Hepatitis C virus NS3 protease genotyping and drug concentration determination during triple therapy with telaprevir or boceprevir for chronic infection with genotype 1 viruses, southeastern France

Journal of Medical Virology

Volumn 86, Issue 11, 2014, Pages 1868-1876

  Aherfi, Sarah ^a,b   Solas, Caroline ^a,c   Motte, Anne ^a   Moreau, Jacques ^d   Borentain, Patrick ^e   Mokhtari, Saadia ^d   Botta Fridlund, Danielle ^e   Dhiver, Catherine ^e   Portal, Isabelle ^e   Ruiz, Jean Marie ^f   Ravaux, Isabelle ^e   Bregigeon, Sylvie ^b   Poizot Martin, Isabelle ^g   Stein, Andreas ^e   Gérolami, René ^e   Brouqui, Philippe ^d   Tamalet, Catherine ^a,b   Colson, Philippe ^a,b  

^a TIMONE HOSPITAL   (France)

^b AIX MARSEILLE UNIVERSITY   (France)

^c University of the Mediterranean Aix Marseille II   (France)

^d HÔPITAL NORD   (France)

^e HÔPITAL DE LA CONCEPTION   (France)

^f Hopitaux Sud AP HM   (France)

^g AIX MARSEILLE UNIV   (France)

Author keywords

Boceprevir; Drug concentration; Hepatitis C virus; Protease inhibitor; Resistance mutation; Telaprevir

Indexed keywords

ATAZANAVIR PLUS RITONAVIR; BOCEPREVIR; DARUNAVIR; EMTRICITABINE; LOPINAVIR PLUS RITONAVIR; NONSTRUCTURAL PROTEIN 3; PEGINTERFERON; RALTEGRAVIR; RIBAVIRIN; RITONAVIR; TELAPREVIR; TENOFOVIR; VIRUS RNA; ALPHA INTERFERON; ANTIVIRUS AGENT; N-(3-AMINO-1-(CYCLOBUTYLMETHYL)-2,3-DIOXOPROPYL)-3-(2-((((1,1-DIMETHYLETHYL)AMINO)CARBONYL)AMINO)-3,3-DIMETHYL-1-OXOBUTYL)-6,6-DIMETHYL-3-AZABICYCLO(3.1.0)HEXAN-2-CARBOXAMIDE; NS3 PROTEIN, HEPATITIS C VIRUS; OLIGOPEPTIDE; PROLINE; VIRUS PROTEIN;

ADULT; AMINO ACID SUBSTITUTION; ANTIVIRAL RESISTANCE; ARTICLE; CLINICAL ARTICLE; DRUG BLOOD LEVEL; DRUG EXPOSURE; DRUG HYPERSENSITIVITY; DRUG MONITORING; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; FRANCE; GENE SEQUENCE; HEPATITIS C; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS SUBTYPE 1A; HEPATITIS C VIRUS SUBTYPE 1B; HUMAN; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; LIMIT OF QUANTITATION; MALE; MEDICATION COMPLIANCE; MIXED INFECTION; NUCLEOTIDE SEQUENCE; OBSERVATIONAL STUDY; RETROSPECTIVE STUDY; VIRUS LOAD; ANALOGS AND DERIVATIVES; CHEMISTRY; DRUG COMBINATION; GENETICS; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; ISOLATION AND PURIFICATION; MIDDLE AGED; MISSENSE MUTATION; PLASMA; PROCEDURES; TREATMENT FAILURE; UNIVERSITY HOSPITAL; VIROLOGY; YOUNG ADULT;

ADULT; AMINO ACID SUBSTITUTION; ANTIVIRAL AGENTS; DRUG RESISTANCE, VIRAL; DRUG THERAPY, COMBINATION; FEMALE; FRANCE; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HOSPITALS, UNIVERSITY; HUMANS; INTERFERON-ALPHA; MALE; MIDDLE AGED; MUTATION, MISSENSE; OLIGOPEPTIDES; PLASMA; PROLINE; RIBAVIRIN; TREATMENT FAILURE; VIRAL LOAD; VIRAL NONSTRUCTURAL PROTEINS; YOUNG ADULT;

EID: 84906832230     PISSN: 01466615     EISSN: 10969071     Source Type: Journal    
DOI: 10.1002/jmv.24016     Document Type: Article

References (30)

1. Anonymous. 2011. FDA Advisory Committee reviews safety of boceprevir. AIDS Patient Care STDS 25:384.
2. Anonymous. 2012. INCIVEKTM (telaprevir) film coated tablets, for oral use initial U.S. approval: 2011. http://www.natap.org/2010/HCV/201917s004lbl.pdf
3. Anonymous. 2013. Prise de position de la Société de Pathologie Infectieuse de Langue Française (SPILF), l'Association Française pour l'Etude du Foie (AFEF), la Société Française de Lutte contre le Sida (SFLS), et la Société Nationale Française de Médecine Interne (SNFMI) sur l'utilisation des inhibiteurs de protease du VHC de premiere generation chez les patients co-infectes par le VIH et le VHC, de génotype 1. http://www.vih.org/sites/default/files/RecomandationsIPantiVHC%20coinfection%20VIHVHC220313.pdf
4. Bartels DJ, Zhou Y, Zhang EZ, Marcial M, Byrn RA, Pfeiffer T, Tigges AM, Adiwijaya BS, Lin C, Kwong AD, Kieffer TL. 2008. Natural prevalence of hepatitis C virus variants with decreased sensitivity to NS3.4A protease inhibitors in treatment-naive subjects. J Infect Dis 198:800-807.
5. Burger D, Back D, Buggisch P, Buti M, Craxi A, Foster G, Klinker H, Larrey D, Nikitin I, Pol S, Puoti M, Romero-Gomez M, Wedemeyer H, Zeuzem S. 2013. Clinical management of drug-drug interactions in HCV therapy: Challenges and solutions. J Hepatol 58:792-800.
6. Cento V, Mirabelli C, Salpini R, Dimonte S, Artese A, Costa G, Mercurio F, Svicher V, Parrotta L, Bertoli A, Ciotti M, Di PD, Sarrecchia C, Andreoni M, Alcaro S, Angelico M, Perno CF, Ceccherini-Silberstein F. 2012. HCV genotypes are differently prone to the development of resistance to linear and macrocyclic protease inhibitors. PLoS ONE 7:e39652.
7. Colson P, Purgus R, Borentain P, Gerolami R. 2012. Natural presence of NS3 protease R155K hepatitis C virus variants with decreased sensitivity to protease inhibitors. J Clin Virol 53:178-180.
8. De Meyer S, Ghys A, Foster GR, Beumont M, Van BB, Lin TI, Dierynck I, Ceulemans H, Picchio G. 2013. Analysis of genotype 2 and 3 hepatitis C virus variants in patients treated with telaprevir demonstrates a consistent resistance profile across genotypes. J Viral Hepat 20:395-403.
9. Edgar RC. 2004. MUSCLE: Multiple sequence alignment with high accuracy and high throughput. Nucleic Acids Res 32:1792-1797.
10. Hulskotte EG, Feng HP, Xuan F, van Zutven MG, Treitel MA, Hughes EA, O'Mara E, Youngberg SP, Wagner JA, Butterton JR. 2013. Pharmacokinetic interactions between the hepatitis C virus protease inhibitor boceprevir and ritonavir-boosted HIV-1 protease inhibitors atazanavir, darunavir, and lopinavir. Clin Infect Dis 56:718-726.
11. Jiang M, Mani N, Lin C, Ardzinski A, Nelson M, Reagan D, Bartels D, Zhou Y, Nicolas O, Rao BG, Muh U, Hanzelka B, Tigges A, Rijnbrand R, Kieffer TL. 2013. In vitro phenotypic characterization of hepatitis C virus NS3 protease variants observed in clinical studies of telaprevir. Antimicrob Agents Chemother 57:6236-6245.
12. Kieffer TL, Sarrazin C, Miller JS, Welker MW, Forestier N, Reesink HW, Kwong AD, Zeuzem S. 2007. Telaprevir and pegylated interferon-alpha-2a inhibit wild-type and resistant genotype 1 hepatitis C virus replication in patients. Hepatology 46:631-639.
13. Knox TA, Oleson L, von Moltke LL, Kaufman RC, Wanke CA, Greenblatt DJ. 2008. Ritonavir greatly impairs CYP3A activity in HIV infection with chronic viral hepatitis. J Acquir Immune Defic Syndr 49:358-368.
14. Lavanchy D. 2011. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect 17:107-115.
15. Leroy V, Serfaty L, Bourliere M, Bronowicki JP, Delasalle P, Pariente A, Pol S, Zoulim F, Pageaux GP. 2012. Protease inhibitor-based triple therapy in chronic hepatitis C: Guidelines by the French Association for the Study of the Liver. Liver Int 32:1477-1492.
16. Liang TJ, Ghany MG. 2013. Current and future therapies for hepatitis C virus infection. N Engl J Med 368:1907-1917.
17. Lopez-Labrador FX. 2008. Hepatitis C virus NS3/4A protease inhibitors. Recent Pat Antiinfect Drug Discov 3:157-167.
18. Marcellin P, Pequignot F, Delarocque-Astagneau E, Zarski JP, Ganne N, Hillon P, Antona D, Bovet M, Mechain M, Asselah T, Desenclos JC, Jougla E. 2008. Mortality related to chronic hepatitis B and chronic hepatitis C in France: Evidence for the role of HIV coinfection and alcohol consumption. J Hepatol 48:200-207.
19. Nasu A, Marusawa H, Ueda Y, Nishijima N, Takahashi K, Osaki Y, Yamashita Y, Inokuma T, Tamada T, Fujiwara T, Sato F, Shimizu K, Chiba T. 2011. Genetic heterogeneity of hepatitis C virus in association with antiviral therapy determined by ultra-deep sequencing. PLoS ONE 6:e24907.
20. Pearlman BL. 2012. Protease inhibitors for the treatment of chronic hepatitis C genotype-1 infection: The new standard of care. Lancet Infect Dis 12:717-728.
21. Reesink HW, Zeuzem S, Weegink CJ, Forestier N, van VA, van de Wetering de Rooij J, McNair L, Purdy S, Kauffman R, Alam J, Jansen PL. 2006. Rapid decline of viral RNA in hepatitis C patients treated with VX-950: A phase Ib, placebo-controlled, randomized study. Gastroenterology 131:997-1002.
22. Sarrazin C, Zeuzem S. 2010. Resistance to direct antiviral agents in patients with hepatitis C virus infection. Gastroenterology 138:447-462.
23. Shepard CW, Finelli L, Alter MJ. 2005. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis 5:558-567.
24. Smith DB, Bukh J, Kuiken C, Muerhoff AS, Rice CM, Stapleton JT, Simmonds P. 2013. Expanded classification of hepatitis C Virus into 7 genotypes and 67 Subtypes: Updated criteria and assignment web resource. Hepatology 59:318-327.
25. Stone J, Wenning LA, Hang Y, Su J, Gupta S, Tsai K, Brass CA, O'Mara E. 2011. Assessment of boceprevir pharmacokinetic/pharmacodynamic relationships for sustained viral response and occurrence of anemia from phase 3 data. Hepatology 54:993A.
26. Tamura K, Peterson D, Peterson N, Stecher G, Nei M, Kumar S. 2011. MEGA5: Molecular evolutionary genetics analysis using maximum likelihood, evolutionary distance, and maximum parsimony methods. Mol Biol Evol 28:2731-2739.
27. Trimoulet P, Pinson P, Papuchon J, Foucher J, Vergniol J, Chermak F, Wittkop L, Castaing N, Merrouche W, Reigadas S, Molimard M, Kann M, Fleury H, de Lédinghen V. 2013. Dynamic and rapid changes in viral quasispecies by UDPS in chronic hepatitis C patients receiving telaprevir-based therapy. Antivir Ther 18:723-727.
28. Vallet S, Viron F, Henquell C, Le Guillou-Guillemette H, Lagathu G, Abravanel F, Trimoulet P, Soussan P, Schvoerer E, Rosenberg A, Gouriou S, Colson P, Izopet J, Payan C. 2011. NS3 protease polymorphism and natural resistance to protease inhibitors in French patients infected with HCV genotypes 1-5. Antivir Ther 16:1093-1102.
29. Wenning LA, Flexner C, Liu R, Poland B, Tsai K, Ping Feng H, Stone JA, Wahl J, Sklar P, Greaves W, Sulkowski MS. 2012. Pharmacokinetic/pharmacodynamic relationships for sustained viral response (SVR) and occurrence of anemia: Results in HCV/HIV co-infected patients and in combined mono and co-infected patients. Hepatology 56:564A.
30. Wyles DL. 2012. Beyond telaprevir and boceprevir: Resistance and new agents for hepatitis C virus infection. Top Antivir Med 20:139-145.