This study will evaluate a single-visit approach to hepatitis C treatment in patients seen in the emergency department. Participants with hepatitis C will receive rapid testing and, if eligible, hepatitis C medication before leaving the emergency department. The study will also use a smart pillbox, an AI-powered virtual agent, and community health worker support to help participants take their medication as prescribed. Participants will have follow-up visits and testing to assess medication adherence and whether the hepatitis C infection is cured.

Start Date01 Dec 2026

Sponsor / Collaborator

University of Kentucky

NCT07560046

/ Not yet recruitingPhase 4IIT

Combating Related Epidemics in HCV Through Simplified Testing and Treatment. A Cluster Randomized Trial of Point-of-care Hepatitis C Testing and Treatment Among Key Populations

This is a two-arm cluster randomized control trial to evaluate the effectiveness of a single-visit point-of-care (POC) test and treat bundle (intervention arm) compared to the current standard-of-care (SOC, control arm). 1:1 randomization occurs at the site level.

Start Date01 Aug 2026

Sponsor / Collaborator

Duke University

[+8]

NCT07098481

/ Not yet recruitingPhase 4IIT

Access to Hepatitis C Treatment in Cameroon: Comparison of a Simplified Test and Treat Strategy to a Standard Strategy

Hepatitis C is a common and potentially serious disease. However, there are treatments that can cure it. That's why it's so important to detect the hepatitis C virus (HCV) and treat those affected. Today, many hepatitis C sufferers in Cameroon (and elsewhere) remain untreated.
The aim of this research is therefore to evaluate a simplified screening and treatment strategy (developed specifically for the Cameroonian context) in comparison with a standard strategy (based on usual care), in order to improve access to hepatitis C treatment in Cameroon. If the results of this research are positive, this strategy could be recommended to health authorities in Cameroon and other comparable countries.

Start Date01 Sep 2025

Sponsor / Collaborator

Université d'Aix-Marseille

[+1]

100 Clinical Results associated with Sofosbuvir/Velpatasvir

100 Translational Medicine associated with Sofosbuvir/Velpatasvir

100 Patents (Medical) associated with Sofosbuvir/Velpatasvir

Literatures (Medical) associated with Sofosbuvir/Velpatasvir

01 Jan 2025·Clinics

TeleHCV: A single-visit protocol and minimal passive remote monitoring are sufficient to achieve high SVR with a sofosbuvir-velpatasvir regimen

Article

Author: Álvares-da-Silva, Mário Reis ; Costa, Raquel Boff ; Katz, Natan ; Schacher, Fernando Comunello ; Costa, Marisa Boff ; Oliveira, Jerônimo De Conto ; Kolling, Maurício Godinho ; Gonçalves, Marcelo Rodrigues ; Scherer, Henrique Cabral ; Fernandes, Paula Martins ; Rados, Dimitris Varvaki

AIM:

Chronic Hepatitis-C Virus (HCV) treatment has evolved significantly in recent years with Direct-Acting Antivirals (DAAs). The traditional care cascade includes several steps that limit its impact, and simplification protocols have emerged. Therefore, the authors explore a simplified treatment strategy for HCV in a healthcare system with limited access to specialized care.

SUBJECT AND METHODS:

Chronic HCV, DAA-naïve patients waiting for in-person specialized care were invited to a single-arm non-inferiority trial to evaluate a simplified treatment protocol with a single face-to-face appointment and minimal monitoring of antiviral therapy. The unique visit consisted of an HCV presentation followed by individual medical consultation, blood tests, and delivery of sofosbuvir-velpatasvir pills for a 12-week treatment. Patients were remotely monitored without scheduled on-treatment appointments or phone calls. After treatment, teleconsultation using video was offered. The primary outcome was Sustained Virological Response (SVR) 12-weeks post-treatment. It was analyzed with Intention-To-Treat (ITT) and Per-Protocol (PP) approaches.

CLINICALTRIALS:

gov: NCT04039698.

RESULTS:

The authors included 144 patients, of which 54.2 % were male, mean age was 52 years. Most individuals (84.7 %) had an APRI score < 1. All patients received at least one dose of DAA, 139 completed antiviral therapy, and 131 had SVR evaluation. The ITT SVR rate was 90.3 % (130/144 patients; 95 % CI 84.2 %‒94.6 %), and the PP SVR was 99.2 % (130/131 patients; 95 % CI 95.8 %‒100 %). Eighty-three adverse events were reported, and 93 % were handled with remote care.

CONCLUSION:

This simplified strategy achieved a high SVR rate in a population with restricted access to specialized care. Telehealth tools and minimal monitoring are promising components for policies aimed at HCV elimination.

01 Jul 2024·CTS-Clinical and Translational Science

Pharmacokinetics of Sofosbuvir/Velpatasvir and efficacy of an alternate‐day treatment in hemodialysis patients with chronic hepatitis C infection

Article

Author: Prompila, Nantaporn ; Trakarnvanich, Thananda ; Tangkijvanich, Pisit ; Lekhyananda, Sookruethai ; Kerr, Stephen ; Praditpornsilpa, Kearkiat ; Chariyavilaskul, Pajaree ; Avihingsanon, Anchalee ; Susantitaphong, Paweena ; Wittayalertpanya, Supeecha ; Jeenapongsa, Somboon ; Prasithsirikul, Wisit

Abstract:

Sofosbuvir/Velpatasvir (SOF/VEL) is a combination drug used for chronic hepatitis C (HCV) infection. However, limited information exists regarding the pharmacokinetics of SOF/VEL and its metabolites in hemodialysis patients. We conducted a prospective investigation of the pharmacokinetic parameters of SOF/VEL after a single dose of SOF/VEL (400/100 mg) on days with and without dialysis in 12 Thai hemodialysis patients with chronic HCV infection, who had been undergoing hemodialysis for a duration of 0.5–20 years. Blood samples were collected before dose (0) and 0.5, 1.0, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 8.0, and 12.0 h after dose. Dialysate samples were also collected before dose (0) and 1.0, 2.0, 3.0, and 4.0 h after dose. Plasma and dialysate samples were quantified for SOF and its metabolite, GS‐331007, and VEL concentrations using a fully validated LCMS technique. In addition, a preliminary efficacy study was conducted using the proposed SOF/VEL dose reduction regimen in all patients. No differences in SOF/VEL PK parameters between on‐ and off‐dialysis studies. On the contrary, GS‐331007 exhibited a 30% reduction in the area under the plasma concentration–time curve from time 0 to 24 h (AUC0‐24h) on dialysis days compared with non‐dialysis days (AUC0‐24h ratio 0.68 vs. 1.04, respectively). The dialysis clearance of SOF and GS‐331007 was 9.35 (8.72–15.11) and 8.89 (8.52–14.07) mL/min, respectively. Subsequently, an alternate‐day regimen of SOF/VEL (400/100 mg) was administered for 12 weeks, resulting in an undetectable plasma HCV viral load without side effects. Further clinical studies are warranted to validate the efficacy and safety of our proposed dose reduction regimen.

01 Jun 2024·Journal of pediatric gastroenterology and nutrition

Sofosbuvir–velpatasvir in children 3–17 years old with hepatitis C virus infection

Article

Author: Kathleen B. Schwarz ; Sanjay Bansal ; Jiang Shao ; Rene Romero ; Girish S. Rao ; William F. Balistreri ; Karen F. Murray ; Suzanne Whitworth ; Jan de Jong ; Gabriella Verucchi ; Jessica Wen ; Wikrom Karnsakul ; Anu Osinusi ; Michael R. Narkewicz ; Kathryn Kersey ; Chuan‐Hao Lin ; Daniel H. Leung ; Philip Rosenthal ; Regino P. Gonzalez‐Peralta ; Alessandra Mangia ; Bandita Parhy ; Maureen M. Jonas ; Etienne M. Sokal

Abstract:

Background:

The safety and efficacy of sofosbuvir–velpatasvir in children aged 3–17 years with chronic hepatitis C virus (HCV) infection of any genotype were evaluated.

Methods:

In this Phase 2, multicenter, open‐label study, patients received once daily for 12 weeks either sofosbuvir–velpatasvir 400/100 mg tablet (12–17 years), 200/50 mg low dose tablet or oral granules (3–11 years and ≥17 kg), or 150/37.5 mg oral granules (3–5 years and <17 kg). The efficacy endpoint was sustained virologic response 12 weeks after therapy (SVR12). Dose appropriateness was confirmed by intensive pharmacokinetics in each age group.

Findings:

Among 216 patients treated, 76% had HCV genotype 1% and 12% had genotype 3. Rates of SVR12 were 83% (34/41) among 3–5‐year‐olds, 93% (68/73) among 6–11‐year‐olds, and 95% (97/102) among 12–17‐year‐olds. Only two patients experienced virologic failure. The most common adverse events were headache, fatigue, and nausea in 12–17‐year‐olds; vomiting, cough, and headache in 6–11‐year‐olds; and vomiting in 3–5‐year‐olds. Three patients discontinued treatment because of adverse events. Four patients had serious adverse events; all except auditory hallucination (n = 1) were considered unrelated to study drug. Exposures of sofosbuvir, its metabolite GS‐331007, and velpatasvir were comparable to those in adults in prior Phase 2/3 studies. Population pharmacokinetic simulations supported weight‐based dosing for children in this age range.

Interpretation:

The pangenotypic regimen of sofosbuvir–velpatasvir is highly effective and safe in treating children 3–17 years with chronic HCV infection.

News (Medical) associated with Sofosbuvir/Velpatasvir

19 Aug 2026

·www.biospace.com

Model Medicines Discovers the RdRp Thumb-1 Pocket as a Conserved Target for Broad-Spectrum Antiviral Development

Discovery described as a “fundamental shift in antiviral drug development” by an expert peer reviewer; serves as the basis for an armamentarium of broad-spectrum, direct-acting antivirals. SAN DIEGO — Model Medicines , an AI-first biotechnology company developing first-in-class therapeutics against multi-indication biological choke points, today announced the publication of a manuscript that establishes the RNA-dependent RNA polymerase (RdRp) Thumb-1 pocket as a conserved, druggable target for broad-spectrum antiviral development. The Thumb-1 pocket is a cryptic, allosteric site on the viral RdRp that controls an essential conformational change required for polymerase initiation. Pharmaceutical engagement traps the viral polymerase in a catalytically incompetent state, inhibiting replication. “The scientific literature states that conserved, druggable, allosteric viral biology targets do not exist,” said Daniel Haders, PhD, Founder and CEO of Model Medicines. “The broad-spectrum RdRp Thumb-1 pocket disproves decades of dogma that has influenced and continues to influence every antiviral drug program. We discovered a target the field dismissed as impossible. We did this by methodically developing a platform that allows us to do the tedious work of target discovery that others will not do or cannot do.” The preprint, “The RdRp Thumb-1 Pocket is a Conserved Target for Broad-Spectrum Antiviral Development,” is available on bioRxiv . It is accompanied by a companion preprint reporting preclinical proof of concept for MDL-001, the company’s oral, direct-acting antiviral discovered against this target. Model Medicines has been invited to present the RdRp Thumb-1 findings at IDWeek 2026 this October in Washington, D.C. “This is a highly innovative and mechanistically compelling abstract with strong novelty and potential significance for antiviral drug development,” said an IDWeek 2026 expert peer reviewer. “Demonstrates conservation of an allosteric site across viral families, directly contradicting established belief that non-nucleoside antivirals cannot achieve broad-spectrum activity. This is a fundamental shift in antiviral drug development strategy.” Model Medicines has now presented the discovery of the RdRp Thumb-1 site at IDWeek 2025 [1] , AASLD 2025 [2] , HepDART 2025 [3] , CROI 2026 [4] , ESCMID Global 2026 [5] , SERVC 2026 [6] , EASL 2026 [7] , and ASV 2026 [8] . The MDL-001 preprint has also been featured in the recent launch of the Intercept Fund , a $500 million philanthropic initiative, backed by leaders across technology and global health, including Stripe, Anthropic, the OpenAI Foundation, Jane Street, and the Flu Lab. [9] The World Is No Better Prepared for the Next Pandemic Than the Last RNA virus pandemics and epidemics occur regularly and cause widespread death and economic devastation. In the last 25 years, humanity has endured at least six major viral outbreaks: West Nile virus, SARS-CoV-1, swine-origin H1N1 influenza, MERS-CoV, Ebola, and COVID-19. [10] The COVID-19 pandemic caused an estimated 14.8 million deaths, resulted in $13.8 trillion in cumulative economic losses, and pushed 97 million people into extreme poverty. [11] [12] [13] Beyond the threat of the next pandemic, the annual toll is significant. Each winter, clinicians face a recurring tripledemic of influenza, RSV, and SARS-CoV-2 that causes hundreds of millions of infections and hundreds of thousands of deaths worldwide every year. [14] In a non-pandemic year in the U.S. alone, adults experience two to six of these respiratory viral illnesses and children approximately six to eight, at an economic cost exceeding $100 billion. [15] [16] A Parallel Crisis in the Liver and a Different Kind of Need Chronic viral hepatitis is a health crisis of comparable scale. Hepatitis B and C infections persist in 254 million and 50 million people worldwide, respectively. [17] An estimated 12–72 million people also carry hepatitis D, a satellite virus that cannot replicate without hepatitis B. [18] It is estimated that 5–15 million carry both HCV and HBV at once, yet most will never be diagnosed. Only 13% of HBV infections and 36% of HCV infections are identified globally, and fewer than 1% of co-infected patients know their status. Co-infection is not merely additive. Patients carrying both viruses are over 100-fold more likely to develop hepatocellular carcinoma than uninfected individuals. [19] Compounding the danger, every FDA-approved HCV direct-acting antiviral (DAA) carries a black box warning for the risk of hepatitis B virus (HBV) reactivation in patients with current or prior HBV infection. This reactivation can lead to fulminant hepatitis, liver failure, or death. [20] This FDA-mandated warning, added in 2016, applies to all DAA regimens, such as Epclusa, Harvoni, Mavyret, and others. Together, these gaps point to a single, persistent, and largely unaddressed need: one oral agent with broad-spectrum, direct-acting activity across the viruses that drive both crises. A Conserved Target Hidden in Plain Sight Conventional wisdom held that allosteric sites on viral polymerases are too poorly conserved to support pharmaceutical engagement beyond genotype- or species-specific activity. [21] Beclabuvir, the only approved Thumb-1 inhibitor, was developed for hepatitis C and is inactive against a diverse panel of non-HCV viruses, including poliovirus, rhinovirus, coronavirus, coxsackievirus, influenza, and HIV. [22] The Thumb-1 pocket had gone unrecognized because it is cryptic, and Beclabuvir MoA and activity data were misinterpreted. Beclabuvir’s lack of activity across viruses led to the conclusion that the pocket either did not exist or was undruggable on other viruses. This conclusion was seemingly validated because in the polymerase’s resting state the viral Λ1-loop occupies the site, rendering it invisible to conventional virtual screening. Model Medicines followed biology, rather than human dogma. Model Medicines' structural biology agent identified the pocket in viruses beyond HCV. The company then analyzed published HCV inhibitor co-crystal structures to define a fifteen-residue consensus Thumb-1 pocket. Model Medicines then aligned those residues across six coronaviruses spanning both Alphacoronavirus and Betacoronavirus genera to demonstrate that the pocket and its associated Λ1-loop are conserved across RNA viral families. Following the Science to a Novel Drug Class Model Medicines used the molecular-geometric deep-learning model, ChemPrint TM , within its peer-reviewed [23] , experimentally validated GALILEO™ drug discovery platform to find chemistry capable of engaging Thumb-1 across viral families. The company assembled a proprietary, three-tier bioactivity dataset spanning explicit HCV Thumb-1 chemistry and cross-family inhibitor scaffolds, then trained its model to separate HCV-restricted chemistry from genuinely broad-spectrum chemistry. In an accompanying preprint , Model Medicines demonstrates that MDL-001 inhibits Influenza, Coronaviruses, RSV, HCV, HBV, and HDV. MDL-001 is the first Thumb-1 inhibitor demonstrated to cross viral families. These findings establish RdRp Thumb-1 as both a conserved allosteric pocket and a druggable target built to yield successive generations of broad-spectrum, pandemic-ready therapeutics. The Discovery of Novel Druggable Targets is Rare in Virology Prior broad-spectrum drug discovery programs focused on developing nucleoside/nucleotide therapeutics that directly target the viral polymerase active site or host-targeted antivirals. None of the compounds active against these target classes have achieved broad-spectrum FDA approvals for Universal Influenza-like-Illness (ILI) or Universal Chronic Hepatitis. Few recently approved direct-acting antivirals act through clearly new target classes. Notable examples include baloxavir, an influenza cap-dependent endonuclease inhibitor, and lenacapavir, an HIV capsid inhibitor. [24] [25] RdRp Thumb-1 adds a new, broad-spectrum target to that short and commercially significant list. A New Blueprint for Drug Discovery Model Medicines broke with existing drug development paradigms to discover RdRp Thumb-1. In structure-based design, molecules are docked into a target's resolved 3D structure. This method would have failed to detect RdRp Thumb-1, because its pocket is cryptic and remains closed in the polymerase’s resting state. Conversely, similarity-based ligand approaches rank molecules by similarity to known actives and look for close chemical relatives. This method would have failed to discover broad-spectrum RdRp Thumb-1 inhibitors because the search would have kept returning the same narrow HCV-specific chemistry. To discover RdRp Thumb-1, Model Medicines fused the two paradigms. To establish the biology, the team overlaid crystal structures of the HCV RdRp Thumb-1 pocket bound to inhibitors and compared the polymerase across many viral families. This comparison confirmed that the pocket is conserved. The team then ran molecular-dynamics simulations to show how a bound drug displaces the Λ1-loop. To find the chemistry, the team used its GALILEO™ AI engine to train a geometry-aware deep-learning model on a proprietary dataset of small molecules. The model learned the features that make a molecule broad-spectrum rather than the features tied to any single virus. It identified the chemistry responsible for broad-spectrum interaction with the RdRp Thumb-1 pocket. About Model Medicines Model Medicines is an AI-first biotechnology company engineering first-in-class small molecules that target the biological linchpins underlying disease. The company’s research spans infectious disease, oncology, and inflammation, with programs designed around conserved molecular choke points that drive multiple pathologies. Model Medicines has discovered a direct-acting, non-nucleoside, broad-spectrum antiviral (MDL-001) and a potent, selective, and novel BRD4 inhibitor (MDL-4102). Its work demonstrates how large-scale computation can uncover entirely new classes of drugs once thought unreachable. Model Medicines is advancing a new generation of therapeutics that redefine what is possible in modern drug discovery. Learn more at . Media & Investor Contact Patrick O’Neill Head of Partnerships & Investor Relations media@modelmedicines.com [1] MDL-001: A Broad-Spectrum Antiviral Targeting the Thumb-1 Domain of Viral Polymerases, Open Forum Infectious Diseases, Volume 13, Issue Supplement_1, January 2026, ofaf695.084, [2] MDL-001 As A Next Generation HCV Thumb-1 inhibitor With Clinical-Stage Safety, The Liver Meeting: 2025 Abstracts. (2025). Hepatology (Baltimore, Md.), 82(S1), S1–S2308. Abstract 0088. [3] Oral Thumb-1 polymerase inhibitor MDL-001 achieves preclinical HCV and HBV proof-of-concept, including HCV/HBV co-infection and equivalence to sofosbuvir. Paper presented at: HEPDART 2025; December 7–11, 2025 [4] MDL-001, a novel oral thumb-1 polymerase inhibitor, shows efficacy in HCV/HBV in vitro and in vivo. Paper presented at: Conference on Retroviruses and Opportunistic Infections (CROI); February 22–25, 2026; Denver, CO. Abstract 589. / [5] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates broad-spectrum activity against influenza viruses, respiratory syncytial virus, and SARS-CoV-2 with oral proof-of-concept in mice. Abstract presented at: ESCMID Global 2026; April 18, 2026; Munich, Germany. Abstract 5803 MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates single-agent efficacy against HCV/HBV co-infection in vitro, and achieves HCV and HBV preclinical proof-of-concept. Abstract presented at: ESCMID Global 2026; April 18, 2026; Munich, Germany. Abstract 5778. [6] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates broad-spectrum activity against influenza viruses, respiratory syncytial virus, and SARS-CoV-2 with oral proof-of-concept in mice. Paper presented at: the 18th Southeastern Regional Virology Conference (SERVC 2026), April 24–26, 2026 [7] MDL-001, an oral direct-acting Thumb-1 polymerase inhibitor, demonstrates efficacy against HCV/HBV co-infection in vitro, and achieves HCV and HBV preclinical proof-of-concept, including equivalence to sofosbuvir, Journal of Hepatology, Volume 84, Supplement 1, May 2026, Pages S877-S878, THU-580. (26)02352-4/abstract [8] MDL-001, an oral Thumb-1 polymerase inhibitor, demonstrates broad-spectrum antiviral activity across six viral families with oral in vivo proof-of-concept. Paper presented at: the 45th Annual Meeting of the American Society for Virology (ASV 2026), July 27–30, 2026 [9] Ransohoff, N., Petty, C., & Sok, D. (2026, June 24). Ending respiratory infections. Intercept. [10] Tian L, Qiang T, Liang C, et al. RNA-dependent RNA polymerase (RdRp) inhibitors: the current landscape and repurposing for the COVID-19 pandemic. Eur J Med Chem. 2021;213:113201. [11] Msemburi W, Karlinsky A, Knutson V, et al. The WHO estimates of excess mortality associated with the COVID-19 pandemic. Nature. 2023;613:130-137. [12] Gopinath, G. (2022, January 25). A disrupted global recovery. IMF Blog. [13] World Bank. Poverty and Shared Prosperity 2020: Reversals of Fortune. Washington, DC: World Bank; 2020. [14] Luong QXT, Hoang PT, Ho PT, Ayun RQ, Lee TK, Lee S. Potential broad-spectrum antiviral agents: a key arsenal against newly emerging and reemerging respiratory RNA viruses. Int J Mol Sci. 2025;26:1481. [15] Rossignol JF. Rethinking methods used to evaluate effectiveness of therapeutics for COVID-19 and other viral respiratory illnesses. Future Virol. 2022;17:67-69. [16] Hanage, W. P., & Schaffner, W. (2025). Burden of Acute Respiratory Infections Caused by Influenza Virus, Respiratory Syncytial Virus, and SARS-CoV-2 with Consideration of Older Adults: A Narrative Review. Infectious diseases and therapy, 14(Suppl 1), 5–37. [17] World Health Organization. Global hepatitis report 2024: action for access in low- and middle-income countries. Geneva: WHO; 2024. [18] 8. Negro F, Lok AS. Hepatitis D: A Review. JAMA. 2023;330(24):2376-2387. [19] Mavilia MG, Wu GY. HBV-HCV coinfection: viral interactions, management, and viral reactivation. J Clin Transl Hepatol. 2018;6:296-305. [20] U.S. Food and Drug Administration. FDA Drug Safety Communication: FDA warns about risk of hepatitis B reactivating in some patients treated with certain direct-acting antiviral medicines for hepatitis C (DAAs). Silver Spring (MD): FDA; 2016 Oct. [21] De Clercq E. Strategies in the design of antiviral drugs. Nat Rev Drug Discov. 2002;1:13-25. [22] Gentles RG. Discovery of beclabuvir: a potent allosteric inhibitor of the hepatitis C virus polymerase. Top Med Chem. 2019;31:193-228. [23] Umansky TJ, Woods VA, Russell SM, Haders DJ. AmesNet: a task-conditioned deep learning model with enhanced sensitivity and generalization in Ames mutagenicity prediction. Chem Res Toxicol. 2026. Published online June 29, 2026. [24] Y., Frutos-Beltrán, E., Kang, D., Pannecouque, C., De Clercq, E., Menéndez-Arias, L., Liu, X., & Zhan, P. (2021). Medicinal chemistry strategies for discovering antivirals effective against drug-resistant viruses.. Chemical Society reviews. [25] Menéndez-Arias, L., & Gago, F. (2024). Antiviral Agents: Structural Basis of Action and Rational Design.. Sub-cellular biochemistry, 105, 745-784 .

Clinical Study

12 Aug 2026

·ir.ateapharma.com

Atea Pharmaceuticals Reports Second Quarter 2026 Financial Results and Provides Business Update

Phase 3 C-BEYOND Trial Met Primary and Secondary Endpoints, with a Short 8-week Duration for Patients Without Cirrhosis Supporting a Potential Best-in-Class Profile of BEM/RZR for Treatment of HCV C-FORWARD Phase 3 Trial Outside North America on Track with Topline Results Expected Early Q1 2027 AT-587 Phase 1 Clinical Trial Advancing for Treatment of Hepatitis E Virus (HEV) Company Holding Conference Call Today at 4:30 pm ET BOSTON, Aug. 12, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a late-stage clinical biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. In July, Atea announced positive topline results from C-BEYOND, its Phase 3 trial conducted in North America evaluating the regimen of bemnifosbuvir and ruzasvir (BEM/RZR) for the treatment of chronic hepatitis C virus (HCV) infection compared to the regimen of sofosbuvir and velpatasvir (SOF/VEL; Epclusa) in the modified intent-to-treat (mITT) population, achieving the trial’s primary endpoint. C-BEYOND enrolled patients reflective of the current real-world population living with HCV in the US and Canada. Patients in C-BEYOND included those who are taking concomitant medications (~89%), reported injection drug use as the HCV route of transmission (≥ 55%), diagnosed with a comorbid psychiatric disorder (~66%), prematurely discontinued treatment, lost to follow-up or did not adhere to protocol treatment (>10%), underscoring the importance of a simplified treatment option with a short 8-week duration for most patients, low risk of drug-drug interactions, and convenience with no food effect. "The positive Phase 3 C-BEYOND results announced last month represent a pivotal milestone for Atea, validating BEM/RZR's potential to become a highly differentiated, best-in-class treatment for hepatitis C virus (HCV)," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "In the US, a significant HCV treatment gap remains, currently only about 50%, or 85,000 people diagnosed are being treated annually, contributing to the increasing population of up to four million people who are already chronically infected. BEM/RZR's differentiated profile with a short eight-week regimen for non-cirrhotic patients, a low risk of drug-drug interactions and no food restrictions, has the potential to streamline prescribing decisions, and help expand treatment to more patients.” “Looking ahead, we remain focused on delivering topline results from our second Phase 3 trial, C-FORWARD, in early first quarter 2027 while continuing to advance AT-587 for the treatment of HEV, where a substantial commercial opportunity remains due to the lack of any approved therapies," Dr. Sommadossi added. Viral Hepatitis Pipeline Updates Hepatitis C (HCV) C-BEYOND topline Phase 3 results include: Today, the US Centers for Disease Control (CDC) reports approximately 160,000 new HCV infections annually with only an estimated 85,000 patients1 receiving treatment with the current standard of care therapies leaving approximately 75,000 untreated annually, enabling a potential $2.5 billion annual net sales US market opportunity. In the US alone, up to 4 million people are estimated to be infected with HCV. The C-BEYOND results reinforce BEM/RZR’s potential to address this growing treatment gap in today’s patient population and contribute to advancing the World Health Organization’s HCV elimination goal. Atea is advancing C-FORWARD, its second Phase 3 trial, being conducted outside North America. Patient enrollment for C-FORWARD was completed in June 2026 with more than 880 patients across 17 countries. Topline results are expected in early Q1 2027 and will provide additional efficacy data across a broader range of HCV genotypes more commonly found outside of the US and Canada. Following the recent topline readout for C-BEYOND and pending results from C-FORWARD, Atea anticipates submitting a new drug application (NDA) to the US Food & Drug Administration (FDA) in the second quarter of 2027. ______________ 1 IQVIA: NRx (NPA) Audit for the period Jan 2025 – Dec 2025 reflecting estimates of real-world activity. Hepatitis E (HEV) In July, Atea initiated a first-in-human Phase 1 clinical trial evaluating, AT-587, for the treatment of chronic HEV. Atea’s focus will be in an immunocompromised patient population infected with HEV genotypes 3 or 4. There is currently no approved antiviral therapy for HEV and current off-label treatments, including ribavirin, have limited efficacy and tolerability, underscoring a clear and urgent unmet medical need. Second Quarter 2026 Financial Results Cash and Investments: $219.5 million at June 30, 2026 compared to $301.8 million at December 31, 2025. Research and Development Expenses: Research and development expenses decreased by $4.1 million from $32.3 million for the three months ended June 30, 2025 to $28.2 million for the three months ended June 30, 2026. The net decrease was primarily driven by a decrease in external spend for our HCV Phase 3 clinical development offset by an increase in external spend for HEV preclinical development and clinical development startup activities. The decrease in HCV Phase 3 clinical development external spend was principally the result of the completion of the Week 24 post treatment visits by patients in our C-BEYOND Phase 3 clinical trial. The decrease in internal research and development expenses was primarily related to lower stock-based compensation expense in the three months ended June 30, 2026. General and Administrative Expenses: General and administrative expenses decreased by $2.1 million from $9.1 million for the three months ended June 30, 2025 to $7.0 million for the three months ended June 30, 2026. The net decrease was primarily related to lower stock-based compensation expense and lower professional fees. Interest Income and Other, Net: Interest income and other, net, decreased by $2.2 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025, primarily due to lower investment balances. Income Taxes: Income tax expense was $0.1 and $0.2 million for the three months ended June 30, 2026 and 2025, respectively. Conference Call and Webcast Atea will host a conference call and live audio webcast to discuss second quarter 2026 financial results and provide a business update today at 4:30 p.m. ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Atea website at ir.ateapharma.com. To participate via telephone, please dial 1-877-407-0779 (U.S.) or 1-201-389-0914 (International) and use conference ID number 13761501. An archive of the audio webcast will be available on Atea’s website approximately two hours after the conference call and will remain available for at least 90 days following the event. About the C-BEYOND and C-FORWARD Phase 3 Trials in Adults with Chronic HCV The global Phase 3 program is evaluating the fixed-dose combination (FDC) of BEM/RZR for the treatment of chronic HCV in patients with and without compensated cirrhosis. The program consists of two open-label controlled trials, which have collectively enrolled over 1,760 treatment-naïve patients: C-BEYOND (NCT06868264) in North America and C-FORWARD (NCT07037277) outside North America. The trials compare the FDC regimen of bemnifosbuvir (BEM), a nucleotide analog polymerase inhibitor, and ruzasvir (RZR), an NS5A inhibitor, to the FDC regimen of SOF/VEL. The regimen of BEM/RZR is administered orally once daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis), while the regimen of SOF/VEL is administered orally once daily for 12 weeks to all patients, with or without compensated cirrhosis. The primary endpoint for each trial is HCV RNA below the 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. SVR12 is the accepted definition of cure for HCV. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint measurement occurs at the same relative timepoint from the start of treatment in all patients. The primary endpoint was assessed in the mITT population in C-BEYOND, which is comprised of all patients who received at least one dose of the regimen and includes patients who discontinued early, were not compliant or were lost to follow-up. The mITT analysis is the agreed upon primary endpoint with the FDA. About Bemnifosbuvir and Ruzasvir for HCV BEM 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 BEM remained fully active against SOF resistance-associated substitutions (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of BEM supports once-daily dosing for the treatment of HCV. BEM has been shown to have a low risk for drug-drug interactions. BEM has been administered to over 3,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. RZR has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. RZR has been administered to over 3,100 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. The PK profile of RZR supports once-daily dosing. About HCV HCV is a blood-borne, positive-sense, single-stranded RNA (ssRNA) virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of DAAs, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, as many as four million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20 and 49 years old, and it is estimated that approximately 80-90% of people living with HCV in the US do not have cirrhosis. Chronic HCV infection is a leading cause of liver cancer in the US, Europe and Japan. About HEV HEV is a positive sense, ssRNA virus which infects the liver and remains an under-recognized global health challenge with an estimated 20 million infections annually. Waterborne transmission of HEV genotypes 1 and 2 causes mostly acute self-limiting hepatitis in developing regions, whereas foodborne transmission of HEV genotype 3 predominates in the US and Europe and causes chronic hepatitis in immunocompromised patients, which can lead to cirrhosis in three to five years. There is a growing number of immunocompromised patients, a population that includes solid organ transplant and hematopoietic stem cell transplant recipients and patients with hematologic malignancies such as multiple myeloma. Each year, in the US and Europe, 3% of the approximately 665,000 patients who have these underlying medical conditions are at risk of developing chronic HEV. There is currently no approved antiviral therapy for HEV, and current off-label treatments have limited efficacy and tolerability, underscoring a clear and urgent unmet medical need. Atea’s initial HEV clinical efforts are focused on developing AT-587 for the treatment of immunocompromised patients with chronic HEV. About Atea Pharmaceuticals Atea is a late-stage clinical 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 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 Phase 3 program is evaluating the FDC regimen of BEM, a nucleotide analog polymerase inhibitor, and RZR, an NS5A inhibitor, to treat HCV. AT-587, a nucleotide analog, is in Phase 1 development for the treatment of HEV. For more information, please visit www.ateapharma.com. Forward-Looking Statements 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 BEM/RZR regimen for the treatment of HCV, the potential opportunity to advance efforts to eradicate HCV, the potential to develop a product for the treatment of HEV, anticipated milestone events and timelines including the timeline for readout of the C-FORWARD Phase 3 clinical trial results and the potential submission of an NDA for US marketing approval of BEM/RZR, future results of operations and business strategy. 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; dependence on the success of Atea’s most advanced product candidates, in particular the BEM/RZR regimen for the treatment of HCV; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Annual Report on Form 10-K for the year ended December 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. All 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. 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 Barnes SVP, Investor Relations and Corporate Communications 617-818-2985 barnes.jonae@ateapharma.com Joyce Allaire LifeSci Advisors jallaire@lifesciadvisors.com

Phase 3Clinical ResultFinancial StatementPhase 1Phase 2

04 Aug 2026

·www.biospace.com

Gilead Sciences Announces Second Quarter 2026 Financial Results

Product Sales Excluding Veklury Increased 10% Year-Over-Year to $7.6 billion Biktarvy Sales Increased 7% Year-Over-Year to $3.8 billion Diluted Loss Per Share was $(8.45) and Non-GAAP Diluted Loss Per Share was $(6.75) Reflecting $(9.08) Per Share Acquired IPR&D and Tax Expenses Associated with Recent Acquisitions FOSTER CITY, Calif.--(BUSINESS WIRE)-- #Earnings --Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the second quarter 2026. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); “Gilead delivered a very strong second quarter, with 10% year-over-year revenue growth in our base business driven by our HIV portfolio, Trodelvy and Livdelzi. HIV sales grew 12%, reflecting continued strength in treatment and the rapid expansion of our PrEP business, supporting an increase in our base business revenue expectations for 2026,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “We also made significant clinical progress with three FDA approvals and three positive Phase 3 updates. We look forward to delivering on our many opportunities in the second half of the year including another two potential launches in oncology and HIV.” Second Quarter 2026 Financial Results Total second quarter 2026 revenues increased 10% to $7.8 billion compared to the same period in 2025, primarily driven by: Higher sales of HIV products, Trodelvy® (sacituzumab govitecan-hziy) and Livdelzi® (seladelpar), partially offset by lower sales of Veklury® (remdesivir) as well as Cell Therapy and chronic hepatitis C virus (“HCV”) products; and Higher royalty, contract and other revenues related to a previous sale of intellectual property. Diluted (loss) earnings per share (“EPS”) was $(8.45) in the second quarter 2026 compared to $1.56 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired in-process research and development (“IPR&D”) expenses associated with our acquisitions of Arcellx, Inc. (“Arcellx”), Tubulis GmbH (“Tubulis”) and Ouro Medicines, LLC (“Ouro Medicines”), net of the impact of our collaboration with Lakefront Biotherapeutics NV (“Lakefront”) and the related taxes, as well as an IPR&D impairment related to assets previously acquired from Immunomedics, Inc. (“Immunomedics”) and higher operating expenses. The decrease was partially offset by higher revenues, lower income tax expense, and higher net gains from equity securities. Non-GAAP diluted (loss) EPS was $(6.75) in the second quarter 2026 compared to $2.01 in the same period in 2025. The decrease was primarily driven by the $(9.08) per share impact of acquired IPR&D and tax expenses discussed above, as well as higher non-GAAP selling, general and administrative (“SG&A”) expenses and non-GAAP income tax expense, partially offset by higher revenues. As of June 30, 2026, Gilead had $3.2 billion of cash, cash equivalents and marketable debt securities compared to $10.6 billion as of December 31, 2025. The decrease was primarily driven by year-to-date cash outflows of $11.3 billion related to acquisitions, $2.8 billion of debt repayments, $2.1 billion of dividend payments and $774 million of common stock repurchases, partially offset by $4.1 billion of net proceeds from debt financing and $6.1 billion of operating cash flow. During the second quarter 2026, Gilead generated $3.6 billion in operating cash flow. During the second quarter 2026, Gilead paid dividends of $1.0 billion and repurchased $355 million of common stock. Second Quarter 2026 Product Sales Total second quarter 2026 product sales increased 8% to $7.6 billion compared to the same period in 2025. Total second quarter 2026 product sales excluding Veklury increased 10% to $7.6 billion compared to the same period in 2025, primarily due to higher sales of HIV products, Trodelvy and Livdelzi, partially offset by lower sales of Cell Therapy and HCV products. HIV product sales increased 12% to $5.7 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand. Biktarvy® (bictegravir 50mg/emtricitabine (“FTC”) 200mg/tenofovir alafenamide (“TAF”) 25mg) sales increased 7% to $3.8 billion in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price, favorable inventory dynamics and higher demand. Descovy® (FTC 200mg/TAF 25mg) sales increased 48% to $967 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher average realized price and demand. The Liver Disease portfolio sales increased 10% to $877 million in the second quarter 2026 compared to the same period in 2025, primarily reflecting higher demand for Livdelzi, as well as chronic hepatitis B virus (“HBV”) products and Hepcludex® (bulevirtide-gmod), partially offset by lower sales for HCV products. Veklury sales decreased 81% to $23 million in the second quarter 2026 compared to the same period in 2025, primarily driven by lower rates of COVID-19-related hospitalizations. Cell Therapy product sales decreased 14% to $417 million in the second quarter 2026 compared to the same period in 2025, reflecting ongoing competitive headwinds. Yescarta® (axicabtagene ciloleucel) sales decreased 12% to $346 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in- and out-of-class competition. Tecartus® (brexucabtagene autoleucel) sales decreased 24% to $70 million in the second quarter 2026 compared to the same period in 2025, primarily driven by in-class competition. Trodelvy® (sacituzumab govitecan-hziy) sales increased 26% to $457 million in the second quarter 2026 compared to the same period in 2025, primarily driven by higher demand. Second Quarter 2026 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin remained relatively flat at 79.3% in the second quarter 2026 compared to 78.7% in the same period in 2025. Non-GAAP product gross margin also remained flat at 86.9% in the second quarter 2026 compared to the same period in 2025. Research and development (“R&D”) expenses were $1.8 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily due to integration costs and other acquisition-related expenses, partially offset by lower oncology clinical study activity. Non-GAAP R&D expenses were $1.4 billion in the second quarter 2026 compared to $1.5 billion in the same period in 2025, primarily driven by lower oncology clinical study activity. Acquired IPR&D expenses were $11.2 billion in the second quarter 2026, primarily related to $7.0 billion for the Arcellx acquisition, $3.1 billion for the Tubulis acquisition and $1.0 billion for the Ouro Medicines acquisition, net of the impact of the Lakefront collaboration. SG&A expenses were $1.9 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily driven by integration costs related to the acquisitions and higher HIV promotional activities. Non-GAAP SG&A expenses were $1.5 billion in the second quarter 2026 compared to $1.4 billion in the same period in 2025, primarily due to higher HIV promotional activities. The effective tax rate (“ETR”) was (2.4)% in the second quarter 2026 compared to 19.3% in the same period in 2025. The non-GAAP ETR was (11.4)% in the second quarter 2026 compared to 18.8% in the same period in 2025. These changes primarily reflect the non-deductible acquired IPR&D expenses related to our acquisitions of Arcellx, Tubulis, and Ouro Medicines. Guidance and Outlook For the full year 2026, Gilead now expects: (in millions, except per share amounts) August 4, 2026 Guidance Comparison to May 7, 2026 Guidance Low End High End Product sales $ 30,100 $ 30,400 Previously $30,000 to $30,400 Product sales excluding Veklury $ 29,800 $ 30,100 Previously $29,400 to $29,800 Veklury ~ $300 Previously ~ $600 Diluted loss per share $ (3.75) $ (3.40) Previously $(3.25) to $(2.85) Non-GAAP diluted loss per share $ (0.65) $ (0.30) Previously $(1.05) to $(0.65) Our full year 2026 GAAP and non-GAAP diluted loss per share guidance includes the impact of approximately $9.08 due to acquired IPR&D charges of $11.1 billion related to the Arcellx, Tubulis and Ouro Medicines transactions, net of the impact of the Lakefront collaboration and related taxes. Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2026 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 Announced U.S. Food and Drug Administration (“FDA”) accepted a supplemental New Drug Application submission for Yeztugo® (lenacapavir) 300-mg tablets as a potential once-weekly oral formulation for HIV pre-exposure prophylaxis (“PrEP”), with a Prescription Drug User Fee Act target action date of February 2, 2027. Announced positive Phase 3 results from the ISLEND-1 and ISLEND-2 trials, in partnership with Merck, evaluating an investigational long-acting oral treatment regimen of islatravir 2 mg and lenacapavir 300 mg in adults with HIV who are virologically suppressed and switched from Biktarvy (ISLEND-1) or standard of care antiretroviral regimens (ISLEND-2) to the once-weekly combination. Received FDA accelerated approval for Hepcludex for the treatment of chronic hepatitis delta virus (“HDV”) infection in adults without cirrhosis or with compensated cirrhosis, which is now the first and only FDA-approved treatment for HDV in the U.S. Announced a donation of 2,000 vials of remdesivir to the Republic of Uganda to support response efforts to the current outbreak of Ebola Bundibugyo virus disease (“BVD”). Remdesivir is not approved for the treatment of Ebola virus disease, including BVD, anywhere globally, and the safety and efficacy of this use is not known. Oncology Received FDA approval of Trodelvy for the first-line (“1L”) treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (“mTNBC”) as either a single agent for patients who are not candidates for PD-1/PD-L1 inhibitor-based therapy or in combination with Keytruda® (pembrolizumab) or Keytruda Qlex™ (pembrolizumab and berahyaluronidase alfa-pmph) for patients whose tumors express PD-L1 (CPS ≥10). Announced European Commission marketing authorization for Trodelvy as a monotherapy for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and are not candidates for PD-1/PD-L1 inhibitor therapy. Received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Trodelvy in combination with Keytruda® (pembrolizumab) for the treatment of adult patients with unresectable locally advanced or mTNBC who have not received prior systemic therapy for metastatic disease and whose tumors express PD-L1 (CPS≥10). Announced the discontinuation of the Phase 3 EVOKE-03 study, in partnership with Merck, evaluating Trodelvy in combination with Keytruda® for the investigational treatment of 1L metastatic non-small cell lung cancer with high PD-L1 expression (TPS ≥50%). The decision was based on the recommendation of the external Data Monitoring Committee, following review of data from a pre-specified final analysis of progression-free survival and interim analysis of overall survival. Presented new analyses at the 2026 American Society of Clinical Oncology meeting from the Phase 3 ASCENT-03 and ASCENT-04 studies evaluating Trodelvy with or without Keytruda® in 1L mTNBC, as well as new data on investigational anitocabtagene-autoleucel (“anito-cel”) clinical trial manufacturing experience in patients with newly diagnosed or relapsed/refractory multiple myeloma. Presented updated Phase 1 results for KITE-753, an investigational bicistronic autologous CD19/CD20 CAR T-cell therapy for relapsed or refractory B-cell lymphoma at the 2026 European Hematology Association meeting. Completed the acquisition of Tubulis for $3.15 billion in upfront consideration. This acquisition brings Gilead next-generation antibody-drug conjugate (“ADC”) assets, including GS-8824, a NaPi2b-directed topoisomerase-I inhibitor ADC, and a platform to develop novel ADCs. Inflammation Completed the acquisition of Ouro Medicines for $1.675 billion in upfront consideration, which brings Gilead gamgertamig, an investigational clinical stage BCMAxCD3 T cell engager for autoimmune diseases. The acquisition was completed in collaboration with Lakefront, which equally shared the upfront payment and will equally share contingent milestone payments, subject to customary adjustments. Announced positive results from the Phase 3 IDEAL study, supporting the potential of Livdelzi to help people living with primary biliary cholangitis (“PBC”) with elevated alkaline phosphatase (“ALP”) levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with ursodeoxycholic acid (“UDCA”), or who are intolerant to UDCA. Presented data from the open-label Phase 3 ASSURE study at the 2026 European Association for the Study of the Liver Congress evaluating the long-term safety and tolerability pro Livdelzi in people living with PBC with elevated ALP levels (between 1.0 and 1.67xULN) whose disease remains inadequately controlled despite treatment with UDCA, or who are intolerant to UDCA. Corporate Issued $3.0 billion aggregate principal amount of senior unsecured notes and borrowed $1.1 billion aggregate principal amount under a one-year term loan facility. Announced a renewed 5-year collaboration with the World Health Organization to commit funding, strategic support and AmBisome donations toward eliminating visceral leishmaniasis. The Board declared a quarterly dividend of $0.82 per share of common stock for the third quarter of 2026. The dividend is payable on September 29, 2026, to stockholders of record at the close of business on September 15, 2026. Future dividends will be subject to Board approval. 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 and will be archived on 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, restructuring charges and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities, the related tax charges or benefits associated with such exclusions and other discrete tax charges or benefits not representative of underlying trends such as changes in tax laws, transfers of intangible assets between certain legal entities, and effects of 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 2026 financial guidance, including as a result of the uncertainty of the amount and timing of Veklury revenues, the impact from Medicare Part D pricing reform in the Inflation Reduction Act, the expiration of subsidies related to the Affordable Care Act, our most-favored-nation pricing agreement with the U.S. government, 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, inflammation and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the arrangements with Arcellx, Immunomedics, Lakefront, Merck, Ouro Medicines, The World Health Organization and Tubulis; the risk that Gilead’s U.S. manufacturing and R&D investment may not achieve their intended benefits; 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, anito-cel, KITE-753 and lenacapavir (such as ASCENT-03, ASCENT-04, ASSURE, IDEAL, ISLEND-1 and ISLEND-2), 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 pending clinical holds to the satisfaction of the FDA and the risk that FDA may not remove such clinical holds, 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, 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, including those involving Hepcludex, Trodelvy and once-weekly oral Yeztugo; 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, including Hepcludex and Trodelvy; 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, 2026 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, . 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®, JYSELECA®, LIVDELZI®/LYVDELZI®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA®, TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA®, YEZTUGO®/YEYTUO® and ZYDELIG®. Other trademarks and trade names are the property of their respective owners. For more information on Gilead Sciences, Inc., please visit 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) 2026 2025 2026 2025 Revenues: Product sales $ 7,627 $ 7,054 $ 14,574 $ 13,668 Royalty, contract and other revenues 176 27 189 81 Total revenues 7,803 7,082 14,763 13,749 Costs and expenses: Cost of goods sold 1,579 1,501 3,023 3,041 Research and development expenses 1,764 1,491 3,136 2,870 Acquired in-process research and development expenses 11,183 61 11,290 315 In-process research and development impairments 1,750 190 1,750 190 Selling, general and administrative expenses 1,921 1,365 3,372 2,623 Total costs and expenses 18,197 4,608 22,571 9,038 Operating (loss) income (10,394 ) 2,474 (7,808 ) 4,711 Interest expense 247 254 487 513 Other (income) expense, net (387 ) (208 ) (621 ) 120 (Loss) income before income taxes (10,254 ) 2,429 (7,674 ) 4,077 Income tax expense 242 468 801 802 Net (loss) income $ (10,496 ) $ 1,960 $ (8,475 ) $ 3,275 Basic (loss) earnings per share $ (8.45 ) $ 1.57 $ (6.82 ) $ 2.63 Diluted (loss) earnings per share $ (8.45 ) $ 1.56 $ (6.82 ) $ 2.61 Shares used in basic (loss) earnings per share calculation 1,243 1,245 1,243 1,246 Shares used in diluted (loss) earnings per share calculation 1,243 1,255 1,243 1,257 Supplemental Information: Cash dividends declared per share $ 0.82 $ 0.79 $ 1.64 $ 1.58 Product gross margin 79.3 % 78.7 % 79.3 % 77.7 % Research and development expenses as a % of revenues 22.6 % 21.1 % 21.2 % 20.9 % Selling, general and administrative expenses as a % of revenues 24.6 % 19.3 % 22.8 % 19.1 % Operating margin (133.2 )% 34.9 % (52.9 )% 34.3 % Effective tax rate (2.4 )% 19.3 % (10.4 )% 19.7 % Contacts Investors: Jacquie Ross, CFA investor_relations@gilead.com Media: Ashleigh Koss public_affairs@gilead.com Read full story here

100 Deals associated with Sofosbuvir/Velpatasvir

External Link

KEGG	Wiki	ATC	Drug Bank
D10827	Sofosbuvir/Velpatasvir	J05AP55	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Compensated cirrhosis	Japan	Gilead Sciences, Inc.	08 Jan 2019
Decompensated cirrhosis of liver	Japan	Gilead Sciences, Inc.	08 Jan 2019
Hepatitis C, Chronic	European Union	Gilead Sciences Ireland UC	06 Jul 2016
Hepatitis C, Chronic	Iceland	Gilead Sciences Ireland UC	06 Jul 2016
Hepatitis C, Chronic	Liechtenstein	Gilead Sciences Ireland UC	06 Jul 2016
Hepatitis C, Chronic	Norway	Gilead Sciences Ireland UC	06 Jul 2016
Hepatitis C	United States	Gilead Sciences, Inc.	28 Jun 2016

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Cryoglobulinemia	Phase 3	United States	Gilead Sciences, Inc.	01 Feb 2016
HIV Infections	Phase 3	United States	Gilead Sciences, Inc.	01 Jul 2015
Chronic hepatitis C genotype 2	Phase 3	United States	Gilead Sciences, Inc.	01 Sep 2014
Chronic hepatitis C genotype 3	Phase 3	United States	Gilead Sciences, Inc.	01 Jul 2014
Chronic hepatitis C genotype 3	Phase 3	Australia	Gilead Sciences, Inc.	01 Jul 2014
Chronic hepatitis C genotype 3	Phase 3	Canada	Gilead Sciences, Inc.	01 Jul 2014
Chronic hepatitis C genotype 3	Phase 3	France	Gilead Sciences, Inc.	01 Jul 2014
Chronic hepatitis C genotype 3	Phase 3	Germany	Gilead Sciences, Inc.	01 Jul 2014
Chronic hepatitis C genotype 3	Phase 3	Italy	Gilead Sciences, Inc.	01 Jul 2014
Chronic hepatitis C genotype 3	Phase 3	New Zealand	Gilead Sciences, Inc.	01 Jul 2014

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


STORC (EASL2026)	Not Applicable	-	83	Sofosbuvir/Velpatasvir	ubciflvkbd(kktzgfvcho) = ahfffpjmbk pfozxsmsln (hkktwmffrs ) View more	Positive	27 May 2026
DDW2026	Not Applicable	Hepatitis C, Chronic	42	Direct acting antivirals (Chronic hepatitis C)	rywvvxxcxu(oblxsiaolq) = rxkfutqraf azrnnluyam (jxlchkslqd ) View more	Positive	02 May 2026
NCT03819322 (CTgov)	Phase 2	Hepatitis C	5	sofosbuvir/velpatasvir (HCV Seropositive Non-viremic (HCV Ab+/NAT-) Donor)	elfvjlvklw = evyrylkjxb typawyzitp (wbjdjkzwep, rsflhzpqhu - vbntaifutf) View more	-	30 Apr 2026
NCT03819322 (CTgov)	Phase 2	Hepatitis C	5	sofosbuvir/velpatasvir (HCV Seropositive Viremic (HCV Ab+/NAT+) Donor)	elfvjlvklw = nfgysckdia typawyzitp (wbjdjkzwep, msnyrieocp - efjrkermbl) View more	-	30 Apr 2026
NEWS Manual	Not Applicable	Hepatitis B \| Hepatitis C	105	TAF + 索磷布韦维帕他韦（SOF/VEL） (非肝硬化)	axbcuuzeuo(zhurjgjyka) = nxkkaphqxi veibdkxvoc (mianivybbq ) View more	Positive	27 Mar 2025
NEWS Manual	Not Applicable	Hepatitis B \| Hepatitis C	105	TAF + 索磷布韦维帕他韦（SOF/VEL） (代偿期肝硬化)	axbcuuzeuo(zhurjgjyka) = czbimhbcbm veibdkxvoc (mianivybbq ) View more	Positive	27 Mar 2025
NCT04039698 (TeleHCV, Pubmed \| Clinics (Sao Paulo))	Not Applicable	Hepatitis C DAA-naïve	144	Sofosbuvir-velpatasvir regimen	jlxpntprnh(hdxndguwrg) = pyuveqqsnh mxgslrewin (shnjaqmnzv, 84.2 - 94.6)	Positive	01 Jan 2025
NCT04382404 (CTgov)	Phase 1	Hepatitis C, Chronic	11	Sofosbuvir-Velpatasvir Drug Combination	rszhyvmnna(xdkvmfaodn) = aqmuqegcyh ijbukyulhb (taiotpwspa, 38.35) View more	-	01 Jan 2025
NCT05717400 (CTgov)	Phase 4	Advanced Hepatocellular Carcinoma \| Hepatitis C, Chronic	2	sofosbuvir+velpatasvir+atezolizumab+voxilaprevir+bevacizumab	ntlzgxmmuk = fiqnltrfpg qfmlqdkavg (hxiainmdyg, vspfuvfhyj - erfxujwasw) View more	-	10 Dec 2024
NCT03022981 (Pubmed \| J Pediatr Gastroenterol Nutr)	Phase 2	Hepatitis C	216	Sofosbuvir-velpatasvir 400/100 mg tablet (12-17 years)	srqxcqphpn(dqtqgdobbq) = The most common adverse events were headache, fatigue, and nausea in 12-17‐year‐olds; vomiting, cough, and headache in 6-11‐year‐olds; and vomiting in 3-5‐year‐olds. pfmdosaewl (kjhzifoelk )	Positive	01 Jun 2024
NCT03022981 (Pubmed \| J Pediatr Gastroenterol Nutr)	Phase 2	Hepatitis C	216	Sofosbuvir-velpatasvir 200/50 mg low dose tablet or oral granules (6-11 years)		Positive	01 Jun 2024
AASLD2023	Not Applicable	Hepatitis B \| Hepatitis C \| Compensated cirrhosis	60	SOF/VEL 12-week regimen + prophylactic use of TAF	ekcflpadvm(qtcyrpnoxo) = ubhiqvttot mkqkkgswgi (fgzhrsdmiq )	-	10 Nov 2023
AASLD2023	Not Applicable	Chronic hepatitis C genotype 3	22	SOF/VEL	aorhplfrqw(rtcnlhfdqn) = ibinynrsot rbfrsaravj (jnaqxxrxrd )	-	10 Nov 2023

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis