New concepts of sofosbuvir-based treatment regimens in patients with hepatitis C

Gut

Volumn 63, Issue 2, 2014, Pages 207-215

  Mariño, Zoe ^a   Van Bömmel, Florian ^b   Forns, Xavier ^a   Berg, Thomas ^b  

^a INSTITUT D INVESTIGACIONS BIOMÈDIQUES AUGUST PI I SUNYER IDIBAPS   (Spain)

^b UNIVERSITY HOSPITAL LEIPZIG   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

BOCEPREVIR; DACLATASVIR; LEDIPASVIR; PEGINTERFERON ALPHA; PLACEBO; RIBAVIRIN; SOFOSBUVIR; TELAPREVIR;

ANTIVIRAL ACTIVITY; ARTICLE; DRUG ABSORPTION; DRUG CLEARANCE; DRUG EFFICACY; DRUG ELIMINATION; DRUG HALF LIFE; DRUG METABOLISM; DRUG POTENCY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; HEALTH CARE QUALITY; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; NONHUMAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RELAPSE; TIME TO MAXIMUM PLASMA CONCENTRATION; UNSPECIFIED SIDE EFFECT; VIRUS REPLICATION;

EID: 84891735608     PISSN: 00175749     EISSN: 14683288     Source Type: Journal    
DOI: 10.1136/gutjnl-2013-305771     Document Type: Article

References (43)

1. Deuffic-Burban S, Deltenre P, Louvet A, et al. Impact of viral eradication on mortality related to hepatitis C: a modeling approach in France. J Hepatol 2008;49:175-83.
2. Deuffic-Burban S, Babany G, Lonjon-Domanec I, et al. Impact of pegylated interferon and ribavirin on morbidity and mortality in patients with chronic hepatitis C and normal aminotransferases in France. Hepatology 2009;50:1351-9.
3. Choo QL, Kuo G, Weiner AJ, et al. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science 1989;244:359-62. (Pubitemid 19117877)
4. Kolykhalov AA, Agapov EV, Blight KJ, et al. Transmission of hepatitis C by intrahepatic inoculation with transcribed RNA. Science 1997;277:570-4. (Pubitemid 27369006)
5. Yanagi M, Purcell RH, Emerson SU, et al. Transcripts from a single full-length cDNA clone of hepatitis C virus are infectious when directly transfected into the liver of a chimpanzee. Proc Natl Acad Sci 1997;94:8738-43. (Pubitemid 27335109)
6. Hinrichsen H, Benhamou Y, Wedemeyer H, et al. Short-term antiviral efficacy of BILN 2061, a hepatitis C virus serine protease inhibitor, in hepatitis C genotype 1 patients. Gastroenterology 2004;127:1347-55. (Pubitemid 39457761)
7. Welsch C, Jesudian A, Zeuzem S, et al. New directacting antiviral agents for the treatment of hepatitis C virus infection and perspectives. Gut 2012;61:i36-46.
8. 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.
9. Zeuzem S, Andreone P, Pol S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011;364:2417-28.
10. Poordad F, McCone J Jr., Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1195-206.
11. 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.
12. Pawlotsky JM. Treatment of chronic hepatitis C: current and future. Curr Top Microbiol Immunol 2013;369:321-42.
13. Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49:1335-74.
14. Shiffman ML, Suter F, Bacon BR, et al. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med 2007;357:124-34. (Pubitemid 47057730)
15. Sofia MJ, Bao D, Chang W, et al. Discovery of a beta-d-2'-deoxy-2'-alpha- fluoro-20-beta-Cmethyluridine nucleotide prodrug (PSI-7977) for the treatment of hepatitis C virus. J Med Chem 2010;53:7202-18.
16. Hassanein T, Lawitz E, Crespo I, et al. Once daily sofosbuvir (GS-7977) plus PEG/RBV: high early response rates are maintained during post-treatment follow-up in treatment-naive patients with HCV genotype 1, 4, and 6 infection in the ATOMIC study. Hepatology 2012;56:307A.
17. Rodriguez-Torres M, Lawitz E, Kowdley KV, et al. Sofosbuvir (GS-7977) plus peginterferon/ribavirin in treatment-naïve patients with HCV genotype 1: a randomized, 28-day, dose-ranging trial. J Hepatol 2013;58:663-8.
18. Cornpropst M, Denning J, Clemons D, et al. The Effect of Renal Impairment and End Stage Renal Disease on the Single-Dose Pharmacokinetics of GS-7977. J Hepatol 2012;56:S433.
19. Mathias A, Cornpropst M, Clemons D, et al. No Clinically Significant Pharmacokinetic Drug-Drug Interactions between Sofosbuvir (GS-7977) and the Immunosuppressants, Cyclosporine A or Tacrolimus in Healthy Volunteers. Hepatology 2012;56:1063A-4A.
20. Kirby B, Mathias A, Rossi S, et al. No clinically significant pharmacokinetic interactions between sofosbuvir (GS-7977) and HIV antiretrovirals Atripla, rilpivirine, darunavir/ritonavir, or raltegravir in healthy volunteers. 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), November 9.13, 2012, Boston, MA. Abstract 1877.
21. Gane EJ, Stedman CA, Hyland RH, et al. All-oral sofosbuvir-based 12-week regimens for the treatment of chronic HCV infection: the ELECTRON study. J Hepatol 2013;58:S6.
22. Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naïve and previously treated patients with genotype 1 hepatitis C: the LONESTAR study. Hepatology 2013;58:1092A.
23. Lalezari JP, Nelson DR, Hyland RH, et al. Once daily sofosbuvir plus ribavirin for 12 and 24 weeks in treatment-naïve patients with hCV infection: the QUANTUM study. J Hepatol 2013;58:S236.
24. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al.; AI444040 Study Group. 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 treatmentnaive patients chronically infected with HCV GT 1, 2, or 3. 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 2012 November 9.13; Boston, MA. Abstract LB-2.
25. Osinusi A, Meissner EG, Bon D, et al. High Efficacy of Sofosbuvir in Combination with Weight Based Ribavirin for 24 weeks in Difficult to Treat HCV Infected Genotype-1 Patients. 20th Conference on Retroviruses and Opportunistic Infections, Atlanta, GA, March 3.6, 2013. Abstract 157B.
26. Lawitz E, Ghalib R, Rodriguez-Torres M, et al. SVR4 results of a once daily regimen of simeprevir (TMC435) plus sofosbuvir (GSs-7977) with or without ribavirin (RBV) in HCV GT 1 null responders. Digestive Disease Week, Orlando, May 18.21 2013. Abstract Sa2073.
27. 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.
28. Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013;368:1867-77.
29. Lawitz E, Lalezari JP, Hassanein T, et al. 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. Lancet Infect Dis 2013;13:401-8.
30. Kowdley KV, Lawitz E, Crespo I, et al. 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. Lancet 2013;381:2100-7.
31. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013;368:1878-87.
32. Lam AM, Espiritu C, Bansal S, et al. Genotype and subtype profiling of PSI-7977 as a nucleotide inhibitor of hepatitis C virus. Antimicrob Agents Chemother 2012;56:3359-68.
33. Svarovskaia ES, Dvory-Sobol H, Gontcharova V, et al. Comprehensive Resistance testing in patients who relapsed after treatment with sofosbuvir (GS-7977) - containing regimens in phase 2 studies. Hepatology 2012;56:551A.
34. Lawitz E, Ghalib R, Rodriguez-Torres M, et al. Suppression of Viral Load through 4 Weeks Post-Treatment Results of a Once-daily Regimen of Simeprevir +Sofosbuvir with or without Ribavirin in Hepatitis C Virus GT 1 Null Responders. 20th Conference on Retroviruses and Opportunistic Infections. 20th Conference on Retroviruses and Opportunistic Infections. Atlanta, March 3.6, 2013. Abstract 155LB.
35. Heim MH. Innate immunity and HCV. J Hepatol 2013;58:564-74.
36. Rotman Y, Noureddin M, Feld JJ, et al. Effect of ribavirin on viral kinetics and liver gene expression in chronic hepatitis C. Gut 2014;63:161-9.
37. Testoni B, Durantel D, Levrero M, et al. In vivo ribavirin effects on interferon stimulated genes transcriptional regulation involves chromatin remodelling and histone methylation mediated by the G9a methyl-transferase. J Hepatol 2013;58:S5.
38. Barrett L, Shivasabesan G, Wang C, et al. Altered immune responses during interferon free HCV DAA therapy. J Hepatol 2013;58:S1.
39. Lawitz E, Gane EJ, Lalezari J, et al. High Concordance of SVR4, SVR12, and SVR24 in Patients With HCV Infection who have received treatment with sofosbuvir. J Hepatol 2013;58:S48.
40. Kowdley KV, Hassanein T, Gane EJ, et al. Sofosbuvir Safety and Tolerability in 778 Patients Treated for Up to 24 Weeks in Four Phase 2 Studies. J Hepatol 2013;58:S345.
41. Rodriguez-Torres M, Gonzales M, Rodriguez J, et al. HIV/HCV coinfected and HCV monoinfected patients have similar early HCV viral kinetics with the potent HCV nucleotide polymerase inhibitor sofosbuvir (SOF). 52nd Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, 2012. Abstract H-1921a.
42. Fontana RJ, Hughes EA, Bifano M, et al. Sofosbuvir and daclatasvir combination therapy in a liver transplant recipient with severe recurrent cholestatic hepatitis C. Am J Transplant 2013;13:1601-5.
43. Lawitz E, Rodriguez-Torres M, Denning J, et al. Alloral therapy with nucleotide inhibitors sofosbuvir and GS-0938 for 14 days in treatment-naive genotype 1 hepatitis C (NUCLEAR). J Viral Hepat 2013;20:699-707.