151
Views
6
CrossRef citations to date
0
Altmetric
Drug Profile

ABT-450: a novel agent for the treatment of CHC genotype 1: focus on treatment-experienced patients

, &

References

  • MohdHanafiah K, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology 2013;57:1333-42
  • Shepard C, Finelli L, Alter M. Global epidemiology of hepatitis C infection. Lancet Infect Dis 2005;5:558-67
  • World Health Organization. Available from: www.who.int [Accessed 3 June 2014]
  • Negro F, Alberti A. The global health burden of hepatitis C virus infection. Liver Int 2011;31(Suppl 2):1-3
  • Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect 2011;17(2):107-15
  • Backus LI, Boothroyd DB, Phillips BR, et al. A sustained virologic response reduces risk of all-cause mortality in patients with hepatitis C. Clin Gastroenterol Hepatol 2011;9(6):509-16
  • Morgan RL, Baack B, Smith BD, et al. Eradication of hepatitis C virus infection and the development of hepatocellular carcinoma: a meta-analysis of observational studies. Ann Intern Med 2013;158(5 Pt 1):329-37
  • Manns MP, 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 randomised trial. Lancet 2001;358(9286):958-65
  • 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(13):975-82
  • McHutchison JG, Lawitz EJ, Shiffman ML, et al. Peginterferon alfa-2b or alfa-2a with ribavirin for treatment of hepatitis C infection. N Engl J Med 2009;361(6):580-93
  • Rosen HR. Clinical practice. Chronic hepatitis C infection. N Engl J Med 2001;364(25):2429-38
  • Poordad F, McCone JJr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364(13):1195-206
  • Jacobson IM, McHutchison JG, Dusheiko G, et al. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364(25):2405-16
  • 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(4902):359-64
  • Scheel TK, Rice CM. Understanding the hepatitis C virus life cycle paves the way for highly effective therapies. Nat Med 2013;19(7):837-49
  • Moradpour D, Penin F, Rice CM. Replication of hepatitis C virus. Nat Rev Microbiol 2007;5(6):453-63
  • Pawlotsky JM, Chevaliez S, McHutchison JG. The hepatitis C virus life cycle as a target for new antiviral therapies. Gastroenterology 2007;132(5):1979-98
  • Conteduca V, Sansonno D, Russi S, et al. Therapy of chronic hepatitis C virus infection in the era of direct-acting and host-targeting antiviral agents. J Infect 2014;68(1):1-20
  • Dufner-Beattie J, O’Guin A, O’Guin S, et al. Identification of AP80978, a novel small-molecule inhibitor of hepatitis c virus replication that targets NS4B. Antimicrob Agents Chemother 2014;58(6):3399-410
  • Menon RM, Klein CE, Lawal AA, et al. Pharmacokinetics and tolerability of the HCV protease inhibitor ABT-450 following single ascending doses in healthy adult volunteers with and without ritonavir. Global Antiviral J 2009;5:31
  • Bernstein B, Menon RM, Klein CE, et al. Pharmacokinetics, safety and tolerability of the HCV protease inhibitor ABT-450 with ritonavir following multiple ascending doses in healthy adult volunteers. Presented at Annual Meeting of HepDART; 06-10 December 2009; Kohala Coast, Hawaii, USA
  • Khatri A, Gaultier IA, Menon R, et al. Pharmacokinetics and safety of co-administered ABT-450 plus ritonavir (ABT 450/r), ABT-267 and ABT-333 as a single dose in subjects with normal hepatic function and in subjects with mild, moderate and severe hepatic impairment. Presented at 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 9-13 November 2012; Boston, MA, USA
  • Lalezari J, Sullivan J, Rustgi V, et al. Abbvie IFN-free 3D regimen in HCV genotype 1-infected patients on methadone or buprenorphine. Presented at 21st Annual Conference on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, MA, USA
  • Cohen D, Siggelkow S, Hairell J, et al. ABT-450/ritonavir-containing interferon-free regimens are not associated with changes in total cholesterol or triglycerides during 12 weeks of dosing in hcv genotype 1-infected subjects. Presented at 7th International Workshop in Clinical Pharmacology of Hepatitis Therapy; 27-28 June 2012; Cambridge, MA, USA
  • Menon R, Badri P, Das U, et al. Drug-drug interactions with direct acting antiviral combination therapy of ABT-450/r, ombitasvir and dasabuvir. Presented at 54th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); 5-9 September 2014; Washington, DC, USA
  • Poordad F, Lawitz E, Kowdley KV, et al. Exploratory study of oral combination antiviral therapy for hepatitis C. N Engl J Med 2013;368(1):45-53
  • Lawitz E, Hezode C, Varunok P, et al. Interferon- and ribavirin-free regimen of ABT-450/r + ABT-267 in HCV genotype 1b-infected treatment-naive patients and prior null responders. Presented at 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 1-5 November 2013; Washington, DC, USA
  • Kowdley KV, Lawitz E, Poordad F, et al. Phase 2b trial of interferon-free therapy for hepatitis C virus genotype 1. N Engl J Med 2014;370(3):222-32
  • Bourliere M, Poordad F, Vrijens B, et al. High medication adherence in HCV-infected patients taking a triple-DAA regimen for 12 weeks. Presented at 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). 1-5 Nov 2013; Washington, DC, USA
  • ClinicalTrials.gov. A Phase 2 Study to Evaluate the Safety, Tolerability, Antiviral Activity, and Pharmacokinetics of ABT-450 With Ritonavir (ABT-450/r) and ABT-267 in Japanese Adults With Chronic Hepatitis C Virus Infection. Available from: https://clinicaltrials.gov/ct2/show/NCT01672983?term=abt+450+experienced&rank=8 [Accessed 17 July 2014]
  • ClinicalTrials.gov. An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct-Acting Antiviral Agent (DAA) Treatment in Combination With Peginterferon α-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous AbbVie or Abbott DAA Combinationstudy. Available from: https://clinicaltrials.gov/ct2/show/NCT01609933?term=abt+450+experienced&rank=6 [Accessed 17 July 2014]
  • Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370(17):1604-14
  • Andreone P, Colombo MG, Enejosa J, et al. ABT-450, ritonavir, ombitasvir, and dasabuvir achieves 97% and 100% sustained virologic response with or without ribavirin in treatment-experienced patients with HCV genotype 1b infection. Gastroenterology 2014;147(2):359-65
  • Bernstein D, Marinho R, Cohen D, et al. Adherence to Prescribed Doses of ABT-450/r/Ombitasvir, Dasabuvir, and Ribavirin in the Phase 3 PEARL-II, PEARL-III, and PEARL-IV Trials. Presented at The annual meeting of the American association for the study of the Liver diseases (AASLD); 7-11 November 2014; Boston, MA,USA
  • Poordad F, Hezode C, Trinh R, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 2014;370(21):1973-82
  • ClinicalTrials.gov. A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Treatment-Naïve and Treatment-Experienced Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection With and Without Compensated Cirrhosis (GIFT I). Available from: https://clinicaltrials.gov/ct2/show/study/NCT02023099?term=abt+450+experienced&rank=3 [Accessed 17 July 2014]
  • ClinicalTrials.gov. An Open-Label, Multicenter Study to Evaluate Long-term Outcomes With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection(TOPAZII). Available from: https://clinicaltrials.gov/ct2/show/study/NCT02167945?term=abt+450+experienced&rank=7 [Accessed 17 July 2014]
  • Clinicaltrials.gov. A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon a-2a and Ribavirin in Treatment-Experienced Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE-II). Available from: https://clinicaltrials.gov/ct2/show/study/NCT01854528?term=abt+450+experienced&rank=2 [Accessed 16 July 2014]
  • Colombo M, Weiland O, Cohen D. SVR12 Rate of 98.6% in 992 HCV Genotype 1b-Infected Patients Treated with ABT-450/r/Ombitasvir and Dasabuvir With or Without Ribavirin. Presented at The annual meeting of the American association for the study of the Liver diseases (AASLD); 7–11 November 2014; Boston, MA, USA
  • Zeuzem S, Soriano V, Asselah T, et al. SVR4 and SVR12 with an interferon-free regimen of BI201335 and BI207127, +/− ribavirin, in treatment-naive patients with chronic genotype-1 HCV infection: interim results of Sound-C2. J Hepatol 2012;56:S45
  • Sulkowski M, Rodriguez-Torres M, Lawitz E, et al. High sustained virologic response rate in treatment-naive HCV genotype 1a and 1b patients treated for 12 weeks with an interferon-free all-oral quad regimen: interim results. J Hepatol 2012;56:S56
  • Bacon BR, Gordon SC, Lawitz E, et al. Boceprevir for previously treated chronic HCV genotype 1 infection. N Engl J Med 2011;364(13):1207-17
  • 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
  • Krishnan P, Tripathi R, Schnell G, et al. Pooled analysis of resistance in patients treated with ombitasvir/ABT-450/r and dasabuvir with or without ribavirin in Phase 2 and Phase 3 clinical trials. Presented at The annual meeting of the American association for the study of the Liver diseases (AASLD); 7-11 November 2014; Boston, MA,USA
  • 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(5):478-87
  • Zeuzem S, Berg T, Gane et al. Simeprevir increases rate of sustained virologic response among treatment-experienced patients with HCV genotype-1 infection: a phase IIb trial. Gastroenterology 2014;146(2):430-41
  • Lawitz E, Sulkowski MS, Ghalib R. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet 2014;S0140:6736(14):61036-9
  • Afdhal N, Reddy KR, Nelson DR, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014;370(16):1483-93
  • 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(3):211-21
  • Zeuzem S, Hezode C, Bronowicki J-PP, et al. Daclatasvir in combination with simeprevir ± ribavirin for hepatitis C virus genotype 1 infection. Abstract presented at 21st Conference on Retroviruses and Opportunistic Infections; 3-6 March 2014; Boston, USA
  • Wyles D, Sulkowski M, Eron J, et al. TURQUOISE-I: 94% SVR12 in HCV/HIV-1 coinfected patients treated with ABT-450/r/Ombitasvir, Dasabuvir and Ribavirin. Presented at The annual meeting of the American association for the study of the Liver diseases (AASLD); 7–11 November 2014; Boston, MA, USA
  • Mantry P, Kwo P, Coakley E, et al. High sustained virologic response rates in liver transplant recipients with recurrent HCV genotype 1 infection receiving ABT-450/r/ombitasvir+dasabuvir plus ribavirin. Presented at The annual meeting of the American association for the study of the Liver diseases (AASLD); 7–11 November 2014; Boston, MA,USA
  • Khatri A, Dutta S, Marbury T, et al. The pharmacokinetics and safety of the direct acting antiviral regimen of ABT-450/r, ombitasvir with/without dasabuvir in subjects with mild, moderate and severe renal impairment compared to subjects with normal renal function. Presented at The annual meeting of the American association for the study of the Liver diseases (AASLD); 7–11 November 2014; Boston, MA, USA
  • Flamm S, Gane E, Dufour J, et al. Safety of ABT-450/r/ombitasvir + dasabuvir with or without ribavirin in HCV genotype 1-infected patients ≥65 years of age: results from phase 2 and 3 trials. Presented at The annual meeting of the American association for the study of the Liver diseases (AASLD); 7–11 November 2014; Boston, MA, USA
  • Clinicaltrials.gov. A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis. Available from: https://clinicaltrials.gov/ct2/show/NCT02265237?term=abt+450&rank=22 [Accessed 28 November 2014]
  • Clinicaltrials.gov. A Study to Evaluate ABT-450 With Ritonavir (ABT-450/r) When Given Together With ABT-267 and With and Without Ribavirin (RBV) in Treatment-Naïve Subjects With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV).(Navigator). Available from: https://clinicaltrials.gov/ct2/show/NCT01458535?term=abt+450&rank=13 [Accessed 28 November 2014]
  • Clinicaltrials.gov. A Study to Evaluate the Safety and Efficacy of ABT-450/Ritonavir/ABT-267 and ABT-333 With Ribavirin in Adults With Genotype 1 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (TURQUOISE-CPB). Available from: http://clinicaltrials.gov/ct2/show/NCT02219477?term=AbbVie+and+Hepatitis +C&recr=Open&no_unk=Y&rank=2 [Accessed 2 September 2014]
  • Hoofnagle JH, Averell H. Therapy for hepatitis C – the costs of success. N Engl J Med 2014;370(16):1552-3

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.