Oral antiviral therapies for chronic hepatitis C infection

Therapeutic Advances in Infectious Disease

Volumn 1, Issue 3, 2013, Pages 107-116

  Pol, Stanislas ^a   Corouge, Marion ^a   Sogni, Philippe ^a  

^a Institut Cochin   (France)

Author keywords

cirrhosis; combination therapy; direct acting antiviral; hepatitis C virus; polymerase inhibitor; protease inhibitor; replication complex inhibitor

Indexed keywords

EID: 84993724934     PISSN: 20499361     EISSN: 2049937X     Source Type: Journal    
DOI: 10.1177/2049936113488359     Document Type: Review

References (45)

1. Bacon B. Gordon S. Lawitz E. Marcellin P. Vierling J. Zeuzem S. et al (2011) Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 364: 1207–1217.
2. Bronowicki J. Pol S. Thuluvath P. Larrey D. Martorell C. Rustgi V. et al (2011) BMS-650032, an NS 3 inhibitor, in combination with peginterferon alpha-2a and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C infection. J Hepatol 54(Suppl. 1): S472–S472.
3. Buhler S. Bartenschlager R. (2012) New targets for antiviral therapy of chronic hepatitis C. Liver Int 32(Suppl.): 19–26.
4. Burger D. Back D. Buggisch P. Buti M. Craxí A. Foster G. et al (2013) Clinical management of drug–drug interactions in HCV therapy: challenges and solutions. J Hepatol 58: 792–800.
5. Burioni R. Perotti M. Mancini N. Clementi M. (2008) Perspectives for the utilization of neutralizing human monoclonal antibodies as anti-HCV drugs. J Hepatol 49: 299–300.
6. Cacoub P. Bourlière M. Lübbe J. Dupin N. Buggisch P. Dusheiko G. et al (2012) Dermatological side effects of hepatitis C and its treatment: patient management in the era of direct-acting antivirals. J Hepatol 56: 455–463.
7. Coelmont, L., Hanoulle, X., Chatterji, U., Berger, C., Snoeck, J., Bobardt, M. (2010). DEB 025 (Alisporivir) inhibits hepatitis C virus replication by preventing a cyclophilin A induced cis-trans isomerisation in domain II of NS5A. PloS ONE. 5: e13687.
8. Dieterich D. Asselah T. Guyader D. Berg T. Ceausu E. Preotescu L. et al (2011) Silen-C3: treatment for 12 or 24 weeks with BI 201335 combined with Peginterferon alpha-2A and ribavirin (P/R) in treatment-naïve patients with chronic genotype-1 HCV infection. Hepatology 54(Suppl.): 378A–378A.
9. Donnelly R. Kotenko S. (2010) Interferon-lambda: a new addition to an old family. J. Interferon Cytokine Res 30: 555–564.
10. European Association for the Study of the Liver (2011) EASL Clinical Practice Guidelines: management of chronic hepatitis C virus infection. J Hepatol 55: 245–264.
11. Flisiak R. Dumont J. Crabbe R. (2007) Cyclophilin inhibitors in hepatitis C viral infection. Expert Opin Inv Drugs 16: 1345–1354.
12. Foster G. Hezode C. Bronowicki J. Carosi G. Weiland O. Verlinden L. et al (2011) Telaprevir alone or with peginterferon and ribavirin reduces HCV RNA in patients with chronic genotype 2 but not genotype 3 infections. Gastroenterology 141: 881–889.
13. Fried M. Buti M. Dore G. Flisiak R. Ferenci P. Jacobson I. et al (2011) TMC 435 in combination with peginterferon and ribavirin in treatment naïve HCV genotype 1 patients: final analysis of the Pillar phase IIb study. Hepatology 54(Suppl.): 1429A–1429A.
14. Gane E. Roberts S. Stedman C. Angus P. Ritchie B. Elston R. et al (2010) Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and Danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet 376: 1467–1475.
15. Gane E. Stedman C. Hyland R. Ding X. Svarovskaia E. Symonds W. et al (2013) Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 368: 34–44.
16. Gao M. Nettles R. Belema M. Snyder L. Nguyen V. Fridell R. et al (2010) Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature 465: 96–100.
17. Gish, R.G., Meanwell, N.A. (2011) The NS5A replication complex inhibitors: difference makers? Clin Liver Dis 15: 627–639.
18. Hezode, C., Dorival, C., Zoulim, F., Poynard, T., Mathurin, P., Pol, S. et al. (2012 a) Safety of telaprevir or boceprevir in combination with peginterferon alpha/ribavirin, in cirrhotic non responders. First results of the French early access program (ANRS C020-CUPIC). J Hepatol 56(Suppl. 2): S4.
19. Hezode C. Hirschfield G. Ghesquiere W. Sievert W. Rodriguez-Torres M. Shafran S. et al (2012 b) Daclatasvir, an NS5A replication complex inhibitor, combined with peginterferon alpha-2a and ribavirin in treatment-naïve HCV-genotype 1 or 4 subjects: phase 2b COMMAND-1 SVR 12 results [Abstract]. Hepatology 56(Suppl. 4): 553A–554A.
20. Jacobson I. McHutchison J. Dusheiko G. Di Bisceglie A. Reddy K. Bzowej N. et al (2011) Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 364: 2405–2416.
21. Kowdley, K., Lawitz, E., Crespo, I., Hassanein, T., Davis, M., de Micco, M. et al. (2013) Sofosbuvir, an NS 5 nucleotide polymerase inhibitor, with peginterferon alpha-2a and ribavirin in treatment-naïve patients with hepatitis C genotypes 1, 4, and 6 infection (ATOMIC): an open-label, randomised, multicentre, phase 2 trial. Lancet Infect Dis. DOI: 10.1016/S0140-6736 (13)60247-0.
22. Kowdley K. Lawitz E. Poordad F. Cohen D. Nelson D. Zeuzem S. et al (2012) A 12-week interferon-free treatment regimen with ABT-450/r, ABT-267, ABT-333 and ribavirin achieves SVR 12 rates (observed data) of 99% in treatment-naïve patients and 93% in prior null responders with HCV genotype 1 infection. Hepatology 56(Suppl. 4): abstract LB–01.
23. Lenz, O., Fevery, B., Vijgen, L., Verbeeck, J., Peeters, M., Beumont-Mauviel, M. et al. (2012) TMC 435 in patients infected with HCV genotype 1 who have failed previous pegylated interferon / ribavirin treatment: virological analysis of the ASPIRE trial. J Hepatol 56(Suppl. 2): S5.
24. Lenz O. Vijgen L. Berke J. Cummings M. Fevery B. Peeters M. et al (2013) Virologic response and characterisation of HCV genotype 2-6 in patients receiving TMC 435 monotherapy (study TMC435-C202). J Hepatol 58: 445–451.
25. Lok A. Gardiner D. Lawitz E. Martorell C. Everson G. Ghalib R. et al (2012) Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 366: 216–224.
26. Manns M. Gane E. Rodriguez-Torres M. Stoehr A. Yeh C. Marcellin P. et al (2012) MK-7009 Protocol 007 Study Group. Vaniprevir with pegylated interferon alpha-2a and ribavirin in treatment-naïve patients with chronic hepatitis C: a randomized phase II study. Hepatology 56: 884–893.
27. Moradpour D. Penin F. Rice C. (2007) Replication of hepatitis C virus. Nat Rev Microbiol 5: 453–463.
28. Pawlotsky, J.M., Chevaliez, S., McHutchison, J.G. (2007) The hepatitis C virus life cycle as a target for new antiviral therapies. Gastroenterology 132: 1979–98.
29. Pockros P. Jensen D. Tsai N. Taylor R. Ramji A. Cooper C. et al (2012) SVR-12 among G1/4 treatment-naïve patients receiving mericitabine in combination with PEG-IFN a-2A/RBV: interim analysis from the JUMP-C study. J Hepatol 56(Suppl. 2): S477–S478.
30. Pol S. (2013) Daclatasvir, an efficient inhibitor of the hepatitis C virus replication complex protein NS5A: review of virological data, treatment rationale and clinical trials. Clin Invest 3: 191–208.
31. Pol S. Ghalib R. Rustgi V. Martorell C. Everson G. Tatum H. et al (2012) Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis 12: 671–677.
32. Poordad F. Lawitz E. Kowdley K. Cohen D. Podsadecki T. Siggelkow S. et al (2013) Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med 368: 45–53.
33. Poordad F. McCone J. Jr. Bacon B. Bruno S. Manns M. Sulkowski M. et al (2011) Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 364: 1195–1206.
34. Rallón N. Pineda J. Soriano V. Neukam K. Vispo E. Rivero A. et al (2012) Differences in virological response to peginterferon-α plus ribavirin in HIV-positive patients coinfected with HCV subtypes 1a or 1b. J Acquired Immune Defic Syndr 60: 117–123.
35. Ratziu V. Gadano A. Pol S. Hézode C. Ramji A. Cheng W. et al (2012) Triple therapy with daclatasvir (DCV; BMS-790052), peginterferon alpha-2a and ribavirin in HCV-infected prior null and partial responders: 12-week results of phase 2b COMMAND-2 trial. J Hepatol 56(Suppl. 2): S478–S479.
36. Sarrazin C. Hezode C. Zeuzem S. Pawlotsky J. (2012) Antiviral strategies in hepatitis C virus infection. J. Hepatol 56(Suppl. 1): S88–S100.
37. Soriano V. Gane E. Angus P. Stickel F. Bronowicki J.-P. Roberts S. et al (2012) The efficacy and safety of the interferon-free combination of BI 201335 and BI 207127 in genotype 1 HCV patients with cirrhosis. Interim analysis from SOUND-C2. J Hepatol 56(Suppl. 2): S559–S559.
38. Sulkowski, M., Asselah, T., Lalezari, J., Ferenci, P., Fainboim, H., Legett, B. et al. (2013) Faldaprevir combined with peginterferon alpha-2a and ribavirin in treatment naïve patients with chronic genotype-1 HCV: SILEN-C1 trial. Hepatology. DOI: 10.1002/hep.26276.
39. Sulkowski M. Gardiner D. Rodriguez-Torres M. Reddy R. Hassanein T. Jacobson I. et al (2012 a) High rate of sustained virologic response with the all-oral Combination of Daclatasvir (NS5A inhibitor) plus Sofosbuvir (nucleotide NS5B inhibitor), with or without ribavirin, in treatment-naïve patients chronically infected with HCV genotype 1, 2, or 3. Hepatology 56(Suppl. 4): abstract LB–02.
40. Sulkowski M. Rodriguez-Torres M. Lawitz E. Shiffman M. Pol S. Herring R. et al (2012 b) High sustained virologic response rate in treatment-naïve HCV genotype 1a and 1B patients treated for 12 weeks with an interferon-free all oral QUAD regimen: interim results. EASL 2012. J Hepatol 56(Suppl. 2): S560–S560.
41. Suzuki F. Chayama K. Kawakami Y. Toyota J. Karino Y. Mochida S. et al (2011) BMS-790052, an NS5A replication complex inhibitor, in combination with peginterferon alpha-2b and ribavirin in Japanese treatment-naïve and nonresponder patients with chronic HCV genotype 1 infection [Abstract]. Hepatology 54(Suppl.): 1441A–1441A.
42. Tellinghuisen, T.L., Marcotrigiano, J., Rice, C.M. (2005) Structure of the zinc-binding domain of an essential component of the hepatitis C virus replicase. Nature 435: 374–379.
43. Yang P. Gao M. Lin K. Liu Q. Villareal V. (2011) Anti-HCV drugs in the pipeline. Curr Opin Virol 1: 607–616.
44. Zeuzem S. Andreone P. Pol S. Lawitz E. Diago M. Roberts S. et al (2011 a) Telaprevir for retreatment of HCV infection. N Engl J Med 364: 2417–2428.
45. Zeuzem S. Asselah T. Angus P. Zarski J. Larrey D. Müllhaupt B. et al (2011 b) Efficacy of the protease inhibitor BI 201335, the polymerase inhibitor BI 207127 and ribavirin in patients with chronic hepatitis C. Gastroenterology 141: 2047–2055.