Gilead Presents Real-World Evidence Reinforcing the Use of Biktarvy® for the Treatment of People Living With HIV With a Range of Comorbidities

– New Clinical Outcomes from BICSTaR Study Show Sustained Impact of Biktarvy for People with HIV –

– Five-Year Data from Studies 1489 and 1490 Solidify the Robust and Durable Efficacy and Safety Profile of Biktarvy –

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced the presentation of real-world results from the BICSTaR study, highlighting Biktarvy^® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a generally well tolerated and efficacious regimen regardless of prior treatment and comorbidity status in people with HIV. The latest five-year data from two Phase 3 studies (Study 1489 and Study 1490) provide evidence of the long-term safety and efficacy profile of Biktarvy in those who switch from a dolutegravir-containing regimen. The data were presented at the 30th International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2022).

New real-world data was presented from the 24-month BICSTaR follow-up analysis, evaluating the effectiveness and safety of Biktarvy in clinical practice across nine countries. The analysis included follow-up during the COVID-19 pandemic and considered age, race, sex, adherence, and late diagnosis in the population group. Trial participants who initiated treatment with Biktarvy experienced high viral suppression (HIV-1 RNA <50 copies/mL). Overall, 97% (104/107) of treatment-naïve and 95% (497/521) of treatment-experienced participants achieved viral suppression (missing=excluded analysis) at 24 months. There were no reports of treatment-emergent resistance. Treatment discontinuations (14% overall) were low, and few people (7%) discontinued Biktarvy as a result of drug-related AEs (DRAEs). The most commonly reported drug-related adverse events were weight change (3%) and depression (1%). These data reinforce the safety and durability of Biktarvy for people with HIV with a high level of comorbidities.

“These latest data demonstrate how innovation and improvement in HIV treatment options can help people living with HIV and their clinicians identify an HIV treatment regimen that supports their treatment over the long-term,” said Benoit Trottier, MD, Physician and Director of Research at Clinique de Médecine Urbaine du Quartier Latin, Montreal, Canada. “Factors such as aging and comorbidities are vital components of long-term health discussions. The BICSTaR study reinforces the real-world effectiveness of Biktarvy across populations with a range of comorbidities and the findings are consistent with evidence from randomized clinical trials of Biktarvy treatment.”

Additional data from Study 1489 and Study 1490 presented at the conference show Biktarvy to have high efficacy and sustained safety for people switching to the treatment, with a continued high barrier to resistance. These outcomes were reported in participants 96 weeks after switching to open-label Biktarvy following 144 weeks of blinded dolutegravir + 2 NRTIs. At Week 240, more than 99% of participants in both Study 1489 (217/218; missing=excluded) and Study 1490 (232/234; missing=excluded) achieved viral suppression. Additionally, at every visit through 240 weeks, the study showed that following the switch to Biktarvy, efficacy was >96% (missing=excluded), demonstrating that Biktarvy may provide sustained viral suppression for people with HIV, even after switching treatments. Biktarvy was generally well tolerated, with 0.4% (2/519) of switch participants in both studies experiencing an AE that led to drug discontinuation in the open-label extension period. There were no renal discontinuations. The most commonly reported adverse events during the open-label extension phase were diarrhea (0.6%) and weight change (0.6%).

On October 14, 2022, the U.S. Food and Drug Administration (FDA) approved a label change for Biktarvy, updating the prescribing information to include efficacy data from 144 weeks and safety data from 240 weeks of clinical trial data in adults with HIV who were initiating therapy in Study 1489 and Study 1490.

“As we strive to advance scientific innovation with the goal of helping to end the HIV epidemic, we’re committed to a treatment research program that addresses the individual needs of all people with HIV,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Gilead’s ongoing, person-centered research is focused on the evolving needs and preferences of people living with HIV. These latest data presented at HIV Glasgow 2022 demonstrate the clinical use of innovative medicines like Biktarvy to help a broad range of people with HIV, regardless of their burden of comorbidities.”

Please see below for the U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy.

There is currently no cure for HIV or AIDS.

About the BICSTaR Study

The Bictegravir Single Tablet Regimen (BICSTaR) study is an ongoing, multinational, observational single-arm, non-comparative real-world cohort study, which aims to evaluate the effectiveness, safety, tolerability, and patient-reported outcomes of treatment with Biktarvy in treatment‐naïve and treatment‐experienced people with HIV. Among the people with HIV enrolled in the BICSTaR study, there is a high baseline prevalence of comorbidities.

About Studies 1489 and 1490

Study 1489 and Study 1490 are Phase 3, randomized, double-blind, active-controlled studies. For 144 weeks, treatment-naïve participants were blinded to receive either Biktarvy (n=634) or a dolutegravir-containing triple therapy (n=640). The primary endpoint 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 assessed through Weeks 96 and 144. Beyond week 144, participants were given the option to receive Biktarvy in an active open-label extension phase for up to 96 weeks.

About Biktarvy

Biktarvy is a complete HIV treatment that combines three 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 STR and should not be taken with other HIV medicines.

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.

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.

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 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 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, and the first, long-acting injectable HIV treatment medication administered twice-yearly. 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 was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.

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 or studies within currently anticipated timelines or at all, 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, 2022, 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, including BOXED WARNING, is available at www.gilead.com.

Biktarvy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other trademarks are the property of their respective owner(s).

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.

Contacts

Jacquie Ross, Investors

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Brian Plummer, Media

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