Literature DB >> 24442794

Sofosbuvir: first global approval.

Gillian M Keating1, Asha Vaidya.   

Abstract

Sofosbuvir (Solvadi™), a nucleotide analogue hepatitis C virus NS5B polymerase inhibitor, is under development with Gilead Sciences for the once-daily, oral treatment of chronic hepatitis C. Oral sofosbuvir has been approved in the US for the treatment of chronic hepatitis C as a component of a combination antiviral regimen. In addition, the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of sofosbuvir for the treatment of chronic hepatitis C. This article summarizes the milestones in the development of sofosbuvir leading to this first approval for chronic hepatitis C.

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Year:  2014        PMID： 24442794     DOI： 10.1007/s40265-014-0179-7

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


  13 in total

1.  Sofosbuvir-based interferon-free therapy for patients with HCV infection.

Authors:  Tarik Asselah
Journal:  J Hepatol       Date:  2013-07-25       Impact factor: 25.083

2.  Lack of a clinically important pharmacokinetic interaction between sofosbuvir or ledipasvir and hormonal oral contraceptives norgestimate/ethinyl estradiol in HCV-uninfected female subjects.

Authors:  P German; L Moorehead; Phillip Pang; M Vimal; A Mathias
Journal:  J Clin Pharmacol       Date:  2014-06-24       Impact factor: 3.126

3.  Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial.

Authors:  Kris V Kowdley; Eric Lawitz; Israel Crespo; Tarek Hassanein; Mitchell N Davis; Michael DeMicco; David E Bernstein; Nezam Afdhal; John M Vierling; Stuart C Gordon; Jane K Anderson; Robert H Hyland; Hadas Dvory-Sobol; Di An; Robert G Hindes; Efsevia Albanis; William T Symonds; M Michelle Berrey; David R Nelson; Ira M Jacobson
Journal:  Lancet       Date:  2013-03-15       Impact factor: 79.321

4.  Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial.

Authors:  Eric Lawitz; Jay P Lalezari; Tarek Hassanein; Kris V Kowdley; Fred F Poordad; Aasim M Sheikh; Nezam H Afdhal; David E Bernstein; Edwin Dejesus; Bradley Freilich; David R Nelson; Douglas T Dieterich; Ira M Jacobson; Donald Jensen; Gary A Abrams; Jama M Darling; Maribel Rodriguez-Torres; K Rajender Reddy; Mark S Sulkowski; Natalie H Bzowej; Robert H Hyland; Hongmei Mo; Ming Lin; Michael Mader; Robert Hindes; Efsevia Albanis; William T Symonds; Michelle M Berrey; Andrew Muir
Journal:  Lancet Infect Dis       Date:  2013-03-15       Impact factor: 25.071

5.  Sofosbuvir for previously untreated chronic hepatitis C infection.

Authors:  Eric Lawitz; Alessandra Mangia; David Wyles; Maribel Rodriguez-Torres; Tarek Hassanein; Stuart C Gordon; Michael Schultz; Mitchell N Davis; Zeid Kayali; K Rajender Reddy; Ira M Jacobson; Kris V Kowdley; Lisa Nyberg; G Mani Subramanian; Robert H Hyland; Sarah Arterburn; Deyuan Jiang; John McNally; Diana Brainard; William T Symonds; John G McHutchison; Aasim M Sheikh; Zobair Younossi; Edward J Gane
Journal:  N Engl J Med       Date:  2013-04-23       Impact factor: 91.245

6.  Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options.

Authors:  Ira M Jacobson; Stuart C Gordon; Kris V Kowdley; Eric M Yoshida; Maribel Rodriguez-Torres; Mark S Sulkowski; Mitchell L Shiffman; Eric Lawitz; Gregory Everson; Michael Bennett; Eugene Schiff; M Tarek Al-Assi; G Mani Subramanian; Di An; Ming Lin; John McNally; Diana Brainard; William T Symonds; John G McHutchison; Keyur Patel; Jordan Feld; Stephen Pianko; David R Nelson
Journal:  N Engl J Med       Date:  2013-04-23       Impact factor: 91.245

7.  Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics: a randomized clinical trial.

Authors:  Anuoluwapo Osinusi; Eric G Meissner; Yu-Jin Lee; Dimitra Bon; Laura Heytens; Amy Nelson; Michael Sneller; Anita Kohli; Lisa Barrett; Michael Proschan; Eva Herrmann; Bhavana Shivakumar; Wenjuan Gu; Richard Kwan; Geb Teferi; Rohit Talwani; Rachel Silk; Colleen Kotb; Susan Wroblewski; Dawn Fishbein; Robin Dewar; Helene Highbarger; Xiao Zhang; David Kleiner; Brad J Wood; Jose Chavez; William T Symonds; Mani Subramanian; John McHutchison; Michael A Polis; Anthony S Fauci; Henry Masur; Shyamasundaran Kottilil
Journal:  JAMA       Date:  2013-08-28       Impact factor: 56.272

Review 8.  Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence.

Authors:  Khayriyyah Mohd Hanafiah; Justina Groeger; Abraham D Flaxman; Steven T Wiersma
Journal:  Hepatology       Date:  2013-02-04       Impact factor: 17.425

9.  Sofosbuvir plus ribavirin for the treatment of chronic genotype 4 hepatitis C virus infection in patients of Egyptian ancestry.

Authors:  Peter J Ruane; Dani Ain; Richard Stryker; Raymond Meshrekey; Mina Soliman; Peter R Wolfe; Joseph Riad; Sameh Mikhail; Kathryn Kersey; Deyuan Jiang; Benedetta Massetto; Brian Doehle; Brian J Kirby; Steven J Knox; John G McHutchison; William T Symonds
Journal:  J Hepatol       Date:  2014-11-05       Impact factor: 25.083

Review 10.  Current prospects for interferon-free treatment of hepatitis C in 2012.

Authors:  Catherine A M Stedman
Journal:  J Gastroenterol Hepatol       Date:  2013-01       Impact factor: 4.029
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  27 in total

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Authors:  Pedro N Batalha; Luana S M Forezi; Carolina G S Lima; Fernanda P Pauli; Fernanda C S Boechat; Maria Cecília B V de Souza; Anna C Cunha; Vitor F Ferreira; Fernando de C da Silva
Journal:  Bioorg Chem       Date:  2020-11-19       Impact factor: 5.275

Review 2.  Animal Models of Zika Virus Infection, Pathogenesis, and Immunity.

Authors:  Thomas E Morrison; Michael S Diamond
Journal:  J Virol       Date:  2017-03-29       Impact factor: 5.103

Review 3.  Structure and function of Zika virus NS5 protein: perspectives for drug design.

Authors:  Boxiao Wang; Stephanie Thurmond; Rong Hai; Jikui Song
Journal:  Cell Mol Life Sci       Date:  2018-02-08       Impact factor: 9.261

4.  2'-C-methylated nucleotides terminate virus RNA synthesis by preventing active site closure of the viral RNA-dependent RNA polymerase.

Authors:  Alyson K Boehr; Jamie J Arnold; Hyung S Oh; Craig E Cameron; David D Boehr
Journal:  J Biol Chem       Date:  2019-10-01       Impact factor: 5.157

5.  The FDA-approved drug sofosbuvir inhibits Zika virus infection.

Authors:  Kristen M Bullard-Feibelman; Jennifer Govero; Zhe Zhu; Vanessa Salazar; Milena Veselinovic; Michael S Diamond; Brian J Geiss
Journal:  Antiviral Res       Date:  2016-11-27       Impact factor: 5.970

6.  Direct Acting Anti-hepatitis C Virus Drugs: Clinical Pharmacology and Future Direction.

Authors:  Ayman Geddawy; Yasmine F Ibrahim; Nabil M Elbahie; Mohammad A Ibrahim
Journal:  J Transl Int Med       Date:  2017-03-31

7.  Screening HCV genotype-specific epitope peptides based on conserved sequence analysis and B cell epitope prediction in HCV E2 region.

Authors:  Rui Hua; Xiaoyu Jiang; Lingxia Qi; Shanshan Guan; Ziyu Kuai; Yongbo Qiao; Yan Xu; Xin Gong; Yuhua Shi; Wei Kong; Junqi Niu; Hao Zhang; Yaming Shan
Journal:  Immunol Res       Date:  2018-02       Impact factor: 2.829

Review 8.  Modern Approaches for Asymmetric Construction of Carbon-Fluorine Quaternary Stereogenic Centers: Synthetic Challenges and Pharmaceutical Needs.

Authors:  Yi Zhu; Jianlin Han; Jiandong Wang; Norio Shibata; Mikiko Sodeoka; Vadim A Soloshonok; Jaime A S Coelho; F Dean Toste
Journal:  Chem Rev       Date:  2018-04-02       Impact factor: 60.622

9.  Discovery of a Series of 2'-α-Fluoro,2'-β-bromo-ribonucleosides and Their Phosphoramidate Prodrugs as Potent Pan-Genotypic Inhibitors of Hepatitis C Virus.

Authors:  Seema Mengshetti; Longhu Zhou; Ozkan Sari; Coralie De Schutter; Hongwang Zhang; Jong Hyun Cho; Sijia Tao; Leda C Bassit; Kiran Verma; Robert A Domaoal; Maryam Ehteshami; Yong Jiang; Reuben Ovadia; Mahesh Kasthuri; Olivia Ollinger Russell; Tamara McBrayer; Tony Whitaker; Judy Pattassery; Maria Luz Pascual; Lothar Uher; Biing Y Lin; Sam Lee; Franck Amblard; Steven J Coats; Raymond F Schinazi
Journal:  J Med Chem       Date:  2019-02-07       Impact factor: 7.446

10.  Genotypic and phenotypic analyses of hepatitis C virus variants observed in clinical studies of VX-222, a nonnucleoside NS5B polymerase inhibitor.

Authors:  Min Jiang; Eileen Z Zhang; Andrzej Ardzinski; Ann Tigges; Andrew Davis; James C Sullivan; Michelle Nelson; Joan Spanks; Jennifer Dorrian; Olivier Nicolas; Doug J Bartels; B Govinda Rao; Rene Rijnbrand; Tara L Kieffer
Journal:  Antimicrob Agents Chemother       Date:  2014-06-30       Impact factor: 5.191
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