Ombitasvir (ABT-267), a novel NS5A inhibitor for the treatment of hepatitis C

Bibliography

• Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect 2011;17:107-15
   PubMed Web of Science ®Google Scholar
• Smith DB, Bukh J, Kuiken C, et al. Expanded classification of hepatitis C virus into 7 genotypes and 67 subtypes: updated criteria and genotype assignment Web resource. Hepatology 2014;59:318-27
   PubMed Web of Science ®Google Scholar
• Chamberlain RW, Adams N, Saeed AA, et al. Complete nucleotide sequence of a type 4 hepatitis C virus variant, the predominant genotype in the Middle East. J Gen Virol 1997;78(Pt 6):1341-7
   Google Scholar
• Murphy DG, Willems B, Vincelette J, et al. Biological and clinicopathological features associated with hepatitis C virus type 5 infections. J Hepatol 1996;24:109-13
   Google Scholar
• Li CSY, Chan PKS, Tang JW. Molecular epidemiology of hepatitis C genotype 6a from patients with chronic hepatitis C from Hong Kong. J Med Virol 2009;81:628-33
   Google Scholar
• Freeman AJ, Dore GJ, Law MG, et al. Estimating progression to cirrhosis in chronic hepatitis C virus infection. Hepatology 2001;34:809-16
   PubMed Web of Science ®Google Scholar
• El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology 2012;142:1264-73
   PubMed Web of Science ®Google Scholar
• Aghemo A, De Francesco R. New horizons in hepatitis C antiviral therapy with direct-acting antivirals. Hepatology 2013;58:428-38
   PubMed Web of Science ®Google Scholar
• Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014;370:211-21
   PubMed Web of Science ®Google Scholar
• Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 2014;59:2083-91
   PubMed Web of Science ®Google Scholar
• Lok AS, Gardiner DF, Hézode C, et al. Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders. J Hepatol 2014;60:490-9
   PubMed Web of Science ®Google Scholar
• Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and Sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014;370:1889-98
   PubMed Web of Science ®Google Scholar
• Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and Sofosbuvir for Previously Treated HCV Genotype 1 Infection. N Engl J Med 2014;370:1483-93
   PubMed Web of Science ®Google Scholar
• Vince B, Hill JM, Lawitz EJ, et al. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4. J Hepatol 2014;60:920-7
   PubMed Web of Science ®Google Scholar
• Lawitz E, Rodriguez-Torres M, Nguyen T, et al. A Phase II Study of Samatasvir (IDX719) in Combination with Simeprevir and Ribavirin in Treatment-Naïve HCV-Infected Subjects with Genotypes 1b and 4 (HELIX-1 Study). Int. Liver Congr. 2014- 49th Annu. Meet. Eur. Assoc. Study Liver; London; Poster Present 2014. p. 1222
   Google Scholar
• Moradpour D, Penin F, Rice CM. Replication of hepatitis C virus. Nat Rev Microbiol 2007;5:453-63
   PubMed Web of Science ®Google Scholar
• Lange CM, Bellecave P, Dao Thi VL, et al. Determinants for Membrane Association of the Hepatitis C Virus NS2 Protease Domain. J Virol 2014;88:6519-23
   Google Scholar
• Tellinghuisen TL, Marcotrigiano J, Rice CM. Structure of the zinc-binding domain of an essential component of the hepatitis C virus replicase. Nature 2005;435:374-9
   PubMed Web of Science ®Google Scholar
• Lim PJ, Chatterji U, Cordek D, et al. Correlation between NS5A dimerization and hepatitis C virus replication. J Biol Chem 2012;287:30861-73
   PubMed Web of Science ®Google Scholar
• Huang L, Hwang J, Sharma SD, et al. Hepatitis C virus nonstructural protein 5A (NS5A) is an RNA-binding protein. J Biol Chem 2005;280:36417-28
   PubMed Web of Science ®Google Scholar
• Liang Y, Ye H, Kang CB, et al. Domain 2 of nonstructural protein 5A (NS5A) of hepatitis C virus is natively unfolded. Biochemistry 2007;46:11550-8
   Google Scholar
• Hanoulle X, Verdegem D, Badillo A, et al. Domain 3 of non-structural protein 5A from hepatitis C virus is natively unfolded. Biochem Biophys Res Commun 2009;381:634-8
   Google Scholar
• Degoey DA, Randolph JT, Liu D, et al. Discovery of ABT-267, a pan-genotypic inhibitor of HCV NS5A. J Med Chem 2014;57:2047-57
   PubMed Web of Science ®Google Scholar
• Krishnan P, Beyer J, Mistry N, et al. Antiviral activity and resistance profiles for ABT-267, a novel HCV NS5A inhibitor, in vitro and during 3-day monotherapy in HCV genotype-1 (GT-1)-infected treatemnt-naïve subjects. Liver Meet. 2012, 63rd Annu. Meet. AASLD, Boston; Poster Present 2012. p. 188
   Google Scholar
• Lawitz E, Marbury T, Campbell A, et al. Safety and antiviral activity of ABT-267, a novel NS5A inhibitor, during 3-day monotherapy: first study in HCV Genotype-1 (GT1)-infected treatment-naïve subjects. Int. Liver Congr. 2012- 47th Annu. Meet. Eur. Assoc. Study Liver; Barcelona; Poster Present 2012. p. 118
   Google Scholar
• Dumas E, Lawal A, Menon R, et al. Pharmacokinetics, safety and tolerability of the HCV NS5A inhibitor ABT-267 following single and multiple doses in healthy adult volunteers. Int. Liver Congr. 2011- 46th Annu. Meet. Eur. Assoc. Study Liver; Berlin; Poster Present 2011. p. 120
   Google Scholar
• Menon R, Kapoor M, Dumas E, et al. Multi-dose pharmacokinetics and safety following coadministration of ABT-450/r, ABT-267 and ABT-333 in Japanese, Chinese and Caucasian subjects. 23rd Conf. Asian Pacific Asoc. Study Liver; Singapore; Poster Present 2013. p. 1497
   Google Scholar
• Khatri A, Gaultier IA, Menon R, et al. Pharmacokinetics and safety of co-administered ABT-450 plus ritonavir (ABT 450/r), ABT-267 and ABT-333 as a single dose in subjects with normal hepatic function and in subjects with mild, moderate and severe hepatic impairment. Liver Meet. 2012, 63rd Annu. Meet. AASLD, Boston; Poster Present p. 2012. 758
   Google Scholar
• Badri P, Cohen D, Ding B, et al. Pharmacokinetics, safety and tolerability of cyclosporine or tacrolimus following coadministration of ABT-450/r, ABT-267 and ABT-333 in healthy subjects. World Transpl. Congr. 2014- 2nd Jt. Meet. Am. Soc. Transpl. Surg. (ASTS), Transplant. Soc. Am. Soc. Transplant. (AST); San Francisco; Poster Present 2014. p. B1121
   Google Scholar
• Neumann AU, Lam NP, Dahari H, et al. Hepatitis C viral dynamics in vivo and the antiviral efficacy of interferon-alpha therapy. Science 1998;282:103-7
   PubMed Web of Science ®Google Scholar
• Rong L, Dahari H, Ribeiro RM, et al. Rapid emergence of protease inhibitor resistance in hepatitis C virus. Sci Transl Med 2010;2:30ra32
   PubMed Web of Science ®Google Scholar
• Pawlotsky J-M. NS5A inhibitors in the treatment of hepatitis C. J Hepatol 2013;59:375-82
   PubMed Web of Science ®Google Scholar
• Wang C, Sun J-H, O’Boyle DR, et al. Persistence of resistant variants in hepatitis C virus-infected patients treated with the NS5A replication complex inhibitor daclatasvir. Antimicrob Agents Chemother 2013;57:2054-65
   PubMed Web of Science ®Google Scholar
• Schneider MD, Sarrazin C. Antiviral therapy of hepatitis C in 2014: do we need resistance testing? Antiviral Res 2014;105:64-71
   PubMed Web of Science ®Google Scholar
• Cheng G, Peng B, Corsa A, et al. Antiviral activity and resistance profile of the novel HCV NS5A inhibitor GS-5885. Int. Liver Congr. 2012 - 47th Annu. Meet. Eur. Assoc. Study Liver; Barcelona; Poster Present 2012. p. 1172
   Google Scholar
• Sullivan JG, Rodriguez-Torres M, Lawitz E, et al. ABT-267 combined with pegylated interferon Alpha-2a/ribavirin in genotype 1 (GT1) HCV-infected treatment-naïve subjects: 12-week antiviral and safety analysis. Int. Liver Congr. 2012 - 47th Annu. Meet. Eur. Assoc. Study Liver; Barcelona; Poster Present 2012. p. 121
   Google Scholar
• Epstein M, Felizarta F, Marbury T, et al. Study of ABT-267 2-day monotherapy followed by 12-week combination therapy in treatment-naïve patients with chronic HCV genotype 1 infection. Int. Liver Congr. 2013 - 48th Annu. Meet. Eur. Assoc. Study Liver; Amsterdam; Poster Present 2013. p. 119
   Google Scholar
• Kowdley K V, Lawitz E, Poordad F, et al. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med 2014;370:222-32
   Google Scholar
• Lawitz E, Sullivan G, Rodriguez-Torres M, et al. A 12-week trial of interferon-free regimens containing ABT-450/r and ABT-267 ± ribavirin (RBV) in treatment-naïve patients with HCV genotypes 1-3. 23rd Conf. Asian Pacific Asoc. Study Liver; Singapore; 2013. Poster Present 2013. p. 612
   Google Scholar
• Lawitz E, Hezode C, Varunok P, et al. Interferon- and ribavirin-free regimen of ABT-450/r + ABT-267 in HCV genotype 1b-infected treatment-naïve patients and prior null responders. 64th Annu. Meet. Am. Assoc. Study Liver Dis. Washington. 2013; Poster Present 2013. p. 75
   Google Scholar
• Hezode C, Marcellin P, Pol S, et al. Results from the Phase 2 PEARL-I study: interferon-free regimens of ABT-450/r + ABT-267 with or without ribavirin in patients with HCV genotype 4 infection. Int. Liver Congr. 2014 - 49th Annu. Meet. Eur. Assoc. Study Liver; London; Oral Present 2014. p. 58
   Google Scholar
• Kwo P, Mantry P, Coakley E, et al. Results of the phase 2 study M12-999: interferon-free regimen of ABT-450/r/ABT-267 + ABT-333 + ribavirin in liver transplant recipients with recurrent HCV genotpye 1 infection. Int. Liver Congr. 2014 - 49th Annu. Meet. Eur. Assoc. Study Liver; London; Oral Present 2014. p. 114
   Google Scholar
• Lalezari L, Sullivan J, Varunok P. IFN-free 3 DAA regimen in HCV genotype 1-infected patients on methadone or buprenorphine. 21th Conf. Retroviruses Opportunistic Infect. (CROI); Boston; 2014. Poster Present p. 662
   Google Scholar
• Feld JJ, Kowdley K V, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370:1594-603
   PubMed Web of Science ®Google Scholar
• Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1207-17
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Berg T, Gane E, et al. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology 2014;146:430-41.e6
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370:1604-14
   PubMed Web of Science ®Google Scholar
• Poordad F, Hezode C, Trinh R, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis c with cirrhosis. N Engl J Med 2014;370(21):1973-82
   PubMed Web of Science ®Google Scholar
• Messina JP, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology 2014. Available from: http://www.ncbi.nlm.nih.gov/pubmed/25069599 [Accessed 29 July 2014]
   Google Scholar
• Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002.347:975-82
   Google Scholar
• Karino Y, Toyota J, Ikeda K, et al. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol 2013.58:646-54
   Google Scholar
• Ng T, Krishnan P, Kati W, et al. ABT-530, an HCV NS5A inhibitor with potent pangenotypic activity and high genetic barrier to resistance. 21th Conf. Retroviruses Opportunistic Infect. (CROI); Boston; 2014. Poster Present 2014. p. 639
   Google Scholar
• Cheng G, Tian Y, Ya M, et al. GS-5816, a second-generation HCV NS5A inhibitor with potent antiviral activity, broad genotypic coverage, and a high resistance barrier. Int. Liver Congr. 2013 - 48th Annu. Meet. Eur. Assoc. Study Liver; Amsterdam; Poster Present 2013. p. 1191
   Google Scholar
• Liu R, Kong R (Stephanie), Mann P, et al. In vitro resistance analysis of Merck’s HCV NS5a inhibitor MK-8742 demonstrates increased potency against clinical resistance variants and improved resistance profile. Int. Liver Congr. 2012 - 47th Annu. Meet. Eur. Assoc. Study Liver; Barcelona; Poster Present 2012. p. 858
   Google Scholar
• Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364:2405-16
   PubMed Web of Science ®Google Scholar
• Poordad F, McCone J, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1195-206
   PubMed Web of Science ®Google Scholar
• Kowdley K V, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014;370:1879-88
   Google Scholar
• Manns MP, Bourlière M, Benhamou Y, et al. Potency, safety, and pharmacokinetics of the NS3/4A protease inhibitor BI201335 in patients with chronic HCV genotype-1 infection. J Hepatol 2011;54:1114-22
   PubMed Web of Science ®Google Scholar
• Zeuzem S, Buggisch P, Agarwal K, et al. The protease inhibitor, GS-9256, and non-nucleoside polymerase inhibitor tegobuvir alone, with ribavirin, or pegylated interferon plus ribavirin in hepatitis C. Hepatology 2012;55:749-58
   PubMed Web of Science ®Google Scholar
• A Study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before (MALACHITE-I). Clin. Available from: http//clinicaltrials.gov/show/NCT01854697 [Last accessed 30 August 2014]
   Google Scholar
• A study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) for treatment of chronic hepatitis C infection in treatment-experienced adults (MALACHITE-II). Clin. Available from: http//clinicaltrials.gov/ct2/show/NCT01854528 [Last accessed 30 August 2014]
   Google Scholar
• A Study to evaluate the safety and efficacy of ABT-450/Ritonavir/ABT-267 and ABT-333 coadministered with ribavirin in adults with genotype 1 chronic hepatitis C virus infection and human immunodeficiency virus, type 1 (HIV-1) coinfection (TURQUOISE-I). Clin. Available from: http//clinicaltrials.gov/show/NCT01939197 [Last accessed 30 August 2014]
   Google Scholar
• Gane EJ, Stedman CA, Hyland RH, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 2013;368:34-44
   PubMed Web of Science ®Google Scholar
• Josephson F. Drug-drug interactions in the treatment of HIV infection: focus on pharmacokinetic enhancement through CYP3A inhibition. J Intern Med 2010;268:530-9
   PubMed Web of Science ®Google Scholar
• Di Maio VC, Cento V, Mirabelli C, et al. Hepatitis C virus genetic variability and the presence of NS5B resistance-associated mutations as natural polymorphisms in selected genotypes could affect the response to NS5B inhibitors. Antimicrob Agents Chemother 2014;58:2781-97
   PubMed Web of Science ®Google Scholar
• Wedemeyer H, Duberg AS, Buti M, et al. Strategies to manage hepatitis C virus (HCV) disease burden. J Viral Hepat 2014;21(Suppl 1):60-89
   PubMed Web of Science ®Google Scholar
• Love RA, Brodsky O, Hickey MJ, et al. Crystal structure of a novel dimeric form of NS5A domain I protein from hepatitis C virus. J Virol 2009;83:4395-403
   PubMed Web of Science ®Google Scholar
• Gao M, Nettles RE, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature 2010;465:96-100
   PubMed Web of Science ®Google Scholar
• Dousson CB, La Colla M, Chapron C, et al. Idenix NS5A HCV replication inhibitors with low picomolar, pan-genotypic in vitro antiviral activity. Int. Liver Congr. 2011 - 46th Annu. Meet. Eur. Assoc. Study Liver; Berlin; Poster Present 2011. p. 815
   Google Scholar
• Feld JJ, Kowdley K V, Coakley E, et al. SAPPHIRE I: Phase 3 placebo-controlled study of interferon-free, 12-week regimen of ABT-450/r/ABT-267. ABT-333, and ribavirin in 631 treatment-naïve adults with hepatitis C virus genotype 1. Int. Liver Congr. 2014 - 49th Annu. Meet. Eur. Assoc. Study Liver; London; Oral Present 2014. p. 60
   Google Scholar
• Zeuzem S, Jacobson I, Baykal T, et al. SAPPHIRE II: Phase 3 placebo-controlled study of interferon-free, 12-week regimen of ABT-450/r/ABT-267, ABT-333, and ribavirin in treatment-experienced adults with hepatitis C virus genotype 1. Int. Liver Congr. 2014 - 49th Annu. Meet. Eur. Assoc. Study Liver; London; Oral Present 2014. p. 1
   Google Scholar