Naturally occurring resistance mutations to inhibitors of HCV NS5A region and NS5B polymerase in DAA treatment-naïve patients

Virology Journal

Volumn 10, Issue , 2013, Pages

  Paolucci, Stefania ^a   Fiorina, Loretta ^a   Mariani, Bianca ^a   Gulminetti, Roberto ^b   Novati, Stefano ^b   Barbarini, Giorgio ^a   Bruno, Raffaele ^a   Baldanti, Fausto ^a  

^a FONDAZIONE IRCCS POLICLINICO SAN MATTEO   (Italy)

^b UNIVERSITY OF PAVIA   (Italy)

Author keywords

DAA inhibitors; HCV baseline resistance; Hepatitis C virus; NS5A and NS5B genes

Indexed keywords

DACLATASVIR; DELEOBUVIR; FILIBUVIR; LEDIPASVIR; MERICITABINE; NONSTRUCTURAL PROTEIN 5A; NONSTRUCTURAL PROTEIN 5B; SAMATASVIR; SOFOSBUVIR; TEGOBUVIR;

ARTICLE; CLINICAL ARTICLE; FEMALE; GENE MUTATION; GENOTYPE; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; MALE; NONHUMAN;

HEPATITIS C VIRUS;

ANTIVIRAL AGENTS; DRUG RESISTANCE, VIRAL; FEMALE; GENOTYPE; HEPACIVIRUS; HEPATITIS C; HUMANS; MALE; MOLECULAR SEQUENCE DATA; MUTATION, MISSENSE; RNA, VIRAL; SEQUENCE ANALYSIS, DNA; VIRAL NONSTRUCTURAL PROTEINS;

EID: 84890289271     PISSN: None     EISSN: 1743422X     Source Type: Journal    
DOI: 10.1186/1743-422X-10-355     Document Type: Article

References (37)

1. An updated analysis of hepatitis C virus genotypes and subtypes based on the complete coding region. Nakano T, Lau GM, Lau GM, Sugiyama M, Mizokami M, Liver Int 2012 32 339 345 10.1111/j.1478-3231.2011.02684.x 22142261
2. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, Goodman ZD, Koury K, Ling M, Albrecht JK, Lancet 2001 358 958 965 10.1016/S0140-6736(01)06102-5 11583749 (Pubitemid 32913521)
3. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, Bodenheimer H Jr, Bernstein D, Rizzetto M, Zeuzem S, Pockros PJ, Lin A, Ackrill AM, PEGASYS International Study Group, Ann Intern Med Mar 2004 140 346 355 10.7326/0003-4819-140-5-200403020-00010
4. Hematologic side effects of interferon and ribavirin therapy. Kowdley KV, J Clin Gastroenterol 2005 39 1 Suppl 3 S8 15597025
5. What are the promising new therapies in the field of chronic hepatitis C after the first-generation direct-acting antivirals? Hunt D, Pockros P, Curr Gastroenterol 2013 15 303
6. In vitro resistance profile of the hepatitis C virus NS3/4A protease inhibitor TMC435. Lenz O, Verbinnen T, Lin TI, Vijgen L, Cummings MD, Lindberg J, Berke JM, Dehertogh P, Fransen E, Scholliers A, Vermeiren K, Ivens T, Raboisson P, Edlund M, Storm S, Vrang L, de Kock H, Fanning GC, Simmen KA, Antimicrob Agents Chemother 2010 54 1878 1887 10.1128/AAC.01452-09 20176898
7. In vitro resistance profile of the hepatitis C virus NS3 protease inhibitor BI 201335. Lagacé L, White PW, Bousquet C, Dansereau N, Dô F, Llinas-Brunet M, Marquis M, Massariol MJ, Maurice R, Spickler C, Thibeault D, Triki I, Zhao S, Kukolj G, Antimicrob Agents Chemother 2012 56 569 572 10.1128/AAC.05166-11 22024816
8. The HCV NS5B nucleoside and non-nucleoside inhibitors. Membreno FE, Lawitz EJ, Clin Liver Dis 2011 15 611 626 10.1016/j.cld.2011.05.003 21867940
9. Interferon free hepatitis C treatment regimens: the beginning of another era. Chee GM, Poordad F, Curr Gastroenterol 2012 14 74 77 10.1007/s11894-011- 0229-1
10. Best strategies for global HCV eradication. Hagan LM, Schinazi RF, Liver Int 2013 33 Suppl 1 68 79 23286849
11. NS5A inhibitors in the treatment of hepatitis C. Pawlotsky JM, J Hepatol 2013 59 375 382 10.1016/j.jhep.2013.03.030 23567084
12. The presence of resistance mutations to protease and polymerase inhibitors in Hepatitis C virus sequences from the Los Alamos databank. Alves R, Queiroz AT, Pessoa MG, da Silva EF, Mazo DF, Carrilho FJ, Carvalho-Filho RJ, de Carvalho IM, J Viral Hepat 2013 20 414 421 10.1111/jvh.12051 23647958
13. Clinical implications of hepatitis C viral kinetics. Zeuzem S, Hepatol 1999 31 1 61 64 (Pubitemid 30002693)
14. Implications of baseline polymorphisms for potential resistance to NS3 protease inhibitors in Hepatitis C virus genotypes 1a, 2b and 3a. Palanisamy N, Danielsson A, Kokkula C, Yin H, Bondeson K, Wesslén L, Duberg AS, Lennerstrand J, Antiviral Res 2013 99 12 17 10.1016/j.antiviral.2013.04.018 23648709
15. Resistance analysis of the hepatitis C virus NS5A inhibitor BMS-790052 in an in vitro replicon system. Fridell RA, Qiu D, Wang C, Valera L, Gao M, Antimicrob Agents Chemother 2010 54 3641 3650 10.1128/AAC.00556-10 20585111
16. A multi-variant, viral dynamic model of genotype 1 HCV to assess the in vivo evolution of protease-inhibitor resistant variants. Adiwijaya BS, Herrmann E, Hare B, Kieffer T, Lin C, Kwong AD, Garg V, Randle JC, Sarrazin C, Zeuzem S, Caron PR, PLoS Comput Biol 2010 15 6(4) 1000745
17. Hepatitis C virus variants with decreased sensitivity to direct-acting antivirals (DAAs) were rarely observed in DAA-naive patients prior to treatment. Bartels DJ, Sullivan JC, Zhang EZ, Tigges AM, Dorrian JL, De Meyer S, Takemoto D, Dondero E, Kwong AD, Picchio G, Kieffer TL, J Virol 2013 87 1544 1553 10.1128/JVI.02294-12 23152524
18. In vitro selection and characterization of HCV replicons resistant to multiple non-nucleoside polymerase inhibitors. Delang L, Vliegen I, Leyssen P, Neyts J, J Hepatol 2012 56 41 48 10.1016/j.jhep.2011.04.016 21703175
19. Genotypic and phenotypic analysis of variants resistant to hepatitis C virus nonstructural protein 5A replication complex inhibitor BMS-790052 in humans: in vitro and in vivo correlations. Fridell RA, Wang C, Sun JH, O'Boyle DR 2nd, Nower P, Valera L, Qiu D, Roberts S, Huang X, Kienzle B, Bifano M, Nettles RE, Gao M, Hepatology 2011 54 1924 1935 10.1002/hep.24594 21809362
20. Effect on hepatitis C virus replication of combinations of direct-acting antivirals, including NS5A inhibitor daclatasvir. Pelosi LA, Voss S, Liu M, Gao M, Lemm JA, Antimicrob Agents Chemother 2012 56 5230 5239 10.1128/AAC.01209-12 22850513
21. Characterization of resistance to the nonnucleoside NS5B inhibitor filibuvir in hepatitis C virus-infected patients. Troke PJ, Lewis M, Simpson P, Gore K, Hammond J, Craig C, Westby M, Antimicrob Agents Chemother 2012 56 1331 1341 10.1128/AAC.05611-11 22203605
22. Hepatitis C therapy: highlights from the 2012 annual meeting of the European Association for the Study of the Liver. Barreiro P, Vispo E, Poveda E, Fernández-Montero JV, Soriano V, Clin Infect Dis 2013 56 560 566 10.1093/cid/cis915 23090932
23. Natural prevalence of hepatitis C virus variants with decreased sensitivity to NS3.4A protease inhibitors in treatment-naive subjects. Bartels DJ, Zhou Y, Zhang EZ, Marcial M, Byrn RA, Pfeiffer T, Tigges AM, Adiwijaya BS, Lin C, Kwong AD, Kieffer TL, J Infect Dis 2008 198 800 807 10.1086/591141 18637752
24. Naturally occurring dominant resistance mutations to hepatitis C virus protease and polymerase inhibitors in treatment-naïve patients. Kuntzen T, Timm J, Berical A, Lennon N, Berlin AM, Young SK, Lee B, Heckerman D, Carlson J, Reyor LL, Kleyman M, McMahon CM, Birch C, Schulze Zur Wiesch J, Ledlie T, Koehrsen M, Kodira C, Roberts AD, Lauer GM, Rosen HR, Bihl F, Cerny A, Spengler U, Liu Z, Kim AY, Xing Y, Schneidewind A, Madey MA, Fleckenstein JF, Park VM, et al. Hepatology 2008 48 1769 1778 10.1002/hep.22549 19026009
25. Future treatment of chronic hepatitis C with direct acting antivirals: is resistance important? Halfon P, Sarrazin C, Liver Int 2012 32 Suppl 1 79 87
26. Naturally occurring mutations to HCV protease inhibitors in treatment-naïve patients. Paolucci S, Fiorina L, Piralla A, Gulminetti R, Novati S, Barbarini G, Sacchi P, Gatti M, Dossena L, Baldanti F, Virol J 2012 24 9 245
27. Prevalence of hepatitis C virus variants resistant to NS3 protease inhibitors or the NS5A inhibitor (BMS-790052) in hepatitis patients with genotype 1b. Suzuki F, Sezaki H, Akuta N, Suzuki Y, Seko Y, Kawamura Y, Hosaka T, Kobayashi M, Saito S, Arase Y, Ikeda K, Kobayashi M, Mineta R, Watahiki S, Miyakawa Y, Kumada H, J Clin Virol 2012 54 352 354 10.1016/j.jcv.2012.04.024 22658798
28. Prevalence of natural polymorphisms at the HCV NS5A gene associated with resistance to daclatasvir, an NS5A inhibitor. Plaza Z, Soriano V, Vispo E, del Mar Gonzalez M, Barreiro P, Seclén E, Poveda E, Antivir Ther 2012 17 921 926 10.3851/IMP2091 22436385
29. A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C. Lawitz EJ, Gruener D, Hill JM, Marbury T, Moorehead L, Mathias A, Cheng G, Link JO, Wong KA, Mo H, McHutchison JG, Brainard DM, J Hepatol 2012 57 24 31 10.1016/j.jhep.2011.12.029 22314425
30. Preclinical characterization of GSK2336805, a novel inhibitor of hepatitis C virus replication that selects for resistance in NS5A. Walker J, Crosby R, Wang A, Woldu E, Vamathevan J, Voitenleitner C, You S, Remlinger K, Duan M, Kazmierski W, Hamatake R, Antimicrob Agents Chemother 2013 [Epub ahead of print]
31. Hepatitis C Virus NS5A Inhibitor IDX719 Demonstrates Potent, Pan-genotypic Activity in Preclinical and Clinical Studies [abstract]. McCarville JF, Chapron C, LaColla M, Bilello JP, Lallos LB, Seifer M, Standring DN, Hepatol Int 2013 7 330
32. In Vivo Emergence of a Novel Mutant L159F/L320F in the NS5B Polymerase Confers Low-Level Resistance to the HCV Polymerase Inhibitors Mericitabine and Sofosbuvir. Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Nájera I, J Infect Dis 2013 [Epub ahead of print]
33. Hepatitis C virus nucleotide inhibitors PSI-352938 and PSI-353661 exhibit a novel mechanism of resistance requiring multiple mutations within replicon RNA. Lam AM, Espiritu C, Bansal S, Micolochick Steuer HM, Zennou V, Otto MJ, Furman PA, J Virol 2011 85 12334 12342 10.1128/JVI.05639-11 21957306
34. Mechanistic characterization of GS-9190 (Tegobuvir), a novel nonnucleoside inhibitor of hepatitis C virus NS5B polymerase. Shih IH, Vliegen I, Peng B, Yang H, Hebner C, Paeshuyse J, Pürstinger G, Fenaux M, Tian Y, Mabery E, Qi X, Bahador G, Paulson M, Lehman LS, Bondy S, Tse W, Reiser H, Lee WA, Schmitz U, Neyts J, Zhong W, Antimicrob Agents Chemother 2011 55 4196 4203 10.1128/AAC.00307-11 21746939
35. Antiviral effect, safety, and pharmacokinetics of five-day oral administration of Deleobuvir (BI 207127), an investigational hepatitis C virus RNA polymerase inhibitor, in patients with chronic hepatitis C. Larrey D, Lohse AW, Trepo C, Bronowicki JP, Arastéh K, Bourlière M, Calleja JL, Stern JO, Nehmiz G, Abdallah N, Berger KL, Marquis M, Steffgen J, Kukolj G, BI 207127 Study Group, Antimicrob Agents Chemother 2013 57 4727 4735 10.1128/AAC.00565-13 23856779
36. Natural prevalence of NS5A polymorphisms in subjects infected with hepatitis C virus genotype 3 and their effects on the antiviral activity of NS5A inhibitors. Hernandez D, Zhou N, Ueland J, Monikowski A, McPhee F, J Clin Virol 2013 57 13 18 10.1016/j.jcv.2012.12.020 23384816
37. Genotype and subtype profiling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus. Lam AM, Espiritu C, Bansal S, Micolochick Steuer HM, Niu C, Zennou V, Keilman M, Zhu Y, Lan S, Otto MJ, Furman PA, Antimicrob Agents Chemother 2012 56 3359 3368 10.1128/AAC.00054-12 22430955