HIV-1 pol inhibitors(Human immunodeficiency virus type 1 Pol protein 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 2Coinfection+ [7]

Originator Organization

AbbVie, Inc.

Active Organization

AbbVie Biotherapeutics, Inc.

Inactive Organization

AbbVie, Inc.AbbVie Deutschland GmbH & Co. KG

License Organization-

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

1. To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in chronic HCV infected patients in those with CKD versus ESRD in Assiut Hospital University .
2. 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·Annals of Saudi medicine

Experience with direct-acting antivirals in genotype 1–5 infected chronic hepatitis C patients in Turkey

Article

Author: Sahin, Ahmet ; Akay, Ozlem

BACKGROUND::

Hepatitis C virus (HCV) can cause chronic liver disease, hepatic cirrhosis, hepatocellular carcinoma, liver transplantation, and death. Early diagnosis and treatment are thus vital.

OBJECTIVES::

We aimed to investigate the sustained virological response (SVR) rates in chronic hepatitis C patients infected with different genotypes, receiving different direct-acting antiviral treatments (DAAs).

DESIGN::

Retrospective, observational

SETTING::

Clinic for infectious diseases and clinical microbiology

PATIENTS AND METHODS::

Patients diagnosed with chronic hepatitis C who applied to our outpatient clinic between January 2016 and November 2022 and were treated with a DAA were included in the study. Treatment responses were evaluated after each patient was treated with either ledipasvir plus sofosbuvir (LDV/SOF), LDV/SOF + ribavirin (RBV), SOF+RBV, ombitasvir/paritaprevir/ritonavir plus dasabuvir (OBV/PTV/r±DSV) ±RBV, or glecaprevir plus pibrentasvir (GLE/PIB).

MAIN OUTCOME MEASURES::

Sustained virological response (SVR) rates at 12 weeks (SVR12) post-treatment.

SAMPLE SIZE::

360 patients.

RESULTS::

Of 360 patients who met the inclusion criteria, 218 (60.6%) were male and 142 (39.4%) were female with no statistically significant differences in SVR between sexes ( P =.252). Nearly all had a SVR (n=353, 98.1%). The median (IQR) age of the patients was 56 (30.3) years. There were 42 (11.7%), 199 (55.3%), 4 (1.1%), 106 (29.4%), 8 (2.2%) and 1 (0.3%) patient with genotypes 1a, 1b, 2, 3, 4 and 5, respectively, and SVR12 did not differ significantly between genotypes ( P =.066). SVR12 response was higher in 246 (68.3%) non-injecting drug users compared to 114 (31.7%) injecting drug users ( P =.005). The SVR12 response was achieved in 100% of patients with genotypes 1a, 2, 4, and 5. SVR12 response could not be obtained in 1 of 199 genotype 1b patients and 6 of 106 genotype 3 patients. The common feature of 6 reinfection patients with genotype 3 was that they were using intravenous drugs. These 6 patients were reinfected due to their continued intravenous drug use.

CONCLUSION::

In conclusion, DAAs provide high SVR12 rates in cirrhotic/non-cirrhotic, pegylated interferon-naive/experienced patient groups and in patients infected with all genotypes. DAAs have a high SVR12 rate in patients with chronic hepatitis C.

LIMITATIONS::

Retrospective, single-center.

01 Sep 2023·Drug information journal

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

Abstract:

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 Aug 2019·Journal of viral hepatitis

Efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with low‐dose ribavirin in patients with chronic hepatitis C virus genotype 1a infection without cirrhosis

Article

Author: Poordad, Fred ; Unnebrink, Kristina ; Nelson, David R. ; Epstein, Michael ; Bernstein, David ; Bank, Leslie ; Martinez, Marisol ; Pockros, Paul J. ; Lucey, Michael R. ; Polepally, Akshanth R. ; Ravendhran, Natarajan ; Krishnan, Preethi ; Reindollar, Robert ; Trinh, Roger ; Sedghi, Shahriar

Abstract:

Patients infected with hepatitis C virus (HCV) treated with interferon‐free direct‐acting antivirals may still require ribavirin. However, ribavirin is associated with adverse events that can limit its use. This open‐label, multicentre, Phase 3 study evaluated the safety and efficacy of ombitasvir/paritaprevir/ritonavir + dasabuvir (OBV/PTV/r + DSV) with low‐dose ribavirin for 12 weeks in genotype 1a‐infected patients without cirrhosis. The primary efficacy endpoint was sustained virologic response at post‐treatment Week 12 (SVR12). The primary safety endpoint was haemoglobin <10 g/dL during treatment and decreased from baseline. Overall, 105 patients enrolled. The SVR12 rate was 89.5% (n/N = 94/105; 95% CI, 83.7‐95.4). The study did not achieve noninferiority versus the historic SVR12 rate for OBV/PTV/r + DSV plus weight‐based ribavirin. Five patients experienced virologic failure, four discontinued, and two had missing SVR12 data. Excluding nonvirologic failures, the SVR12 rate was 94.9% (n/N = 94/99). One patient met the primary safety endpoint. OBV/PTV/r + DSV plus low‐dose ribavirin offers an alternative option for patients in whom full‐dose ribavirin may compromise tolerability, although noninferiority to the weight‐based ribavirin regimen was not met.

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

22 Jul 2015

·www.biospace.com

Nine Boston Biotechs That Are Actually Profitable

July 22, 2015 By Alex Keown , BioSpace.com Breaking News Staff BOSTON – Not all biotech companies show an annual profit, but nine Boston-based pharmaceutical firms were able to please investors with a strong financial year, the Boston Business Journal reported this morning. The drug companies and annual revenues, compiled by the Boston Business Journal , are below: 1. Biogen, Inc. The company’s 12-month revenue is about $103 billion with annual earnings per share of $13.90. Biogen will release its full-year financials later this week, although the company’s stock took a hit this morning after it announced results from its latest clinical trials around its Alzheimer’s drug BIIB037, or aducanumab , which had shown promise in reducing amyloid brain plaque in earlier tests. This morning Biogen announced that the new data was consistent with previously reported results. The 54-week data from the six milligram patients showed a statistically significant decrease of beta amyloid in the brain, but did not show a statistically significant improvement in cognitive decline, although apparently it did show some improvement, something that has not impressed investors this morning. 2. Shire Pharmaceuticals The Ireland-based company’s 12-month revenues are approximately $6.16 billion with annual earnings per share of $11.04. Shire is expected to release its full-year financial reports later this week. Shire ’s big revenue drug drivers are Vyvanse, used in ADHD and Lialta, for ulcerative colitis. Like many other pharmaceutical companies, Shire has been Shire has been driving growth through acquisitions . In January, Shire greed to buy U.S. group NPS Pharmaceuticals, Inc. for $5.2 billion Shire (SHPGY) has been involved with more than $250 billion worth of acquisitions this year, Reuters noted. A $50 billion deal between Shire and AbbVie to merge fell apart last year after the U.S. government changed the tax rules on companies relocating their corporate headquarters overseas to receive tax breaks. In 2011, Shire had also been in talks with Cubist Pharmaceuticals, Inc. for a possible acquisition, but that never transpired. Cubist was acquired by Merck & Co. earlier this year. 3. AMAG Pharmaceuticals, Inc. Amag ’s 12-month trailing revenue is approximately $93 million, with earnings per share of $6.45. Amag ’s revenues are driven primarily by sales of Makena, a drug used to prevent premature birth, Faraheme, an iron deficiency drug and Mugard, a drug used in the treatment of oral mucositis. 4. Enanta Pharmaceuticals, Inc. Enanta ’s 12-month trailing revenue was reported to be $180 million, driven in part by large milestone payments from AbbVie for the hepatitis C drug, Viekirax. The company’s 12-month trailing earnings are $6.23 per share. 5. Charles River Laboratories Charles River ’s revenue is driven primarily from biotech companies that outsource research. The company’s 12-month trailing revenue is reported to be about $1.32 billion with 12-month earnings per share at $2.70. Earlier this month, Charles River bolstered its microbial detection business with the $212 million acquisition of Celsis International Ltd. Charles River said it expects the acquisition of Celsis , a provider of rapid microbial detection systems for quality control testing in the biopharmaceutical and consumer products industries, to make its Endotoxin and Microbial Detection business a “one-stop-shop” for rapid quality control testing. 6. Juniper Pharmaceuticals Juniper ’s 12-month trailing revenue is about $34 million with 12-months earnings per share at .25 cents. The company’s revenue is driven by sales of Crinone, a progesterone gel. 7. pSivida Corp. Illuvien-maker pSivida Corp. has a 12-month trailing revenue of $26 million and 12-month earnings per share of .25 cents. 8. Repligen Corporation Repligen Corp. , a maker of Protein A and other substances and equipment for the manufacture of biologics drugs, has 12-month trailing revenue of about $68 million and 12-month earnings per share of .21 cents. 9. Harvard Bioscience Harvard Bioscience , driven by sales of research equipment, has 12-month trailing revenue of about $109 million with 12-month earnings per share of .01 cents.

Clinical ResultAcquisition

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
Hepatocellular Carcinoma	Phase 3	-	AbbVie, Inc.	01 Jul 2015
Decompensated cirrhosis of liver	Phase 3	-	AbbVie, Inc.	24 Nov 2014
Kidney Failure, Chronic	Phase 3	-	AbbVie, Inc.	23 Sep 2014
Liver Cirrhosis	Phase 3	-	AbbVie, Inc.	01 Sep 2014
Chronic hepatitis C genotype 2	Phase 3	-	AbbVie, Inc.	01 Jan 2014
Coinfection	Phase 3	-	AbbVie, Inc.	30 Aug 2013
Compensated cirrhosis	Phase 3	-	AbbVie, Inc.	01 Oct 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)	jgrsflnoph = fcffccmjap xcoffxotuw (bgwixbwogt, hmjlxkdhud - psycsmizgx) View more	-	22 Jan 2021
NCT02461745 (CTgov)	Phase 4	Chronic hepatitis C genotype 1	200	OMBITASVIR/PARITAPREVIR/RITONAVIR+dasabuvir (Genotype 1b)	jgrsflnoph = hywnishsrg xcoffxotuw (bgwixbwogt, lknmnqwyly - duphumxwvi) View more	-	22 Jan 2021
ERA2020	Not Applicable	Hepatocellular Carcinoma Alfa feto protein	165	Ombitasvir/Paritaprevir/Ritonavir (OMV/PTV/RTV) regimen	xllpwnjzeo(gbtckezeng) = xfnymfdufx lzdzcgtiqu (staavzyaol ) View more	Positive	06 Jun 2020
ERA2020	Not Applicable	Hepatocellular Carcinoma Alfa feto protein	165	Sofosbuvir/Daclatasvir regimen	xllpwnjzeo(gbtckezeng) = ixecqbruwr lzdzcgtiqu (staavzyaol )	Positive	06 Jun 2020
NCT02874066 (PIVOTAL, CTgov)	Phase 4	Hepatitis C \| Hepatitis C, Chronic	46	PTV/r/OBV/DSV	sfibaslrzl = afhomslzjs mfqsxcpasl (kvqxvberqr, vwguhnarwm - japngxjvmg) 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])	vqtrwcqhlj = aaxxfpatxl qtsxqnqizn (eqipujfrxx, ijzcrjxhln - eyyiznklwv) View more	-	04 Jun 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 B [INI-based ART + PTV/r/OBT + DSV +/- RBV 12 Weeks])	vqtrwcqhlj = bccmcrsfgi qtsxqnqizn (eqipujfrxx, hemnbheqra - oktogmptwy) View more	-	04 Jun 2019
TOPAZ-I and TOPAZ-II (EASL2019)	Phase 3	Chronic hepatitis C genotype 1 Other Biomarkers	2,211	ombitasvir/paritaprevir/ritonavir + dasabuvir ± ribavirin	boyhtxasgv(wqkqkbinde) = dishrfhyue whlocoacyr (hyihhrniao )	-	13 Apr 2019
NCT03341988 (Pubmed \| Clin Res Hepatol Gastroenterol)	Phase 1	Kidney Failure, Chronic	110	ombitasvir/paritaprevir/ritonavir plus ribavirin	rlkoqdyjzh(vlfvjqitjk) = There were no reported serious adverse events fyliybfoqn (pwzpzcipeg )	-	01 Feb 2019
NCT02517528 (CTgov)	Phase 3	Chronic hepatitis C genotype 1b \| Fibrosis	104	ABT-450/r/ABT-267+ABT-333+ribavirin	iuttcueplg = umkktctvyg sapbygutsh (tuayuybaqw, ugsiboplec - itzirwsouu) 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))	uvgcvwgkiu = yqhplqwxvp yzghrwghcu (vattrajbsc, uujqirvmno - qldnzesshr) View more	-	06 Jul 2018
NCT02292719 (Quartz II/III, CTgov)	Phase 2		70	OBV/PTV/r+Sofosbuvir+Ribavirin (RBV) (Arm B (GT3, Noncirrhotic))	uvgcvwgkiu = wdcaruiebj yzghrwghcu (vattrajbsc, kqwnrssqfp - dparqqiaiu) View more	-	06 Jul 2018
NCT02582632 (GARNET, CTgov)	Phase 3	Chronic hepatitis C genotype 1b	166	ombitasvir/paritaprevir/ritonavir+dasabuvir	aajajxyqlr = cnlbtktluw uzjhzxlrgp (lzrafmopxa, nrpnnbhrhz - wtgalnsbcd) View more	-	13 Dec 2017
NCT02504099 (GEODE - I, CTgov)	Phase 3	Hepatocellular Carcinoma \| Hepatitis C \| Hepatitis C, Chronic	3	ombitasvir/paritaprevir/ritonavir+dasabuvir+ribavirin	eetngnaeon(wsekiwbmlq) = dgufkxmjmn muejdmyngy (rmufuftrad, xwvkgdoguj - hudtwkdxvd) View more	-	12 Dec 2017

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

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

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

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

Ask any biopharma research question→

Get started for free today!

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

Discover Synapse Data Servers

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

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis