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 DisordersOther Diseases

Active Indication-

Inactive Indication

Compensated cirrhosisFibrosisHepatitis C+ [1]

Originator Organization

AbbVie, Inc.

Active Organization-

Inactive Organization

AbbVie, Inc.

Drug Highest PhaseWithdrawn

First Approval Date

US (19 Dec 2014),

Hepatitis C, Chronic

RegulationBreakthrough Therapy (US), Fast Track (US)

Structure

Molecular FormulaC26H27N3NaO5S

InChIKeyCNUGIPSJLQIKHL-UHFFFAOYSA-N

CAS Registry1132940-11-4

View All Structures (4)

Clinical Trials associated with Dasabuvir Sodium/Ombitasvir/Paritaprevir/Ritonavir

CTR20150567 / CompletedPhase 1

ABT-450/利托那韦/ABT-267（ABT-450/r/ABT-267）和ABT-333多剂量联合给药在健康中国受试者中的药代动力学、安全性和耐受性

[Translation] Pharmacokinetics, safety, and tolerability of multiple-dose combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in healthy Chinese subjects

在健康的中国成年受试者中评价ABT-450/利托那韦/ABT-267和ABT-333于非空腹条件下多剂量口服联合给药的药代动力学和安全性。

[Translation]

The pharmacokinetics and safety of multiple oral doses of ABT-450/ritonavir/ABT-267 and ABT-333 combined under non-fasting conditions were evaluated in healthy Chinese adult subjects.

Start Date18 Aug 2015

Sponsor / Collaborator

AbbVie Ireland NL B.V.

[+2]

NCT02517515 / CompletedPhase 3

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.

Start Date01 Jul 2015

Sponsor / Collaborator

AbbVie, Inc.

NCT02734173 / CompletedPhase 4IIT

Pilot Evaluation of the Influence of ABT450r, Ombitasvir, Dasabuvir +/- Ribavirin HCV Therapy on Insulin Resistance and Lipid Profile

There is compelling data supporting the pursuit of research into the effects of HCV antivirals on metabolic homeostasis. As a further rationale and justification, the experience with HIV antiretrovirals has clearly demonstrated that antiviral medications can produce profound changes in glucose metabolism, lipid profile and other measures of metabolic homeostasis. This establishes biological plausibility for this focus of research in HCV.
The new knowledge created from this research will:
Provide new information on the metabolic effects of the Abbvie 3D HCV antiviral regimen.
Provide insight as to whether there are metabolic advantages with RBV-free compared to RBV-containing HCV regimens. This is particularly relevant given the current uncertainty regarding the need for RBV in IFN-free, oral DAA regimens.
Provide insight into the impact of cirrhosis on metabolic milieu before, during and after HCV antiviral therapy

Start Date01 Jul 2015

Sponsor / Collaborator

Ottawa Hospital Research Institute

[+1]

100 Clinical Results associated with Dasabuvir Sodium/Ombitasvir/Paritaprevir/Ritonavir

100 Translational Medicine associated with Dasabuvir Sodium/Ombitasvir/Paritaprevir/Ritonavir

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

Literatures (Medical) associated with Dasabuvir Sodium/Ombitasvir/Paritaprevir/Ritonavir

01 Mar 2024·Infectious diseases and therapy

Direct-Acting Antivirals Remain Cost-Effective Treatments for Chronic Hepatitis C in Australia Despite Changes to the Treated Population and the Availability of Retreatment: The Glecaprevir/Pibrentasvir (Maviret®) Example

Article

Author: Sharratt, Gillian C ; Arteaga, Aitor ; Castles, Belinda J C ; Warren, Emma

INTRODUCTION:

The first direct-acting antiviral (DAA) therapies for chronic hepatitis C virus (HCV) infection were reimbursed via Australia's Pharmaceutical Benefits Scheme (PBS) in March 2016. This was based on the recommendation from the Pharmaceutical Benefits Advisory Committee (PBAC) that the regimens would be acceptably cost-effective at an incremental cost-effectiveness ratio (ICER) no greater than $15,000/quality-adjusted life-year (QALY). Since the initial PBS listings for DAA therapies and subsequent listings of newer DAA treatments such as glecaprevir/pibrentasvir (Maviret^®), the demographics and some of the disease characteristics of currently treated patients have markedly changed. This analysis aims to reassess the cost-effectiveness of glecaprevir/pibrentasvir, accounting for the changes to the HCV population currently seeking treatment and incorporating retreatment in first-line failures and the treatment of new infections in previously treated individuals.

METHODS:

To assess the cost-effectiveness 7 years after initial listing of DAAs, an update was made to the Markov model used to achieve PBS reimbursement for Viekira-Pak^® in May 2016. Amendments to the Viekira-Pak^® model include: changes to baseline age and fibrosis distribution of treated patients, and inclusion of retreatment of first-line failures [those not achieving a sustained virologic response (SVR12)] and reinfected individuals. Treatment-related inputs including SVR12 response rates, adverse events, treatment-related disutility, and discontinuations were sourced from pivotal glecaprevir/pibrentasvir clinical trials.

RESULTS:

Using the published price of glecaprevir/pibrentasvir, the ICER is below $15,000/QALY.

CONCLUSIONS:

Despite changes in demographics and disease characteristics of treated patients, and changes to the model structure to reflect retreatment in clinical practice in Australia, DAAs remain cost-effective in 2023.

04 Jul 2022·Molecular pharmaceuticsQ2 · MEDICINE

Overcoming Bioavailability Challenges of Dasabuvir and Enabling a Triple-Combination Direct-Acting Antiviral HCV Regimen through a Salt of Very Weak Acid for Oral Delivery

Q2 · MEDICINE

Article

Author: Henry, Rodger F. ; Lou, Xiaochun ; Sheikh, Ahmad Y. ; Lipert, Maya P. ; Chen, Shuang ; Gao, Yi ; Stolarik, DeAnne F. ; Zhang, Geoff G. Z.

Dasabuvir is a non-nucleoside polymerase inhibitor for the treatment of hepatitis C virus (HCV) infection. It is an extremely weak diacidic drug (pK_a = 8.2 and 9.2) and a prolific solvate former. Due to its exceedingly low aqueous solubility (≤0.127 μg/mL at pH 1-6.8, dose number of 1.31 × 10⁴), crystalline dasabuvir free acid exhibited poor oral bioavailability in initial animal pharmacokinetic (PK) assessment. This necessitated the development of enabling formulation for human clinical studies to achieve the required therapeutic in vivo concentration of dasabuvir. While salt formation has been widely used to enhance the solubility and dissolution rate of solids, this approach has rarely been applied to develop oral solid dosage forms for acidic drugs as weak as dasabuvir due to concerns of rapid disproportionation and crystallization of its free acid. In this contribution, we detail our efforts in identifying dasabuvir monosodium monohydrate as a drug substance that is stable, manufacturable, and, most importantly, significantly enhances the dissolution and oral absorption of this poorly soluble drug. The oral delivery of dasabuvir through the salt approach has enabled the commercialization of the triple-combination direct-acting antiviral HCV regimen, Viekira Pak. The methodologies and solutions identified in targeted studies to overcome technical challenges encountered along the way (i.e., incorporation of polymers to inhibit crystallization and disproportionation and species mapping to enable salt manufacturing process, etc.) can be applied to other insoluble compounds.

23 Mar 2020·Journal of biomolecular structure & dynamics

Discovery of hit molecules targeting allosteric site of hepatitis C virus NS5B polymerase

Article

Author: Bheemanati, Raghu ; Vishwakarma, Vinita ; Polamreddy, Prasanthi ; Kacker, Puneet ; Mahto, Manoj Kumar ; Esram, Poornima ; Arumugam, Premkumar

Nonstructural protein 5B (NS5B), the RNA-dependent RNA polymerase of Hepatitis C Virus (HCV), plays a key role in viral amplification and is an attractive and most explored target for discovery of new therapeutic agents for Hepatitis C. Though safe and effective, NS5B inhibitors were launched in 2013 (Sovaldi) and 2014 (Harvoni, Viekira Pak), the high price tags of these medications limit their use among poor people in developing countries. Hence, still there exists a need for cost-effective and short duration anti-HCV agents especially those targeting niche patient population who were non-respondent to earlier therapies or with comorbid conditions. The present study describes the discovery of novel non-nucleoside (NNI) inhibitors of NS5B using a series of rational drug design techniques such as virtual screening, scaffold matching and molecular docking. 2D and 3D structure based virtual screening technique identified 300 hit compounds. Top 20 hits were screened out from identified hits using molecular docking technique. Four molecules, that are representative of 20 hits were evaluated for binding affinity under in vitro conditions using surface plasmon resonance-based assay and the results emphasized that compound with CoCoCo ID: 412075 could exhibit good binding response toward NS5B and could be a potential candidate as NS5B inhibitor.Communicated by Ramaswamy H. Sarma.

News (Medical) associated with Dasabuvir Sodium/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

23 Apr 2015

·www.biospace.com

AbbVie Reports First-Quarter 2015 Financial Results

NORTH CHICAGO, Ill., April 23, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced financial results for the first quarter ended March 31, 2015. "AbbVie had an exceptional first quarter, delivering on our projection of top-tier EPS growth, as well as robust sales growth and significant margin expansion," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We also announced the acquisition of Pharmacyclics, which will establish AbbVie as a leader in the hematologic oncology market and provide an important growth platform for the future. And, we continued to gain momentum with the launch of our HCV therapy, Viekira, and further advancement of our late stage pipeline. Certainly, 2015 is a pivotal year for AbbVie and we are off to an impressive start." Help employers find you! Check out all the jobs and post your resume.

Financial StatementAcquisition

13 Feb 2015

·www.biospace.com

Gilead Agrees to a Discounted Price of $46,000 for Sovaldi in Europe

February 13, 2015 By Riley McDermid, BioSpace.com Breaking News Sr. Editor Biotech darling Gilead Sciences, Inc. has once again been pressured to drop the price for its hepatitis C drug Sovaldi, this time offering a discount to German regulators to $46,625 for a 12-week course of the drug, an almost fire sale drop from its regular cost of $84,000 per course. The GKV association of Germany's statutory medical insurers, who provide coverage for 90 percent of Germans, said Friday that is has managed to talk Gilead into lowering the price of Sovaldi to 43,562.52 euros. Then that price tag is subject to a further 5.88 percent discount for other statutory insurers, leaving Gilead and its shareholders increasingly frustrated by the brutal pricing war surrounding its hepatitis C therapies. Sovaldi sells for approximately $1,000 per pill, while its sister medication, also from Gilead, Harvoni, sold about $2.1 billion in 2014. Similar competitor AbbVie ’s HCV medication Humira recorded $12.5 billion in sales and is now gaining on the coattails of AbbVie’s new hepatitis C treatment, Viekira Pak. The news is not entirely unexpected, Gilead has had to offer discounts in the American market as well, a fact it lamented to Citgroup analysts earlier this week, said head biotech analyst Yaron Werber in a note to investors. “Gilead believes that they had to provide higher rebates to get access to the public segments as state Medicaid programs have more restrictions than private plans. AbbVie was very aggressive on pricing and so the landscape weakened considerably faster than anticipated due to exclusivity contracts,” wrote Werber. “Gilead expects volume to ramp up but it is not clear how fast in the public system. The 46 percent gross/net adjustment assumes a certain level of use in the public system and could be lower if the volume is slower to materialize,” he said. “The prison system is expected to kick into gear in 2016. In general rebates for Sovaldi are much lower than Harvoni.” Gilead has been continuing its charm offensive this week, on Wednesday sending Chief Operating Officer John Milligan and Vice President of Investor Relations Patrick O’Brien to lunch with analysts at Citigroup, who came away upbeat about the controversial firm’s business structure and convinced it will soon be attempting more mergers and acquisitions. “We came out bullish that Sovaldi/Harvoni's volume will increase in U.S. and Europe in 2015 driven by increased rebates to public segments. Gilead's pipeline is also advancing and Simtuzumab should have interim 48 week data in late 2015 in NASH,” wrote Werber. Despite telling the BIO CEO and Investor Forum this week that Gilead “feels no urgency for mergers/acquisitions, but if we did, it would be thoughtful and reflective," Milligan’s time with Citi left analysts feeling the company is hungry for new deals, particularly in oncology. “We detect that management is definitely gearing up the company to be very active on M&A in 2015 and oncology will likely be a key focus,” wrote Werber. “We do not anticipate one sizable deal that will have an imminent change but instead see a few smaller deals to bolster the pipeline for the mid-term.” Gilead’s team also remains convinced profits will stay high, just months after Gilead Sciences, Inc. (GILD) sold $10.3 billion of its new hepatitis C drug Sovaldi in 2014. Both Sovaldi and Harvoni have treatment rates close to 90 percent, making them essentially a cure for many patients—success several companies are attempting to duplicate soon, posited analysts. “Management is also confident of the sustainability of hepatitis C cash flow for the next decade based on the rate of patients being treated, continuing innovation, and focus on eradication of disease,” said Werber. “Hence management is very confident in its ability to do stock buybacks, provide a dividend, and do M&A. But the meeting also noted that there is little visibility as to how fast the public hepatitis C segment will grow, where treatment volumes will grow to, and where pricing will be as the market will get more competitive.” BioSpace Temperature Poll Who Do You Think Will Be Sanofi’s New CEO? French drugmaker Sanofi said Thursday that it will name a new chief executive in mere weeks, as it attempted to put to rest rumors that the company could not find any executives willing to take the reins after it unceremoniously ousted its previous CEO last fall. Who do you think will soon be crowned king? BioSpace wants your opinion!

Acquisition

100 Deals associated with Dasabuvir Sodium/Ombitasvir/Paritaprevir/Ritonavir

External Link

KEGG	Wiki	ATC	Drug Bank
-	Dasabuvir Sodium/Ombitasvir/Paritaprevir/Ritonavir	J05AP52	-

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Compensated cirrhosis	US	AbbVie, Inc.	22 Apr 2016
Fibrosis	US	AbbVie, Inc.	22 Apr 2016
Hepatitis C, Chronic	US	AbbVie, Inc.	19 Dec 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis C	Phase 1	CN	AbbVie, Inc.	18 Aug 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ERA2017	Not Applicable	-	-	3D regimen	zalutwswrg(tfsgjvuehw) = xceitpmvns erbgrmozxe (smlbewqcci, 12.6)	-	26 May 2017
				SOF-based regimens	zalutwswrg(tfsgjvuehw) = vpdbievcnx erbgrmozxe (smlbewqcci, 14.7)

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