RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (China), Special Review Project (China)

Structure/Sequence

Molecular FormulaC22H29FN3O9P

InChIKeyTTZHDVOVKQGIBA-IQWMDFIBSA-N

CAS Registry1190307-88-0

287

Clinical Trials associated with Sofosbuvir

NCT07770984

/ Not yet recruitingPhase 2/3IIT

Clinical Study Evaluating the Optimal Drug Therapy in Chronic Kidney Disease Patients With HCV

The goal of this clinical trial is to evaluate the optimal drug therapy of HCV in CKD Patients different stages with or without compensated cirrhosis. The main questions it aims to answer are:
outcome measure 1: Efficacy of the treatment by the assessment of sustained virological response (SVR12) following 12 weeks after the last dose HCV RNA drop to undetectable levels.
outcome measure 2: Safety of the treatment by comparing the biochemical parameters before and after treatment.
If there is a comparison group: Researchers will compare biochemical parameters of the participants before and after treatment to see if there is any decline in the general health.
Participants will be divided to two groups according to their kidney status depending on their GFR, Group 1: 25 CKD Patients with eGFR more than 30ml/min with HCV infection and will receive Sofosbuvir and Daclatasvir regimen for 12 weeks, Group 2: 25 CKD Patients with eGFR less than 30ml/min with HCV infection and will receive Paritaprevir, Ombitasvir, Ritonavir and Ribavirin for 12 weeks.

Start Date15 Sep 2026

Sponsor / Collaborator

Tanta University

CTIS2024-510949-34-00

/ Not yet recruitingPhase 4IIT

YF_PROTECT: Prophylactic Treatment with Sofosbuvir for Yellow fever Exemption Circumstances and Travel

Start Date11 Sep 2024

Sponsor / Collaborator

Leids Universitair Medisch Centrum

ChiCTR2600115919

/ CompletedNot ApplicableIIT

A Prospective and Observational Study Evaluating the Efficacy and Safety of Coblopasvir in Combination with Sofosbuvir for the Treatment of Hepatitis C in the Northwest Region

Start Date05 Jul 2023

Sponsor / Collaborator-

100 Clinical Results associated with Sofosbuvir

100 Translational Medicine associated with Sofosbuvir

100 Patents (Medical) associated with Sofosbuvir

4,158

Literatures (Medical) associated with Sofosbuvir

01 Aug 2026·JOURNAL OF VIRAL HEPATITIS

Nationwide Socioeconomic Evaluation of Direct‐Acting Antivirals for Chronic Hepatitis C Virus Infection in Japan Between 2014 and 2023

Article

Author: Esmaili, Saeed ; Eslam, Mohammed ; Suoh, Maito ; George, Jacob

ABSTRACT:

Interferon‐free direct‐acting antivirals (DAAs), which are highly effective in eliminating hepatitis C virus (HCV), became available in Japan in 2014. This study aimed to estimate the nationwide socioeconomic outcomes of DAA therapy in Japan using publicly available records, including data from the hepatitis subsidy program and universal healthcare claims between fiscal years 2014 and 2023. Based on the standard dose of each DAA regimen, approximately 300,000 people were estimated to have been treated with DAA therapy by 2023, with a cumulative drug cost of at least 1.23 trillion Japanese yen (10.8 billion United States dollars). The main indication for DAA therapy was the initial treatment of chronic HCV infection without cirrhosis. The estimated cost and number of treated people peaked in 2015, followed by a declining trend. For most DAA regimens, annual prescriptions were the greatest in the same or the following year of approval. Sofosbuvir/ledipasvir and glecaprevir/pibrentasvir were the two most common regimens. The age of people treated with DAA therapy shifted towards younger people during the survey period, particularly in males. While the estimated prevalence of people treated with DAA therapy was higher in Western Japan, the estimated number of treated people and population in each prefecture showed a linear association ( p < 0.001). Despite the large economic impact, the rapid uptake of DAA therapy suggests an active program of case finding and treatment with the goal of HCV elimination in Japan. Whereas the demographics of people receiving DAA therapy changed over time, treatments were provided uniformly across the nation.

01 Aug 2026·INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES

A Multicenter, open-label, randomized, non-inferiority trial of 8 versus 12 weeks of sofosbuvir/ravidasvir treatment in non-cirrhotic patients with chronic hepatitis C virus infection (EASE trial)

Article

Author: Leman, Fatin Norhasny ; Muhamad, Nor Asiah ; Ngah, Nor Fariza ; Rosli, Izzah Athirah ; Abu Hassan, Muhammad Radzi ; Mohd Dali, Nor Soleha ; Zulkifli Supramaniam, Deanna Nadia ; Mohammed, Noor Syahireen ; Maamor, Nur Hasnah ; Soelar, Shahrul Aiman ; Md Salleh, Muhammad Firdaus ; Chan, Huan-Keat ; Mohd Suan, Mohd Azri ; Jogulu, Sathya Rao

OBJECTIVE:

To determine whether an 8-week regimen of sofosbuvir/ravidasvir is non-inferior to the standard 12-week regimen in non-cirrhotic chronic hepatitis C virus (HCV) infection.

DESIGN OR METHODS:

We conducted a multicenter open-label, randomized, non-inferiority clinical trial across nine hospitals and 17 primary healthcare centers in Malaysia. Adults aged 18-69 years with chronic HCV infection without cirrhosis were randomized (1:1) to receive 8 or 12 weeks of sofosbuvir/ravidasvir. The primary endpoint was sustained virologic response 12 weeks post-treatment (SVR12). The non-inferiority margin was 5%. The primary analysis was performed in the modified intention-to-treat population, excluding participants with missing primary endpoint data.

RESULTS:

Between March 2021, and March 2023, 322 participants were randomized (161 per arm). Among those with available SVR12 results, 142/152 (93.4%) in the 8-week group and 143/153 (93.5%) in the 12-week group (difference: -0.04%; 90% CI: -4.94% to 4.85%; P = 0.047), demonstrating non-inferiority. Efficacy was consistent across genotype, baseline viral load, and HIV co-infection subgroups. Treatment-emergent adverse events were comparable and predominantly mild; no treatment-related serious adverse events occurred.

CONCLUSION:

An 8-week sofosbuvir/ravidasvir regimen achieved SVR12 comparable to 12 weeks in non-cirrhotic adults with chronic HCV infection and was well tolerated. Further pragmatic and cost-effectiveness studies are needed to inform large-scale implementation.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT04885855 [09/05/2021].

01 Aug 2026·HEPATOLOGY RESEARCH

Long‐Term Outcomes of Sofosbuvir/Velpatasvir Treatment for Hepatitis C Virus‐Related Decompensated Cirrhosis: A Retrospective Multicenter Cohort Study

Article

Author: Araki, Masahiro ; Morimoto, Naoki ; Takakusagi, Satoshi ; Miura, Kouichi ; Tano, Shigeo ; Hatanaka, Takeshi ; Suzuki, Yuhei ; Fukaya, Yukimura ; Fukuda, Kuniaki ; Arisaka, Takahiro ; Fukuchi, Toru ; Ueno, Takashi ; Kakizaki, Satoru ; Iizuka, Keisuke ; Majima, Yuichi ; Kurata, Hidekazu ; Yamazaki, Yuichi ; Watanabe, Shunji ; Suga, Takayoshi ; Tojima, Hiroki ; Hoshino, Takashi ; Tahara, Toshiyuki ; Ikegami, Tadashi ; Naganuma, Atsushi ; Ohtake, Toshiya ; Takaoka, Yoshinari ; Horiuchi, Katsuhiko ; Takagi, Hitoshi ; Soeda, Atsuko ; Saito, Shuichi ; Takizawa, Daichi ; Kanayama, Yuki ; Kamoshida, Toshiro ; Iijima, Makoto ; Arai, Hirotaka

ABSTRACT:

Background:

Sofosbuvir/velpatasvir (SOF/VEL) treatment for hepatitis C virus (HCV)–related decompensated cirrhosis has been shown to achieve a high sustained virologic response (SVR) rate and to improve liver function. However, limited data are available regarding the association between improvements in liver function and long‐term survival. This multicenter study aimed to evaluate longitudinal changes in liver function and factors associated with long‐term prognosis in patients treated with SOF/VEL.

Methods:

Ninety‐one patients who received SOF/VEL for HCV‐related decompensated cirrhosis between March 2019 and December 2021 were enrolled. SVR rates, changes in Child–Pugh scores at 12, 24, 48, 72, and 120 weeks after treatment, changes in albumin–bilirubin (ALBI) scores, and overall survival (OS) were assessed. The impact of post‐treatment ALBI improvement on prognosis was examined, and its predictive ability for 60‐month OS was evaluated using receiver operating characteristic analysis. Survival was compared using the Kaplan–Meier method.

Results:

The median age was 68.0 years; 36.3% of patients were male, and 24.2% had a history of hepatocellular carcinoma. SVR was achieved in 96.7% of patients. The median observation period was 57.0 months (IQR, 43.0–72.0), and 27 patients (29.7%) died during the observation period. Child–Pugh scores improved from the end of treatment and continued to improve; at 120 weeks, 55.9% of patients had scores of 5 or 6. The median OS was not reached, and the 5‐year survival rate was 73.2%. ALBI improvement predicted 60‐month OS with a sensitivity of 0.494, a specificity of 0.851, and an optimal cutoff value of a decrease in ALBI score of ≥ 0.103. Patients with ALBI improvement showed significantly better OS.

Conclusions:

SOF/VEL therapy achieved high SVR rates and demonstrated that post‐treatment improvement in the ALBI score is strongly associated with a favorable long‐term prognosis in patients with decompensated cirrhosis.

246

News (Medical) associated with Sofosbuvir

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

28 Jul 2026

·www.fiercebiotech.com

Atea’s hepatitis C asset matches Gilead’s Epclusa in phase 3 trial

Atea Pharmaceuticals’ hepatitis C prospect has matched Gilead’s Epclusa in a phase 3 trial, keeping the biotech barreling toward a second readout for its shorter, simpler treatment regimen. Boston-based Atea ran the pivotal C-Beyond study to compare its once-daily fixed-dose combination of bemnifosbuvir and ruzasvir (BEM/RZR) to Gilead’s incumbent hepatitis C drug. Gilead sells the product, a once-daily fixed-dose combination of sofosbuvir and velpatasvir, as Epclusa. The clinical trial enrolled 905 treatment-naive patients, including 184 people with cirrhosis. At Week 24, BEM/RZR achieved a 93.9% sustained virologic response (SVR) rate versus 94.8% for Epclusa, hitting the trial’s primary endpoint of statistical non-inferiority. An eight-week course of BEM/RZR matched the SVR achieved by a 12-week course of Epclusa in the 721 patients without cirrhosis. Patients with cirrhosis all received 12 weeks of treatment, with BEM/RZR again matching Epclusa in the subpopulation. The pivotal readout achieved all the objectives that Atea management had previously outlined, William Blair analysts said in a note to investors. As well as showing non-inferiority to Epclusa in the modified intent-to-treat population favored by the FDA, BEM/RZR matched Gilead’s product in the per-protocol analysis preferred by the European Medicines Agency. Atea’s other phase 3 trial, C-Forward, is using the per-protocol population for its primary endpoint. Data from the second study, which enrolled patients outside North America, are due early next year and will complete the global regulatory submission package. An eight-week treatment period in non-cirrhotic patients is part of Atea’s positioning of BEM/RZR in a space served by AbbVie and Gilead. AbbVie’s hepatitis C drug Mavyret is given (PDF) for eight weeks in cirrhotic and non-cirrhotic patients but, unlike BEM/RZR and Epclusa, is only taken with food. Atea sees the favorable drug-drug interaction profile of BEM/RZR as another differentiator against the incumbents. Showing superiority over Epclusa would have further strengthened Atea’s hand, but that outcome was a long shot. In a note to investors back in April, William Blair analysts said they didn’t view superiority over Epclusa as the most likely scenario. Atea shares rose 2.3% to $4.93 in premarket trading Tuesday. With a market cap of $386 million before the phase 3 readout, Atea is only trading a little above the $256 million it had in the bank at the end of March. William Blair analysts pointed to the valuation to argue Atea is “a meaningfully underappreciated story” in a market that continues to support blockbuster sales. Sales of Gilead’s hepatitis C blockbusters Harvoni and Sovaldi peaked at $19.1 billion in 2015. Since then, the clearance of pent-up demand—which drove explosive sales growth—and intensifying competition have shrunk Gilead’s hepatitis C business. Even so, Gilead reported blockbuster hepatitis C sales last year. AbbVie’s rival hepatitis C drug Mavyret also delivered another year of blockbuster sales in 2025.

Phase 3Clinical ResultDrug Approval

100 Deals associated with Sofosbuvir

External Link

KEGG	Wiki	ATC	Drug Bank
D10366	Sofosbuvir	J05AP08	DB08934

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C	Japan	Gilead Sciences, Inc.	26 Mar 2015
Hepatitis C, Chronic	United States	Gilead Sciences, Inc.	06 Dec 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Compensated cirrhosis	Phase 3	Australia	Bristol Myers Squibb Co.	01 Feb 2015
Compensated cirrhosis	Phase 3	France	Bristol Myers Squibb Co.	01 Feb 2015
Fibrosis	Phase 3	United States	Bristol Myers Squibb Co.	01 Mar 2014
Liver Cirrhosis	Phase 3	United States	Bristol Myers Squibb Co.	01 Mar 2014
Chronic hepatitis C genotype 2	Phase 3	Japan	Gilead Sciences, Inc.	01 Feb 2013
HIV Infections	Phase 3	United States	Gilead Sciences, Inc.	01 Jul 2012
Chronic hepatitis C genotype 3	Phase 3	United States	Gilead Sciences, Inc.	01 Mar 2012
Chronic hepatitis C genotype 3	Phase 3	Australia	Gilead Sciences, Inc.	01 Mar 2012
Chronic hepatitis C genotype 3	Phase 3	Canada	Gilead Sciences, Inc.	01 Mar 2012
Chronic hepatitis C genotype 3	Phase 3	New Zealand	Gilead Sciences, Inc.	01 Mar 2012

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04885855 (EASE, Pubmed \| Int J Infect Dis)	Phase 4	Hepatitis C, Chronic	322	Sofosbuvir/Ravidasvir for 8 weeks	jwbamvdshv(ufelkfiaco) = ttuspyjhju ralbsevybu (vdomkcukhj )	Non-inferior	01 Aug 2026
				Sofosbuvir/Ravidasvir for 12 weeks	jwbamvdshv(ufelkfiaco) = uvumiwyenq ralbsevybu (vdomkcukhj )
NCT04532931 (CTgov)	Phase 2	COVID-19	192	SOC+Paracetamol (SOC) (Arm A)	mmjjaninog = efpibtswjh zclawpecet (inmctoupma, wzjmwhfldj - tmutdctvmu) View more	-	28 Jul 2025
				Artesunate+Amodiaquine (Arm B)	mmjjaninog = pidgyrfogl zclawpecet (inmctoupma, bqsjfadrvc - vohoplnnkp) View more
IAS2025	Not Applicable	Hepatitis C	152	VelpatasvirSofosbuvir + VelpatasvirSofosbuvirr	dbktgqcxqo(gqfxnzkyuz) = thqxfmtwgs vibowltofi (wiosgowelg ) View more	Positive	13 Jul 2025
DDW 12024 \| DDW 22024 \| DDW 32024 \| DDW 42024	Not Applicable	-	-	Sofosbuvir-based DAA treatment	jfywpwahls(epjknwdydm) = AFP was lower ethqjfdcyd (qvlghkiprn ) View more	-	18 May 2024
				Placebo
DDW 12024 \| DDW 22024 \| DDW 32024 \| DDW 42024	Not Applicable	-	-	Sofosbuvir-based DAA treatment	mhkworlopb(globrpcqyk) = iotxhxxqit qqetcxqyvb (yqurbjcjmu ) View more	-	18 May 2024
AASLD2023	Not Applicable	Hepatitis C, Chronic	65	Sofosbuvir/Velpatasvir with Ribavirin	whnovhugav(zedymngpdg) = escvwpduzc akbjkqzrbq (foxycugegy ) View more	-	10 Nov 2023
				Sofosbuvir/Velpatasvir without Ribavirin	whnovhugav(zedymngpdg) = lrhxzdyomn akbjkqzrbq (foxycugegy ) View more
AASLD2023	Not Applicable	Hepatitis C, Chronic	12	SOF/VEL/VOX	vebbbtpooo(midfefznvc) = kttajaqlgg gnvbrvmdio (bjnroicymt )	-	10 Nov 2023
AASLD2023	Not Applicable	Hepatitis C	452	Sofosbuvir/Velpatasvir	cdrqcxxrgn(axfilvvctc) = showed a significant decrease from baseline to SVR12(-2.91 vs. -3.11 P < 0.001) ptthtedqiv (sdyvimhbrf ) View more	-	10 Nov 2023
				Sofosbuvir/Velpatasvir with Ribavirin
HEP-C II TURKEY STUDY (AASLD2023)	Not Applicable	Hepatitis C, Chronic	127	Sofosbuvir/Velpatasvir/Voxilaprevir	icoxcrhuxl(svyugzxeog) = iyxjwvwcdq dzyimcfrqo (dbnwrzsjxj ) View more	-	10 Nov 2023
NCT03483987 (Pubmed \| J Clin Exp Hepatol)	Not Applicable	Hepatitis C	12	Sofosbuvir	wxsdelvrei(rcwjrodhll) = ybhtvgriwl hsnirpqtyr (wgbpwmcgqz )	Positive	01 Sep 2023
				Daclatasvir	wxsdelvrei(rcwjrodhll) = mentmhyemk hsnirpqtyr (wgbpwmcgqz )

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