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Gilead Announces New Data on Biktarvy® for the Treatment of HIV in Black Americans

GILD | October 21, 2020

CA-GILEAD-SCIENCES

– BRAAVE 2020 Study Demonstrates Non-Inferiority of Biktarvy for the Treatment of HIV in Black Americans Who Are Virologically Suppressed, Including Patients With a History of Treatment Failure or Pre-Existing Resistance –

– Additional Analysis Shows Potential of Biktarvy to Be an Important Treatment Option for People Living With HIV Who are Virologically Suppressed and Have End Stage Renal Disease Requiring Hemodialysis –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced 48-week data from the BRAAVE 2020 study, a Phase 3 clinical trial evaluating the safety and efficacy of switching to Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) in virologically suppressed adults living with HIV who self-identified as Black or African American. These data presented at IDWeek 2020 show that switching from a standard regimen of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent to Biktarvy is an effective treatment regimen in Black Americans with HIV who are virologically suppressed, including individuals with a history of treatment failure or pre-existing resistance.

BRAAVE 2020 is a Phase 3 clinical trial evaluating the specific treatment responses of virologically suppressed adults living with HIV who self-identified as Black or African American following a switch to Biktarvy from a variety of regimens. A total of 495 study participants were randomized 2:1 to switch to open-label Biktarvy or to stay on a standard regimen of two NRTIs plus a third agent for 24 weeks with a delayed switch to Biktarvy until week 48. The study demonstrated that at 48 weeks, treatment with Biktarvy maintained high rates of virologic suppression in study participants and did not result in treatment-emergent resistance to any component of Biktarvy. In the analysis of preexisting resistance and virologic outcomes, similar virologic suppression rates were achieved irrespective of the presence of preexisting drug resistance substitutions. Through 48 weeks, 99% of study participants in the Biktarvy group (324/327) and 100% of study participants in the delayed switch group (162/162) maintained HIV-1 RNA <50 copies/mL. The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational.

“Black and African Americans in this country have the highest rates of new HIV infections every year compared to other races. Adding to that burden are other inequalities such as lack of health insurance, difficulties navigating the healthcare system, and poverty; all of which contribute to higher rates of drug resistance,” explained Debbie P. Hagins, MD, FAPCR, Medical Director, CARE Centers of Southeast Georgia, Coastal Health District, Savannah, GA and Principal Investigator for the BRAAVE 2020 study. “As drug resistance builds, treatment options become more limited, sometimes leading to less desirable, but often necessary, complicated treatment regimens. Again, lending itself to further adherence challenges. These data from BRAAVE 2020, a landmark study, designed with community input to understand specific treatment responses of Black and African Americans, show Biktarvy is an effective regimen for Black Americans, including those with a history of some drug resistance.”

Biktarvy is indicated in the United States as a complete regimen for the treatment of HIV-1 infection in adults or pediatric patients weighing at least 25 kg who have no antiretroviral (ARV) treatment history. While it is also indicated for adults and pediatric patients weighing at least 25 kg who are virologically suppressed and on a stable ARV regimen, these people must have no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy. Please see below for U.S. Important Safety Information for Biktarvy, including a Boxed Warning on the risk of post-treatment acute exacerbation of hepatitis B.

Gilead presented additional Biktarvy clinical development program data at IDWeek 2020, including 48-week findings from a Phase 3, open-label, 48-week extension study, which found that a once-daily regimen of Biktarvy maintained virologic suppression in people living with HIV on chronic hemodialysis. This shows the potential of Biktarvy as an effective treatment option with convenient single tablet regimen dosing that can lessen the burden of complex dose-adjusted regimens that many people living with HIV on hemodialysis require. In addition, Gilead will present findings from an in vitro simulation examining Biktarvy’s effect on drug resistance during short lapses in adherence.

“An HIV treatment clinical trial program that addresses the specific needs of people living with HIV such as disproportionately impacted and underrepresented populations, or those who have specific comorbidities, is central to Gilead’s mission of helping to end the HIV epidemic,” said Diana Brainard, MD, Senior Vice President and Virology Therapeutic Area Head, Gilead Sciences. “The data presented at IDWeek highlight Gilead’s commitment and Biktarvy’s potential to meet the specific treatment needs of diverse groups of people living with HIV today, from individuals facing drug resistance from prior treatment regimens to men and women aging with HIV who are managing other health conditions.”

Additional data from a late-breaking oral presentation provide important insight on tenofovir alafenamide’s (TAF) impact on weight, further supporting the hypothesis that a switch from tenofovir disoproxil fumarate (TDF) to TAF may result in weight gain because the TDF-induced weight suppression is no longer present. The study evaluated weight change in virologically suppressed people living with HIV on a standard regimen of two NRTIs plus an integrase strand transfer inhibitor (INSTI). After one year, those who switched from TDF to TAF (n=828) and those who switched from abacavir (ABC) to TAF (n=142) experienced a mean unadjusted weight gain of 1.4 kg and 0.2 kg, respectively (p=0.039). In the TDF to TAF switch group, 40% experienced weight gain ≥ 3% compared with 27% of those in the ABC to TAF switch group (p=0.003).

The use of Biktarvy in individuals with a history of treatment failure or known resistance to the components of Biktarvy is investigational; this use is not approved by the U.S. FDA, and the safety and efficacy of Biktarvy for this use has not been established. Please see below for the U.S. Indication for Biktarvy.

Biktarvy does not cure HIV or AIDS.

U.S. Important Safety Information and Indication 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: 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, 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 percent), 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: Patients weighing ≥25 kg: 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. 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 HIV-1 infection in adults and pediatric patients weighing at least 25 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 history of treatment failure and no known resistance to any component of Biktarvy.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California.

For more than 30 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention, testing and linkage to care, and cure research. Today, it’s estimated that more than 12 million people living with HIV globally receive antiretroviral therapy provided by Gilead or one of the company’s manufacturing partners.

Gilead is committed to supporting the global health community to quickly and effectively respond to serious and life-threatening viral outbreaks worldwide. To that end, we are contributing our antiviral expertise and resources to help investigate potential treatments for patients with COVID-19.

Forward-Looking Statement

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 the possibility of unfavorable results from ongoing and additional clinical trials involving Biktarvy, and the possibility that we are unable to complete one or more of such trials on the currently anticipated timelines or at all. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.

U.S. Prescribing Information for Biktarvy including BOXED WARNING , is available at www.gilead.com .

Biktarvy, Gilead and the Gilead logo are 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.