HIV-1 pol inhibitors(Human immunodeficiency virus type 1 protease inhibitors), NS3/NS4A inhibitors(Hepatitis C virus serine protease, NS3/NS4A inhibitors), NS5A inhibitors(Nonstructural protein 5A inhibitors)

Therapeutic Areas

Infectious DiseasesDigestive System Disorders

Active Indication

Chronic hepatitis C genotype 1

Inactive Indication

Chronic hepatitis C genotype 1bChronic hepatitis C genotype 2Compensated cirrhosis+ [5]

Originator Organization

AbbVie, Inc.

Active Organization

AbbVie Biotherapeutics, Inc.

Inactive Organization

AbbVie, Inc.AbbVie Deutschland GmbH & Co. KG

Drug Highest PhaseApproved

First Approval Date

European Union (14 Jan 2015),

Hepatitis C, Chronic

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

Structure/Sequence

Molecular FormulaC37H48N6O5S2

InChIKeyNCDNCNXCDXHOMX-XGKFQTDJSA-N

CAS Registry155213-67-5

View All Structures (3)

Clinical Trials associated with Ombitasvir/Paritaprevir/Ritonavir

NCT03499639

/ CompletedPhase 4IIT

Efficacy and Safety of Ombitasvir/ Paritaprevir / Ritonavir Plus Ribavirin in Management HCV Genotype 4 and End-stage Kidney Disease With or Without Hemodialysis (An Open Label- Multicenter Prospective Study)

Management of patients with hepatitis C virus (HCV) related liver disease with concomitant co-morbidity was challenging, especially in the period before the era of new direct-acting antiviral (DAA) agents. With the introduction of DAAs protocols, the therapeutic options were expanded to endorse many patients that were previously assigned as difficult-to-treat population. Different situations were encountered with co-infection with HCV such as chronic kidney disease (CKD) with its spectrum from mild forms to the end-stage kidney disease (ESKD), patients on hemodialysis (HD), and in post-renal transplant settings. Till now, pooled data about the safety and efficacy of different DAAs regimens in different renal situations are still under evaluation, especially in Egypt, where HCV genotype 4 the most dominating genotype. In Egypt, there were two adopted protocols for patients with HCV and CKD; the sofosbuvir-based combinations and the ombitasvir, paritaprevir, and ritonavir plus ribavirin-based combination. Sofosbuvir was proved to be contraindicated in patients with end-stage renal diseases as its elimination based mainly on renal route that may affect its bioavailability. On the other hand, ombitasvir, paritaprevir, and ritonavir plus ribavirin regimen was proved to be a well-tolerated protocol in non-cirrhotic patients with CKD.

Start Date01 May 2018

Sponsor / Collaborator

Assiut University

[+2]

NCT03549832

/ CompletedNot ApplicableIIT

Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin Versus Sofosbuvir /Ombitasvir/ Paritaprevir /Ritonavir/Ribavirin in the Management of Hepatitis C Patients Fauilre to Prior Sofosbuvir/ Daclatasvir (An Open-labeled Randomized Trial)

Now many cases reported failure to HCV treatment with Sofosbuvir/ Daclatasvir. retreat those patients is challenging. So, we aimed to Study the efficacy and safety of Sofosbuvir /Simeprevir/ Daclatasvir/Ribavirin versus Sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis C patients who failed to prior Sofosbuvir/ Daclatasvir regimens in an open-labeled randomized trial.

Start Date01 Jan 2018

Sponsor / Collaborator

Assiut University

[+2]

NCT03341988

/ CompletedPhase 1IIT

Evaluation of the Clinical Effects of Ombitasvir/Paritaprevir/Ritonavir Regimen in the Treatment of Chronic HCV Patients in CKD Versus ESRD Patients in Assiut University Hospital

To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected patients in those with CKD versus ESRD in Assiut Hospital University .
Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD versus ESRD in Assiut Hospital.

Start Date22 Nov 2017

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Ombitasvir/Paritaprevir/Ritonavir

100 Translational Medicine associated with Ombitasvir/Paritaprevir/Ritonavir

100 Patents (Medical) associated with Ombitasvir/Paritaprevir/Ritonavir

Literatures (Medical) associated with Ombitasvir/Paritaprevir/Ritonavir

01 Sep 2023·Therapeutic innovation & regulatory science

Evaluation of the Safety Profile of Direct-Acting Antivirals on Patients with Hepatitis C Virus: A Pharmacovigilance Study.

Review

Author: Sabri, Nagwa A ; Solayman, Mohamed H ; El-Marakby, Mai G

BACKGROUND:

Hepatitis C virus (HCV) is the primary contributor to chronic hepatic diseases. A rapid change in the situation took place with the advent of oral direct-acting antivirals (DAAs). However, a comprehensive review of the adverse event (AE) profile of the DAAs is lacking. This cross-sectional study aimed to analyze the reported Adverse Drug Reactions (ADRs) with DAA treatment using data from VigiBase, the WHO Individual Case Safety Report (ICSR) database.

METHODS:

All ICSRs reported to VigiBase with sofosbuvir (SOF), daclatasvir (DCV), sofosbuvir /ledipasvir (SOF/LDV) and ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in Egypt were extracted. Descriptive analysis was performed to summarize patients' and reactions' characteristics. Information components (ICs) and proportional reporting ratios (PRRs) for all reported ADRs were calculated to identify signals of disproportionate reporting. Logistic regression analysis was performed to identify the DAAs association with serious events of concern while adjusting for age, gender, pre-existing cirrhosis, and ribavirin use.

RESULTS:

Out of 2925 reports, 1131 (38.6%) were serious. The most commonly reported reactions; anaemia (21.3%), HCV relapse (14.5%) and headache (14%). For the disproportionality signals; HCV relapse was reported with SOF/DCV (IC 3.65, 95% CrI 3.47-3.79) and SOF/RBV (IC 3.69, 95% CrI 3.37-3.92), while anaemia (IC 2.85, 95% CrI 2.26-3.27) and renal impairment (IC 2.12, 95% CrI 0.7-3.03) were reported with OBV/PTV/r.

CONCLUSION:

The highest severity index and seriousness were reported with SOF/RBV regimen. A significant association was found for OBV/PTV/r with renal impairment and anaemia although being the superior regimen in terms of efficacy. The study findings call for further population-based studies for clinical validation.

01 Oct 2022·Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society

The effectiveness and safety of direct-acting antivirals for hepatitis C virus treatment: A single-center experience in Saudi Arabia

Article

Author: Alotaibi, Anfal ; Alzahrani, Abdullah ; Almutairi, Malak ; Alhomaid, Njood ; Korayem, Ghazwa B ; Alharthi, Noori ; Alghamdi, Abdullah ; Hakami, Mashael ; Alarfaj, Sumaiah J

Background:

The introduction of direct-acting antivirals (DAA) to treat the hepatitis C virus (HCV) overcame many drawbacks of interferon-based therapy. DAA achieved sustained viral response (SVR) rates above 90% and overcame many drawbacks of pegylated interferon regimens.The HCV genotype (GT) distribution varies by geographical area, with GT-4 being most prevalent in the Middle East region, including Saudi Arabia. Yet, the real-world evidence about using DAAs in the Saudi population is limited.Thus, the aim of this study to investigate the effectiveness and safety of DAAs in Saudi patients with HCV infection.

Methods:

A retrospective cohort study included patients treated with DAAs from 2015 to 2017 at a tertiary care hospital in Riyadh, Saudi Arabia. All patients with HCV treated with either ledipasvir plus sofosbuvir (LDS/SOF) ± ribavarin (RBV) or ombitasvir-paritaprevir-ritonavir (OBV/PTV/r) ± dasabuvir (DSV) ± RBV were included. Using a per-protocol analysis, the effectiveness outcome was the end-of-treatment response (EOTr) and Sustained virologic reponce12 weeks after competing the regimen (SVR12). The secondary safety outcome was the adverse event related to the therapy reported by the patients.

Results:

A total of 97 patients were included; with the majority infected with GT-4 (64 %), followed by GT-1 (18 %), in addition to 8 % having a mixed GT (1 + 4). The EOTr and SVR12 rates were 98 % and 96 %, respectively. SVR12 was 94.4 % within the LDS/SOF ± RBV group and 97.7 % within the OBV/PTV/r ± DSV ± RBV group. Only 4 % had a response failure due to relapse or breakthrough, and all were infected with mixed GT1 + 4. Medications were well tolerated with minimal side effects, including vomiting, nausea, and weakness.

Conclusion:

DAAs regimens are associated with high rates of SVR12 and are well tolerated with a good safety profile in Saudi HCV-infected patients.

01 Jan 2022·In vivo (Athens, Greece)Q4 · MEDICINE

Glycemic Control in Patients Undergoing Treatment With Paritaprevir/Ombitasvir/Ritonavir and Dasabuvir for Chronic Hepatitis C Infection

Q4 · MEDICINE

Article

Author: Toma, Radu Valeriu ; Toma, Letitia ; Zgura, Anca ; Ifrim, Chen-Peng ; Iliescu, Laura ; Bacinschi, Xenia ; Mercan-Stanciu, Adriana ; Diaconu, Camelia ; Bacalbasa, Nicolae

BACKGROUND/AIM:

Patients with hepatitis C virus (HCV)-associated cirrhosis are more prone to developing type 2 diabetes mellitus than patients with any other etiology of cirrhosis. The main objective of this study was to evaluate the impact of all oral antiviral treatment with ritonavir-boosted paritaprevir/ombitasvir and dasabuvir (OBV/PTV/r + DSV) in patients with chronic genotype 1b HCV infection.

PATIENTS AND METHODS:

We retrospectively evaluated 806 patients who underwent antiviral therapy between December 2015 and July 2019. The laboratory data analyzed were liver function tests, kidney function tests, HCV viremia, fasting glucose levels, and glycosylated hemoglobin.

RESULTS:

Patients with impaired glucose metabolism were predominantly male and of older age compared to patients with normal glucose tolerance, and also had higher levels of transaminases. Proteinuria and higher creatinine levels were found in patients with impaired glucose metabolism. Overall, we found a 98.01% rate of sustained virologic response (SVR), with a non-significant difference between patients with normal and abnormal glucose metabolism. A statistically significant difference in SVR rates in patients with low degrees of fibrosis (F0-F2) versus those with advanced degrees of fibrosis (F3-F4) was found in both groups. Antiviral treatment resulted in significant decreases in fasting glucose levels and glycosylated hemoglobin levels in all patients with impaired glucose metabolism at SVR.

CONCLUSION:

Patients with pre-diabetes, as well as diabetic patients, achieved a better glycemic control after SVR obtained by ritonavir-boosted paritaprevir/ombitasvir and dasabuvir.

News (Medical) associated with Ombitasvir/Paritaprevir/Ritonavir

21 Sep 2023

·www.biospace.com

Bluejay Therapeutics expands management team and hired Christopher Holterhoff as senior Vice President, head of business development

SAN MATEO, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Bluejay Therapeutics, Inc. a private clinical stage biopharmaceutical company focused on viral and liver diseases, today announced the appointment of Christopher Holterhoff as Senior Vice President, Head of Business Development. Mr. Holterhoff will lead Bluejay’s business and corporate development function and will play a significant role in Bluejay’s corporate strategy and strategic planning activities. He will be a member of Bluejay’s Executive team, reporting to Keting Chu, Founder and CEO of Bluejay Therapeutics. “I am delighted to welcome Chris to the senior leadership team at Bluejay”, stated Mrs. Chu. “Chris has an outstanding track record in business & corporate development with both public and private biotech and pharma companies. His business development experience, as well as his strategic aptitude will play a critical role as we execute on our vision of building a leading biotechnology company focused on curative treatments for serious viral and liver diseases.” “Bluejay is extremely well-positioned with a pipeline of first-in-class or best-in-class treatment options addressing serious and highly prevalent viral and liver diseases where there exists substantial unmet medical need. I am thrilled to join the organization at such a pivotal time in its development, and I look forward to working with Bluejay’s exceptional team and leveraging my experience in business development to advance the company’s promising pipeline toward approval for patients who are in dire need of new treatment options.” Mr. Holterhoff has nearly two decades of diverse experience encompassing business & corporate development, corporate finance & strategy, and capital markets. Before joining Bluejay, he served as VP, Business & Corporate development at LEXEO Therapeutics, where he led all business development, strategic transactions and played a significant role in the company’s capital raising activities. Prior to LEXEO, Mr. Holterhoff served as executive director of business development at Amicus Therapeutics where he executed on new strategic business opportunities for Amicus’ gene therapy pipeline, including license agreements, M&A transactions, and R&D collaborations, and led the alliance management function. Earlier in his career, he worked in healthcare investment banking at MTS Health Partners, where he advised public and private biotechnology and pharmaceutical companies on strategic buy and sell side transactions and financings and served as a senior publishing equity research analyst at Oppenheimer & Co. Inc., providing coverage of biotechnology and pharmaceutical companies. Mr. Holterhoff holds an MBA from Columbia University, MS in Biotechnology from Georgetown University, and BS from Providence College. Mr. Holterhoff joins a seasoned executive leadership team, including: Keting Chu, M.D., Ph.D., founder and chief executive officer, was previously a partner at LYFE Capital and venture partner at Apple Tree Partners, and was responsible for venture philanthropy at The Leukemia and Lymphoma Society. Dr. Chu was also the CEO of several companies, including Mission Therapeutics, DigitAB, and BioCubed Corporation. Earlier in her career, she held R&D leadership roles at Five Prime Therapeutics and Chiron Corporation. Hassan Javanbakht, Ph.D., chief scientific officer, was previously at Hoffman La-Roche, Gilead sciences and SQZ biotechnologies where he worked on developing novel antivirals and immunomodulators to treat HIV, HBV, influenza and other infectious diseases. He was part of the team that advanced Elipida® (RO4970335), a potent and highly selective NNRTI, into clinical development . He led the teams that developed a first-in-class small-molecule viral expression inhibitor (RG7834) and a liver-targeted anti-HBV locked nucleic acid (RG6004). His work also led to discovery of PAPD5/7 as host factors for HBV expression. He has authored more than 45 peer-reviewed scientific publications in high-impact journals and holds more than 11 issued patents and applications. Nancy Shulman, M.D., CMO, has over 20 years of clinical development experience including at Roche, Genentech, AbbVie, and most recently at Ambys Medicines, where she was the vice president of translational medicine. She brings broad clinical development experience ranging from first-in-human and translational studies through Phase 4 studies, including extensive experience in the virology/hepatology disease area, but also in immunology and oncology. She has been a part of multiple INDs and was a key leader on the NDA approvals of the HCV antivirals Viekira Pak®, Viekirax®, and Mavyret®. Kevin Lin, M.D., vice president of development, has over 30 years of experience in the biotechnology industry in the areas of process development, technology transfer, scale up, troubleshooting, GMP manufacturing, and CMC regulatory submission. He has worked at several biotech companies, such as Bayer Healthcare, Catalant, Avid Bioservices, ImmunityBio, and Kindred Biosciences. Jeff Zablocki, Ph.D., vice president of chemistry, has led chemistry teams at AbbVie, Gilead, CV Therapeutics, Amgen, and Searle. Dr. Zablocki has discovered 15 development compounds including 3 approved agents: Lexiscan™ – an adenosine A2A agonist used in over 60 million patients as a pharmacological stress agent capturing a large market share; Ranexa™ for stable angina; and Voxilaprevir™ for Hepatitis C where he helped address pre-clinical metabolism challenges by applying novel medicinal chemistry approaches. About Bluejay Therapeutics Bluejay Therapeutics is a clinical stage private biopharmaceutical company committed to developing effective treatments and cures for viral and liver diseases ( ). Its initial target indications are CHB and CHD, diseases that have a global prevalence and an urgent need for improved medical solutions. Bluejay is advancing two potential therapeutic approaches: best-in-class fully human IgG1 anti-HBs monoclonal antibodies and orally liver-targeted HBV transcript inhibitors. The company has developed a platform for liver-directed drug targeting, with potential applications to multiple therapeutic agents. For more information on potential collaborations with Bluejay Therapeutics regarding partnering opportunities or preclinical or clinical research programs, please contact us at info@bluejaytx.com.

Executive Change

08 Feb 2023

·www.biospace.com

Infectious disease specialist Dr. Regis A. Vilchez is appointed CMO of MicuRx Pharmaceuticals, Inc.

SHANGHAI, Feb. 8, 2023 /PRNewswire/ -- Shanghai MicuRx Pharmaceutical Co., Ltd. ("MicuRx," 688373) announced recently that it has appointed Regis A. Vilchez, MD, PhD, an experienced R&D biopharmaceutical executive and infectious disease expert, as Chief Medical Officer of its American subsidiary, MicuRx Pharmaceuticals, Inc. He oversees new drug development programs and clinical activities in the United States, Europe and other regions. Dr. Vilchez earned an M.D. from the Universidad Autónoma de Centro América in Costa Rica and a Ph.D. from Baylor College of Medicine in Houston, Texas, the United States. He completed an internal medicine residency at Robert Wood Johnson Medical School, a clinical infectious diseases fellowship at the University of Pittsburgh, and a molecular virology fellowship at Baylor College of Medicine. Prior to entering the biopharmaceutical industry, Dr. Vilchez was full time faculty in the Departments of Medicine and Molecular Virology & Microbiology at Baylor College of Medicine. Dr. Vilchez has served in multiple R&D roles at Boehringer Ingelheim, Merck, Roche, Abbott/AbbVie, Mallinckrodt Pharmaceuticals and other smaller biotechnology companies. In those roles, Dr. Vilchez has been a key contributor to the global development of new therapies such as Vicriviroc, Victrelis, Viekirax, Technivie, Ocaliva, Terlivaz, and StrataGraft. Dr. Vilchez has co-authored more than 100 peer-reviewed scientific publications in high impact biomedical journals such as the New England Journal of Medicine, The Lancet, and Clinical Microbiology Reviews. The leadership of Dr. Vilchez will enhance MicuRx's global R&D programs and clinical activities. MicuRx is rapidly expanding its business and assembling an international expert team with extensive experience and an innovative spirit to develop a robust global R&D organization. Moving forward, MicuRx will remain focused on advancing its anti-infective product pipeline, and provide more effective and safer treatment options for patients around the world. View original content to download multimedia: SOURCE MicuRx Pharmaceuticals Company Codes: Shanghai:688373, Shanghai:688373.SS

Executive Change

04 Apr 2012

·www.biospace.com

Enanta Pharmaceuticals, Inc. Announces Positive Phase 2 Results From Interferon-Free Combination Studies With ABT-450 for Hepatitis C Treatment to be Presented at EASL

WATERTOWN, Mass., April. 4, 2012 /PRNewswire/ --Enanta Pharmaceuticals, Inc., a research and development company dedicated to creating best-in-class small molecule drugs in the infectious disease field, announced today that key data from two of its hepatitis C (HCV) programs will be presented at the International Liver Congress 2012 (ILC2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain. Oral presentations will discuss Phase 2 results from "Pilot" and "Co-Pilot", which investigated two different interferon-free combination regimens containing ABT-450, the lead candidate from Enanta's collaborative HCV protease inhibitor program with Abbott. ABT-450 will be included in two additional poster presentations and a third poster presentation will report in vitro data from Enanta's proprietary nucleotide HCV polymerase inhibitor program. Abstracts are available at . Phase 2 Data Highlights In the study known as "Co-Pilot," different doses of ABT-450/r, plus ABT-333 and ribavirin administered for 12 weeks showed sustained virological response at 12 weeks post treatment (SVR12) in 93 percent and 95 percent of treatment-naive genotype 1 (GT1) patients. In these patients, response was independent of HCV subtype, host IL28B genotype or dose of ABT-450/r. In addition, SVR12 was achieved in 47 percent of patients who were previous non-responders to past HCV treatment. In a separate study, known as "Pilot", 91 percent of genotype 1 infected, treatment-naive patients taking ABT-450/r and ABT-072 combined with ribavirin administered for 12 weeks, achieved sustained viral response at 24 weeks (SVR24). "The results from Pilot and Co-Pilot showed very encouraging levels of sustained response and suggest that ABT-450 could be an important component in new interferon-free, all-oral regimens for previously treated and treatment-naive patients with HCV," said Jay Luly, Ph.D., President and CEO of Enanta. "Enanta's involvement in five distinct HCV drug classes provides multiple avenues to pursue our goal of bringing to patients innovative therapies that are safer and more effective than current treatments." Oral Presentations Oral Presentation, Eric Lawitz et al.; Thursday, April 19, 16:00-18:00 CET / 10:00 am - 12:00 pm EDT. A 12-week Interferon-Free Regimen of ABT-450/r, ABT-072, and Ribavirin was Well Tolerated and Achieved Sustained Virologic Response in 91% Treatment-Naive HCV IL28B-CC Genotype-1-Infected Subjects The objectives of the 12-week, phase 2 study were to assess the safety, tolerability, pharmacokinetics, and antiviral activity of ABT-450/r 150/100 mg QD and ABT-072 400 mg QD + ribavirin administered for 12 weeks. The study was conducted in 11 treatment naive adults from multiple ethnic backgrounds with non-cirrhotic HCV GT1 (8 GT 1a, 3 GT 1b). Ribavirin 1000-1200 mg/day was weight-based and dosed twice daily. The primary endpoint was percentage of patients with HCV RNA <25 IU/ml from week 4 through 12. Other trial endpoints include early virologic response, RVR and SVR through 24 weeks. 100 percent of patients maintained HCV RNA levels <25 IU/mL from weeks 4 through 12 of treatment, and all had undetectable HCV RNA from week 5 to the end of treatment. 91 percent of patients achieved SVR24, In the trial, the most common adverse events reported were headache, fatigue, nausea and dry skin. There were no premature discontinuations. Late-Breaking Oral Presentation, Fred Poordad, et al.; Saturday, April 21, 15:30-17:30 CET / 9:30-11:30 am EDT. 12-Week Interferon-Free Regimen of ABT-450/r+ABT-333+Ribavirin Achieved SVR12 in More Than 90% of Treatment-Naive HCV Genotype-1-Infected Subjects and 47% of Previous Non-Responders The objectives of this phase 2 study were to assess safety and tolerability 12-week interferon-free regimens in HCV GT1 patients who were either treatment naive or previous non-responders. The trial had three arms with three primary end points rapid virological response (RVR) at week 4 and SVR at weeks 4 and 12. Enrollment was open to GT1-infected patients regardless of IL28B host genotype and ribavirin dosing was weight-based. 95 percent (18 of 19) of treatment-naive patients infected with HCV GT1 (17 GT 1a, 2 GT 1b) achieved SVR12 with ABT 450/r 250/100 mg dosed once daily (QD) +ABT-333 400 mg dosed twice daily (BID) + ribavirin (Arm 1). 93 percent (13 of 14) of treatment- naive patients infected with HCV GT1 (11 GT 1a, 3 GT1b) achieved SVR12 with ABT 450/r 150/100 mg QD +ABT-333 400 mg BID + ribavirin (Arm 2). 47 percent (8 of 17) of patients with HCV GT1 (16 GT1a, 1 GT1b) who had previously not responded to other HCV treatments achieved SVR12 with ABT 450/r 150/100 mg QD +ABT-333 400 mg BID + ribavirin (Arm 3). One patient in Arm 1 discontinued due to asymptomatic isolated ALT/AST elevations at week 2. One patient in Arm 2 discontinued due to noncompliance in week 1. All remaining patients in Arms 1 and 2 completed treatment and achieved SVR12. In Arm 3, six patients experienced viral breakthrough while on treatment and three patients relapsed after treatment stopped. In the trial the most common adverse events were fatigue (42 percent), nausea (22 percent) and headache (20 percent). Abbott is developing ABT-450 with low dose ritonavir (ABT-450/r) which enhances the pharmacokinetic properties of ABT-450, allowing for once daily dosing. The use of ritonavir 100 mg with ABT-450 for the treatment of HCV is investigational. Poster Presentations Poster #867, Tami Pilot-Matias et al.; Friday, April 20 (11:00-11:30, 12:30-14:00, 15:30-16:00 CET) "In vitro combinatory effect of HCV NS3/4A protease inhibitor ABT-450, NS5A inhibitor ABT-267, and non-nucleoside NS5B polymerase inhibitor ABT-333" Poster #1187, Eric Lawitz et al; Saturday, April 21 (11:00-11:30, 12:30-13:30, 15:00-15:30 CET) "ABT-450/ritonavir (ABT-450/r) combined with pegylated interferon alpha-2a/ribavirin after 3-day monotherapy in genotype 1 (GT1) HCV-infected treatment-naive subjects: 12-week sustained virologic response (SVR12) and safety results" Poster #1200, Christopher M. Owens et al.; Saturday, April 21 (11:00 11:30, 12:30 13:30, 15:00 15:30 CET) "Antiviral Activity of EP-NI266, a Potent Nucleotide HCV Polymerase Inhibitor" About the Hepatitis C Virus Hepatitis C is a liver disease affecting over 170 million people worldwide. The virus is spread through direct contact with the blood of an infected person. Hepatitis C increases a person's risk of developing chronic liver disease, cirrhosis, liver cancer and death. Liver disease associated with HCV infection is growing rapidly, and there is an acute need for new therapies that are safer and more effective. Specifically targeted antiviral therapies for HCV, such as NS3/4a protease and NS5A inhibitors, may have the potential to increase the proportion of patients in whom the virus can be eradicated. About Enanta Enanta Pharmaceuticals is a research and development company that uses its novel chemistry approach and drug discovery capabilities to create best in class small molecule drugs in the infectious disease field. Enanta is discovering and developing novel inhibitors and combinations of inhibitors targeted against the Hepatitis C virus (HCV). These inhibitors include members of the direct acting antiviral (DAA) inhibitor classes protease (partnered with Abbott), NS5A (partnered with Novartis), nucleotide polymerase, and a host targeted antiviral (HTA) inhibitor class targeted against cyclophilin. Through its partnership with Abbott, collaboration protease inhibitor ABT-450 is being evaluated in combination with Abbott's non-nucleoside polymerase and NS5A inhibitors. Additionally, the Company has created a new class of antibiotics, called Bicyclolides, which overcomes bacterial resistance. Antibacterial focus areas include overcoming resistance to superbugs, treating respiratory tract infections, and developing intravenous and oral treatments for hospital and community MRSA infections. Enanta is a privately held company headquartered in Watertown, Mass. Enanta's news releases and other information are available on the company's web site at . For Enanta Investor Relations, please contact: Paul Mellett 617-607-0761 For Enanta Public Relations,please contact MacDougall Biomedical Communications: Kari Watson 781-235-3060 or kwatson@macbiocom.com SOURCE Enanta Pharmaceuticals, Inc.

CollaborateBest in ClassSmall molecular drug

100 Deals associated with Ombitasvir/Paritaprevir/Ritonavir

External Link

KEGG	Wiki	ATC	Drug Bank
-	Ombitasvir/Paritaprevir/Ritonavir	J05AP53	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Chronic hepatitis C genotype 1	China	AbbVie Biotherapeutics, Inc.	20 Sep 2017
Hepatitis C	United States	AbbVie, Inc.	24 Jul 2015
Hepatitis C, Chronic	European Union	AbbVie Deutschland GmbH & Co. KG	14 Jan 2015
Hepatitis C, Chronic	Iceland	AbbVie Deutschland GmbH & Co. KG	14 Jan 2015
Hepatitis C, Chronic	Liechtenstein	AbbVie Deutschland GmbH & Co. KG	14 Jan 2015
Hepatitis C, Chronic	Norway	AbbVie Deutschland GmbH & Co. KG	14 Jan 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
HIV Infections	Phase 3	Australia	AbbVie, Inc.	01 Jun 2016
HIV Infections	Phase 3	New Zealand	AbbVie, Inc.	01 Jun 2016
HIV Infections	Phase 3	United Kingdom	AbbVie, Inc.	01 Jun 2016
Liver Cirrhosis	Phase 3	South Korea	AbbVie, Inc.	20 Jul 2015
Decompensated cirrhosis of liver	Phase 3	-	AbbVie, Inc.	24 Nov 2014
Kidney Failure, Chronic	Phase 3	-	AbbVie, Inc.	23 Sep 2014
Chronic hepatitis C genotype 2	Phase 3	-	AbbVie, Inc.	01 Jan 2014
Compensated cirrhosis	Phase 3	-	AbbVie, Inc.	01 Oct 2012
Fibrosis	Phase 3	-	AbbVie, Inc.	01 Oct 2012
Chronic hepatitis C genotype 1b	Phase 3	-	AbbVie, Inc.	01 Aug 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02461745 (CTgov)	Phase 4	Chronic hepatitis C genotype 1	200	OMBITASVIR/PARITAPREVIR/RITONAVIR+dasabuvir+ribavirin (Genotype 1a)	oketjhevhc(qfcmvogwon) = mjtrjfjaos toourtlnaa (mnjvtzqagt, mfhrrkyohx - lvqbkffjph) View more	-	22 Jan 2021
				OMBITASVIR/PARITAPREVIR/RITONAVIR+dasabuvir (Genotype 1b)	oketjhevhc(qfcmvogwon) = lclgffuriu toourtlnaa (mnjvtzqagt, zxxeanjjlh - rmmwgbvcbs) View more
P1705 (ERA2020)	Not Applicable	Hepatocellular Carcinoma Alfa feto protein	165	Ombitasvir/Paritaprevir/Ritonavir (OMV/PTV/RTV) regimen	wlffeyrpte(evjbxarnwr) = xmxygpbpar jyvpyujpff (yxuhlzlicz ) View more	Positive	06 Jun 2020
				Sofosbuvir/Daclatasvir regimen	wlffeyrpte(evjbxarnwr) = mlggqrrtyh jyvpyujpff (yxuhlzlicz )
P1384 (ERA2020)	Not Applicable	Renal Insufficiency \| Hepatitis C, Chronic hemoglobin \| serum creatinine	235	Direct Acting Anti-Virus (Anemic CKD patients)	ifbultjcra(yguvwhzgud) = blsrjswlcr dbgjrzivbm (dhrbsczqcv ) View more	Positive	06 Jun 2020
				Direct Acting Anti-Virus (Non-anemic CKD patients)	ifbultjcra(yguvwhzgud) = oihsqigscl dbgjrzivbm (dhrbsczqcv ) View more
NCT02874066 (PIVOTAL, CTgov)	Phase 4	Hepatitis C	46	PTV/r/OBV/DSV	luhrxpdofb(uvpaaqpwsm) = jxiulrrnrk ctjfdxrell (dhuqjnraip, xxwxpjxmnz - nusznipupc) View more	-	19 Jul 2019
NCT02194998 (C_ASCENT, CTgov)	Phase 2	Chronic hepatitis C genotype 1 \| Coinfection	46	Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)+Dasabuvir (DSV)+ribavirin (RBV) (Cohort A [INI-based ART + PTV/r/OBT + DSV +/- RBV 24 Weeks])	zscxxzftej(xqjmfinwxv) = hhmmbhdjfn oqxwoooybp (ciedbrivif, wwueqtctwp - drmcpjpjvv) View more	-	04 Jun 2019
				Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)+Dasabuvir (DSV)+ribavirin (RBV) (Cohort B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks])	zscxxzftej(xqjmfinwxv) = jqtkmpeqpa oqxwoooybp (ciedbrivif, nxgghrgosf - dohjsmhfdy) View more
TOPAZ-I and TOPAZ-II (EASL2019)	Phase 3	Chronic hepatitis C genotype 1 Other Biomarkers	2,211	ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin	ohyovpbgfs(dnmkaqcein) = hvfagtkeoz izqmbitoys (tajbbraidw )	-	13 Apr 2019
EASL2019	Not Applicable	Fibrosis, Liver \| Hepatitis C	3,067	Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir 8 weeks	kcrgmkgnkk(xnvcidhapz) = xygshupjoa icibjtcubi (nhikecfqdo )	Positive	11 Apr 2019
				Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir 12 weeks	kcrgmkgnkk(xnvcidhapz) = kvsjanchil icibjtcubi (nhikecfqdo )
NCT03341988 (Pubmed \| Clin Res Hepatol Gastroenterol)	Phase 1	Kidney Failure, Chronic	110	ombitasvir/paritaprevir/ritonavir plus ribavirin	bqhisgxtwk(ckcfeppwno) = There were no reported serious adverse events vzwkspbcsv (yuxuzsoyoz )	-	01 Feb 2019
NCT02517528 (CTgov)	Phase 3	Chronic hepatitis C genotype 1b \| Fibrosis	104	ABT-450/r/ABT-267+ABT-333+ribavirin	eoparcxbqy(kktezqdtdy) = vkdpxfnrjt kvewocxjkm (fgvglnubli, kdvnhiqtxe - dysdnpzdfu) View more	-	09 Oct 2018
NCT02292719 (Quartz II/III, CTgov)	Phase 2	Chronic hepatitis C genotype 2 \| Fibrosis \| Hepatitis C, Chronic	70	OBV/PTV/r+Sofosbuvir (Arm A (Genotype [GT]3, Noncirrhotic))	rkopksxkps(nodclcwvcp) = ughxtyswbj gpgmqhglje (lzpsmbiozc, qgtgbgifdi - jpwnrvyrok) View more	-	06 Jul 2018
				OBV/PTV/r+Sofosbuvir+Ribavirin (RBV) (Arm B (GT3, Noncirrhotic))	rkopksxkps(nodclcwvcp) = mybprsyaal gpgmqhglje (lzpsmbiozc, agvetkjqqg - zoxmttxttw) View more

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