Simeprevir for the treatment of chronic hepatitis C

Expert Opinion on Pharmacotherapy

Volumn 14, Issue 18, 2013, Pages 2581-2589

  You, David M ^a   Pockros, Paul J ^b,c  

^a NAVAL MEDICAL CENTER SAN DIEGO   (United States)

^b SCRIPPS CLINIC   (United States)

^c SCRIPPS TRANSLATIONAL SCIENCE INSTITUTE   (United States)

Author keywords

Chronic hepatitis C; Genotype 1; Protease inhibitor; Simeprevir; TMC435

Indexed keywords

BOCEPREVIR; CYCLOSPORIN; PEGINTERFERON; PEGINTERFERON ALPHA2A; PLACEBO; RIBAVIRIN; SIMEPREVIR; SOFOSBUVIR; TACROLIMUS; TELAPREVIR; VIRUS RNA;

ANEMIA; ANTIVIRAL ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASTHENIA; CLINICAL EFFECTIVENESS; DIARRHEA; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG HALF LIFE; DRUG INTERACTION; DRUG METABOLISM; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DRY SKIN; DYSGEUSIA; DYSPNEA; FATIGUE; FEVER; FLU LIKE SYNDROME; GENOTYPE; HEADACHE; HEPATITIS C; HEPATITIS C VIRUS; HUMAN; MAXIMUM PLASMA CONCENTRATION; NAUSEA; OUTCOME ASSESSMENT; PEER REVIEW; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SIDE EFFECT; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; TREATMENT RESPONSE; VIRUS LOAD;

ANTIVIRAL AGENTS; CLINICAL TRIALS, PHASE III AS TOPIC; DRUG THERAPY, COMBINATION; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HETEROCYCLIC COMPOUNDS, 3-RING; HUMANS; INTERFERON-ALPHA; POLYETHYLENE GLYCOLS; PROTEASE INHIBITORS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECOMBINANT PROTEINS; RIBAVIRIN; SULFONAMIDES;

EID: 84887865879     PISSN: 14656566     EISSN: 17447666     Source Type: Journal    
DOI: 10.1517/14656566.2013.850074     Document Type: Article

References (27)

1. Hepatitis C fact sheet No. 164. World Health Organization. 2012. Available from: Http://www.who.int/ mediacentre/factsheets/fs164/en/ [Last accessed 20 June 2013]
2. Hepatitis C: Fact sheet no 220402. Atlanta; Centers for Disease Control and Prevention. 2013. Available from: Http://www.cdc. gov/knowmorehepatitis/ Media/PDFs/ FactSheet-ChronicHepC-GenInfo.pdf [Last accessed 20 June 2013]
3. Manns M, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: A randomized trial. Lancet 2001;358:958-65
4. Fried MW, Shiffman ML, Reddy KR, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347:975-82
5. McHutchison JG, Lawitz EJ, Shiffman ML, et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Eng J Med 2009;361:580-93
6. Soriano V, Vispo E, De Mendoza C, et al. Hepatitis C therapy with HCV NS5B polymerase inhibitors. Expert Opin Pharmacother 2013;14:1161-70
7. Ghany M, Nelson D, Strader D, et al. An update on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver diseases. Hepatology 2011;54:1433-44
8. Jacobson IM, McHutchinson 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 previously treated chronic HCV infection. N Engl J Med 2010;362:1292-303
10. Poordad F, McCone J, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1207-17
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. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013;1878-87
13. Lin T, Lenz O, Fanning G, et al. In vitro activity and preclinical profile of TMC435350, a potent hepatitis C virus protease inhibitor. Antimicrob Agents Chemother 2009;53(4):1377-85
14. Reesink HW, Fanning GC, Farha KA, et al. Rapid HCV-RNA decline with once daily TMC435: A Phase I study in healthy volunteers and hepatitis C patients. Gastroenterology 2010;138:913-21
15. Manns M, Reesink H, Berg T, et al. Rapid viral response of once-daily TMC435 plus pegylated interferon/ ribavirin in hepatitis C genotype-1 patients: A randomized trial. Antivir Ther 2011;16:1021-33
16. Ouwerkerk-Mahadevan S, Simion A, Mortier S, et al. No clinically significant interaction between the investigational HCV protease inhibitor TMC435 and the immunosuppressives cyclosporine and tacrolimus [abstract 80]. 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2012); 9-13 November 2012; Boston
17. Ouwerkerk-Mahadevan S, Beumont M, Spittaels KF, et al. No pharmacokinetic interaction between the investigational HCV protease inhibitor TMC435 and an oral contraceptive containing ethinylestradiol and norethindrone [abstract 773]. 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2012); 9-13 November 2012; Boston
18. Fried M, Buti M, Dore GJ, et al. Once-daily simeprevir (TMC435) with peginterferon and ribavirin in treatment-naïve genotype 1 hepatitis C: The randomized PILLAR study. Hepatology 2013; [Epub ahead of print]
19. Zeuzem S, Berg T, Gane E, et al. TMC435 in HCV genotype 1 patients who have failed previous pegylated interferon/ribavirin treatment: Final SVR24 results of the ASPIRE trial [abstract 2]. Presented at the 47th Annual Meeting of the European Association for the Study of the Liver; 18-22 April 2012; Barcelona, Spain
20. Scott J, Rosa K, Fu M, et al. Improved SVR with simeprevir (TMC435) associated with reduced time with patient-reported fatigue in treatment-naïve, HCV-infected patients in the PILLAR phase IIb trial [abstract 902]. Presented at the 48th Annual Meeting of the European Association for the Study of the Liver; 24-28 April 2013; Amsterdam, the Netherlands
21. Scott J, Rosa K, Zeuzem S, et al. Adding simeprevir (TMC435) to pegylated interferon/ribavirin does not increase patient-reported fatigue in treatment-experienced patients with chronic HCV infection: Results from the ASPIRE trial [abstract 901]. Presented at the 48th Annual Meeting of the European Association for the Study of the Liver; 24-28 April 2013; Amsterdam, the Netherlands
22. Jacobson I, Dore GJ, Foster GR, et al. Simeprevir (TMC435) with peginterferon/ribavirin for chronic HCV genotype 1 infection for chronic HCV genotype 1 infection in treatment-naïve patients: Results from QUEST-1, a phase III trial [abstract 1525]. Presented at the 48th Annual Meeting of the European Association for the Study of the Liver; 24-28 April 2013; Amsterdam, the Netherlands
23. Manns M, Marcellin P, Poordad FP, et al. Simeprevir (TMC435) with peginterferon/ribavirin for treatment of chronic HCV genotype-1 infection in treatment-naïve patients: Results from QUEST-2, a phase III trial [abstract 1413]. Presented at the 48th Annual Meeting of the European Association for the Study of the Liver; 24-28 April 2013; Amsterdam, the Netherlands
24. Lawitz E, Forns X, Zeuzem S, et al. Simeprevir (TMC435) with Peginterferon/Ribavirin for Treatment of Chronic HCV Genotype 1 Infection in Patients who Relapsed After Previous Interferon-Based Therapy: Results from PROMISE, a Phase III trial [abstract 869b]. Presented at Digestive Disease Week; 18-21 May; Orlando, Florida
25. 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 [abstract 155LB]. Presented at the 20th Conference on Retroviruses and Opportunistic Infections; 3-6 March 2013. Atlanta
26. Bristol-Myers Squibb. Study of Daclatasvir and TMC435 for Subjects with Genotype 1 Chronic Hepatitis C. [ClinicalTrials.gov identifier NCT01628692]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from: Http://www.clinicaltrials. gov [Accessed 20 June 2013]
27. Idenix Pharmaceuticals. IDX719 in Combination with Simeprevir and Ribavirin for 12 Weeks in Subjects With Chronic Hepatitis C Infection. [ClinicalTrials.gov identifier NCT01852604]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from: Http://www.clinicaltrials. gov [Accessed 20 July 2013