at Least 14 kg –

– Biktarvy Provides an Effective Treatment Option for a Diverse Range of People Living with HIV, including Children –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy^® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who are virologically suppressed or new to antiretroviral therapy. The approval of this supplemental New Drug Application (sNDA) expands the indication for Biktarvy to include younger children living with HIV-1 infection and will help to close the gap between HIV treatment options available for adults and children.

“Children living with HIV are in need of effective and accessible formulations of antiretroviral therapy,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “To address this unmet need, innovations in pediatric formulations must strive towards expanding treatment options for children. The sNDA approval is an important step in fulfilling Gilead’s commitment to a goal of bringing pediatric formulations of Biktarvy to children living with HIV around the world.”

While effective available treatment options for pregnant women living with HIV lower the likelihood of perinatal HIV infection transmission, pediatric HIV remains a global health problem. Each day in 2020, approximately 850 children worldwide became infected with HIV and approximately 330 children died from AIDS-related causes, mostly because of inadequate access to HIV care and treatment services. The availability of a single-tablet antiretroviral regimen for children weighing at least 14 kg is a significant milestone with the potential to save many lives.

“As children living with HIV will be on therapy for the foreseeable future and from such a young age, there are a number of factors I weigh as a clinician when prescribing the right HIV treatment option to my pediatric patients,” said Carina Rodriguez, MD, Professor of Pediatrics and Division Chief of Pediatric Infectious Diseases at the University of South Florida Morsani College of Medicine. “Finding an efficacious treatment option is paramount, but tolerability and safety are keys to ensuring treatment success. With this expanded approval, clinicians can add Biktarvy to their arsenal of options to help ensure these children maintain virologic suppression with a treatment option that makes sense for them.”

In the United States, Biktarvy is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Biktarvy has a Boxed Warning for post treatment acute exacerbation of hepatitis B; please see below for additional Important Safety Information for Biktarvy.

The approval of Biktarvy for children weighing at least 14 kg is based on data from Cohort 3 of a Phase 2/3 open-label, single-arm study (NCT02881320), which found Biktarvy low-dose tablets to be effective and generally well-tolerated through 24 weeks in virologically suppressed children living with HIV-1. Cohort 3 enrolled 22 participants weighing ≥14 to <25 kg who continued on treatment for 48 weeks and could then continue to receive study drug through an extension phase. After switching to Biktarvy, 91% (20/22) of participants remained virologically suppressed at Week 24, and the mean change in CD4 % from baseline was 0.2%. HIV-1 RNA was not collected at Week 24 for two participants because of COVID-19 pandemic-related study disruption. In pediatric studies, no new adverse reactions or laboratory abnormalities were identified compared to those observed in adults.

Biktarvy does not cure HIV or AIDS.

About Pediatric HIV

While there have been many advances in the treatment of HIV in children and adolescents, there still remains a need to prioritize, evaluate and develop options for the nearly 3 million children worldwide under the age of 19 living with HIV. An estimated 120,000 children and adolescents died from AIDS-related causes in 2020. About 72 percent of these mostly preventable deaths occurred among children under 10 years old. Newer, child-friendly formulations with appropriate dosing for children and adolescents represent an unmet need that is an important part of the considerations associated with long-term health and wellness for people who will live with HIV for their entire lives until we find a cure. Gilead has partnered with a number of global organizations and initiatives to ensure that we are optimizing and closing treatment gaps for children and adolescents in need so that ultimately, we can end the epidemic.

About Biktarvy

Biktarvy is a complete HIV-1 treatment that combines 3 powerful medicines to form the smallest 3-drug, integrase strand transfer inhibitor (INSTI)-based single-tablet regimen (STR) available, offering simple once-daily dosing with or without food, with a limited drug interaction potential and a high barrier to resistance. Biktarvy combines the novel, unboosted INSTI bictegravir, with the Descovy^® (emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, F/TAF) backbone. Biktarvy is a complete single-tablet regimen and should not be taken with other HIV-1 medicines.

In February 2018, the U.S. FDA approved Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a once-daily single-tablet regimen for the treatment of HIV-1 infection in adults. In June 2019, the FDA approved labeling revisions to Biktarvy, expanding the patient population to include pediatric patients weighing at least 25 kg. In October 2021, the FDA approved a new low-dose tablet formulation of Biktarvy (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg. For all patient populations, Biktarvy is only indicated for the treatment of HIV-1 infection in people who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

U.S. Important Safety Information for Biktarvy

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 children 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: There is insufficient human data on the use of BIKTARVY during pregnancy. Dolutegravir, another integrase inhibitor, has been associated with neural tube defects. Discuss the benefit-risk of using BIKTARVY during pregnancy and conception. 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.

U.S. Indication for Biktarvy

Biktarvy is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 11 HIV medications, including the first single-tablet regimen to treat HIV and the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, including those involving Biktarvy; the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy; Gilead’s ability to receive FDA and other regulatory approvals for additional indications for Biktarvy, and the risk that any such approvals, if granted, may have significant limitations on its use; the risk that physicians may not see the benefits of prescribing Biktarvy; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

U.S. Prescribing Information for Biktarvy and Descovy, including BOXED WARNINGS,are available at www.gilead.com.

Biktarvy, Descovy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

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Source: Gilead Sciences, Inc.