221
Views
16
CrossRef citations to date
0
Altmetric
Drug Profiles

Ombitasvir: a potent pan-genotypic inhibitor of NS5A for the treatment of hepatitis C virus infection

, &

References

  • Lavanchy D. Evolving epidemiology of hepatitis C virus. Clin Microbiol Infect 2011;17(2):107-15
  • Hoofnagle JH. Hepatitis C: the clinical spectrum of disease. Hepatology 1997;26(3 Suppl 1):15S-20S
  • Sagnelli E, Pisaturo M, Stanzione M, et al. Clinical presentation, outcome, and response to therapy among patients with acute exacerbation of chronic hepatitis C. Clin Gastroenterol Hepatol 2013;11(9):1174-80
  • Coppola N, Gentile I, Pasquale G, et al. Anti-HBc positivity was associated with histological cirrhosis in patients with chronic hepatitis C. Ann Hepatol 2014;13(1):20-6
  • Maasoumy B, Wedemeyer H. Natural history of acute and chronic hepatitis C. Best Pract Res Clin Gastroenterol 2012;26(4):401-12
  • Gentile I, Coppola N, Pasquale G, et al. A simple noninvasive score based on routine parameters can predict liver cirrhosis in patients with chronic Hepatitis C. Hepat Mon 2013;13(5):e8352
  • Fortunato G, Calcagno G, Bresciamorra V, et al. Multiple sclerosis and hepatitis C virus infection are associated with single nucleotide polymorphisms in interferon pathway genes. J Interferon Cytokine Res 2008;28(3):141-52
  • Fortunato G, Castaldo G, Oriani G, et al. Multivariate discriminant function based on six biochemical markers in blood can predict the cirrhotic evolution of chronic hepatitis. Clin Chem 2001;47(9):1696-700
  • Gentile I, Meola M, Buonomo AR, et al. Human platelet antigen-3 genotype predicts platelet count in patients with HCV infection. In Vivo 2013;27(6):773-7
  • Filippini P, Coppola N, Scolastico C, et al. Does HIV infection favor the sexual transmission of hepatitis C? Sex Transm Dis 2001;28(12):725-9
  • Sagnelli E, Pasquale G, Coppola N, et al. Influence of chronic coinfection with hepatitis B and C virus on liver histology. Infection 2004;32(3):144-8
  • Gentile I, Buonomo AR, Zappulo E, Borgia G. Is it possible to predict HCV-related liver cirrhosis non-invasively through routine laboratory parameters? Infez Med 2014;22(1):11-18
  • Ferrari SM, Fallahi P, Mancusi C, et al. HCV-related autoimmune disorders in HCV chronic infection. Clin Ter 2013;164(4):e305-12
  • Coppola N, Pisaturo M, Guastafierro S, et al. Increased hepatitis C viral load and reactivation of liver disease in HCV RNA-positive patients with onco-haematological disease undergoing chemotherapy. Dig Liver Dis 2012;44(1):49-54
  • Zampino R CN, Cirillo G, Boemio A, et al. Abdominal fat interacts with PNPLA3 I148M, but not with the APOC3 variant in the pathogenesis of liver steatosis in chronic hepatitis C. J Viral Hepat 2013;20:517-23
  • Coppola N, Pascalis SD, Pisaturo M, et al. Sustained virological response to antiviral treatment in chronic hepatitis C patients may be predictable by HCV-RNA clearance in peripheral blood mononuclear cells. J Clin Virol 2013;58(4):748-50
  • Fusco F, D’Anzeo G, Rossi A, et al. Erectile dysfunction in patients with chronic viral hepatitis: a systematic review of the literature. Expert Opin Pharmacother 2013;14(18):2533-44
  • Sagnelli E, Stroffolini T, Mele A, et al. The importance of HCV on the burden of chronic liver disease in Italy: a multicenter prevalence study of 9,997 cases. J Med Virol 2005;75(4):522-7
  • Petruzziello A, Coppola N, Diodato AM, et al. Age and gender distribution of hepatitis C virus genotypes in the metropolitan area of Naples. Intervirology 2013;56(3):206-12
  • Guadagnino V, Stroffolini T, Caroleo B, et al. Hepatitis C virus infection in an endemic area of Southern Italy 14 years later: evidence for a vanishing infection. Dig Liver Dis 2013;45(5):403-7
  • Guadagnino V, Stroffolini T, Rapicetta M, et al. Prevalence, risk factors, and genotype distribution of hepatitis C virus infection in the general population: a community-based survey in southern Italy. Hepatology 1997;26(4):1006-11
  • Gentile I, Di Flumeri G, Scarica S, et al. Acute hepatitis C in patients undergoing hemodialysis: experience with high-dose interferon therapy. Minerva Urol Nefrol 2013;65(1):83-4
  • Carney K, Dhalla S, Aytaman A, et al. Association of tattooing and hepatitis C virus infection: a multicenter case-control study. Hepatology 2013;57(6):2117-23
  • Coppola N, Pisapia R, Tonziello G, et al. Improvement in the aetiological diagnosis of acute hepatitis C: a diagnostic protocol based on the anti-HCV-IgM titre and IgG Avidity Index. J Clin Virol 2009;46(3):222-9
  • Coppola N, Pisapia R, Marrocco C, et al. Anti-HCV IgG avidity index in acute hepatitis C. J Clin Virol 2007;40(2):110-15
  • Gentile I, De Stefano A, Di Flumeri G, et al. Concomitant interferon-alpha and chemotherapy in hepatitis C and colorectal cancer: a case report. In Vivo 2013;27(4):527-9
  • Davis GL, Alter MJ, El-Serag H, et al. Aging of hepatitis C virus (HCV)-infected persons in the United States: a multiple cohort model of HCV prevalence and disease progression. Gastroenterology 2010;138(2):513-21
  • Gentile I, Viola C, Graf M, et al. A simple noninvasive score predicts gastroesophageal varices in patients with chronic viral hepatitis. J Clin Gastroenterol 2009;43(1):81-7
  • Gentile I, Borgia G. Surrogate endpoints and non-inferiority trials in chronic viral hepatitis. J Hepatol 2010;52(5):778
  • Braks RE, Ganne-Carrie N, Fontaine H, et al. Effect of sustained virological response on long-term clinical outcome in 113 patients with compensated hepatitis C-related cirrhosis treated by interferon alpha and ribavirin. World J Gastroenterol 2007;13(42):5648-53
  • Tsuda N, Yuki N, Mochizuki K, et al. Long-term clinical and virological outcomes of chronic hepatitis C after successful interferon therapy. J Med Virol 2004;74(3):406-13
  • Bruno S, Stroffolini T, Colombo M, et al. Sustained virological response to interferon-alpha is associated with improved outcome in HCV-related cirrhosis: a retrospective study. Hepatology 2007;45(3):579-87
  • Di Marco V, Almasio PL, Ferraro D, et al. Peg-interferon alone or combined with ribavirin in HCV cirrhosis with portal hypertension: a randomized controlled trial. J Hepatol 2007;47(4):484-91
  • Hermine O, Lefrere F, Bronowicki JP, et al. Regression of splenic lymphoma with villous lymphocytes after treatment of hepatitis C virus infection. N Engl J Med 2002;347(2):89-94
  • Takahashi K, Nishida N, Kawabata H, et al. Regression of Hodgkin lymphoma in response to antiviral therapy for hepatitis C virus infection. Intern Med 2012;51(19):2745-7
  • Morisco F, Granata R, Stroffolini T, et al. Sustained virological response: a milestone in the treatment of chronic hepatitis C. World J Gastroenterol 2013;19(18):2793-8
  • Chen J, Florian J, Carter W, et al. Earlier sustained virologic response end points for regulatory approval and dose selection of hepatitis C therapies. Gastroenterology 2013;144(7):1450-5
  • Venkatraman S, Bogen SL, Arasappan A, et al. Discovery of (1R,5S)-N-[3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl]- 3-[2(S)-[[[(1,1-dimethylethyl)amino]carbonyl]amino]-3,3-dimethyl-1-oxobutyl]- 6,6-dimethyl-3-azabicyclo[3.1.0]hexan-2(S)-carboxamide (SCH 503034), a selective, potent, orally bioavailable hepatitis C virus NS3 protease inhibitor: a potential therapeutic agent for the treatment of hepatitis C infection. J Med Chem 2006;49(20)):6074-86
  • Tong X, Chase R, Skelton A, et al. Identification and analysis of fitness of resistance mutations against the HCV protease inhibitor SCH 503034. Antiviral Res 2006;70(2):28-38
  • Lin C, Kwong AD, Perni RB. Discovery and development of VX-950, a novel, covalent, and reversible inhibitor of hepatitis C virus NS3.4A serine protease. Infect Disord Drug Targets 2006;6(1):3-16
  • Gentile I, Viola C, Borgia F, et al. Telaprevir: a promising protease inhibitor for the treatment of hepatitis C virus infection. Curr Med Chem 2009;16(9):1115-21
  • Coppola N, Pisaturo M, Tonziello G, et al. Efficacy of Pegylated interferon alpha-2a and alpha-2b in patients with genotype 1 chronic hepatitis C: a meta-analysis. BMC Infect Dis 2012;12:357-1471-2334
  • Ghany MG, Strader DB, Thomas DL, Seeff LB. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49(4):1335-74
  • European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C. Agency EM. 2013. Available at www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/11/WC500155469.pdf [ Last accessed 01.02.2014
  • Approval of Sovaldi (sofosbuvir) tablets for the treatment of chronic hepatitis C. FDA. FDA press release; 2013. Available at www.fda.gov/forconsumers/byaudience/forpatientadvocates/ucm377920.htm; Last accessed 17/01/2014
  • 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):1867-77
  • Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013;368(20):1878-87
  • Gentile I, Borgia F, Zappulo E, et al. Efficacy and safety of sofosbuvir in treatment of chronic hepatitis C: the dawn of a new era. Rev Recent Clin Trials 2014;9(1):1-7
  • Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir + Ribavirin for 12 or 24 weeks for patients with HCV genotype 2 or 3: the VALENCE trial. Hepatology 2013;58(4):733-4
  • Lange CM, Bojunga J, Ramos-Lopez E, et al. Vitamin D deficiency and a CYP27B1-1260 promoter polymorphism are associated with chronic hepatitis C and poor response to interferon-alfa based therapy. J Hepatol 2011;54(5):887-93
  • Ismail MH. Prediction of sustained virologic responses to combination therapy of pegylated interferon-alpha and ribavirin in patients with chronic hepatitis C infection. J Family Community Med 2013;20(1):35-40
  • Borgia G, Gentile I, Fortunato G, et al. Homocysteine levels and sustained virological response to pegylated-interferon alpha2b plus ribavirin therapy for chronic hepatitis C: a prospective study. Liver Int 2009;29(2):248-52
  • Distante S, Bjoro K, Hellum KB, et al. Raised serum ferritin predicts non-response to interferon and ribavirin treatment in patients with chronic hepatitis C infection. Liver 2002;22(3):269-75
  • Gentile I, Viola C, Paesano L, et al. Iron depletion before HCV antiviral therapy: a pilot, randomized, controlled trial. J Clin Apher 2009;24(5):190-6
  • Abu-Mouch S, Fireman Z, Jarchovsky J, et al. Vitamin D supplementation improves sustained virologic response in chronic hepatitis C (genotype 1)-naive patients. World J Gastroenterol 2011;17(47):5184-90
  • Nimer A, Mouch A. Vitamin D improves viral response in hepatitis C genotype 2-3 naive patients. World J Gastroenterol 2012;18(8):800-5
  • Coppola N, Marrone A, Pisaturo M, et al. Role of interleukin 28-B in the spontaneous and treatment-related clearance of HCV infection in patients with chronic HBV/HCV dual infection. Eur J Clin Microbiol Infect Dis 2014;33(4):559-67
  • Ghany MG, Nelson DR, Strader DB, 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(4):1433-44
  • Gentile I, Borgia F, Buonomo AR, et al. A novel promising therapeutic option against hepatitis C virus: an oral nucleotide NS5B polymerase inhibitor sofosbuvir. Curr Med Chem 2013;20(30):3733-42
  • Sarrazin C, Hezode C, Zeuzem S, Pawlotsky JM. Antiviral strategies in hepatitis C virus infection. J Hepatol 2012;56(1):S88-S100
  • Gentile I, Borgia F, Coppola N, et al. Daclatasvir: the first of a new class of drugs targeted against hepatitis C virus NS5A. Curr Med Chem 2014;21(12):1391-404
  • Lange CM, Zeuzem S. Perspectives and challenges of interferon-free therapy for chronic hepatitis C. J Hepatol 2013;58(3):583-92
  • Gentile I, Buonomo AR, Borgia F, et al. Ledipasvir: a novel synthetic antiviral for the treatment of HCV Infection. Expert Opin Investig Drugs 2014;23(4):561-71
  • Gentile I, Coppola N, Buonomo AR, et al. Investigational NS polymerase inhibitors and their use in treating HCV. Expert Opin Investig Drugs 2014. [Epub ahead of print]
  • Gentile I, Buonomo AR, Borgia F, et al. MK-5172 : a second-generation protease inhibitor for the treatment of hepatitis C virus infection. Expert Opin Investig Drugs 2014;23(5):719-28
  • Gentile I, Zappulo E, Buonomo AR, Borgia G. Interferon-free therapies for chronic hepatitis C: towards an HCV-free world? Expert Rev Anti Infect Ther 2014;12(7):763-73
  • Smith DB, Bukh J, Kuiken C, et al. Expanded classification of hepatitis C. Virus into 7 genotypes and 67 Subtypes: updated criteria and assignment web resource. Hepatology 2013;1(10):318-27
  • Lindenbach BD, Rice CM. Unravelling hepatitis C virus replication from genome to function. Nature 2005;436(7053):933-8
  • Parfieniuk A, Jaroszewicz J, Flisiak R. Specifically targeted antiviral therapy for hepatitis C virus. World J Gastroenterol 2007;13(43):5673-81
  • Gentile I, Carleo MA, Borgia F, et al. The efficacy and safety of telaprevir - a new protease inhibitor against hepatitis C virus. Expert Opin Investig Drugs 2010;19(1):151-9
  • Gao M. Antiviral activity and resistance of HCV NS5A replication complex inhibitors. Curr Opin Virol 2013;3(5):514-20
  • Tellinghuisen TL, Marcotrigiano J, Rice CM. Structure of the zinc-binding domain of an essential component of the hepatitis C virus replicase. Nature 2005;435(7040):374-9
  • Tripathi LP, Kambara H, Chen YA, et al. Understanding the biological context of NS5A-host interactions in HCV infection: a network-based approach. J Proteome Res 2013;12(6):2537-51
  • Qiu D, Lemm JA, O’Boyle DR 2nd, et al. The effects of NS5A inhibitors on NS5A phosphorylation, polyprotein processing and localization. J Gen Virol 2011;92(Pt 11):2502-11
  • Degoey DA, Randolph JT, Liu D, et al.Discovery of ABT-267, a Pan-Genotypic Inhibitor of HCV NS5A. J Med Chem 2014;15:15
  • Pilot-Matias T, Koev G, Krishnan P, et al. In vitro combinatory effect of HCV NS3/4A Protease Inhibitor ABT-450, NS5A Inhibitor ABT-267, and non-nucleoside NS5B Polymerase Inhibitor ABT-333. In 47th Annual Meeting of the European Association for the Study of the Liver, Barcelona, Spain, 2012
  • Dumas EO, Lawal A, Menon RM, et al. Pharmacokinetics, safety and tolerability of the HCV NS5A Inhibitor ABT-267 following single and multiple doses in healthy adult volunteers. J Hepatol 2011;54:S475-S6
  • Lawitz E, Marbury T, Campbell A, et al. Safety and antiviral activity of ABT-267, a novel NS5A inhibitor, during 3-day monotherapy: first study in HCV genotype-1 (GT1)-infected treatment-naive subjects. J Hepatol 2012;56:S469-S70
  • 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. Hepatology 2012;56:555A-6A
  • Sullivan GJ, Rodriques-Torres M, Lawitz E, et al. ABT-267 combined with Pegylated Interferon alpha-2a/ribavirin in genotype 1 (GT1) HCV-infected treatment-naive subjects: 12 week antiviral and safety analysis. EASL 47th Annual Meeting, Barcelona, Spain; 18-22 April 2012
  • Epstein M, Felizarta F, Marbury T, et al. Study of ABT-267 2-day monotherapy followed by 12-week combination therapy in treatment-naive patients with chronic HCV genotype 1 Infection. J Hepatol 2013;58:S484
  • 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
  • Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370(17):1594-603
  • 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
  • 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;11:11
  • Baran RW, Xie W, Liu Y, et al. Health-related quality of life (hrqol), health state, function and wellbeing of chronic hcv patients treated with interferon-free, oral daa regimens: patient reported outcome (PRO) results from the AVIATOR study. Hepatology 2013;58:750A-1A
  • Krishnan P, Beyer J, Koev G, et al. Antiviral activity and resistance profiles for ABT-267, a Novel HCV NS5A inhibitor, in vitro and during 3-day monotherapy in hcv genotype-1 (gt1)-infected treatment-naive subjects. Hepatology 2012;56:1069A
  • Borgia G, Carleo MA, Gaeta GB, Gentile I. Hepatitis B in pregnancy. World J Gastroenterol 2012;18(34):4677-83
  • Gentile I, Zappulo E, Buonomo AR, Borgia G. Prevention of mother-to-child transmission of hepatitis B virus and hepatitis C virus. Expert Rev Anti Infect Ther 2014;20:1-8
  • Smith BD, Morgan RL, Beckett GA, et al. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945-1965. MMWR Recomm Rep 2012;61(RR-4):1-32

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.