NS3/NS4A inhibitors(Hepatitis C virus serine protease, NS3/NS4A inhibitors), NS5A inhibitors(Nonstructural protein 5A inhibitors), NS5B polymerase inhibitors(Hepatitis C virus NS5B RNA-dependent RNA polymerase inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Hepatitis CHepatitis C, Chronic

Inactive Indication

Chronic hepatitis C genotype 3

Originator Organization

Gilead Sciences, Inc.

Active Organization

Gilead Sciences Ireland UC

Gilead Sciences, Inc.

Gilead Sciences Canada, Inc.

+ [1]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

US (18 Jul 2017),

Hepatitis C, Chronic

RegulationOverseas New Drugs Urgently Needed in Clinical Settings (CN)

Structure/Sequence

Molecular FormulaC49H54N8O8

InChIKeyFHCUMDQMBHQXKK-CDIODLITSA-N

CAS Registry1377049-84-7

View All Structures (3)

Clinical Trials associated with Sofosbuvir/velpatasvir/voxilaprevi

NCT06180590

/ RecruitingNot ApplicableIIT

A Prospective Cohort Study: the Efficacy of Vosevi in Treating Direct Antiviral Agent Therapy Failure Patients

Hepatitis C virus (HCV) infection remains a significant health problem in our country. The World Health Organization estimated that 71 million people worldwide had chronic HCV infection in 2015. And 399,000 people died from cirrhosis or primary hepatocellular carcinoma caused by HCV infection. In 2006, the positive rate of HCV antibody in the population aged 1-59 was 0.43%. Therefore, it was estimated that there were about 5.6 million HCV infected people in the general population, and about 10 million cases of HCV infected people in high-risk groups and high incidence areas.
Universal genotype direct antiviral agent (DAA) is the preferred antiviral therapy for hepatitis C. Sofosbuvir/velpatasvir are direct antiviral agents for hepatitis C. The results of Asian clinical trials mainly in Chinese population showed that the sustained virologic response (SVR) rates of sofosbuvir/velpatasvir at 12 weeks in genotype 1a, 1b, 2, 3a, 3b and 6 were 100%, 100%, 100%, 95%, 76% and 99%, respectively. Limited data showed that the SVR rate of sofosbuvir/velpatasvir at 12 weeks was 96% in Chinese genotype 3b patients without cirrhosis and 50% in patients with cirrhosis.
After standard antiviral therapy for hepatitis C, there are still some patients who cannot obtain SVR, and these patients are defined as DAA-experienced patients. The guidelines recommend that Sofosbuvir/Velpatasvir combined with ribavirin be used as salvage therapy for patients with DAA-experienced failure. Vosevi is a new generation of antiviral therapy for hepatitis C, which contains three components, (Sofosbuvir, Velpatasvir and Voxilaprevir. It was a salvage treatment plan for DAAs-experienced patients which was recommended by the Chinese hepatitis C prevention and treatment guidelines in 2019. However, there are insufficient data on the proportion of SVR acquired in Vosevi treated DAAs-experienced patients in Asian populations and the effectivity of antiviral therapy between Vosevi and Sofosbuvir/Velpatasvir combined with ribavirin.
In the present study, the investigators enroll DAAs-experienced hepatitis C patients. The participants are randomly divided into two groups. Then the participants are treated with Vosevi or Sofosbuvir/Velpatasvir combined with ribavirin respectively. All enrolled participants are followed-up for 3 years. Objectives of the present study are as follows:
A. To clarify the sustained virologic response rate after Vosevi therapy for DAAs-experienced patients.
B. To clarify the safety and efficacy between the Vosevi therapy and the Sofosbuvir/Velpatasvir combined with ribavirin therapy.
C. To clarify the changes of biochemistry indexes in DAAs-experienced patients after Vosevi therapy.
D. To clarify the virological relapse rate at 12 weeks after Vosevi therapy. E. To clarify the rate of cirrhosis and liver cancer during the follow-up.

Start Date28 Feb 2023

Sponsor / Collaborator

The Third Affiliated Hospital of Guangzhou Medical University Stomatology

NCT05467826

/ Unknown statusPhase 4IIT

Efficacy and Safety of Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks or Sofosbuvir/Velpatasvir/Voxilaprevir for 12 Weeks in DAA Treatment Naïve HCV Subjects With GT3b, Compensated Cirrhosis in China

Direct-acting antiviral agents (DAAs) targeting HCV have revolutionized the treatment of HCV. The efficacy of DAA-based therapy can depend on patient-related factors such as treatment experience, cirrhosis, but also on viral genotype. The high prevalence of genotype 3, which is considered difficult to cure, remains a challenge because many oral DAAs are less effective for this genotype, particularly subtype 3b than for others. Current guidance generally recommends sofosbuvir (SOF)/velpatasvir (VEL) ± ribavirin (RBV), glecaprevir/pibrentasvir and SOF/VEL/voxilaprevir (VOX) as first-line therapy for genotype 3, and an interferon-based regimen - SOF plus pegylated interferon and ribavirin is still recommended as an alternative treatment option. These recommendations are based on clinical data generated in regions where genotype 3a predominates. Our recent study indicated that sofosbuvir plus ribavirin for 24 weeks in subjects with HCV genotype 3 infection resulted in high rates of SVR. However, the SVR12 rate among subjects with genotype 3b was lower than that observed in subjects with genotype 3a infection, particularly among treatment-experienced subjects with cirrhosis.
Our study aimed to investigate the efficacy and safety of SOF/VEL plus RBV for 12 weeks or SOF/VEL/VOX for 12 weeks in DAAs treatment naïve HCV subjects with GT3b, compensated cirrhosis in China.

Start Date01 Sep 2022

Sponsor / Collaborator

Peking University People's Hospital

NCT05092074

/ Unknown statusNot ApplicableIIT

Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) for Patients With Hepatitis C Virus Infection: Real-world Effectiveness and Safety in Taiwan

The investigators aim to assess the effectiveness and safety of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) for 12 weeks in hepatitis C virus (HCV)-infected patients who fail to prior NS5A-containing DAA regimens and HCV genotype 1a and 3 patients who fail to prior non-NS5A-containing DAA regimen in Taiwan on a basis of a multicenter observational study.

Start Date01 Oct 2021

Sponsor / Collaborator

National Taiwan University Hospital

100 Clinical Results associated with Sofosbuvir/velpatasvir/voxilaprevi

100 Translational Medicine associated with Sofosbuvir/velpatasvir/voxilaprevi

100 Patents (Medical) associated with Sofosbuvir/velpatasvir/voxilaprevi

Literatures (Medical) associated with Sofosbuvir/velpatasvir/voxilaprevi

28 Sep 2020·Journal of Clinical and Translational Hepatology

Review of Clinically Relevant Drug Interactions with Next Generation Hepatitis C Direct-acting Antiviral Agents

Review

Author: Yoshida, Eric M ; Wright, Robert C ; Partovi, Nilu ; Hong, Jenny ; Hussaini, Trana

In this review, we examine the pharmacokinetics and clinically relevant drug interactions of the newer generation direct-acting antivirals (DAAs) for the treatment of chronic hepatitis C, specifically sofosbuvir/velpatasvir (Epclusa^®), sofosbuvir/velpatasvir/voxilaprevir (Vosevi^®), glecaprevir/pibrentasvir (Maviret^®), and elbasvir/grazoprevir (Zepatier^®). We searched MEDLINE (1948-January 2020), Embase (1964-January 2020), Google, and GoogleScholar using the terms pharmacokinetics, drug interaction, drug metabolism, sofosbuvir, velpatasvir, Epclusa, voxilaprevir, Vosevi, glecaprevir, pibrentasvir, Maviret, elbasvir, grazoprevir, and Zepatier, from inception to January 13, 2020. The search was limited to randomized controlled trials, in vitro studies, prospective and retrospective human studies, drug monographs, abstracts, and conference proceedings. All relevant published literature on pharmacokinetic and pharmacodynamic interactions involving DAAs were reviewed and the data extracted. Numerous clinically relevant drug-drug interactions (DDIs) were identified with the newer generation DAAs and commonly prescribed drugs. NS3/4A protease inhibitors are more likely to be involved in DDIs, followed by NS5A inhibitors and NS5B polymerase inhibitor. The majority of clinically relevant DDIs are predictable, according to known pharmacokinetic, pharmacodynamics, and physicochemical properties of DAAs; however, in select cases, unpredictable DDIs do occur. As expected, many drug interactions exist between newer generation DAAs and commonly prescribed medications. While the majority of clinically relevant interactions are predictable, many require therapeutic dose adjustment or careful selection of non-interacting drugs. In select cases, severe and unpredictable drug interactions can occur. Clinicians should consult hepatitis C virus pharmacotherapy experts and tertiary drug interaction resources when initiating DAA therapy in patients taking other medications.

01 Dec 2019·Virology journalQ3 · MEDICINE

Sofosbuvir-based regimen is safe and effective for hepatitis C infected patients with stage 4–5 chronic kidney disease: a systematic review and meta-analysis

Q3 · MEDICINE

ReviewOA

Author: Li, Yi ; Li, Mingshu ; Chen, Jun ; Fang, Zhixiong ; Lin, Qian

BACKGROUND:

Whether sofosbuvir is suitable for hepatitis C virus (HCV) infected patients with severe renal impairment is inconclusive. This systematic review aims to evaluate the safety and effectiveness of SOF-based regimen in the setting of stage 4 and 5 chronic kidney disease (CKD).

METHODS:

We conducted a systematic literature search in PubMed, Web of Science, EMBASE and Google Scholar with searching strategy: (sofosbuvir OR Sovaldi OR Harvoni OR Epclusa OR Vosevi) AND (severe kidney impairment OR severe renal impairment OR end-stage renal disease OR dialysis OR renal failure OR ESRD OR renal insufficiency OR hepatorenal syndrome OR HRS). Sustained virological response (SVR12/24) rate and serious adverse event (SAE) rate with 95% confidence intervals were aggregated. Subgroup analysis was implemented to evaluate the impact of treatment strategy and patient characteristics.

RESULTS:

Twenty-one studies met inclusion criteria, totaling 717 HCV infected patients with CKD stage 4 or 5 (58.4% on dialysis). Pooled SVR12/24 was 97.1% (95% CI 93.9-99.3%), and SAE rate was 4.8% (95% CI 2.1-10.3%). There was no significant difference at SVR12/24 (97.1% vs 96.2%, p = 0.72) or SAE rate (8.8% vs 2.9%, p = 0.13) between subgroups applying full or decreased dose of sofosbuvir. Cirrhotic and non-cirrhotic patients achieved comparable sustained virological response (RR 0.93, 95% CI 0.85-1.02). Four studies reported eGFR/serum creatinine pre- and post- treatment, with no significant modification.

CONCLUSIONS:

Our study suggests SOF-based regimen might be used safely and effectively in patients living with HCV infection/stage 4-5 CKD, with normal and reduced dose of sofosbuvir. Prospective and well-controlled trials are needed to confirm these findings.

TRIAL REGISTRATION:

PROSPERO CRD42018107440 .

01 Aug 2019·Bioorganic & medicinal chemistry lettersQ4 · MEDICINE

Discovery of the pan-genotypic hepatitis C virus NS3/4A protease inhibitor voxilaprevir (GS-9857): A component of Vosevi®

Q4 · MEDICINE

Article

Author: Taylor, James G ; Katana, Ashley ; Link, John O ; Kobayashi, Tetsuya ; Wang, Yujin ; Karki, Kapil K ; Villaseñor, Armando G ; Siegel, Dustin ; Sangi, Michael ; Cheng, Guofeng ; Yang, Zheng-Yu ; Vivian, Randy ; Yang, Cheng Y ; Martinez, Ruben ; Ramey, Kyla ; Zablocki, Jeff ; Barauskas, Ona ; Wang, Kelly ; Jin, Debi ; Appleby, Todd ; Zipfel, Sheila ; Schrier, Adam ; Schultz, Brian E ; Kato, Darryl ; Tran, Chinh V ; Chan, Katie

Treatment of hepatitis C virus (HCV) infection has been historically challenging due the high viral genetic complexity wherein there are eight distinct genotypes and at least 86 viral subtypes. While HCV NS3/4A protease inhibitors are an established treatment option for genotype 1 infection, limited coverage of genotypes 2 and/or 3 combined with serum alanine transaminase (ALT) elevations for some compounds has limited the broad utility of this therapeutic class. Our discovery efforts were focused on identifying an NS3/4A protease inhibitor with pan-genotypic antiviral activity, improved coverage of resistance associated substitutions, and a decreased risk of hepatotoxicity. Towards this goal, distinct interactions with the conserved catalytic triad of the NS3/4A protease were identified that improved genotype 3 antiviral activity. We further discovered that protein adduct formation strongly correlated with clinical ALT elevation for this therapeutic class. Improving metabolic stability and decreasing protein adduct formation through structural modifications ultimately resulted in voxilaprevir. Voxilaprevir, in combination with sofosbuvir and velpatasvir, has demonstrated pan-genotypic antiviral clinical activity. Furthermore, hepatotoxicity was not observed in Phase 3 clinical trials with voxilaprevir, consistent with our design strategy. Vosevi^® (sofosbuvir, velpatasvir, and voxilaprevir) is now an approved pan-genotypic treatment option for the most difficult-to-cure individuals who have previously failed direct acting antiviral therapy.

News (Medical) associated with Sofosbuvir/velpatasvir/voxilaprevi

13 Jul 2022

·www.biospace.com

Global Roundup: Nucana Wins Patent Dispute Against Gilead in German Court

Scotland-based NuCana plc picked up a patent infringement win in a European court against Gilead Sciences. The Regional Court of Dusseldorf ruled that several drug products of Gilead Sciences Ireland UC and Gilead Sciences GmbH, including hepatitis drugs Sovaldi and Harvoni, infringed on Nucana's composition of matter claims in Germany. For Nucana, the legal judgment has been nearly 20 years in the making. In 2003, Nucana filed a patent infringement claim regarding European Patent 2955190 related to "a small group of phosphoramidate nucleotides" that includes sofosbuvir, the active ingredient of Sovaldi. Sofosbuvir is also used in the combination drugs Harvoni, Vosevi and Epclusa. Nucana noted in its announcement that the nucleotides were invented by Chris McGuigan and preceded the first filing data for Gilead Sciences' Sovaldi patent "by several years." The decision of the Germany-based court applies only to Germany, and Gilead may appeal the decision. Last year, Gilead Sciences attempted to challenge the Nucana patent claim in the German court, but that was rejected. Nucana noted that last year, Gilead Sciences filed a lawsuit against the company in the United Kingdom Patent Court, seeking to revoke the designation for the 2955190 patent in that country. Nucana filed a counterclaim, and the proceedings in the U.K. are ongoing. Elsewhere around the globe: MediWound – Israel-based MediWound Ltd. announced positive initial data from 11 patients in its ongoing open-label Phase I/II study of MW005 for the treatment of low-risk Basal Cell Carcinoma (BCC). Initial data showed that MW005 is safe and well-tolerated. Also, MediWound noted that most of the patients who completed the study achieved complete histological clearance of their target lesions following treatment with MW005. The company anticipates announcing the final data in the second half of 2022. Iterum Therapeutics – Ireland's Iterum Therapeutics announced an agreement with the U.S. Food and Drug Administration under the special protocol assessment process for a Phase III trial evaluating oral sulopenem etzadroxil-probenecid for the treatment of uncomplicated urinary tract infections. The company said the SPA agreement provides that the design and planned analysis of the trial, as set out in the protocol submitted to the FDA. The primary endpoint of the study is the overall response after 12 days. The study is expected to enroll approximately 1,966 patients and is anticipated to start enrolling in the fourth quarter of this year. Medtronic plc – Also based in Ireland, Medtronic entered into a partnership agreement with Israel's CathWorks in order to advance the understanding of how coronary artery disease (CAD) is diagnosed and treated. Fractional flow reserve (FFR) is a diagnostic technique that evaluates the physiologic impact of coronary artery stenosis. Medtronic will invest up to $75 million and immediately begin co-promotion of CathWorks' FFRangio System in the U.S., Europe and Japan, where it is commercially available. FFRangio has shown diagnostic accuracy of 93%, sensitivity of 91%, and specificity of 94%. This non-invasive technology has the potential to disrupt and expand traditional FFR segments. As part of a separate agreement, Medtronic will have the option to acquire CathWorks once certain undisclosed milestones are met. The acquisition option agreement will expire in July 2027. Quotient Limited – Based in Jersey, Channel Islands, Quotient Limited reached an agreement with InfYnity Biomarkers to partner on the development of an infectious disease testing platform. Under the collaboration agreement, InfYnity Biomarkers will assist Quotient in researching and designing infectious disease assays to enrich and expand the Quotient MosaiQ Serology Disease Screening menu. InfYnity is developing antibodies and antigens suitable for multiplexed infectious disease blood screening, confirmatory testing, determining vaccine efficacy, and monitoring testing that will be evaluated as part of the research collaboration. Cyxone – Sweden's Cyxone received a response from a Type B meeting with the FDA regarding an upcoming study of rabeximod, a potential treatment for rheumatoid arthritis. The FDA response allows Cyxone to continue planning the phase IIb study. The aim of the study is to confirm the therapeutic efficacy of Rabeximod in this patient population, as well as to expand the safety data documentation. CQDM – The Quebec Breast Cancer Foundation and Theratechnologies secured a $2 million placement that will be used to finance a collaborative research project that intends to demonstrate the "efficacy and safety of a potential innovative treatment" for patients affected by metastatic cancer. Today's announcement will allow Theratechnologies, a Montreal-based company, to further evaluate the potential of TH1902, a peptide-drug conjugate. Granite Bio – Switzerland-based Granite Bio closed a Master Services Agreement with Germany's ProBioGen. The agreement supports the development of Granite Bio's mAb pipeline. Granite Bio's lead candidate is a novel monoclonal antibody for the treatment of autoimmune and certain cancer indications. Longenesis – Based in Latvia, Longenesis announced preliminary results from its study on Type 1 Diabetes care in partnership with Medtronic. The study found that insulin pump use supports a higher quality of life. Data evaluated the efficiency of local reimbursement policies for insulin pumps and glucose monitors. HutchMed – Hong Kong's HutchMed announced it will present the first data from the ongoing Phase II SAVANNAH trial at the International Association for the Study of Lung Cancer in Austria next month. The study is evaluating the combination of savolitinib with AstraZeneca's Tagrisso in epidermal growth factor receptor-mutated non-small cell lung cancer patients with mesenchymal-epithelial transition receptor driven tumors, following disease progression on treatment with Tagrisso. Zai Lab Limited – Based in China, Zai Lab announced that China's National Medical Products Administration accepted the Biologics License Application for efgartigimod alfa injection, a first-in-class neonatal Fc receptor antagonist, for the treatment of adult patients with generalized myasthenia gravis.

CollaborateAntibodyFirst in ClassVaccineAcquisition

28 Jun 2022

·www.globenewswire.com

Hepion Pharmaceuticals Further Strengthens Board with Appointments of Accomplished Biopharmaceutical Executives, Mr. Anand Reddi and Dr. Kaouthar Lbiati

EDISON, N.J., June 28, 2022 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical mid-stage biopharmaceutical company focused on Artificial Intelligence (“AI”)-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis (“NASH”) and hepatocellular carcinoma (“HCC”), today announced the appointments of Anand Reddi, M.S., and Kaouthar Lbiati, M.D., to its Board of Directors, effective immediately. “We are thrilled to welcome individuals of this caliber to our Board,” said Hepion’s Chairman, Gary S. Jacob, Ph.D. “Mr. Reddi and Dr. Lbiati have a remarkable wealth of experience across all aspects of drug development, from clinical research to medical affairs, marketing, market access and patient advocacy. Their combined expertise comes at an opportune time, as we are in final preparations to advance our lead drug candidate, rencofilstat, into three Phase 2 clinical trials, and are beginning to actively explore partnering and licensing opportunities for this liver-targeting, orally administered, novel cyclophilin inhibitor.” Appointment of Anand Reddi Mr. Reddi has an accomplished history, spanning a variety of activities including corporate strategy, strategic partnerships, R&D strategy, investor relations, corporate affairs, medical affairs, international commercial operations, global marketing, market access and patient advocacy during his time in the global biopharmaceutical industry. He is currently Vice President of Corporate Strategy and External Affairs & Engagement, as well as Chief of Staff at Adverum Biotechnologies, a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases. Prior to joining Adverum, Mr. Reddi held strategic and operational leadership positions of increasing responsibility during his seven-year career at Gilead Sciences, most recently serving as Director and Head, Digital Innovation Customer Engagement. At Gilead, Mr. Reddi was instrumental in establishing international access and emerging markets initiatives in over 140 countries for the HIV medicines Truvada®, Descovy®, Genvoya® and Biktarvy®; hepatitis B treatments Viread® and Vemlidy®; and the hepatitis C cures Sovaldi®, Harvoni®, Epclusa® and Vosevi®; resulting in over 20 million patients with access to these treatments in resource limited settings. Previously, he was active in HIV/AIDS global health policy, basic science and clinical research focused on bone tissue engineering, and skin cancer metastasis and signal transduction. Mr. Reddi has authored or co-authored more than 20 peer-reviewed articles in scientific journals such as Science, Nature Biotechnology, JAMA Pediatrics, and AIDS; written op-eds for several major media outlets, such as The Washington Post and The New York Times; and is a featured blogger on The Huffington Post. He holds a Master of Science degree from the University of Colorado School of Medicine, where he studied medicine. He received a Bachelor of Arts degree in history and a Bachelor of Science degree in biology from the University of Michigan. In addition, Mr. Reddi has the distinction of serving as a J. William Fulbright Scholar in South Africa. Mr. Reddi commented, “I am honored to join the Hepion Board particularly as the Company is at the stage where its clinical program is maturing, and its activities are increasingly encompassing those areas of interest I believe I will be able to most impact. What excites me most about Hepion is the great potential of the Company’s lead drug to benefit the millions of people suffering from chronic liver disease, including NASH and HCC. I believe my extensive experience in biopharma strategy and operations, as well as dealing with global public health issues, will make an impact as we move forward with the development of rencofilstat as a potential transformational medicine and bring value to patients, physicians, and health care systems.” Appointment of Dr. Kaouthar Lbiati Dr. Lbiati is a multi-functional executive with a combination of scientific, business, finance, global health policy, and health economics skills. She is currently Vice President, Strategy & Corporate Development at Cytovia Therapeutics, a biopharmaceutical company specializing in immuno-oncology and cell therapies. Dr. Lbiati previously served in global and regional leadership roles at Amgen, Glaxo Smith Kline, and Sanofi, where she supported the registration, launch and/or indication extension and reimbursement of three innovative cancer drugs – Blincyto®, Jevtana® and Votrient® – in the U.S., EU and MENA regions, with a focus on global medical affairs; strategic planning, health economics and outcomes research; and market access across multiple countries. Most recently, Dr. Lbiati has served as a strategic advisor to several biotech companies and venture capital firms. She headed the portfolio strategy at Steba Biotech (a radio-pharmaceutical and oncology company); served as a medical technology investment consultant to Forepont Capital Partners; and was Director, Strategic Market Access at Amaris, a global pharmaceutical consulting company. Dr. Lbiati received a Doctor of Medicine degree from Rabat, Morocco’s Mohammed V University, a fellowship in oncology from the Gustave Roussy Institute in Paris, a Specialized Executive Master’s degree in Strategy & Management from ESSEC Business School in Paris, and a Master of Science in International Policy and Health Economics from the London School of Economics. “I am pleased to be joining the Hepion Board at this momentous time, as I believe Hepion’s rencofilstat has the potential to become an important new treatment for NASH and HCC, and the Company is in the midst of preparing this promising candidate for Phase 2 trials in both indications,” commented Dr. Lbiati. “One of the key elements as the Company moves forward with further clinical development of rencofilstat will involve strategic issues that have been a keen interest of mine throughout my career. I look forward to contributing to the work of the Board and Hepion’s pioneering management team as we continue to advance rencofilstat’s development program.” About Hepion Pharmaceuticals The Company's lead drug candidate, rencofilstat, is a potent inhibitor of cyclophilins which are involved in many disease processes. Rencofilstat is currently in clinical-phase development for the treatment of NASH, with the potential to impact the overall course of disease at various stages, from triggering events through to end-stage disease. Rencofilstat has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH, and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms in nonclinical studies. In November 2021, the U.S. Food and Drug Administration (“FDA”) granted Fast Track designation for rencofilstat for the treatment of NASH. That was soon followed in December 2021 by the FDA’s acceptance of Hepion’s investigational new drug (IND) application for rencofilstat for the treatment of hepatocellular carcinoma (HCC). In June 2022, rencofilstat was granted Orphan Drug designation by the FDA for the treatment of HCC. Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to rencofilstat, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion intends to use the platform to identify additional potential indications for rencofilstat to expand the company's footprint in the cyclophilin inhibition therapeutic space. Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimated,” and “intend,” among others. These forward-looking statements are based on Hepion Pharmaceuticals’ current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals’ Form 10-K for the year ended December 31, 2021, and other periodic reports filed with the Securities and Exchange Commission. For further information, please contact: Stephen KilmerHepion Pharmaceuticals Investor RelationsDirect: (646) 274-3580skilmer@hepionpharma.com

Gene TherapyOrphan DrugCell TherapyFast Track

100 Deals associated with Sofosbuvir/velpatasvir/voxilaprevi

External Link

KEGG	Wiki	ATC	Drug Bank
-	Sofosbuvir/velpatasvir/voxilaprevi	J05A	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatitis C	CN	Gilead Sciences Ireland UC	03 Dec 2019
Hepatitis C, Chronic	US	Gilead Sciences, Inc.	18 Jul 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic hepatitis C genotype 3	Phase 3	US	Gilead Sciences, Inc.	23 Dec 2015
Chronic hepatitis C genotype 3	Phase 3	AU	Gilead Sciences, Inc.	23 Dec 2015
Chronic hepatitis C genotype 3	Phase 3	CA	Gilead Sciences, Inc.	23 Dec 2015
Chronic hepatitis C genotype 3	Phase 3	FR	Gilead Sciences, Inc.	23 Dec 2015
Chronic hepatitis C genotype 3	Phase 3	DE	Gilead Sciences, Inc.	23 Dec 2015
Chronic hepatitis C genotype 3	Phase 3	NZ	Gilead Sciences, Inc.	23 Dec 2015
Chronic hepatitis C genotype 3	Phase 3	PR	Gilead Sciences, Inc.	23 Dec 2015
Chronic hepatitis C genotype 3	Phase 3	GB	Gilead Sciences, Inc.	23 Dec 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04211909 (CTgov)	Phase 3	Hepatitis C, Chronic	87	SOF/VEL (SOF/VEL)	hpuucypgyb(ocrkjrczkk) = qtccutqead cwkkhruiua (tckoefzoqa, frioekoaie - bnjdaivffh) View more	-	27 Oct 2021
				SOF/VEL/VOX (SOF/VEL/VOX)	hpuucypgyb(ocrkjrczkk) = xcbioxnvqn cwkkhruiua (tckoefzoqa, plmfsvveuc - odslkxdwrh) View more
NCT03619837 (PRO-ACT:, CTgov)	Phase 4	Hepatitis C	122	Sofosbuvir/Velpatasvir+Sofosbuvir/Velpatasvir/Voxilaprevir	vvorkfesty(jtpbnedbvw) = adlloikmfc byejwnvlti (orxwkwdmfu, gisxtbglck - sedkbcrloo) View more	-	03 Mar 2021
NCT02938013 (deLIVER, CTgov)	Phase 4	HIV Infections \| Hepatitis C	15	Sofosbuvir/Velpatasvir/Voxilaprevir [SOF/VEL/VOX] (Group A)	ttgdpcsdac(hpslfpnmqs) = gqhvzxxiry uxcohcxywf (opkpjtitei, nesqsbuhmv - vsmerjxzeb) View more	-	16 Nov 2020
				Sofosbuvir/Velpatasvir (SOF/VEL) (Group B)	ttgdpcsdac(hpslfpnmqs) = lncfoukjwm uxcohcxywf (opkpjtitei, rzycrcbzdb - aqrrsxjbzm) View more
NCT03820258 (CTgov)	Phase 2	Hepatitis C, Chronic	21	SOF+VEL+VOX	owzipyatji(vvxvwilxgv) = ikmwohovqh qnjehvqmww (tbkffqgfoc, japevahzfm - hbhcfasljk) View more	-	31 Aug 2020
NCT03118843 (CTgov)	Phase 3	Hepatitis C	31	SOF/VEL/VOX	ogrzbolofp(jdffefknjo) = ezlmxbcnwb fhrfpwtuul (wccgghikyz, krqmjxbfqj - ahtcegjhml) View more	-	03 Apr 2019
NCT02745535 (RESOLVE, CTgov)	Phase 2	Hepatitis C, Chronic	77	Sofosbuvir/Velpatasvir/Voxilaprevir	matlxngngg(unlyynntfv) = jabxvlenle jgdaguzfjn (yohpgcrrdp, lorhlmjqqj - jgighvazmh) View more	-	27 Mar 2019
NCT02607735 (POLARIS-1, CTgov)	Phase 3	Hepatitis C, Chronic	416	SOF/VEL/VOX (SOF/VEL/VOX (Primary Study))	beizhgmyxy(nyuzehzgwp) = yakjtvipow ysqcxzitck (qmtzspoypv, keqqfsqguu - guwajnyhak) View more	-	13 Dec 2017
				Placebo (Placebo (Primary Study))	xkikxazaoo(kpwyqpvmml) = yvwbzinqpx qrqqlxbdix (sersqsdozy, htxgnigqwi - jyvmeutqqk) View more
NCT02639338 (POLARIS-3, CTgov)	Phase 3	Chronic hepatitis C genotype 3	220	SOF+VEL+VOX (SOF/VEL/VOX 8 Weeks)	lqvbtyyiig(nmwlqfwhnv) = vnjtetelwl wgttbgogry (wwzvyjqxou, thjdvgmbhp - nwcnhyqcvp) View more	-	14 Nov 2017
				SOF+VEL (SOF/VEL 12 Weeks)	lqvbtyyiig(nmwlqfwhnv) = ghsnfkbker wgttbgogry (wwzvyjqxou, qcdjhrlaei - dvjvmexnts) View more
NCT02607800 (POLARIS-2, CTgov)	Phase 3	Hepatitis C, Chronic	943	SOF/VEL	irdnlrphgj(ptgdignmjz) = nrgvhlvfic vrfqzusgef (jobfugslzy, dawhqznqnw - mjjzqfoows) View more	-	08 Nov 2017
NCT02639247 (POLARIS-4, CTgov)	Phase 3	Hepatitis C, Chronic	333	SOF+VEL+VOX (SOF/VEL/VOX 12 Weeks)	bmiahqopfs(tvqipekrol) = igjxwnlviy rcudvsssra (vzwtimyuvy, krchyeehuk - kfeknoyxjw) View more	-	06 Nov 2017
				SOF+VEL (SOF/VEL 12 Weeks)	bmiahqopfs(tvqipekrol) = bwxasmzbfb rcudvsssra (vzwtimyuvy, tevcnpuotw - emazlfowlj) View more

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