Finally sofosbuvir: An oral anti-HCV drug with wide performance capability

Pharmacogenomics and Personalized Medicine

Volumn 7, Issue , 2014, Pages 387-397

  Kayali, Zeid ^a   Schmidt, Warren N ^b,c  

^a UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^b VETERANS AFFAIRS MEDICAL CENTER   (United States)

^c UNIVERSITY OF IOWA   (United States)

Author keywords

Hepatitis C virus; Interferon free treatment; Polymerase inhibitors; Sofosbuvir

Indexed keywords

ABT 072; ALPHA1 INTERFERON; ANTICONVULSIVE AGENT; ANTIVIRUS AGENT; ASUNAPREVIR; BECLABUVIR; BOCEPREVIR; DACLATASVIR; DANOPREVIR; DASABUVIR; DIRECT ACTING ANTIVIRAL AGENT; FALDAPREVIR; GRAZOPREVIR; LEDIPASVIR; MERCITABINE; MERICITABINE; NONNUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR; NONSTRUCTURAL PROTEIN 5A INHIBITOR; PARITAPREVIR; PEGINTERFERON; PHENOBARBITAL; PROTEINASE; RIBAVIRIN; RIFABUTIN; RIFAPENTINE; SIMEPREVIR; SOFOSBUVIR; TELAPREVIR; UNCLASSIFIED DRUG; UNINDEXED DRUG; VX 135;

ANEMIA; CARDIOTOXICITY; COMBINATION CHEMOTHERAPY; DRUG APPROVAL; DRUG CLEARANCE; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG MARKETING; DRUG METABOLISM; DRUG POTENCY; DRUG POTENTIATION; DRUG SAFETY; DRUG STRUCTURE; DRUG TOLERABILITY; DRUG WITHDRAWAL; EARLY INTERVENTION; ETHNIC DIFFERENCE; FOOD AND DRUG ADMINISTRATION; GENOTYPE; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; HYPERBILIRUBINEMIA; MONOTHERAPY; NONHUMAN; PATIENT CARE; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROGNOSIS; QUALITY OF LIFE; RASH; RELAPSE; RELIABILITY; REVIEW; SEX DIFFERENCE; TREATMENT DURATION; TREATMENT FAILURE; TREATMENT OUTCOME; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VIRUS LOAD;

EID: 84916891867     PISSN: None     EISSN: 11787066     Source Type: Journal    
DOI: 10.2147/PGPM.S52629     Document Type: Review

References (65)

1. Hope VD, Eramova I, Capurro D, et al. Prevalence and estimation of hepatitis B and C infections in the WHO European Region: a review of data focusing on the countries outside the European Union and the European Free Trade Association. Epidemiol Infect. 2014;142: 270–286.
2. Naggie S, Patel K, McHutchison J. Hepatitis C virus directly acting antivirals: current developments with NS3/4A HCV serine protease inhibitors. J Antimicrob Chemother. 2010;65:2063–2069.
3. Kayali Z, Labrecque DR, Schmidt WN. Treatment of hepatitis C cryoglobulinemia: mission and challenges. Curr Treat Options Gastroenterol. 2006;9:497–507.
4. Hoofnagle JH. Hepatitis C: the clinical spectrum of disease. Hepatology. 1997;26:S15–S20.
5. Rosen HR. Chronic hepatitis C infection. N Engl J Med. 2011;364: 2429–2438.
6. Lindenbach BD, Rice CM. Unravelling hepatitis C virus replication from genome to function. Nature. 2005;436:933–938.
7. Major ME, Feinstone SM. The molecular virology of hepatitis C. Hepatology. 1997;25:1527–1538.
8. Bartenschlager R, Lohmann V. Replication of hepatitis C virus. J Gen Virol. 2000;81:1631–1648.
9. Lindenbach BD, Evans MJ, Syder AJ, et al. Complete replication of hepatitis C virus in cell culture. Science. 2005;309:623–626.
10. Simmonds P, Holmes EC, Cha TA, et al. Classification of hepatitis C virus into 6 major genotypes and a series of subtypes by phylogenetic analysis of the Ns-5 region. J Gen Virol. 1993;74:2391–2399.
11. Domingo E, Holland JJ. RNA virus mutations and fitness for survival. Annu Rev Microbiol. 1997;51:151–178.
12. Blight KJ, McKeating JA, Rice CM. Highly permissive cell lines for subgenomic and genomic hepatitis C virus RNA replication. J Virol. 2002;76:13001–13014.
13. Lohmann V, Korner F, Koch JO, et al. Replication of subgenomic hepatitis C virus RNAs in a hepatoma cell line. Science. 1999;285: 110–113.
14. Pietschmann T, Lohmann V, Rutter G, et al. Characterization of cell lines carrying self-replicating hepatitis C virus RNAs. J Virol. 2001;75: 1252–1264.
15. 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;127:1347–1355.
16. Hoofnagle JH, Mullen KD, Jones DB, et al. Treatment of chronic non-A, non-B hepatitis with recombinant human alpha interferon. A preliminary report. N Engl J Med. 1986;315:1575–1578.
17. Martinot-Peignoux M, Stern C, Maylin S, et al. Twelve weeks posttreatment follow-up is as relevant as 24 weeks to determine the sustained virologic response in patients with hepatitis C virus receiving pegylated interferon and ribavirin. Hepatology. 2010;51:1122–1126.
18. Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011;364:2405–2416.
19. Poordad F, McCone J Jr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1195–1206.
20. Sherman KE, Flamm SL, Afdhal NH, et al. Response-guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med. 2011;365:1014–1024.
21. McHutchison JG, Manns MP, Muir AJ, et al. Telaprevir for previously treated chronic HCV infection. N Engl J Med. 2010;362:1292–1303.
22. Muir AJ, Poordad FF, McHutchison JG, et al. Retreatment with telaprevir combination therapy in hepatitis C patients with well-characterized prior treatment response. Hepatology. 2011;54: 1538–1546.
23. Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med. 2011;364: 1207–1217.
24. Thompson AJ, Muir AJ, Sulkowski MS, et al. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology. 2010;139:120–178.
25. Koziel MJ, Peters MG. Viral hepatitis in HIV infection. N Engl J Med. 2007;356:1445–1454.
26. Soriano V, Peters MG, Zeuzem S. New therapies for hepatitis C virus infection. Clin Infect Dis. 2009;48:313–320.
27. Sarrazin C, Zeuzem S. Resistance to direct antiviral agents in patients with hepatitis C virus infection. Gastroenterology. 2010;138:447–462.
28. Migliaccio G, Tomassini JE, Carroll SS, et al. Characterization of resistance to non-obligate chain-terminating ribonucleoside analogs that inhibit hepatitis C virus replication in vitro. J Biol Chem. 2003;278:49164–49170.
29. 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;56:3359–3368.
30. Carroll SS, Ludmerer S, Handt L, et al. Robust antiviral efficacy upon administration of a nucleoside analog to hepatitis C virus-infected chimpanzees. Antimicrob Agents Chemother. 2009;53:926–934.
31. 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.
32. Lawitz E, Poordad FF, Pang PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014;383:515–523.
33. Nelson DR, Zeuzem S, Andreone P, et al. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012;11:15–31.
34. Pockros P, Jensen D, Tsai N, et al. First SVR data with the nucleoside analogue polymerase inhibitor mericitabine (RG7128) combined with peginterferon/ribavirin in treatment-naive HCV G1/4 patients: interim analysis from the JUMP-C trial. J Hepatol. 2011;54:S538–S538.
35. Pawlotsky JM, Najera I, Jacobson I. Resistance to mericitabine, a nucleoside analogue inhibitor of HCV RNA-dependent RNA polymerase. Antivir Ther. 2012;17:411–423.
36. Gane EJ, Roberts SK, Stedman CAM, et al. 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. 2010;376:1467–1475.
37. Pawlotsky JM. Treatment failure and resistance with direct-acting antiviral drugs against hepatitis C virus. Hepatology. 2011;53: 1742–1751.
38. Schmidt WN, Nelson DR, Pawlotsky JM, et al. Direct acting antiviral agents and the path to interferon independence. Clin Gastroenterol Hepatol. 2014;12(5):728–737.
39. Susser S, Welsch C, Wang YL, et al. Characterization of resistance to the protease inhibitor boceprevir in hepatitis C virus-infected patients. Hepatology. 2009;50:1709–1718.
40. Bartenschlager R, Lohmann V, Penin F. The molecular and structural basis of advanced antiviral therapy for hepatitis C virus infection. Nat Rev Microbiol. 2013;11:482–496.
41. Kieffer TL, Sarrazin C, Miller JS, et al. Telaprevir and pegylated interferon-alpha–2a inhibit wild-type and resistant genotype 1 hepatitis C virus replication in patients. Hepatology. 2007;46:631–639.
42. Targett-Adams P, Graham EJ, Middleton J, et al. Small molecules targeting hepatitis C virus-encoded NS5A cause subcellular redistribution of their target: insights into compound modes of action. J Virol. 2011;85:6353–6368.
43. Gao M, Nettles RE, Belema M, et al. Chemical genetics strategy identifies an HCV NS5A inhibitor with a potent clinical effect. Nature. 2010;465:96–108.
44. Wang CF, Huang HC, Valera L, et al. Hepatitis C virus RNA elimination and development of resistance in replicon cells treated with BMS-790052. Antimicrob Agents Chemother. 2012;56:1350–1358.
45. 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(20):1867–1877.
46. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previ­ously untreated chronic hepatitis C infection. N Engl J Med. 2013;368:1878–1887.
47. Murakami E, Tolstykh T, Bao H, et al. Mechanism of activation of PSI-7851 and its diastereoisomer PSI-7977. J Biol Chem. 2010;285: 34337–34347.
48. Lam AM, Murakami E, Espiritu C, et al. PSI–7851, a pronucleotide of beta-D–2′-deoxy–2′-fluoro–2′-C-methyluridine monophosphate, is a potent and pan-genotype inhibitor of hepatitis c virus replication. Antimicrob Agents Chemother. 2010;54:3187–3196.
49. Davis GL, Esteban-Mur R, Rustgi V, et al. Interferon alfa-2b alone or in combination with ribavirin for the treatment of relapse of chronic hepatitis C. International Hepatitis Interventional Therapy Group. N Engl J Med. 1998;339:1493–1499.
50. Osinusi A, Meissner EG, Lee YJ, et al. Sofosbuvir and ribavirin for hepatitis C genotype 1 in patients with unfavorable treatment characteristics a randomized clinical trial. JAMA. 2013;310:804–811.
51. Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir plus ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial. Hepatology. 2013;58:733a–734a.
52. Jacobson IM, Ghalib RH, Rodriguez-Torres M, et al. SVR results of a once-daily regimen of simeprevir (TMC435) plus sofosbuvir (GS-7977) with or without ribavirin in cirrhotic and non-cirrhotic HCV genotype 1 treatment-naive and prior null responder patients: the COSMOS study. Hepatology. 2013;58:1379a–1380a.
53. 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;370:211–221.
54. Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014;370:1483–1493.
55. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014;370: 1889–1898.
56. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1889–1898.
57. Gane EJ, Hyland RH, An D, et al. Sofosbuvir/Ledipasvir fixed dose combination is safe and effective in difficult-to-treat populations including genotype-3 patients, decompensated genotype-1 patients, and genotype-1 patients with prior Sofosbuvir treatment experience. J Hepatol. 2014;60:S3.
58. Naggie S, Sulkowski M, Lalezari J, et al. Sofosbuvir plus ribavirin for HCV genotype 1–3 infection in HIV coinfected patients (PHOTON-1). Conference on Retroviruses and Opportunistic Infections; March 3–6, 2014; Boston, MA, USA.
59. Curry MP, Forns X, Chung RT, et al. Pretransplant sofosbuvir and ribavirin to prevent recurrence of HCV infection after liver transplantation. Hepatology. 2013;58:314a–315a.
60. Charlton MR, Gane EJ, Manns MP, et al. Sofosbuvir and ribavirin for the treatment of established recurrent hepatitis c infection after liver transplantation: preliminary results of a prospective, multicenter study. Hepatology. 2013;58:1378a–1378a.
61. Koff RS. Review article: the efficacy and safety of sofosbuvir, a novel, oral nucleotide NS5B polymerase inhibitor, in the treatment of chronic hepatitis C virus infection. Aliment Pharmacol Ther. 2014;39:478–487.
62. Karageorgopoulos DE, El-Sherif O, Bhagani S, et al. Drug interactions between antiretrovirals and new or emerging direct-acting antivirals in HIV/hepatitis C virus coinfection. Curr Opin Infect Dis. 2014;27:36–45.
63. Sulkowski M, Jacobson IM, Ghalib R, et al. Once-daily Simeprevir (TMC435) plus Sofosbuvir (GS-7977) with or without ribavirin in HCV genotype 1 prior null responders with METAVIR FO-2: COSMOS Study subgroup analysis. J Hepatol. 2014;60:S4.
64. Lawitz E, Ghalib R, Rodriguez-Torres M, et al. Simeprevir plus sofos­buvir with/without ribavirin in HCV genotype-1 prior null-responder / treatment-naïve patients (COSMOS study): primary endpoint (SVR12) results in patients with METAVIR F3-4 (Cohort 2). J Hepatol. 2014;60:S524.
65. Sofosbuvir for Treatment of Chronic Hepatitis C Infection, Antiviral Drugs Advisory Committee Meeting Briefing Document. Gilead Sciences, Inc.; 2013. Available from: http://www.natap.org/2013/HCV/20131025-AVDAC-B1-02-Gilead.pdf. Accessed August 25, 2014.