Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Infection With Direct-Acting Antiviral Therapy

To learn if giving immune checkpoint therapy (such as atezolizumab) and bevacizumab to patients who have HCC and are receiving DAAs may help to control HCC and hepatitis C.

Start Date17 Mar 2023

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

NCT05016609

/ RecruitingPhase 4IIT

Same-visit Hepatitis C Testing and Treatment to Accelerate Cure Among People Who Inject Drugs: a Cluster Randomised Control Trial (The QuickStart Study)

The QuickStart study aims to assess the impact of three models of HCV care on HCV treatment uptake and cure among people who inject drugs. Rapid point-of-care (POC) HCV testing and test-and-treat strategies will be utilised in primary health care settings across Australia.

Start Date09 Mar 2022

Sponsor / Collaborator

The Macfarlane Burnet Institute For Medical Research & Public

EUCTR2020-003879-18-PL

/ Not yet recruitingPhase 4IIT

Treatment of chronic hepatitis C in children aged 6 – 18 years using a pangenotypic direct-acting antiviral (sofosbuvir/velpatasvir)

Start Date21 Apr 2021

Sponsor / Collaborator

Warszawski Uniwersytet Medyczny

100 Clinical Results associated with Velpatasvir

100 Translational Medicine associated with Velpatasvir

100 Patents (Medical) associated with Velpatasvir

1,124

Literatures (Medical) associated with Velpatasvir

01 Nov 2025·Journal of Clinical and Experimental Hepatology

Impact of Resistance Associated Substitutions and Predictors of Treatment Failure Following Direct-acting Antiviral Therapy in a Viral Hepatitis C Elimination Cohort

Article

Author: Gupta, Ekta ; Dhiman, Radha K ; Verma, Nipun ; Duseja, Ajay ; Taneja, Sunil ; De, Arka ; Grover, Gagandeep S ; Sharma, Prerna ; Nain, Jasvinder ; Sandhu, Anchal ; Premkumar, Madhumita

Background:

The National Viral Hepatitis Control Program (NVHCP) has a cure rate of 91.6% when using direct-acting antivirals (DAAs)-sofosbuvir with an NS5A inhibitor (ledipasvir, daclatasvir or velpatasvir) ± ribavirin in the Punjab hub-and-spoke model of hepatitis C virus (HCV) elimination.

Methods:

We collected the clinical and virological data for the ∼8.4% treatment failure cases. Sanger nucleotide sequencing was performed to identify the resistance-associated substitutions (RAS) following treatment failure. We ascertained the clinical and virological predictors of treatment failure under the NVHCP.

Results:

Between April 2019 and December 2023, 50865 patients with HCV were treated; median age 41.6 years, 65% men, 85.8% without cirrhosis, 8.5% treatment experienced, median viral load (x10⁶) of 4.1 (2.9-7.8),71.3% genotype (GT)-3, with cure rate of 89.5%. On multivariable analysis, age (aOR 1.5, 95% CI: 1.3-1.9, P = 0.021), presence of cirrhosis (aOR1.8, 95% CI: 1.3-2.5, P < 0.001), and poor drug compliance (aOR 0.3, 95% CI: 0.2-0.6, P < 0.001) predicted treatment failure. We enrolled a difficult-to-treat group of 640 persons for virological testing, aged 39.2 ± 15.1 years, median HCV viral load (x10⁶) of 1.98 (1.5-2.4). Of these, 56.6% were treatment-experienced, 11.1% were prior defaulters, with predominant GT3 (73.3%) and GT1 (18.7%) with coinfection rates of 3.8% and 4.4% for hepatitis B virus (HBV) and human immunodeficiency virus (HIV), respectively. Presumed modes of transmission in this subgroup were unsafe injections (57%), and injection drug use (32.8%). A total of 243 patient samples underwent RAS testing, with 45 patients having detectable variants, and finally 31 RAS mutations were detected in the NS5A gene, with no clinically significant resistance observed in the NS5B gene. In GT-3, the RAS observed were A30K, L31 M/R, A62S, A62T, and Y93H. In GT-1, the RAS observed were M28A, H58P, G30 H/R, H58D, and Y93K. Among these Y93K, L30R, G30 H/R confer resistance to velpatasvir; such patients received retreatment with voxilaprevir-containing regimens.

Conclusion:

Patient factors like compliance and the presence of cirrhosis predicted treatment failures. RAS do not appear to be a primary factor for treatment failure in a public health setting.

Clinical trials gov number:

NCT03488485 available from https://clinicaltrials.gov/study/NCT03488485.

01 Aug 2025·MOLECULAR IMMUNOLOGY

DNA vaccination combined with immune checkpoint inhibition eradicates tumors, inducing life-long immunity against breast cancer in mice

Article

Author: Martínez-Zarco, Braulio A ; Manoutcharian, Karen ; Odales, Josué ; Martínez-Cortés, Fernando ; Esquivel-García, Christian Alejandro ; Villegas-Ruiz, Vanessa ; Maruri, Jorge ; Domínguez-Romero, Allan Noé ; Gevorkian, Goar ; Abraham-Ruiz, Samir

The employment of cancer vaccines as stand-alone or combined therapies has not yet reached clinically relevant endpoints in large clinical trials in the vast majority of patients, and there is a clear need for novel ideas and qualitatively new vaccine design approaches. In this study, we used a novel Variable Epitope Library (VEL) vaccine strategy, which incorporates thousands to millions of mutated variant epitopes within a combinatorial library, to target extreme variability and intratumoral heterogeneity of tumor antigens. A single intrasplenic vaccination with a VEL DNA vaccine encoding the amino-terminal region of mouse survivin, carrying eight mutated amino acid positions, induced significant tumor growth inhibition and suppression of lung metastasis in an aggressive and highly metastatic 4T1 triple-negative breast cancer (TNBC) preclinical model. Combining this vaccine with an immune checkpoint inhibitor (ICI) αCTLA-4 resulted in the elimination of established tumors, tumor-free survival of up to 412 days and life-long sterile immunity against tumor rechallenge in 77 % of mice. A significant increase in the number of CD3⁺ CD8⁺ Ly6C⁺ effector T cells in the lungs and spleens of vaccinated mice and the presence of central memory (T_CM) and effector memory (T_EM) T cells at different time points was documented. Likewise, the reduction of numbers of CD11b⁺ Ly6C^int Ly6G⁺ granulocytic myeloid-derived suppressor cells (G-MDSC) in vaccinated mice was observed. These data suggest that VEL immunogens are feasible candidates for inclusion/testing in clinical trials targeting multiple cancer types due to their universal nature.

01 Aug 2025·JOURNAL OF VIRAL HEPATITIS

CHIME: Sofosbuvir/Velpatasvir (S/V) for the Treatment of HCV Infection Among Vulnerable Inner‐City Residents

Article

Author: Conway, Brian ; Truong, Daivd ; Yi, Shana

ABSTRACT:

The combination of Sofosbuvir/Velpatasvir(S/V) is approved for the treatment of chronic HCV infection. In registrational trials, cure rates of 95% or more were achieved when administered as one pill per day for a period of 12 weeks, regardless of genotype or disease stage. There is a need to develop and evaluate systems of care in populations excluded from clinical trials. We aim to evaluate the safety and efficacy of S/V in a prospective study of HCV‐infected inner‐city residents enriched for risk behaviours for non‐adherence to therapy, including problematic drug use and unstable housing. Through dedicated outreach events, we identified HCV‐infected patients who were not currently engaged in health care and who were eligible to receive government‐funded antiviral treatment for HCV infection. We offered them the opportunity to enrol in a multidisciplinary programme of care to address medical, psychological, social, and addiction‐related needs, and provide S/V therapy in this context, with enhanced supervision of adherence. We identified 222 eligible subjects, 31.5% female, median age of 47 (24–81) years. The most common genotype was 1, followed by 3 (48.2%, 38.7%) and 21.2% scored F3‐F4 FibroScan scores. 55.9% have unstable housing, and 98.6% are active drug users, with the majority utilising fentanyl, followed by amphetamines (82.9%, 64.9%). HCV treatment has been started in all 222 persons within a median of 6 weeks of engagement in care. 218 persons completed treatment, one individual withdrew from the treatment, and 3 overdose deaths were documented. HCV cure was documented in 211/218 (96.8%). Virologic relapse was documented in the other 7 cases. The intent‐to‐treat SVR rate of HCV treatment with S/V was 211/222 (95.0%). Taken together, our data validate the development of multidisciplinary programmes such as ours to address HCV infection, yielding high rates of engagement and retention in care, promoting initiation of treatment (usually within 6 weeks) and > 97% rate of cure.

News (Medical) associated with Velpatasvir

07 Aug 2025

·www.gilead.com

Gilead Sciences Announces Second Quarter 2025 Financial Results

Product Sales Excluding Veklury Increased 4% Year-Over-Year to $6.9 billion Biktarvy Sales Increased 9% Year-Over-Year to $3.5 billion FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its second quarter 2025 results of operations. “This was a very successful second quarter for Gilead, including the FDA approval for Yeztugo as the world’s first twice-yearly HIV prevention option,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “Our strong growth this quarter was driven by Biktarvy, Descovy, Trodelvy and Livdelzi, reflecting the diversity of our portfolio. As we enter the third quarter, we are increasing revenue and earnings guidance for the year, and look forward to delivering continued innovation and growth across our core therapeutic areas.” Second Quarter 2025 Financial Results Total second quarter 2025 revenue increased 2% to $7.1 billion compared to the same period in 2024, driven by higher HIV, Livdelzi® (seladelpar) and Trodelvy® (sacituzumab govitecan-hziy) sales, partially offset by lower chronic hepatitis C virus (“HCV”) and Veklury® (remdesivir) sales. Diluted earnings per share (“EPS”) was $1.56 in the second quarter 2025 compared to $1.29 in the same period in 2024. The increase was primarily driven by net unrealized gains on securities compared to net unrealized losses in 2024 and higher product sales, partially offset by a pre-tax in-process research and development (“IPR&D”) impairment charge of $190 million related to assets acquired as part of the MYR GmbH (“MYR”) acquisition and higher research and development (“R&D”) expenses. Non-GAAP diluted EPS of $2.01 in the second quarter 2025 remained flat compared to the same period in 2024, with higher product sales offset by higher R&D expenses. As of June 30, 2025, Gilead had $7.1 billion of cash, cash equivalents and marketable debt securities compared to $10.0 billion as of December 31, 2024. During the second quarter 2025, Gilead generated $827 million in operating cash flow, net of a final $1.3 billion transition tax payment associated with the Tax Cuts and Jobs Act of 2017. During the second quarter 2025, Gilead paid dividends of $994 million and repurchased $527 million of common stock. Second Quarter 2025 Product Sales Total second quarter 2025 product sales increased 2% to $7.1 billion compared to the same period in 2024. Total second quarter 2025 product sales excluding Veklury increased 4% to $6.9 billion compared to the same period in 2024, primarily due to higher HIV, Livdelzi and Trodelvy sales, partially offset by lower HCV sales. HIV product sales increased 7% to $5.1 billion in the second quarter 2025 compared to the same period in 2024, primarily driven by increased demand and higher average realized price. Biktarvy®(bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 9% to $3.5 billion in the second quarter 2025 compared to the same period in 2024, primarily driven by higher demand. Descovy®(FTC 200mg/TAF 25mg) sales increased 35% to $653 million in the second quarter 2025 compared to the same period in 2024, primarily driven by higher average realized price and demand. The Liver Disease portfolio sales decreased 4% to $795 million in the second quarter 2025 compared to the same period in 2024. This was primarily driven by lower HCV sales, partially offset by increased demand for Livdelzi, Hepcludex® (bulevirtide) and chronic hepatitis B virus (“HBV”) products. Veklury sales decreased 44% to $121 millionin the second quarter 2025 compared to the same period in 2024, primarily driven by lower rates of COVID-19-related hospitalizations. Cell Therapy product sales decreased 7% to $485 million in the second quarter 2025 compared to the same period in 2024, reflecting ongoing competitive headwinds. Yescarta® (axicabtagene ciloleucel) sales decreased 5% to $393 million in the second quarter 2025 compared to the same period in 2024, primarily driven by lower demand, partially offset by higher average realized price. Tecartus® (brexucabtagene autoleucel) sales decreased 14% to $92 million in the second quarter 2025 compared to the same period in 2024, primarily reflecting lower demand, partially offset by higher average realized price. Trodelvy sales increased 14% to $364 million in the second quarter 2025 compared to the same period in 2024, primarily driven by higher demand and inventory dynamics. Second Quarter 2025 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 78.7% in the second quarter 2025 compared to 77.7% in the same period in 2024. Non-GAAP product gross margin was 86.9% in the second quarter 2025 compared to 86.0% in the same period in 2024. The increases were primarily driven by product mix. R&D expenses were $1.5 billion in the second quarter 2025 compared to $1.4 billion in the same period in 2024, primarily due to increased clinical manufacturing and study expenses, as well as valuation adjustments to the MYR-related contingent consideration. Non-GAAP R&D expenses were $1.5 billion in the second quarter 2025 compared to $1.3 billion in the same period in 2024, primarily due to increased clinical manufacturing and study activities. Acquired IPR&D expenses were $61 million in the second quarter 2025, primarily reflecting expenses related to the strategic partnership with Kymera Therapeutics, Inc. (“Kymera”) announced in June 2025. Selling, general and administrative (“SG&A”) expenses and non-GAAP SG&A expenses of $1.4 billion in the second quarter 2025 remained flat compared to the same period in 2024, with higher promotional expenses offset by lower corporate expenses. The effective tax rate (“ETR”) was 19.3% in the second quarter 2025 compared to 21.4% in the same period in 2024, primarily driven by lower non-taxable unrealized losses on securities, partially offset by a beneficial prior year settlement with a tax authority that did not repeat. The non-GAAP ETR was 18.8% in the second quarter 2025 compared to 17.8% in the same period in 2024, primarily reflecting the same non-recurring tax settlement in the prior year. Guidance and Outlook For the full-year, Gilead expects: August 7, 2025 Guidance Low End High End Comparison to Prior Guidance Product sales $ 28,300 $ 28,700 Previously $28,200 to $28,600 Product sales excluding Veklury $ 27,300 $ 27,700 Previously $26,800 to $27,200 Veklury $ 1,000 $ 1,000 Previously $1,400 Diluted EPS $ 5.85 $ 6.15 Previously $5.65 to $6.05 Non-GAAP diluted EPS $ 7.95 $ 8.25 Previously $7.70 to $8.10 Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2025 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Received U.S. Food and Drug Administration (“FDA”) approval for Yeztugo® (lenacapavir) for pre-exposure prophylaxis (“PrEP”) to reduce the risk of sexually acquired HIV-1 in adults and adolescents weighing at least 35kg. Yeztugo is the first and only twice-yearly HIV PrEP option available in the United States. Received a positive opinion under accelerated review from the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending lenacapavir for use as PrEP to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk. The recommendation will now be reviewed by the European Commission. Lenacapavir for HIV PrEP is not approved for use outside of the United States. Announced a strategic partnership agreement with the Global Fund to Fight AIDS, Tuberculosis and Malaria (“Global Fund”) to accelerate access, subject to regulatory approvals, to twice-yearly lenacapavir for HIV PrEP for up to two million people in primarily low- and lower-middle-income countries over three years, at no profit to Gilead. Presented new data at the International AIDS Society conference, including from the PURPOSE 1 and 2 trials evaluating twice-yearly lenacapavir for HIV PrEP in a broad range of populations, including pregnant and lactating women, adolescents, and young people. Announced that the World Health Organization released new guidelines recommending the use of twice-yearly lenacapavir for HIV PrEP, as well as new guidelines on HIV testing protocols for long-acting prevention medications. Announced that FDA had placed a clinical hold on the HIV treatment trials of GS-1720 and/or GS-4182, including the WONDERS-1 and WONDERS-2 trials. These drug candidates are investigational and not approved anywhere globally. Presented final data from the Phase 3 MYR301 study evaluating bulevirtide as a treatment for adults with chronic hepatitis delta virus (“HDV”) at the European Association for the Study of the Liver (“EASL”) Congress. Bulevirtide remains the only approved treatment for HDV in the EU and is not approved in the U.S. Additionally, presented clinical and real-world data on HBV and HCV programs. Oncology Announced positive topline results from the Phase 3 ASCENT-03 trial evaluating Trodelvy in patients with 1L metastatic triple-negative breast cancer (“mTNBC”) who are not candidates for PD-1/PD-L1 checkpoint inhibitors. Additionally, presented results from the Phase 3 ASCENT-04 trial evaluating Trodelvy plus Keytruda® (pembrolizumab) in 1L PD-L1+ mTNBC at the American Society of Clinical Oncology (“ASCO”) meeting. Trodelvy is not approved in either of these settings. Presented new real-world data at ASCO supporting the use of Yescarta in outpatient care settings for patients with relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”), as well as other early-stage investigational CAR T data in glioblastoma and LBCL. Presented data in partnership with Arcellx, Inc. (“Arcellx”) at the European Hematology Association congress from the iMMagine-1 trial evaluating investigational anitocabtagene-autoleucel (“anito-cel”) in R/R multiple myeloma. Entered into an exclusive option and license agreement with Kymera to develop novel oral molecular glue CDK2 degraders with broad oncology treatment potential. Inflammation Presented new data from multiple analyses at EASL evaluating Livdelzi for the treatment of primary biliary cholangitis, including interim analysis from the open-label, long-term ASSURE study. Corporate The Board declared a quarterly dividend of $0.79 per share of common stock for the third quarter of 2025. The dividend is payable on September 29, 2025, to stockholders of record at the close of business on September 15, 2025. Future dividends will be subject to Board approval. The Board authorized a new $6.0 billion stock repurchase program, with no fixed expiration, which will commence upon the completion of the previously approved program. Reached a final settlement agreement with the U.S. Department of Justice resolving a legacy compliance matter. This settlement was accrued in 2024 and reported under SG&A expenses. Named by TIME as a 2025 Most Influential Company. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on http://investors.gilead.com and will be archived on www.gilead.com for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with such exclusions as well as changes in tax-related laws and guidelines, transfers of intangible assets between certain legal entities, and legal entity restructurings. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation.Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. 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, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its full year 2025 financial guidance, including as a result of the uncertainty of the amount and timing of Veklury revenues, the impact of the Inflation Reduction Act, changes in U.S. regulatory or legislative policies, and changes in U.S. trade policies, including tariffs; Gilead’s ability to make progress on any of its long-term ambitions or priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the acquisitions of MYR, and the arrangements with Arcellx, Kymera and the Global Fund; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Livdelzi, Trodelvy, Yescarta, Yeztugo (lenacapavir), anito-cel, bulevirtide, GS-1720, and GS-4182 (such as the ASCENT-03, ASCENT-04, ASSURE, iMMagine-1, MYR301, PURPOSE 1 PURPOSE 2, WONDERS-1, and WONDERS-2 studies), and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to resolve the issues cited by the FDA in the clinical hold on the GS-1720 and GS-4182 trials to the satisfaction of the FDA and the risk that FDA may not remove the clinical hold, in whole or in part, in a timely manner or at all; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead’s ability to receive or maintain regulatory approvals in a timely manner or at all, including for additional approvals for lenacapavir for HIV PrEP, and the risk that any such approvals, if granted, may be subject to significant limitations on use and may be subject to withdrawal or other adverse actions by the applicable regulatory authority; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies and may therefore be reluctant to prescribe the products, including Yeztugo; Gilead’s ability to effectively manage the access strategy relating to lenacapavir for HIV PrEP, subject to necessary regulatory approvals; and other risks identified from time to time in Gilead’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended June 30, 2025 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Additional information is available on our Investor Relations website, https://investors.gilead.com. Among other things, an estimate of Acquired IPR&D expenses is expected to be made available on the Quarterly Results page within the first ten (10) days after the end of each quarter. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITE™, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LIVDELZI®/LYVDELZI®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA®, YEZTUGO® and ZYDELIG®. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Other trademarks and trade names are the property of their respective owners. For more information on Gilead Sciences, Inc., please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except per share amounts) 2025 2024 2025 2024 Revenues: Product sales $ 7,054 $ 6,912 $ 13,668 $ 13,559 Royalty, contract and other revenues 27 41 81 81 Total revenues 7,082 6,954 13,749 13,640 Costs and expenses: Cost of goods sold 1,501 1,544 3,041 3,096 Research and development expenses 1,491 1,351 2,870 2,871 Acquired in-process research and development expenses 61 38 315 4,169 In-process research and development impairments 190 — 190 2,430 Selling, general and administrative expenses 1,365 1,377 2,623 2,752 Total costs and expenses 4,608 4,309 9,038 15,317 Operating income (loss) 2,474 2,644 4,711 (1,678 ) Interest expense 254 237 513 491 Other (income) expense, net (208 ) 355 120 265 Income (loss) before income taxes 2,429 2,053 4,077 (2,433 ) Income tax expense 468 438 802 123 Net income (loss) 1,960 1,614 3,275 (2,556 ) Net income attributable to noncontrolling interest — — — — Net income (loss) attributable to Gilead $ 1,960 $ 1,614 $ 3,275 $ (2,556 ) Basic earnings (loss) per share attributable to Gilead $ 1.57 $ 1.29 $ 2.63 $ (2.05 ) Diluted earnings (loss) per share attributable to Gilead $ 1.56 $ 1.29 $ 2.61 $ (2.05 ) Shares used in basic earnings (loss) per share attributable to Gilead calculation 1,245 1,247 1,246 1,247 Shares used in diluted earnings (loss) per share attributable to Gilead calculation 1,255 1,251 1,257 1,247 Supplemental Information: Cash dividends declared per share $ 0.79 $ 0.77 $ 1.58 $ 1.54 Product gross margin 78.7 % 77.7 % 77.7 % 77.2 % Research and development expenses as a % of revenues 21.1 % 19.4 % 20.9 % 21.0 % Selling, general and administrative expenses as a % of revenues 19.3 % 19.8 % 19.1 % 20.2 % Operating margin 34.9 % 38.0 % 34.3 % (12.3 )% Effective tax rate 19.3 % 21.4 % 19.7 % (5.1 )% GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages) 2025 2024 Change 2025 2024 Change Product sales: HIV $ 5,088 $ 4,745 7 % $ 9,675 $ 9,088 6 % Liver Disease 795 832 (4 )% 1,553 1,569 (1 )% Oncology 849 841 1 % 1,606 1,629 (1 )% Other 202 280 (28 )% 410 504 (19 )% Total product sales excluding Veklury 6,934 6,698 4 % 13,245 12,790 4 % Veklury 121 214 (44 )% 423 769 (45 )% Total product sales 7,054 6,912 2 % 13,668 13,559 1 % Royalty, contract and other revenues 27 41 (34 )% 81 81 1 % Total revenues $ 7,082 $ 6,954 2 % $ 13,749 $ 13,640 1 % GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages) 2025 2024 Change 2025 2024 Change Non-GAAP: Cost of goods sold $ 922 $ 965 (4 )% $ 1,883 $ 1,939 (3 )% Research and development expenses $ 1,450 $ 1,335 9 % $ 2,789 $ 2,738 2 % Acquired IPR&D expenses(2) $ 61 $ 38 61 % $ 315 $ 4,169 (92 )% Selling, general and administrative expenses $ 1,358 $ 1,351 — % $ 2,580 $ 2,646 (3 )% Other (income) expense, net $ (66 ) $ (37 ) 82 % $ (164 ) $ (141 ) 17 % Diluted earnings per share attributable to Gilead $ 2.01 $ 2.01 — % $ 3.82 $ 0.70 NM Shares used in non-GAAP diluted earnings per share attributable to Gilead calculation 1,255 1,251 — % 1,257 1,254 — % Product gross margin 86.9 % 86.0 % 89 bps 86.2 % 85.7 % 52 bps Research and development expenses as a % of revenues 20.5 % 19.2 % 128 bps 20.3 % 20.1 % 21 bps Selling, general and administrative expenses as a % of revenues 19.2 % 19.4 % -26 bps 18.8 % 19.4 % -64 bps Operating margin 46.5 % 47.0 % -49 bps 45.0 % 15.7 % NM Effective tax rate 18.8 % 17.8 % 96 bps 17.6 % 51.4 % NM ________________________________ NM - Not Meaningful (1) Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables below. (2) Equal to GAAP financial information. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages and per share amounts) 2025 2024 2025 2024 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,501 $ 1,544 $ 3,041 $ 3,096 Acquisition-related – amortization(1) (579 ) (579 ) (1,158 ) (1,158 ) Restructuring — — — 1 Non-GAAP cost of goods sold $ 922 $ 965 $ 1,883 $ 1,939 Product gross margin reconciliation: GAAP product gross margin 78.7 % 77.7 % 77.7 % 77.2 % Acquisition-related – amortization(1) 8.2 % 8.4 % 8.5 % 8.5 % Restructuring — % — % — % — % Non-GAAP product gross margin 86.9 % 86.0 % 86.2 % 85.7 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,491 $ 1,351 $ 2,870 $ 2,871 Acquisition-related – other costs(2) (35 ) (3 ) (37 ) (70 ) Restructuring (6 ) (13 ) (44 ) (63 ) Non-GAAP research and development expenses $ 1,450 $ 1,335 $ 2,789 $ 2,738 IPR&D impairment reconciliation: GAAP IPR&D impairment $ 190 $ — $ 190 $ 2,430 IPR&D impairment (190 ) — (190 ) (2,430 ) Non-GAAP IPR&D impairment $ — $ — $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,365 $ 1,377 $ 2,623 $ 2,752 Acquisition-related – other costs(2) — (17 ) — (84 ) Restructuring (7 ) (8 ) (43 ) (22 ) Non-GAAP selling, general and administrative expenses $ 1,358 $ 1,351 $ 2,580 $ 2,646 Operating income (loss) reconciliation: GAAP operating income (loss) $ 2,474 $ 2,644 $ 4,711 $ (1,678 ) Acquisition-related – amortization(1) 579 579 1,158 1,158 Acquisition-related – other costs(2) 35 21 37 153 Restructuring 13 21 88 84 IPR&D impairment 190 — 190 2,430 Non-GAAP operating income $ 3,290 $ 3,265 $ 6,183 $ 2,148 Operating margin reconciliation: GAAP operating margin 34.9 % 38.0 % 34.3 % (12.3 )% Acquisition-related – amortization(1) 8.2 % 8.3 % 8.4 % 8.5 % Acquisition-related – other costs(2) 0.5 % 0.3 % 0.3 % 1.1 % Restructuring 0.2 % 0.3 % 0.6 % 0.6 % IPR&D impairment 2.7 % — % 1.4 % 17.8 % Non-GAAP operating margin 46.5 % 47.0 % 45.0 % 15.7 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ (208 ) $ 355 $ 120 $ 265 Gain (loss) from equity securities, net 142 (392 ) (284 ) (405 ) Non-GAAP other (income) expense, net $ (66 ) $ (37 ) $ (164 ) $ (141 ) Income (loss) before income taxes reconciliation: GAAP income (loss) before income taxes $ 2,429 $ 2,053 $ 4,077 $ (2,433 ) Acquisition-related – amortization(1) 579 579 1,158 1,158 Acquisition-related – other costs(2) 35 21 37 153 Restructuring 13 21 88 84 IPR&D impairment 190 — 190 2,430 (Gain) loss from equity securities, net (142 ) 392 284 405 Non-GAAP income before income taxes $ 3,103 $ 3,065 $ 5,834 $ 1,798 GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions, except percentages and per share amounts) 2025 2024 2025 2024 Income tax expense reconciliation: GAAP income tax expense $ 468 $ 438 $ 802 $ 123 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 120 121 241 242 Acquisition-related – other costs(2) — 7 — 37 Restructuring 2 7 15 16 IPR&D impairment 51 — 51 611 (Gain) loss from equity securities, net (11 ) 33 10 (6 ) Discrete and related tax charges(3) (48 ) (60 ) (90 ) (100 ) Non-GAAP income tax expense $ 583 $ 546 $ 1,029 $ 923 Effective tax rate reconciliation: GAAP effective tax rate 19.3 % 21.4 % 19.7 % (5.1 )% Income tax effect of above non-GAAP adjustments and discrete and related tax adjustments(3) (0.5 )% (3.5 )% (2.0 )% 56.4 % Non-GAAP effective tax rate 18.8 % 17.8 % 17.6 % 51.4 % Net income (loss) attributable to Gilead reconciliation: GAAP net income (loss) attributable to Gilead $ 1,960 $ 1,614 $ 3,275 $ (2,556 ) Acquisition-related – amortization(1) 459 458 917 916 Acquisition-related – other costs(2) 35 14 37 117 Restructuring 11 14 72 68 IPR&D impairment 139 — 139 1,819 (Gain) loss from equity securities, net (131 ) 359 275 412 Discrete and related tax charges(3) 48 60 90 100 Non-GAAP net income attributable to Gilead $ 2,521 $ 2,519 $ 4,806 $ 874 Diluted earnings (loss) per share reconciliation: GAAP diluted earnings (loss) per share $ 1.56 $ 1.29 $ 2.61 $ (2.05 ) Acquisition-related – amortization(1) 0.37 0.37 0.73 0.73 Acquisition-related – other costs(2) 0.03 0.01 0.03 0.09 Restructuring 0.01 0.01 0.06 0.05 IPR&D impairment 0.11 — 0.11 1.46 (Gain) loss from equity securities, net (0.10 ) 0.29 0.22 0.33 Discrete and related tax charges(3) 0.04 0.05 0.07 0.08 Non-GAAP diluted earnings per share $ 2.01 $ 2.01 $ 3.82 $ 0.70 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 579 $ 1,158 $ 1,157 Research and development expenses adjustments 41 16 81 133 IPR&D impairment adjustments 190 — 190 2,430 Selling, general and administrative expenses adjustments 7 26 43 106 Total non-GAAP adjustments to costs and expenses 817 620 1,472 3,826 Other (income) expense, net, adjustments (142 ) 392 284 405 Total non-GAAP adjustments before income taxes 675 1,012 1,757 4,231 Income tax effect of non-GAAP adjustments above (162 ) (168 ) (316 ) (900 ) Discrete and related tax charges(3) 48 60 90 100 Total non-GAAP adjustments to net income attributable to Gilead $ 560 $ 905 $ 1,530 $ 3,431 ________________________________ (1) Relates to amortization of acquired intangibles. (2) Adjustments include integration expenses and contingent consideration fair value adjustments associated with Gilead’s recent acquisitions. (3) Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2025 FULL-YEAR GUIDANCE(1) (unaudited) (in millions, except percentages and per share amounts) Provided February 11, 2025 Updated April 24, 2025 Updated August 7, 2025 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 77.0% - 78.0% 77.0% - 78.0% ~ 78.0% Acquisition-related expenses ~ 8.0% ~ 8.0% ~ 8.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% ~ 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $10,200 - $10,700 $10,200 - $10,700 $10,300 - $10,700 Acquisition-related, IPR&D impairment and restructuring expenses ~ 2,500 ~ 2,500 ~ 2,700 Non-GAAP projected operating income $12,700 - $13,200 $12,700 - $13,200 $13,000 - $13,400 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 20% ~ 21% ~ 21% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 1%) (~ 2%) (~ 2%) Non-GAAP projected effective tax rate ~ 19% ~ 19% ~ 19% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.95 - $6.35 $5.65 - $6.05 $5.85 - $6.15 Acquisition-related, IPR&D impairment and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments ~ 1.75 ~ 2.05 ~ 2.10 Non-GAAP projected diluted EPS $7.70 - $8.10 $7.70 - $8.10 $7.95 - $8.25 ________________________________ (1) Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and in-process research and development, transfers of intangible assets from a foreign subsidiary to Ireland and the United States, and legal entity restructurings. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) June 30, December 31, (in millions) 2025 2024 Assets Cash, cash equivalents and marketable debt securities $ 7,126 $ 9,991 Accounts receivable, net 4,781 4,420 Inventories(1) 3,913 3,589 Property, plant and equipment, net 5,459 5,414 Intangible assets, net 18,566 19,948 Goodwill 8,314 8,314 Other assets 7,563 7,319 Total assets $ 55,721 $ 58,995 Liabilities and Stockholders’ Equity Current liabilities $ 11,189 $ 12,004 Long-term liabilities 24,942 27,744 Stockholders’ equity(2) 19,590 19,246 Total liabilities and stockholders’ equity $ 55,721 $ 58,995 ________________________________ (1) Includes current and long-term inventories, which are disclosed separately in the notes to our financial statements in Form 10-K and Form 10-Q. (2) As of June 30, 2025 and December 31, 2024, there were 1,242 and 1,246 shares of common stock issued and outstanding, respectively. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2025 2024 2025 2024 Net cash provided by operating activities $ 827 $ 1,325 $ 2,584 $ 3,544 Net cash used in investing activities (2,116 ) (307 ) (2,531 ) (2,514 ) Net cash used in financing activities (1,566 ) (2,953 ) (4,993 ) (4,314 ) Effect of exchange rate changes on cash and cash equivalents 73 (11 ) 92 (29 ) Net change in cash and cash equivalents (2,782 ) (1,947 ) (4,848 ) (3,313 ) Cash and cash equivalents at beginning of period 7,926 4,718 9,991 6,085 Cash and cash equivalents at end of period $ 5,144 $ 2,772 $ 5,144 $ 2,772 Three Months Ended Six Months Ended June 30, June 30, (in millions) 2025 2024 2025 2024 Net cash provided by operating activities $ 827 $ 1,325 $ 2,584 $ 3,544 Purchases of property, plant and equipment (107 ) (130 ) (211 ) (235 ) Free cash flow(1) $ 720 $ 1,195 $ 2,373 $ 3,309 ________________________________ (1) Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above. GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2025 2024 2025 2024 HIV Biktarvy – U.S. $ 2,799 $ 2,585 $ 5,272 $ 4,900 Biktarvy – Europe 429 370 804 735 Biktarvy – Rest of World 302 277 603 542 3,530 3,232 6,679 6,177 Descovy – U.S. 601 434 1,139 805 Descovy – Europe 24 25 45 51 Descovy – Rest of World 28 26 55 55 653 485 1,239 911 Genvoya – U.S. 322 372 627 704 Genvoya – Europe 40 45 79 95 Genvoya – Rest of World 16 23 35 44 377 440 741 843 Odefsey – U.S. 221 233 436 457 Odefsey – Europe 66 72 123 148 Odefsey – Rest of World 11 10 20 21 298 315 579 626 Symtuza - Revenue share(1) – U.S. 88 131 170 236 Symtuza - Revenue share(1) – Europe 33 34 62 67 Symtuza - Revenue share(1) – Rest of World 3 3 6 6 124 168 238 309 Other HIV(2) – U.S. 65 65 115 125 Other HIV(2) – Europe 33 25 63 70 Other HIV(2) – Rest of World 9 15 19 27 107 105 198 222 Total HIV – U.S. 4,096 3,821 7,760 7,226 Total HIV – Europe 624 571 1,177 1,167 Total HIV – Rest of World 368 353 738 695 5,088 4,745 9,675 9,088 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 184 267 351 515 Sofosbuvir / Velpatasvir(3) – Europe 81 84 161 163 Sofosbuvir / Velpatasvir(3) – Rest of World 76 126 175 203 342 476 687 881 Vemlidy – U.S. 122 117 222 212 Vemlidy – Europe 13 11 24 22 Vemlidy – Rest of World 117 115 257 233 252 243 504 467 Other Liver Disease(4) – U.S. 106 47 175 89 Other Liver Disease(4) – Europe 76 47 152 94 Other Liver Disease(4) – Rest of World 19 19 35 38 201 113 362 221 Total Liver Disease – U.S. 413 431 748 816 Total Liver Disease – Europe 170 142 338 279 Total Liver Disease – Rest of World 211 259 467 474 795 832 1,553 1,569 Veklury Veklury – U.S. 51 76 250 391 Veklury – Europe 19 53 41 123 Veklury – Rest of World 50 85 132 255 121 214 423 769 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended Six Months Ended June 30, June 30, (in millions) 2025 2024 2025 2024 Oncology Cell Therapy Tecartus – U.S. 41 63 82 118 Tecartus – Europe 41 37 72 73 Tecartus – Rest of World 9 7 17 16 92 107 171 207 Yescarta – U.S. 162 186 321 357 Yescarta – Europe 154 169 304 327 Yescarta – Rest of World 77 58 154 110 393 414 779 794 Total Cell Therapy – U.S. 203 250 403 475 Total Cell Therapy – Europe 196 206 376 400 Total Cell Therapy – Rest of World 86 66 171 126 485 521 949 1,001 Trodelvy Trodelvy – U.S. 224 224 405 429 Trodelvy – Europe 96 69 171 137 Trodelvy – Rest of World 44 26 81 62 364 320 657 628 Total Oncology – U.S. 427 474 808 904 Total Oncology – Europe 291 275 547 537 Total Oncology – Rest of World 131 92 252 188 849 841 1,606 1,629 Other AmBisome – U.S. 7 17 13 31 AmBisome – Europe 65 69 132 139 AmBisome – Rest of World 56 65 123 124 129 151 268 294 Other(5) – U.S. 44 98 91 156 Other(5) – Europe 8 8 16 18 Other(5) – Rest of World 21 24 35 36 73 130 143 209 Total Other – U.S. 52 115 104 188 Total Other – Europe 73 77 149 156 Total Other – Rest of World 77 88 158 160 202 280 410 504 Total product sales – U.S. 5,038 4,916 9,669 9,525 Total product sales – Europe 1,178 1,118 2,251 2,262 Total product sales – Rest of World 838 878 1,747 1,772 $ 7,054 $ 6,912 $ 13,668 $ 13,559 ________________________________ (1) Represents Gilead’s revenue from cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company. (2) Includes Atripla, Complera/Eviplera, Emtriva, Sunlenca, Stribild, Truvada, Tybost and Yeztugo. (3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”). (4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Livdelzi/Lyvdelzi, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis and Zydelig. Investors: Jacquie Ross, CFA investor_relations@gilead.com Media: Ashleigh Koss public_affairs@gilead.com

Clinical ResultPhase 3Financial StatementDrug ApprovalLicense out/in

24 Jun 2025

·www.globenewswire.com

Atea Pharmaceuticals Announces Continued Advancement of Global Phase 3 HCV Program with Dosing of First Patient in C-FORWARD Outside North America

C-FORWARD is the Second Phase 3 Trial in the Global HCV Development Program; the First Phase 3 Trial, C-BEYOND, is Currently Enrolling Patients in the US and Canada Regimen has Potential Best-in-Class Profile with Short Treatment Duration, Low Risk for Drug-Drug Interactions and Convenience with No Food Effect HCV Infection Remains a Significant Global Health Burden, with Approximately 50 Million People Infected, Including up to 4 Million in US BOSTON, June 24, 2025 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that the first patient was dosed in the global Phase 3 C-FORWARD trial evaluating the combination regimen of bemnifosbuvir and ruzasvir compared to the regimen of sofosbuvir and velpatasvir for the treatment of hepatitis C virus (HCV). C-FORWARD, the second of two Phase 3 trials comparing this regimen, is being conducted at study sites outside of North America. Atea initiated C-BEYOND, the Company's Phase 3 trial in the US and Canada in April 2025 and continues to enroll patients in that study. In both studies, the regimen of bemnifosbuvir and ruzasvir is being administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is being administered orally once-daily for 12 weeks. “We are pleased to reach another important milestone for our global HCV program with the first patient dosed in C-FORWARD, our HCV Phase 3 trial being conducted outside North America. Our Phase 3 program is now enrolling patients on a global basis,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and founder of Atea. “We are focused on the successful development of a potential best-in-class HCV regimen that may make it easier to treat and cure patients infected with HCV. The target profile of our regimen is particularly well suited for both patients and healthcare providers in test-to-treat models of care, which enables seamless diagnosis and treatment for patients infected with HCV.” HCV continues to be a significant global health burden despite the availability of direct-acting antivirals, with an estimated 50 million people worldwide chronically infected with HCV, and approximately one million new infections each year. It is estimated that between 2.4 to 4 million people in the US alone are living with chronic HCV. “It has been nearly a decade since the last generation of treatments for HCV became available to patients and in this time, the patient population and what they need to obtain a cure has evolved. Many patients infected with HCV are taking concomitant medications, including some that may not be recommended with the currently available HCV therapies,” said Dr. Eric Lawitz, MD, The Texas Liver Institute, Clinical Professor of Medicine, University of Texas Health San Antonio. “The regimen of bemnifosbuvir and ruzasvir may offer a potent and more convenient option for my patients and may also make treatment more accessible for any patient who tests positive for HCV. I look forward to seeing the Phase 3 results when they are available.” “The evolving HCV patient population and rising burden of untreated HCV in Europe mirrors trends seen in North America. Many patients present with co-morbidities and complex medical histories, with treatment decisions often influenced by concomitant medications,” said Tarik Asselah, MD, PhD, a principal investigator in the C-FORWARD trial and a Professor of Hepatology, Hôpital Beaujon, Assistance Publique–Hôpitaux de Paris (AP-HP), University of Paris-Cité, France. “To truly advance HCV eradication and meet the needs of today’s patients, an ideal treatment would combine high efficacy, short duration, and minimal risk of drug-drug interactions." Atea hosted a virtual HCV panel discussion with key opinion leaders (KOLs) on May 14, 2025. A panel of six experts, including leading hepatologists and prescribers from the US, Canada and Europe, discussed the current challenges for patients infected with HCV and the results from Atea’s global Phase 2 study evaluating the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor were reviewed. Company management also reviewed the HCV commercial market opportunity and the design for the global Phase 3 clinical development program. To listen to the replay of the KOL event, please click here. About the Phase 3 C-BEYOND and C-FORWARD Trials in Adults with Chronic HCV Atea is conducting two open-label Phase 3 trials, C-BEYOND in the US and Canada, and C-FORWARD, a global trial outside of North America. Each Phase 3 trial is expected to enroll approximately 880 treatment-naïve patients, including those with and without compensated cirrhosis. The trials are comparing the fixed dose combination (FDC) regimen of bemnifosbuvir and ruzasvir to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir is being administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is being administered orally once-daily for 12 weeks for all patients with or without compensated cirrhosis. The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients. Last month, at the European Association for the Study of the Liver (EASL) Congress 2025, Atea presented results from the full cohort of patients (n=275) enrolled in its Phase 2 study evaluating the regimen. These results showed a robust 98% (210/215) SVR12 with the regimen in the “Per-Protocol Treatment-Adherent Population.” The SVR12 rate was 95% (245/259) in the “Per-Protocol Regardless of Adherence Population” (also referred to as the “efficacy evaluable population”), which included patients who were not treatment adherent (17%). Results from three additional Phase 1 studies demonstrated that the combination of bemnifosbuvir and ruzasvir had a low risk of drug-drug interactions (DDIs) and supported the safety of the regimen in HCV patients co-infected with human immunodeficiency virus (HIV) taking a standard HIV treatment, and the safety of bemnifosbuvir in participants with hepatic or renal impairment with no need for dose adjustments. About HCV HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. A leading cause of chronic liver disease and liver transplants, HCV is mainly spread via blood transfusion, hemodialysis and needle sticks, with 242,000 deaths occurring each year. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan. In the US, HCV infections predominate in patients in the age group between 20-49 years old, and it is estimated that fewer than approximately 10% of patients have cirrhosis. About Bemnifosbuvir and Ruzasvir for HCV Bemnifosbuvir has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. In both nonclinical and clinical studies, bemnifosbuvir has been shown to have a low risk for DDIs. Bemnifosbuvir has been administered to over 2,300 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. Ruzasvir has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 2,100 subjects at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of ruzasvir supports once-daily dosing. About Atea Pharmaceuticals Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea’s lead program and current focus is on the development of the combination of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. For more information, please visit www.ateapharma.com. Forward Looking Statement This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the potential best-in-class profile of the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV and the potential to develop a regimen that makes it easier to treat and cure HCV patients. When used herein, words including “expected,” “should,” “anticipated,” “believe,” “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control, our ability to manufacture sufficient commercial product, competition from approved treatments for HCV, the timeline for the completion of the strategic alternatives review process is unknown and there can be no assurance that the process will result in any particular outcome; dependence on the success of Atea’s most advanced product candidates, in particular the combination of bemnifosbuvir and ruzasvir for the treatment of HCV; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985barnes.jonae@ateapharma.com Joyce AllaireLifeSci AdvisorsJallaire@lifesciadvisors.com

Clinical ResultPhase 3Phase 2Phase 1

29 Apr 2025

·www.gilead.com

Gilead to Present Latest Advancements Across Primary Biliary Cholangitis and Viral Hepatitis

– New findings to be presented at the 2025 European Association for the Study of the Liver (EASL) Congress continue to demonstrate the effectiveness of Livdelzi (seladelpar) in reducing pruritus in people with primary biliary cholangitis (PBC) – – Additional presentations will showcase the potential for maintained virologic response following treatment with investigational bulevirtide in people with hepatitis delta virus (HDV) – – Presentations in hepatitis B virus (HBV) and hepatitis C virus (HCV) will underscore Gilead’s commitment to advancing scientific research and our understanding of viral hepatitis in the real-world setting – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq:GILD) today announced new research to be presented at the European Association for the Study of the Liver (EASL) Congress, May 7-10, 2025, Amsterdam, furthering Gilead’s commitment to transform the lives of people living with liver disease. New data to be presented at EASL will include a subgroup analysis from ASSURE, an ongoing open-label study, and an analysis of the Phase 3 RESPONSE trial and the open-label extension. Data will reinforce the effectiveness of Livdelzi® (seladelpar), known as Lyvdelzi® in the European Union, in reducing pruritus (chronic itch), a debilitating common symptom of primary biliary cholangitis (PBC). Moreover, the results will highlight seladelpar’s ability to deliver a sustained biochemical response regardless of prior treatment history, and as an option for a broad range of people with PBC. “Our focus remains on addressing the areas of greatest unmet need across liver diseases,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “Our deep expertise in treating liver disease has delivered the first and only treatment for hepatitis delta and the first treatment for primary biliary cholangitis that has demonstrated statistically significant improvements across both chronic itch and markers of disease progression. Our studies continue to deliver transformational insights and therapies to help foster healthier futures for the millions of people who live with viral hepatitis and those who live with less prevalent liver conditions with remaining high unmet needs.” Key findings from 29 accepted abstracts will include two oral presentations showcasing new data on the critical goal of maintained virologic response following treatment with 2 mg and 10 mg bulevirtide in people living with hepatitis delta virus (HDV). These findings build on the wealth of long-term data for the treatment of chronic HDV. A late breaker presentation on the final results from the pivotal MYR301 Phase 3 study evaluating the efficacy and safety of 2 mg and 10 mg bulevirtide as monotherapy will reveal long-term response rates, including the proportion of participants with undetectable virus levels two years after treatment cessation. In hepatitis B (HBV), Gilead will present initial results from a Phase 1a study of a novel investigational therapeutic vaccine that shows early promise towards the goal of achieving a functional cure for HBV infection. A separate analysis of real-world data showed that individuals with low-level HBV viremia still have a risk of negative events. Additionally, a retrospective analysis of participants enrolled in two Phase 3 studies evaluating Vemlidy® (tenofovir alafenamide) using a risk score for liver cancer highlights the importance of treatment to help reduce liver cancer risk. Gilead will also showcase real-world data on hepatitis C (HCV), demonstrating the effects of direct-acting antivirals (DAA) against all genotypes of the virus across diverse geographical regions, supporting the global applicability of HCV treatment guidelines. In addition, new real-world insights will show that the choice of DAA for people living with HCV taking other medicines, such as antipsychotics, was associated with reducing the problem of drug-drug interactions. To help raise awareness about HCV and encourage people to get screened for the disease, Gilead will again support EASL’s “Love Your Liver” Campaign at the congress. At the EASL Congress, Gilead, in collaboration with the PBC Foundation and Friends of the PBC Foundation, will also launch “All the Feelings with PBC,” a campaign highlighting the experiences of people living with PBC and emphasizing the importance of listening to and addressing their needs in clinical practice and research. The campaign will feature paintings by Berlin-based artist, Nour Khwies, based on the physical and emotional experiences of people living with PBC: Dilek from Germany, Angela from Scotland, Joana from Portugal, and L. Marie from the United States, whose painting will be painted live at EASL. Key Abstracts at EASL 2025: ID Abstract Title PBC THU-291 Clinical meaningful change of pruritus numeric rating scale in adults with primary biliary cholangitis with moderate-to-severe pruritus THU-286 Seladelpar treatment of patients with primary biliary cholangitis improves the GLOBE score and predicts improved transplant-free survival THU-294 Change in pruritus in patients with primary biliary cholangitis and moderate-to-severe pruritus: A pooled analysis from the RESPONSE and ENHANCE studies THU-274 Efficacy and safety of seladelpar in patients previously treated with fibrates or OCA FRI-318 Evaluation of the potential impact of seladelpar on the pharmacokinetics of midazolam, tolbutamide, simvastatin, rosuvastatin, and atorvastatin HDV OS-066 Predictors of undetectable hepatitis delta virus RNA at 48 weeks after end of treatment with bulevirtide monotherapy in the MYR 301 study OS-070 Achieving undetectable hepatitis delta virus RNA at end of therapy with bulevirtide 10 mg/day with or without pegIFN is strongly associated with post-treatment virologic response in chronic hepatitis delta LBO-004 Final results of MYR301: A randomised Phase 3 study evaluating the efficacy and safety of up to 144 weeks of bulevirtide monotherapy for chronic hepatitis delta and 96 weeks of posttreatment follow-up HCV WED-276 The SVR10K Hepatitis C study: Final results show 98.9% SVR in 7,000 patients treated with SOF/VEL in Asia, Latin America, Middle East, Nordics, and Southern Europe WED-031 Healthcare resource use (HCRU) and cost impact of potential drug-drug interactions (DDIs) among HCV patients receiving Direct-Acting Antivirals (DAAs) concomitantly with antipsychotic drugs in the US HBV THU-246 Safety, tolerability and immunogenicity of GS-2829 and GS-6779, a novel arenaviral vectored therapeutic hepatitis B vaccine: results from a phase 1a study in healthy participants SAT-009 Risk of advanced liver disease among individuals with hepatitis B virus infection with low level viremia compared to individuals with no evidence of hepatitis B virus infection WED-296 Impact of long-term tenofovir-based treatment on hepatocellular carcinoma risk in patients with chronic hepatitis B using the reREACH-B score For more information on the EASL Congress 2025 and Gilead’s presentations, please visit the congress website. About Gilead Sciences in Liver Disease For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into a curable condition. For individuals living with hepatitis B or hepatitis delta, Gilead's focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with PBC. The commitment of Gilead does not stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease. Marketing Authorization In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for Hepcludex® (bulevirtide) 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted a conditional MA from the EC in July 2020 to provide people living with HDV urgent access to treatment. Bulevirtide’s conditional MA license in the UK was converted to a full MA in August 2023, and a full MA was granted in Switzerland in February 2024. In regions where bulevirtide is not approved, including the U.S., bulevirtide 2 mg is an investigational product. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally. In February 2025, the European Commission (EC) granted conditional marketing authorization for Lyvdelzi® (seladelpar) for the treatment of PBC in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA. Lyvdelzi provides an important treatment option for people living with PBC in the European Economic Area (EEA). Gilead is working with health authorities across Europe to ensure people living with PBC who are eligible for Lyvdelzi have access as soon as possible. Continued approval of Lyvdelzi for the approved indication will be contingent on verification and description of clinical benefit in confirmatory trial(s). Lyvdelzi has Priority Medicine (PRIME) designation in the EU, assigned to optimize the development of novel medicines that target conditions with an unmet medical need for which no treatment options exist or where they can offer a major therapeutic advantage over existing treatments, as well as well as Orphan Drug Designation for the treatment of people living with PBC. Livdelzi® received conditional approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in January 2025. In the U.S., Livdelzi® obtained accelerated approval for the treatment of PBC by the U.S. Food and Drug Administration (FDA) in August 2024. Livdelzi received Breakthrough Therapy Designation, as well as Orphan Drug Designation for the treatment of people living with PBC. As part of the FDA accelerated approval, Gilead has committed to AFFIRM, a long-term outcomes study, which has begun in people with compensated cirrhosis. Continued U.S. approval may be contingent upon verification of clinical benefit in confirmatory trial(s). Regulatory review for Livdelzi is underway in Canada, Australia, and Switzerland. U.S. Indication for Livdelzi® Livdelzi is indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have had an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The FDA approved this indication under accelerated approval based on a reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Limitations of Use: Use of Livdelzi is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). U.S. Important Safety Information for Livdelzi Warnings and Precautions Fractures: Fractures occurred in 4% of Livdelzi-treated patients compared to no placebo-treated patients. Consider the risk of fracture in the care of patients treated with Livdelzi and monitor bone health according to current standards of care. Liver Test Abnormalities: Livdelzi has been associated with dose-related increases in serum transaminase (AST and ALT) levels > 3 x ULN in patients receiving 50 mg and 200 mg once daily (5x and 20x higher than the recommended dosage of 10 mg once daily). Perform baseline clinical and laboratory testing when starting Livdelzi® and monitor thereafter according to routine patient management. Interrupt treatment if the liver tests (ALT, AST, total bilirubin, and/or ALP) worsen, or if the patient develops signs and symptoms of clinical hepatitis (eg, jaundice, right upper quadrant pain, eosinophilia). Consider permanent discontinuation if liver tests worsen after restarting Livdelzi. Biliary Obstruction: Avoid use of Livdelzi in patients with complete biliary obstruction. If biliary obstruction is suspected, interrupt Livdelzi and treat as clinically indicated. Adverse Reactions The most common adverse reactions (≥5%) with Livdelzi were headache (8%), abdominal pain (7%), nausea (6%), abdominal distension (6%), and dizziness (5%). Drug Interactions OAT3 Inhibitors and Strong CYP2C9 Inhibitors: Avoid co-administration with L due to increased Livdelzi exposure. Rifampin: Monitor biochemical response (e.g., ALP and bilirubin) when patients initiate rifampin during Livdelzi treatment. Coadministration may result in delayed or suboptimal biochemical response of Livdelzi. Dual Moderate CYP2C9 and Moderate-to-Strong CYP3A4 Inhibitors and BCRP Inhibitors (e.g., cyclosporine): Monitor closely for adverse effects. Concomitant administration with Livdelzi may increase Livdelzi exposure. CYP2C9 Poor Metabolizers Using Moderate-to-Strong CYP3A4 Inhibitors: Monitor more frequently for adverse reactions as concomitant use of a moderate-to-strong CYP3A4 inhibitor in patients who are CYP2C9 poor metabolizers may increase Livdelzi exposure and risk of LIVDELZI adverse reactions. Bile Acid Sequestrants: Administer Livdelzi at least 4 hours before or 4 hours after taking a bile acid sequestrant, or at as great an interval as possible. Pregnancy and Lactation Pregnancy: There is insufficient data from human pregnancies exposed to Livdelzi to allow an assessment of a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Report pregnancies to Gilead Sciences, Inc., at 1-800-445-3235. Lactation: There is no data on the presence of Livdelzi in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Livdelzi and any potential adverse effects on the breastfed infant from Livdelzi. U.S. Indication for Vemlidy® VEMLIDY is indicated for the treatment of chronic hepatitis B virus infection in adults and pediatric patients six years of age and older and weighing at least 25 kg with compensated liver disease. U.S. Important Safety Information for and Indication for the Use of Vemlidy BOXED WARNING: POSTTREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted. Warnings and Precautions Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients:Due to this risk, VEMLIDY alone should not be used for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used. 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 TAF-containing products. Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome. Monitor renal function in all patients – See Dosage and Administration. Lactic Acidosis and Severe Hepatomegaly with Steatosis:Fatal cases have been reported with the use of nucleoside analogs, including tenofovir disoproxil fumarate (TDF). Discontinue VEMLIDY 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 events in the week 96 pediatric population reported in ≥5% were: nasopharyngitis, headache, COVID-19, pyrexia, diarrhea, upper respiratory tract infection, cough, respiratory tract infection viral, abdominal pain upper. Overall, abdominal pain upper and metabolic nephropathy were the only study drug–related adverse events, which occurred in > 1 participant, reported in 2.3% (2/88 participants) each. Drug Interactions Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions. Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) activity may lead to changes in VEMLIDY absorption. Coadministration of VEMLIDY with carbamazepine, the tenofovir alafenamide dose should be increased to two tablets once daily. Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments. Dosage and Administration Testing Prior to Initiation:HIV infection. Prior to or When Initiating, and During Treatment:On a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein in all patients. In patients with chronic kidney disease, also assess serum phosphorus. Dosage:1 tablet taken once daily with food. Renal Impairment:Not recommended in patients with end-stage renal disease (ESRD; eCrCl <15 mL/min) who are not receiving chronic hemodialysis; in patients on chronic hemodialysis, on hemodialysis days, administer VEMLIDY after completion of hemodialysis treatment. No data are available to make dose recommendations in pediatric patients with renal impairment. Hepatic Impairment:Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment. 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, cancer and inflammation. 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 Lyvdelzi®/Livdelzi® (seladelpar), Vemlidy®, bulevirtide, sofosbuvir, velpatasvir, GS-2829 and GS-6779 (such as the ASSURE, MYR301, RESPONSE, SVR10K and any confirmatory studies); uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for seladelpar; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; uncertainties regarding Gilead’s ability to coordinate access to seladelpar in a timely manner or at all; the risk that physicians may not see the benefits of prescribing seladelpar for treatment of PBC; 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, 2024, 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. Hepcludex, Lyvdelzi, Livdelzi, Vemlidy, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies. Full Prescribing Information for Livdelzi® and Vemlidy® are available at www.gilead.com . For more information about Gilead, please visit the company’s website at www.gilead.com , follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences). Blair Baumwell, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com

Clinical ResultBreakthrough TherapyDrug ApprovalPhase 3Phase 2

100 Deals associated with Velpatasvir

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D10806	Velpatasvir	J05AP56	DB11613

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis C, Chronic	Phase 2	United States	Gilead Sciences, Inc.	01 Apr 2013
Hepatitis C, Chronic	Phase 2	Puerto Rico	Gilead Sciences, Inc.	01 Apr 2013

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05717400 (CTgov)	Phase 4	Advanced Hepatocellular Carcinoma \| Hepatitis C, Chronic	2	sofosbuvir+velpatasvir+atezolizumab+voxilaprevir+bevacizumab	ubaharfhku = drhkwlywfd otpatzcbjn (looplmxtjj, wxhhgikacz - wdcntiklek) View more	-	10 Dec 2024
AASLD2023	Not Applicable	Hepatitis C, Chronic	12	SOF/VEL/VOX	mikoxmyzud(nhdrxvlect) = muvsqcalzm vvklybnepy (xzablsvcac )	-	10 Nov 2023
AASLD2023	Not Applicable	Hepatitis C, Chronic	65	Sofosbuvir/Velpatasvir with Ribavirin	nhfbwpkrhy(fgpiyymeoz) = buflmkusiq nrjhakngva (uuzttouzwt ) View more	-	10 Nov 2023
AASLD2023	Not Applicable	Hepatitis C, Chronic	65	Sofosbuvir/Velpatasvir without Ribavirin	nhfbwpkrhy(fgpiyymeoz) = lrlgpvgdrm nrjhakngva (uuzttouzwt ) View more	-	10 Nov 2023
AASLD2023	Not Applicable	Hepatitis C	452	Sofosbuvir/Velpatasvir	adhgkjwuiv(zkeqcnafgu) = showed a significant decrease from baseline to SVR12(-2.91 vs. -3.11 P < 0.001) cvuowvpvtt (clkrcnntts ) View more	-	10 Nov 2023
AASLD2023	Not Applicable	Hepatitis C	452	Sofosbuvir/Velpatasvir with Ribavirin		-	10 Nov 2023
HEP-C II TURKEY STUDY (AASLD2023)	Not Applicable	Hepatitis C, Chronic	127	Sofosbuvir/Velpatasvir/Voxilaprevir	chxkbcuuhr(niuwkcjaps) = ojuesojcjv vdsxvoijrt (elthjxwrlv ) View more	-	10 Nov 2023
NCT03483987 (Pubmed \| J Clin Exp Hepatol)	Not Applicable	Hepatitis C	12	Sofosbuvir	wnsyxynktg(zqlhinsqjk) = ghqtswqpxt fxijyuzccj (tnqzjydlna )	Positive	01 Sep 2023
NCT03483987 (Pubmed \| J Clin Exp Hepatol)	Not Applicable	Hepatitis C	12	Daclatasvir	wnsyxynktg(zqlhinsqjk) = wxvoxafplt fxijyuzccj (tnqzjydlna )	Positive	01 Sep 2023
Pubmed Manual	Not Applicable	Hepatitis C	299	Sofosbuvir+Velpatasvir+Kanamycin Sulfate	tjkocspedg(thlutqamhy) = reebtbomhk mxmuqmrztk (trirnjfncz, 95.4 - 99.3) View more	Positive	20 Apr 2022
NCT02002767 (CTgov)	Phase 1	Hepatitis C	19	velpatasvir (Normal Renal Function)	dgaberwesn(kgxvugldlk) = lcazzxebhh kleolhesib (ainvnieifs, 1749.18) View more	-	16 Nov 2020
NCT02002767 (CTgov)	Phase 1	Hepatitis C	19	velpatasvir (Severe Renal Impairment)	dgaberwesn(kgxvugldlk) = uuexhdozvf kleolhesib (ainvnieifs, 2531.09) View more	-	16 Nov 2020
EASL2020	Not Applicable	Hepatitis C	191	Sofosbuvir/Velpatasvir/Voxilaprevir	hjpyuhwino(wnubmexcqf) = nwlehrsbek dtdquosdju (rmzpzzwsug )	-	27 Aug 2020
EAP (EASL2020)	Not Applicable	Fibrosis NS5A RAS	89	Sofosbuvir/Velpatasvir/Voxilaprevir 400 mg/100 mg/100 mg	sebhubiwoh(gfxmhrwchh) = vijeaoksho cqszvrgzzn (cilsfvqkps )	Positive	27 Aug 2020

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