Literature DB >> 30117020

Danoprevir: First Global Approval.

Anthony Markham1, Susan J Keam2.   

Abstract

Ascletis has developed danoprevir (Ganovo®), an orally-administered hepatitis C virus NS3 protease inhibitor, as a treatment for hepatitis C. Based on positive results in phase II and phase III trials in patients with hepatitis C, danoprevir, in combination with ritonavir, peginterferon alfa and ribavirin was recently approved for marketing in China for the treatment of treatment-naive patients with non-cirrhotic genotype 1b chronic hepatitis C. This article summarizes the milestones in the development of danoprevir leading to this first approval.

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Year:  2018        PMID: 30117020     DOI: 10.1007/s40265-018-0960-0

Source DB:  PubMed          Journal:  Drugs        ISSN: 0012-6667            Impact factor:   11.431


  17 in total

1.  Inhibition and binding kinetics of the hepatitis C virus NS3 protease inhibitor ITMN-191 reveals tight binding and slow dissociative behavior.

Authors:  Ravi Rajagopalan; Shawn Misialek; Sarah K Stevens; David G Myszka; Barbara J Brandhuber; Joshua A Ballard; Steven W Andrews; Scott D Seiwert; Karl Kossen
Journal:  Biochemistry       Date:  2009-03-24       Impact factor: 3.162

2.  Identification of the NS5B S282T resistant variant and two novel amino acid substitutions that affect replication capacity in hepatitis C virus-infected patients treated with mericitabine and danoprevir.

Authors:  Xiao Tong; Lewyn Li; Kristin Haines; Isabel Najera
Journal:  Antimicrob Agents Chemother       Date:  2014-03-17       Impact factor: 5.191

3.  Effect of meal and antisecretory agents on the pharmacokinetics of danoprevir/ritonavir in healthy volunteers.

Authors:  Peter N Morcos; Sebastian A Moreira; Mercidita T Navarro; Núria Bech; Amanda Quatkemeyer; Patrick F Smith; Barbara J Brennan
Journal:  J Pharm Pharmacol       Date:  2013-10-10       Impact factor: 3.765

4.  Randomized study of danoprevir/ritonavir-based therapy for HCV genotype 1 patients with prior partial or null responses to peginterferon/ribavirin.

Authors:  Jordan J Feld; Ira M Jacobson; Donald M Jensen; Graham R Foster; Stanislas Pol; Edward Tam; Maciej Jablkowski; Hanna Berak; John M Vierling; Eric M Yoshida; Héctor R Perez-Gomez; Astrid Scalori; Gregory J Hooper; Jorge A Tavel; Mercidita T Navarro; Saba Shahdad; Rohit Kulkarni; Sophie Le Pogam; Isabel Nájera; Simon Eng; Chin Yin Lim; Nancy S Shulman; Ellen S Yetzer
Journal:  J Hepatol       Date:  2014-09-18       Impact factor: 25.083

5.  Mericitabine and ritonavir-boosted danoprevir with or without ribavirin in treatment-naive HCV genotype 1 patients: INFORM-SVR study.

Authors:  Edward J Gane; Paul J Pockros; Stefan Zeuzem; Patrick Marcellin; Anna Shikhman; Coen Bernaards; Julian Zhou; Ellen S Yetzer; Rosa Ballester; Cindy Dwyer; Xiao Tong; Isabel Nájera; Anne Bertasso; Janet Hammond; Amy Kindrick; Peter N Morcos; Patrick Smith; Saray Stancic; Nancy S Shulman
Journal:  Liver Int       Date:  2014-06-19       Impact factor: 5.828

6.  Two-way interaction study between ritonavir boosted danoprevir, a potent HCV protease inhibitor, and ketoconazole in healthy subjects.

Authors:  Peter N Morcos; Linda Chang; Mercidita Navarro; Diana Chung; Patrick F Smith; Barbara J Brennan; Jonathan Q Tran
Journal:  Int J Clin Pharmacol Ther       Date:  2014-02       Impact factor: 1.366

7.  Ritonavir-boosted danoprevir plus peginterferon alfa-2a and ribavirin in Asian chronic hepatitis C patients with or without cirrhosis.

Authors:  Jia-Horng Kao; Shui-Yi Tung; Younjae Lee; Satawat Thongsawat; Tawesak Tanwandee; I-Shyan Sheen; Jinzi J Wu; Hui Li; Barbara J Brennan; Julian Zhou; Sophie Le Pogam; Isabel Najera; James A Thommes; George Hill
Journal:  J Gastroenterol Hepatol       Date:  2016-10       Impact factor: 4.029

8.  Effect of ritonavir-boosted danoprevir, a potent hepatitis C virus protease inhibitor, on the pharmacokinetics of methadone in healthy subjects undergoing methadone maintenance therapy.

Authors:  Sebastian A Moreira; Peter N Morcos; Mercidita T Navarro; Nuria Bech; Patrick F Smith; Barbara J Brennan
Journal:  Pharmacotherapy       Date:  2013-08-14       Impact factor: 4.705

9.  Global, regional, and national life expectancy, all-cause mortality, and cause-specific mortality for 249 causes of death, 1980-2015: a systematic analysis for the Global Burden of Disease Study 2015.

Authors: 
Journal:  Lancet       Date:  2016-10-08       Impact factor: 79.321

10.  Ritonavir-boosted danoprevir-based regimens in treatment-naive and prior null responders with HCV genotype 1 or 4 and compensated cirrhosis.

Authors:  Edward J Gane; Régine Rouzier; Tarek Hassanein; Catherine A Stedman; Wlodzimierz Mazur; Viera Kupcova; Sophie Le Pogam; Simon Eng; Athina Voulgari; Peter N Morcos; Barbara J Brennan; Astrid Scalori; James Thommes
Journal:  Hepatol Int       Date:  2016-02-17       Impact factor: 9.029

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  7 in total

1.  Pharmacokinetics, Safety, and Tolerability of Ravidasvir, with and without Danoprevir/Ritonavir, in Healthy Subjects.

Authors:  Guolan Wu; Huili Zhou; Jing Wu; Duo Lv; Lihua Wu; You Zhai; Meihua Lin; Jingzi J Wu; Jianzhong Shentu
Journal:  Antimicrob Agents Chemother       Date:  2021-07-12       Impact factor: 5.191

Review 2.  Danoprevir for the Treatment of Hepatitis C Virus Infection: Design, Development, and Place in Therapy.

Authors:  Miao Miao; Xixi Jing; Erik De Clercq; Guangdi Li
Journal:  Drug Des Devel Ther       Date:  2020-07-14       Impact factor: 4.162

Review 3.  COVID-19 treatment: Much research and testing, but far, few magic bullets against SARS-CoV-2 coronavirus.

Authors:  Vladimir V Kouznetsov
Journal:  Eur J Med Chem       Date:  2020-07-15       Impact factor: 6.514

Review 4.  Coronavirus COVID- 19: A critical review of its history, pathogenesis, transmission, diagnosis and treatment.

Authors:  Mohd Sharjeel Sofi; Aadil Hamid; Sami Ullah Bhat
Journal:  Biosaf Health       Date:  2020-11-08

Review 5.  A narrative literature review on traditional medicine options for treatment of corona virus disease 2019 (COVID-19).

Authors:  Amir Mirzaie; Mehrdad Halaji; Farhad Safarpoor Dehkordi; Reza Ranjbar; Hassan Noorbazargan
Journal:  Complement Ther Clin Pract       Date:  2020-06-17       Impact factor: 2.446

Review 6.  Pharmacological treatments of COVID-19.

Authors:  Adeleh Sahebnasagh; Razieh Avan; Fatemeh Saghafi; Mojataba Mojtahedzadeh; Afsaneh Sadremomtaz; Omid Arasteh; Asal Tanzifi; Fatemeh Faramarzi; Reza Negarandeh; Mohammadreza Safdari; Masoud Khataminia; Hassan Rezai Ghaleno; Solomon Habtemariam; Amirhosein Khoshi
Journal:  Pharmacol Rep       Date:  2020-08-20       Impact factor: 3.919

7.  Potential Repurposed Therapeutics and New Vaccines against COVID-19 and Their Clinical Status.

Authors:  Abid H Banday; Shameem A Shameem; Sheikh J Ajaz
Journal:  SLAS Discov       Date:  2020-07-21       Impact factor: 3.341

  7 in total

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