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ADHERE data presentation will highlight first potential innovation for CIDP patients in 30 years Abstracts reflect real-world value and consistent efficacy and safety pro with long-term use of VYVGART® and VYVGART® Hytrulo in gMG patients March 7, 2024, 10:01 pm CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced that eight abstracts, including two oral presentations, featuring clinical trial and real-world data for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in rare autoimmune diseases will be presented at the American Academy of Neurology (AAN) Annual Meeting, taking place in Denver, CO from April 13-18, 2024. “We are opening a new chapter for the VYVGART portfolio,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “While VYVGART continues to reach more gMG patients globally, we are also striving to bring meaningful benefits to people living with CIDP – a community which has been awaiting innovation for 30 years. We are excited to present a broad set of data at AAN this year that collectively demonstrate how we are delivering on our promise to transform patients’ lives with innovative treatments.” Transforming Autoimmunity by Targeting FcRn Findings from the ADHERE study of VYVGART Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) will be presented for the first time in an oral presentation during the Clinical Trials Plenary Session, taking place on Tuesday, April 16, 2024. These positive data from the ADHERE study have been submitted to the FDA for potential approval of VYVGART Hytrulo in CIDP with a PDUFA target action date of June 21, 2024. In addition to the full ADHERE data, the AAN presentations will highlight clinical trial and real-world data showcasing the broad opportunity with VYVGART, a first-in-class neonatal FC receptor (FcRn) inhibitor, and VYVGART Hytrulo, to deliver significant value to the generalized myasthenia gravis (gMG) patient community by driving consistent and repeatable improvements across patient subtypes, a favorable and predictable safety profile, and the ability to individualize treatment across both intravenous and subcutaneous administration and dosing schedules. Achievement of MSE enables significant quality of life improvements: ADAPT/ADAPT+ demonstrate that >40% of patients achieve minimal symptom expression (MSE) across both studies. Patients achieving MSE experience quality of life outcomes comparable to healthy populations, suggesting MSE could be a primary goal of gMG treatment. Favorable safety pro IgG-mediated autoimmune diseases: A review of safety findings across multiple studies of VYVGART in IgG-mediated autoimmune diseases showed VYVGART was consistently well tolerated across all indications and doses studied. ADAPT NXT evaluated additional individualized dosing regimens for initiating long-term treatment: Data from the Phase 3b ADAPT NXT study will provide important guidance on different treatment regimens, which will allow for additional individualization of VYVGART treatment. Potential for tapering of oral corticosteroids (OCS) post-VYVGART initiation: Long-term OCS use continues to be a significant burden on people living with autoimmune disease and reducing or tapering OCS may alleviate the risk of many adverse events related to long-term usage. Early insights into OCS utilization post-efgartigimod initiation in gMG patients indicate that a substantial proportion reduced OCS usage over the first 6 months of treatment. Cost-effectiveness of VYVGART compared to chronic intravenous immunoglobulin (IVIg): Findings from a cost-effectiveness analysis of VYVGART versus chronic IVIg for the treatment of gMG showed that, over a lifetime, VYVGART provided greater benefit at lowers costs. Details for oral and poster presentations at AAN are as follows: Title Lead Author Presentation Efficacy, Safety, and Tolerability of Efgartigimod in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: Results From the ADHERE Trial Jeffrey Allen Oral Presentation during Clinical Trial Plenary Session Tuesday, April 16, 9:15-11:30 a.m. MT Real-world Reduction in Oral Corticosteroid Utilization following Efgartigimod Initiation in Patients Living with Generalized Myasthenia Gravis Neelam Goyal Oral Presentation Wednesday, April 17 3:42 p.m. MT Cost-effectiveness Analysis of Efgartigimod versus Chronic Intravenous Immunoglobulin (IVIg) for Treatment of Acetylcholine Receptor Antibody Positive (AChR-Ab+) Generalized Myasthenia Gravis (gMG) in Canada Zaeem Siddiqi Poster Presentation Monday, April 15 11:45 a.m.-12:45 p.m. MT Overview of the Safety Pro Efgartigimod Clinical Trials in Participants with Diverse IgG-mediated Autoimmune Diseases Tuan Vu Poster Presentation Monday, April 15 11:45 a.m.-12:45 p.m. MT Long-Term Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Participants With Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ Study James Howard Poster Presentation Wednesday, April 17 11:45 a.m.-12:45 p.m. MT Fixed-Cycle and Continuous Dosing of Intravenous Efgartigimod for Generalized Myasthenia Gravis: Study Design of ADAPT NXT Vera Bril Poster Presentation Wednesday, April 17 11:45 a.m.-12:45 p.m. MT Achievement of Minimal Symptom Expression and Effect on Disease-Specific Measures in Acetylcholine Receptor Antibody-Positive Participants With Generalized Myasthenia Gravis Treated With Efgartigimod in ADAPT/ADAPT+ Srikanth Muppidi Poster Presentation Wednesday, April 17 11:45 a.m.-12:45 p.m. MT Analysis of Serious Infections and Malignancy Risk in Myasthenia Gravis: a US Claims Database Study Jana Podhorna Poster Presentation Wednesday, April 17 11:45 a.m.-12:45 p.m. MT More information on the program is available at AAN. See Important Safety Information below, full United States Prescribing Information for VYVGART and full Prescribing Information for VYVGART Hytrulo for additional information. What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection? VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). IMPORTANT SAFETY INFORMATION Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting VYVGART and VYVGART HYTRULO may cause serious side effects, including: Infection VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain. Allergic Reactions (hypersensitivity reactions) VYVGART and VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab. Infusion-Related Reactions VYVGART and VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART or VYVGART HYTRULO, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines, have received or are scheduled to receive a vaccine (immunization), or have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART and VYVGART HYTRULO? The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives. These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO. About Generalized Myasthenia Gravis Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months,1 where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population.1 About Chronic Inflammatory Demyelinating Polyneuropathy Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. About VYVGART® VYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker in the United States, EU and China for the treatment of adults with generalized myasthenia gravis (gMG) who are anti- acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). About VYVGART® Hytrulo VYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection. VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions. About argenx argenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit and follow us on LinkedIn, Twitter, and Instagram. Contacts Media: Ben Petok Bpetok@argenx.com Investors: Alexandra Roy (US) aroy@argenx.com Lynn Elton (EU) lelton@argenx.com Forward-Looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aims,” “committed,” “expects,” “may,” “will,” “strive” or “anticipate” and include statements argenx makes concerning the potential impact of VYVGART and VYVGART Hytrulo for CIDP patients; its promise to transform patients’ lives with innovative treatments; the opportunity with VYVGART and VYVGART Hytrulo to deliver significant value to the gMG patient community by driving consistent and repeatable improvements; its expectation that VYVGART and VYVGART Hytrulo reduce maternal IgG antibody levels, thereby reducing the passive protection to the newborn; and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials, expectations regarding the inherent uncertainties associated with development of novel drug therapies, preclinical and clinical trial and product development activities and regulatory approval requirements, the acceptance of our products and product candidates by our patients as safe, effective and cost-effective, and the impact of governmental laws and regulations on our business. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

Veklury Was Associated With a Lower Risk of Developing Long-COVID in One Analysis Veklury Was Associated With a Reduced Risk of Mortality Among People Who Are Immunocompromised in a Separate Analysis FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced new data from three real-world retrospective studies being presented at the 31st Conference on Retroviruses and Opportunistic Infections (CROI). One study showed Veklury® (remdesivir) was associated with a reduced risk of certain long-COVID symptoms in people who were hospitalized for COVID-19. In a separate study, Veklury use was associated with significantly reduced mortality among people who were immunocompromised and were hospitalized for COVID-19 during the Omicron period (Dec’21 – April’23), irrespective of oxygen requirements. A third analysis revealed that treatment with Veklury and dexamethasone among patients hospitalized for COVID-19 was associated with reduced mortality as compared to treatment with only dexamethasone, irrespective of oxygen requirements. “The real-world data presented at CROI continue to reinforce the strong efficacy and safety pro Veklury, as well as the potential benefit of Veklury for people affected by COVID-19,” said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “As we enter the fourth year of COVID-19, Veklury remains the antiviral standard of care for people hospitalized for COVID-19. These latest data add to our scientific understanding about Veklury’s potential role in reducing mortality, including in immunocompromised people, and helping to reduce the risk of getting long-COVID symptoms.” To understand Veklury’s potential impact on the risk of long-COVID, also known as post-COVID conditions (PCC), Gilead analyzed HealthVerity data from 52,006 patients. Results from the study demonstrate that Veklury use was associated with a 10% lower risk of any PCC in both age groups analyzed: HR 0.90 (95% confidence interval [CI]: 0.86–0.93) in those <65 years old and HR 0.90 (95% CI: 0.86–0.95) in those ≥65 years old. Veklury use was associated with lower risk for 6 of 16 individual symptoms/diagnoses in the ≥65 age group (including cognitive dysfunction, cerebrovascular disease, neuropsychiatric features, diarrhea, chest pain, and dysautonomia) and for 8 of 16 individual symptoms/diagnoses in the <65 age group (including the 6 symptoms in the ≥65 age group, as well as thromboembolic disease and headache). Results from this analysis build on existing evidence that support the importance of treating COVID-19 early in the disease course with an antiviral. In a separate analysis, data from the PINC AI Healthcare database from the Omicron era (Dec’21 – Apr’23) showed an association between Veklury use and reduced mortality among immunocompromised people in the study who were hospitalized for COVID-19. The study included 10,687 immunocompromised people who received Veklury and 4,989 who were matched controls. Results at Day 28 showed that people who were immunocompromised and treated with Veklury had an overall 25% significantly lower mortality risk compared to the non-Veklury group, irrespective of supplemental oxygen requirements (HR: 0.75, 95% CI:0.68-0.83; p<0.0001). This research builds on and further reinforces previous research presented at CROI 2023. Additional data from a real-world study showed improved outcomes among patients with COVID-19 who received treatment with Veklury in combination with dexamethasone compared to dexamethasone alone. The study matched 33,037 patients who received both Veklury and dexamethasone to 33,037 patients who received only dexamethasone. Patients who received the dual therapy had a significantly lower mortality risk compared to dexamethasone monotherapy across all supplemental oxygen requirements at both 14 and 28 days. For patients with no documented use of supplemental oxygen at baseline, treatment with Veklury was associated with a 20% (p<0.001) lower risk of mortality at Day 28. Patients on low-flow or high-flow oxygen had a 26% (p<0.001) and 29% (p<0.001) lower risk of mortality at Day 28, respectively. Patients on invasive mechanical ventilation/ECMO at baseline had a 19% (p=0.0182) reduced risk for mortality at Day 28. 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 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 Veklury Veklury (remdesivir 100 mg for injection) is indicated for the treatment of COVID-19 in adults and pediatric patients (weighing ≥1.5 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 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. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Veklury; uncertainties relating to regulatory applications and related filing and approval timelines; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; 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 Veklury is available at . Veklury, 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) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. View source version on businesswire.com: Contacts Jacquie Ross, Investors investor_relations@gilead.com Meaghan Smith, Media public_affairs@gilead.com Source: Gilead Sciences, Inc. View this news release online at:

- 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.