SLC47A1

FOSTER CITY, Calif., & RAHWAY, N.J.--( BUSINESS WIRE )--Gilead Sciences, Inc. (Nasdaq: GILD) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from the Phase 2 clinical study evaluating the investigational combination of islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor, and lenacapavir, a first-in-class capsid inhibitor. These late-breaking data were presented during an oral session at the 31st Conference on Retroviruses and Opportunistic Infections ( CROI ). Prior to the late-breaker oral presentation, the key findings were featured in a CROI press conference. At 24 weeks, the novel investigational combination maintained a high rate (94.2%) of viral suppression (HIV-1 RNA <50 copies/mL), which is a secondary endpoint of the study. Results of the primary endpoint (HIV-1 RNA ≥50 copies/mL (c/mL) showed that one participant (1.9%) treated with islatravir and lenacapavir had a viral load of >50 copies/mL at Week 24; the participant later suppressed on islatravir and lenacapavir at Week 30. The potent antiviral activities, along with pharmacokinetic profiles of islatravir and lenacapavir, support their development as an investigational once-weekly oral combination regimen. Single-tablet daily oral therapies have helped to transform HIV care, but options that allow for less frequent dosing have the potential to address adherence, stigma and other challenges faced by some individuals taking daily oral antiretroviral therapy. “ HIV treatment is not one size fits all – developing once-weekly treatment options could help meet the needs of each individual, aiming toward maximizing long-term outcomes for people with HIV,” said Jared Baeten, Vice President, MD, PhD, HIV Clinical Development, Gilead Sciences. “ These promising data presented at CROI help bring us one step closer to our goal of providing a wide range of options that may help transform the HIV treatment landscape.” In this open-label, active-controlled study ( NCT05052996 ), virologically suppressed adults (n=104) on Biktarvy ® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) were randomly allocated in a 1:1 ratio to receive either oral islatravir 2 mg and lenacapavir 300 mg once a week (n=52) or to continue daily oral Biktarvy (n=52). The median age of participants was 40 years. Eighteen percent of participants were assigned female at birth, 50% were non-white, and 29% were Hispanic or Latinx. Results of the primary endpoint, measured as HIV-1 RNA ≥50 copies/mL (c/mL) at Week 24 per FDA Snapshot algorithm, showed that one participant (1.9%) treated with islatravir and lenacapavir had a viral load of more than 50 copies/mL at Week 24; the participant later suppressed on islatravir and lenacapavir at Week 30. No participants in the Biktarvy group had a viral load of more than 50 copies/mL at Week 24. Results of the secondary endpoint, as measured by the proportion of individuals with HIV-1 RNA < 50 c/mL at Week 24, showed that participants who switched to treatment with once-weekly islatravir and lenacapavir or continued Biktarvy both maintained comparable high rates of HIV suppression at Week 24 (94.2% v. 94.2%). Grade 1 and 2 treatment-related-adverse events (TRAEs) reported in the islatravir and lenacapavir group included dry mouth and nausea (each 3.8%). No grade 1 and 2 TRAEs were reported in the Biktarvy group. No grade 3 or 4 TRAEs related to study drug in either treatment group were reported. Two participants discontinued islatravir and lenacapavir due to adverse events unrelated to the drug. In addition, no differences were seen between treatment groups for changes in CD4+ T cell counts or absolute lymphocyte counts. “ Our strategies for managing and treating HIV must evolve with the needs of the HIV community and we are excited to have these promising first data from the Phase 2 study for islatravir and lenacapavir presented at CROI,” said Dr. Elizabeth Rhee, vice president, global clinical development, Merck Research Laboratories. “ Gilead and Merck remain committed to this collaboration and to the development of a potential once-weekly oral therapy for people living with HIV who may need additional options to help maintain viral suppression.” The Phase 2 study will continue in an open-label fashion through Week 48. Longer-term data will be presented at a future scientific conference. Islatravir, alone or in combination with lenacapavir, is investigational and not approved anywhere globally. The safety and efficacy of the combination of islatravir and lenacapavir have not been established. Lenacapavir, marketed as Sunlenca ® , is approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom and the United States for the treatment of people with multi-drug resistant HIV in combination with other antiretroviral(s). Please see below for the U.S. Indication and Important Safety Information for Sunlenca. Please also see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. There is currently no cure for HIV or AIDS. About islatravir (MK-8591) Islatravir (MK-8591) is Merck’s investigational nucleoside reverse transcriptase translocation inhibitor under evaluation for the treatment of HIV-1 in combination with other antiretrovirals. For an overview of Merck’s HIV treatment and prevention clinical development program, please click here . About Sunlenca ® Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection) [(lenacapavir)] is a first-in-class, long-acting HIV capsid inhibitor indicated for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is the only HIV treatment option administered twice-yearly. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option. The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being developed as a foundation for future HIV therapies developed by Gilead. The goal is to offer both long-acting oral and injectable options with various dosing frequencies in combination with other antiretroviral agents for treatment or as a single agent for prevention. This approach aims to help address the individual needs and preferences of people with HIV and people who could benefit from pre-exposure prophylaxis (PrEP). The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use has not been established. Lenacapavir is being evaluated as a potential long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Merck’s Commitment to HIV For more than 35 years, Merck has been committed to scientific research and discovery in HIV. Today, we are developing a series of antiviral options designed to help people manage HIV and protect people from HIV, with the goal of reducing the growing burden of infection worldwide. We remain committed to collaborating with others in the global HIV community to address the complex challenges that impede progress toward ending the epidemic. About Gilead Sciences in HIV For more than 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, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, 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 , collaborations, and charitable giving, 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. Learn more about Gilead’s unique collaborations worldwide and the work to help end the global HIV epidemic. U.S. Indication for Sunlenca Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. U.S. Important Safety Information for Sunlenca Contraindications Coadministration: Concomitant administration of SUNLENCA is contraindicated with strong CYP3A inducers. Warnings and precautions Immune reconstitution syndrome , including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy. Long-acting properties and potential associated risks with SUNLENCA: Residual concentrations of SUNLENCA may remain in the systemic circulation of patients for up to 12 months or longer. SUNLENCA may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing SUNLENCA, begin alternate suppressive ARV regimen within 28 weeks from last injection. Injection site reactions may occur, and nodules and indurations may be persistent. Adverse reactions Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%). Drug interactions Prescribing information: Consult the full prescribing information for SUNLENCA for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of SUNLENCA. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of SUNLENCA. SUNLENCA may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of SUNLENCA, which may increase the potential risk of adverse reactions. Dosage and administration Dosage: Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food. Initiation Option 1: Day 1: 927 mg by subcutaneous injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Initiation Option 2: Day 1: 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous injection. Maintenance: 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection. Missed Dose: During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue SUNLENCA treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2. Pregnancy and lactation Pregnancy: There is insufficient human data on the use of SUNLENCA during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Lactation: Individuals 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 or suspected substitutions associated with resistance to bictegravir or tenofovir. 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. Gilead 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, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Biktarvy and lenacapavir; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2023, 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 involve risks and uncertainties 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. Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). U.S. full Prescribing Information for Biktarvy, including BOXED WARNING , and U.S. full Prescribing Information for Sunlenca are available at www.gilead.com . Biktarvy, Sunlenca, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. All other marks are the property of their respective owners. For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on Twitter ( @Gilead Sciences ) and LinkedIn , or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

- Key Findings from HIV Treatment Research Studies Evaluating Biktarvy® and Investigational Long-Acting Combination Regimens Affirm Commitment to Continuous Biomedical Innovation – – Latest Real-World Evidence Analyses Evaluate Impact of Veklury® on Mortality and Long-COVID – – New Data Evaluating the Safety and Efficacy of Hepcludex® in People with HIV/HBV/HDV Coinfection to Be Presented – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the upcoming presentation of new clinical data and real-world evidence (RWE) from its antiviral research and development programs at the 31st Conference on Retroviruses and Opportunistic Infections (CROI 2024) taking place from March 3-6. The data from nearly eighty studies across HIV, COVID-19 and viral hepatitis include late-breaking data, four oral presentations, and reflect Gilead’s commitment to address the evolving needs of a diverse range of people and communities affected by some of the world’s most challenging viruses. “At CROI 2024, we look forward to sharing new research that highlights the breadth of our antiviral portfolio and expanding pipeline as we strive to treat, prevent, cure and help eradicate viral diseases worldwide,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “The data selected for presentation at CROI is a reflection of our unwavering commitment to advancing person-centered biomedical innovation in virology, aimed at fulfilling urgent global needs.” HIV Treatment Research Scientific discovery in HIV treatment is a pillar of Gilead’s commitment to help end the epidemic. At CROI 2024, presented study results and analyses will include further evaluation of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) as a long-term treatment option for a broad range of people with HIV who may also have common comorbidities and other specific health needs. Outcomes from pipeline research studies will also provide insights into investigational treatment candidates, including the novel combination regimen of lenacapavir plus bictegravir. Additionally, key findings from a study evaluating the investigational combination of lenacapavir with broadly neutralizing antibodies (bNAbs) will be featured in a late-breaker oral presentation. A late-breaker oral presentation of Week 24 data from the ongoing Phase 2 study evaluating an investigational once-weekly oral combination regimen of islatravir and lenacapavir will also be presented. Specifically, Biktarvy presentations will include a two-year analysis of data from the Phase 3 ALLIANCE trial evaluating factors associated with hepatitis B (HBV) treatment response in adults with HIV-1/HBV co-infection initiating treatment. Additionally, a late-breaker oral presentation of Week 24 data from the INSIGHT trial evaluating Biktarvy in people with HIV and tuberculosis will be presented. Gilead will also present outcomes from the ARTISTRY-1 Phase 2/3 study investigating the efficacy and safety of switching from a complex stable baseline regimen to an investigational once-daily single-tablet regimen of lenacapavir and bictegravir. Additional lenacapavir data presented at CROI 2024 will evaluate the efficacy and safety of the novel antiviral agent in combination with broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) as a potential long-acting treatment regimen with twice-yearly dosing. Additional HIV treatment research pipeline findings include an oral presentation of new proof-of-concept data on GS-1720, a novel once-weekly integrase strand transfer inhibitor (INSTI) and PRESTIGIO registry data evaluating sensitivity to broadly neutralizing antibodies teropavimab (GS-5423) and zinlirvimab (GS-2872) in people with multi-drug resistant HIV. COVID-19 Research Gilead remains committed to understanding the COVID-19 treatment landscape and will present multiple RWE analyses, including on the impact of Veklury® (remdesivir) in reducing mortality in immunocompromised people hospitalized for COVID-19 during the Omicron period (Dec’21 - April’23). Gilead will also present a study on the disparities in COVID-19 treatment initiation by race and ethnicity among hospitalized patients and one on the effect of Veklury on long-COVID among people hospitalized with COVID-19. Additional presentations will include RWE of Veklury in combination with dexamethasone for the treatment of COVID-19, and study results from kidney transplant patients hospitalized with COVID-19. Viral Hepatitis Research Gilead will present new data evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with the coinfections of HIV, hepatitis B (HBV) and hepatitis delta (HDV). The aim of this 96-week analysis from the Phase 3 MYR301 study is to evaluate the safety and efficacy of Hepcludex (2 mg or 10 mg) in patients with HIV/HBV/HDV coinfection. A separate analysis of RWE will examine liver-related events in people living with HIV/HBV coinfection with and without HDV. Since limited data is available to describe the natural history of triple infection with HBV/HIV/HDV, this retrospective cohort study, conducted using HealthVerity claims data from the US, evaluates baseline liver health, HDV prevalence, and the risk of liver-related events in individuals with HBV/HIV with or without HDV. Select accepted abstracts are as follows: HIV Treatment Research (B/F/TAF) Disposition Factors associated with HBV response to B/F/TAF vs. DTG + F/TDF at W96 in people with HIV-1 and HBV Poster Efficacy, safety and PK of BIC/FTC/TAF in adults with HIV and Tuberculosis on rifampicin at Week 24 LB Oral Inflammatory pro B/F/TAF, DTG/ABC/3TC, and DTG+F/TAF over 5-years and effects of viral blips Poster Longitudinal analysis of preexisting resistance-associated mutations prior to B/F/TAF switch Poster Safety of tenofovir alafenamide in individuals with a history of proximal renal tubulopathy on TDF Poster Weight gain in people with HIV (PWH) vs people without HIV (PWoH) over a 3-year period Poster A randomized trial switching adults ≥ 60 years old from first-line ART to B/F/TAF: week 48 results Poster Long-Acting HIV Treatment Research (Lenacapavir) Efficacy and safety of weekly islatravir plus lenacapavir in PWH at 24 weeks: a Phase 2 study LB Oral Lenacapavir efficacy in CAPELLA patients with no fully active agents in optimized background regimen Poster Lenacapavir plus bNAbs for people with HIV and sensitivity to either teropavimab or zinlirvimab Oral HIV Pipeline Research Phase 2 study of switch to daily BIC + LEN in individuals on a multi-tablet HIV treatment regimen Poster Preclinical characterization of GS-5894, a potent NNRTI with once-weekly oral dosing potential Poster Antiviral activity, safety, and pharmacokinetics of GS-1720, a novel weekly oral INSTI Oral Teropavimab and zinlirvimab sensitivity in people living with MDR HIV-1: PRESTIGIO registry data Poster Type I IFN signaling and regulation in vesatolimod-treated virally suppressed adults with HIV-1 Poster HIV Prevention Research Sexual health outcomes among daily and on-demand oral PrEP users in China Oral HIV Cure Research Immune pro ATI in AELIX-002 HTI vaccine trial and its role in post-intervention control Oral COVID-19 Research Remdesivir reduces mortality in immunocompromised patients hospitalized for COVID-19 during Omicron LB Poster Effect of remdesivir on post-COVID conditions among individuals hospitalized with COVID-19 by age LB Poster Disparities in treatment initiation by race and ethnicity among patients hospitalized for COVID-19 Poster Remdesivir+dexamethasone vs. dexamethasone for the treatment of COVID-19: real-world study in the US LB Poster Characteristics and outcomes of kidney transplant patients hospitalized for COVID-19 in the United States Poster Viral Hepatitis Research Risk of liver-related events in individuals with HBV/HIV coinfection with and without HDV Poster Efficacy and safety of BLV 2 or 10 mg for 96 weeks in CHD including two patients with HIV/HBV/HDV Poster For more information, including a complete list of abstracts and their corresponding oral and poster sessions, please visit . Teropavimab, zinlirvimab, vesatolimod, GS-5894 and GS-1720 are investigational compounds, and alone or in combination with lenacapavir, are not approved by the U.S. Food and Drug Administration or any other regulatory authority for any use. Their safety and efficacy are unknown. Lenacapavir, marketed as Sunlenca®, is approved in Australia, Canada, the European Union, Israel, Japan, Switzerland, the United Arab Emirates, the United Kingdom and the United States for the treatment of people with multi-drug resistant HIV in combination with other antiretroviral(s). Lenacapavir is being studied in multiple ongoing early and late-stage development programs and has the potential to offer a diverse set of person-centric options for treatment and prevention that could uniquely fit into the lives of people living with HIV and people who would benefit from pre-exposure prophylaxis (PrEP). The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Islatravir, alone or in combination with lenacapavir, is investigational and not approved anywhere globally. Their safety and efficacy have not been established. Bictegravir is an investigational compound and is not approved by any regulatory authority for use as a single-agent; its safety and efficacy are not established. ​ Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. Their safety and efficacy have not yet been established. The use of Biktarvy in individuals with HIV-1/HBV co-infection is investigational, and the safety and efficacy of Biktarvy for this use have not been established. Hepcludex (bulevirtide) has received full marketing authorization from the European Commission for the treatment of adults with chronic HDV and compensated liver disease. In the United States and other areas outside of the European Union and European Economic Area, bulevirtide is an investigational product and its safety and efficacy have not been established. Please see below for the U.S. Indication and Important Safety Information for Veklury and Sunlenca®. Please also see below for U.S. Indication and Important Safety Information, including Boxed Warning, for Biktarvy. There is currently no cure for HIV or AIDS. 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. About Sunlenca Sunlenca (300 mg tablet and 463.5 mg/1.5 mL injection) [(lenacapavir)] is a first-in-class, long-acting HIV capsid inhibitor for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV who are heavily treatment-experienced. Sunlenca is the only HIV treatment option administered twice-yearly. Sunlenca tablets are approved for oral loading during initiation of Sunlenca treatment, prior to or at the time of the first long-acting lenacapavir injection depending on initiation option. The multi-stage mechanism of action of Sunlenca’s active pharmaceutical agent, lenacapavir, is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, Sunlenca is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes. Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead's HIV prevention and treatment research program. Lenacapavir for HIV prevention is investigational, and its safety and efficacy for this use have not been established. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV. About Veklury Veklury (remdesivir) is a nucleotide analog prodrug invented by Gilead, building on more than a decade of the company’s antiviral research. Veklury is the antiviral standard of care for the treatment of hospitalized patients with COVID-19 and is a recommended treatment for reducing disease progression in non-hospitalized patients at high risk of disease progression. Veklury has an established safety pro limited known drug interactions in diverse populations. It plays an important role in reducing disease progression across a spectrum of disease severity and enabling patients to recover faster. Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components. Please see below for the U.S. Indication and Important Safety Information for Veklury. Veklury directly inhibits viral replication inside of the cell by targeting the SARS-CoV-2 viral RNA polymerase. Based on in vitro analyses, Veklury retains antiviral activity against recent Omicron subvariants of concern, including XBB, XBB.1.5 and CH.1.1. Veklury continues to be evaluated against emerging variants of interest and concern, including EG.5, EG.5.1 and BA.2.86. Veklury is approved in more than 50 countries worldwide. To date, Veklury and generic remdesivir have been made available to more than 14 million patients around the world, including more than 8 million people in middle- and low-income countries through Gilead’s voluntary licensing program. 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. U.S. Indication for Sunlenca Sunlenca, a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations. U.S. Important Safety Information for Sunlenca Contraindications Coadministration: Concomitant administration of Sunlenca is contraindicated with strong CYP3A inducers. Warnings and precautions Immune reconstitution syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported in patients treated with combination antiretroviral (ARV) therapy. Long-acting properties and potential associated risks with Sunlenca: Residual concentrations of Sunlenca may remain in the systemic circulation of patients for up to 12 months or longer. Sunlenca may increase exposure, and potential risk of adverse reactions, to drugs primarily metabolized by CYP3A initiated within 9 months after last injection. Counsel patients regarding the dosing schedule because nonadherence could lead to loss of virologic response and development of resistance. If virologic failure occurs, switch to an alternative regimen if possible. If discontinuing Sunlenca, begin alternate suppressive ARV regimen within 28 weeks from last injection. Injection site reactions may occur, and nodules and indurations may be persistent. Adverse reactions Most common adverse reactions (incidence ≥3%, all grades) are injection site reactions (65%) and nausea (4%). Drug interactions Prescribing information: Consult the full prescribing information for Sunlenca for more information on Contraindications, Warnings, and potentially significant drug interactions, including clinical comments. Enzymes/transporters: Drugs that are strong or moderate inducers of CYP3A may significantly decrease the concentration of Sunlenca. Drugs that strongly inhibit CYP3A, P-gp, and UGT1A1 together may significantly increase the concentration of Sunlenca. Sunlenca may increase the exposure of drugs primarily metabolized by CYP3A, when initiated within 9 months after the last injection of Sunlenca, which may increase the potential risk of adverse reactions. Dosage and administration Dosage: Initiation with 1 of 2 options, followed by maintenance dosing once every 6 months. Tablets may be taken with or without food. Initiation Option 1: Day 1: 927 mg by subcutaneous injection and 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Initiation Option 2: Day 1: 600 mg orally (2 x 300-mg tablets). Day 2: 600 mg orally (2 x 300-mg tablets). Day 8: 300 mg orally (1 x 300-mg tablet). Day 15: 927 mg by subcutaneous injection. Maintenance: 927 mg by subcutaneous injection every 26 weeks +/- 2 weeks from date of last injection. Missed Dose: During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue Sunlenca treatment, restart the initiation dosage regimen from Day 1, Option 1 or Option 2. Pregnancy and lactation Pregnancy: There is insufficient human data on the use of Sunlenca during pregnancy. An Antiretroviral Pregnancy Registry (APR) has been established. Lactation: Individuals infected with HIV-1 should be instructed not to breastfeed, due to the potential for HIV-1 transmission. U.S. Indication for Veklury Veklury (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) who are: Hospitalized, or Not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death. For more information, please see the U.S. full Prescribing Information available at . U.S. Important Safety Information for Veklury Contraindication Veklury is contraindicated in patients with a history of clinically significant hypersensitivity reactions to Veklury or any of its components. Warnings and precautions Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of Veklury; most occurred within one hour. Monitor patients during infusion and observe for at least one hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue Veklury and initiate appropriate treatment (see Contraindications). Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received Veklury; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing Veklury if ALT levels increase to >10x ULN. Discontinue Veklury if ALT elevation is accompanied by signs or symptoms of liver inflammation. Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of Veklury with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in antiviral activity of Veklury. Adverse reactions The most common adverse reaction (≥5% all grades) was nausea. The most common lab abnormalities (≥5% all grades) were increases in ALT and AST. Drug interactions Drug interaction trials of Veklury and other concomitant medications have not been conducted in humans. Dosage and administration Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible. Treatment duration: For patients who are hospitalized, Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19. For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days. For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days. For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. Veklury should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use. Testing prior to and during treatment: Perform hepatic laboratory, and prothrombin time testing prior to initiating Veklury and during use as clinically appropriate. Renal impairment: No dose adjustment of Veklury is recommended in patients with any degree of renal impairment, including patients on dialysis. Veklury may be administered without regard to the timing of dialysis. Pregnancy and lactation Pregnancy: A pregnancy registry has been established for Veklury. Available clinical trial data for Veklury in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes following second- and third-trimester exposure. There are insufficient data to evaluate the risk of Veklury exposure during the first trimester. Maternal and fetal risks are associated with untreated COVID-19 in pregnancy. Lactation: Veklury can pass into breast milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Veklury and any potential adverse effects on the breastfed child from Veklury or from an underlying maternal condition. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. About Gilead Sciences in Virology 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, COVID-19, and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead has a long history in virology and has pioneered inventions once thought impossible, including antiviral treatments for people and communities affected by some of the most challenging public health concerns including HIV, viral hepatitis and COVID-19. Gilead helps people and communities across the full continuum of care in virology by developing bold advances that treat, prevent and cure viral diseases and collaborating with community and research partners around the world. Gilead is deploying decades of antiviral expertise to provide solutions that help address the unmet and evolving needs of those impacted by viral diseases. Our work in virology has helped to transform the global health landscape and we are committed to advancing person-centered science and actionable education programs that make a difference for people and communities affected by viral diseases. 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, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Biktarvy, Hepcludex, Veklury, lenacapavir, teropavimab, vesatolimod, zinlirvimab, GS-1720 and GS-5894; uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2023, 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 involve risks and uncertainties 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. full Prescribing Information for Biktarvy, including BOXED WARNING, U.S. full Prescribing Information for Sunlenca, and U.S. full Prescribing Information for Veklury are available at . Biktarvy, Sunlenca, Veklury, Hepcludex, 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 , follow Gilead on Twitter ( @Gilead Sciences ) and LinkedIn, or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

-- Biktarvy Now First and Only INSTI-Based Single-Tablet Regimen That is FDA Approved and DHHS Guideline Recommended for People Who are Virologically Suppressed with M184V/I Resistance -- -- M184V/I One of the Most Common Forms of Resistance Among People with HIV -- -- Biktarvy Is a Long-Term Treatment Option with a High Barrier to Resistance for a Broad Range of Individuals -- FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc., (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved a new, expanded indication for Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to treat people with HIV (PWH) who have suppressed viral loads with known or suspected M184V/I resistance, a common form of treatment resistance. HIV treatment resistance is permanent and irreversible, which can jeopardize future treatment options for PWH. The M184V/I resistance mutation has been found to be present in a range (22-63%) of PWH with pre-existing resistance to nucleoside reverse transcriptase inhibitors (NRTIs) across various HIV subtypes. This label update is supported by Study 4030, which evaluated the efficacy, safety, and tolerability pro Biktarvy in a broad range of people with HIV-1 with or without pre-existing NRTI resistance, including those with the M184V/I resistance. Biktarvy is now the first and only integrase strand transfer inhibitor (INSTI)-based single-tablet regimen that is FDA approved and U.S. Department of Health and Human Services (DHHS) guideline recommended for PWH who are virally suppressed with M184V/I resistance. “Clinical data have established Biktarvy as a long-term HIV treatment option for a broad range of PWH. With this label update, healthcare providers have a better understanding of the efficacy of Biktarvy in an underserved segment of PWH,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “Thanks to decades of therapeutic improvements, PWH may live longer, healthier lives, but treatment needs remain. Treatment resistance is one such area. We are committed to a person-centered approach to HIV treatment research that not only advances continuous scientific innovations to help address public health needs, but also maximizes long-term outcomes for PWH.” The expanded label is based on Week 48 data from Study 4030, a Phase 3 randomized, double-blinded study of virologically suppressed adults with HIV-1 on a baseline regimen of dolutegravir (DTG) + either emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF). Participants were randomized 1:1 to switch to Biktarvy (n=284) or DTG+F/TAF (n=281). Study participants must have been stably suppressed (HIV-1 RNA < 50 copies/mL) with current baseline regimen for at least six months if NRTI resistance was documented or suspected, or at least three months if NRTI resistance was not documented or suspected prior to trial entry. Of the participants receiving Biktarvy, 47 had HIV-1 with pre-existing M184V/I resistance substitutions. The primary endpoint was the proportion of participants with HIV RNA ≥ 50 copies/mL at Week 48. Eighty-nine percent (42/47) of participants with M184V/I remained suppressed (HIV-1 RNA < 50 copies/mL) and 11% (5/47 participants) did not have virologic data at the Week 48 timepoint. No participants with M184V/I who received Biktarvy and had virologic data had HIV RNA ≥ 50 copies/mL at Week 48. Additionally, at Week 48 the proportion of subjects with HIV-1 RNA ≥ 50 copies/mL was 0.4% (1/284) in the Biktarvy group and 1.1% (3/281) in the DTG+F/TAF group (difference -0.7% [95% CI: -2.8%, 1.0%]). There were also zero cases of treatment-emergent resistance to Biktarvy, regardless of known or suspected pre-existing M184V/I resistance, in the final resistance analysis population. Overall, the safety pro virologically suppressed adults in Study 4030 was similar to that in participants in other studies of Biktarvy with no antiretroviral treatment history. Once someone with HIV has developed resistance to a treatment, it will persist for the rest of their life. Reducing the risk of drug resistance is a key goal in HIV therapy. HIV drug resistance continues to receive clinical and public health attention because it may hinder the ability of HIV medicines to suppress and block replication of the virus over the course of an individual’s life. Resistance may lead to treatment failure in individuals, while also creating the potential for transmission of treatment-resistant HIV within communities. “Treatment failure in HIV must be avoided whenever possible, so a high barrier to resistance should be standard of care to maximize the chances of durable virologic suppression,” said Paul E. Sax, MD, Clinical Director, Division of Infectious Diseases, Brigham and Women’s Hospital, Professor of Medicine, Harvard Medical School. “This label update builds on the established high resistance barrier of Biktarvy by showing that it’s effective in PWH who may have certain forms of pre-existing resistance or a history of past treatment failure.” Please see below for U.S. Indications and Important Safety Information for Biktarvy, including Boxed Warning. There is no cure for HIV or AIDS. 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 (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg) 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 (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. 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 and address unmet needs in virology, oncology and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. For more than 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, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly. Our advances in medical research have helped to transform HIV into a treatable, 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. Learn more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic for everyone, everywhere. 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, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Biktarvy; the risk that physicians may not see the benefits of prescribing Biktarvy to treat virologically suppressed people with HIV; 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 September 30, 2023, 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 involve risks and uncertainties, 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 Biktarvy, 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 , follow Gilead on Twitter (@Gilead Sciences) and LinkedIn, or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.