232
Views
5
CrossRef citations to date
0
Altmetric
Drug Safety Evaluation

Asunaprevir for hepatitis C: a safety evaluation

, , , &

Bibliography

  • Wedemeyer H, Dore GJ, Ward JW. Estimates on HCV disease burden worldwide - filling the gaps. J Virol Hepat 2015;22(Suppl 1):1–5
  • Zampino R, Pisaturo MA, Cirillo G, et al. Hepatocellular carcinoma in chronic HBV-HCV co-infection is correlated to fibrosis and disease duration. Ann Hepatol 2015;14:75–82
  • Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology (Baltimore, Md) 2009;49:1335–74
  • Gentile I, Buonomo AR, Zappulo E, et al. Is it possible to predict HCV-related liver cirrhosis non-invasively through routine laboratory parameters? Infez Med 2014;22:11–18
  • 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 Hepatitis Monthly. 2013;13:e8352
  • Gentile I, Scarano F, Celotti A, et al. Low Vitamin D Levels Are Associated with the Presence of Serum Cryoglobulins in Patients with Chronic HCV Infection. In vivo (Athens. Greece) 2015;29:399–404
  • Ferrari SM, Fallahi P, Mancusi C, et al. HCV-related autoimmune disorders in HCV chronic infection. Clin Ter 2013;164:e305–12
  • 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;14:2533–44
  • Morisco F, Granata R, Stroffolini T, et al. Sustained virological response: A milestone in the treatment of chronic hepatitis C. World J Gastroenterol 2013;19:2793–8
  • Gentile I, Borgia G. Surrogate endpoints and non-inferiority trials in chronic viral hepatitis. J Hepatol 2010;52:778
  • 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;358:958–65
  • Sarrazin C, Hezode C, Zeuzem S, et al. Antiviral strategies in hepatitis C virus infection. J Hepatol 2012;56(Suppl 1):S88–100
  • Shepard CW, Finelli L, Alter MJ. Global epidemiology of hepatitis C virus infection. Lancet Infect Dis 2005;5:558–67
  • Rosina F, Tosti ME, Borghesio E, et al. Pegylated interferon alpha plus ribavirin for the treatment of chronic hepatitis C: a multicentre independent study supported by the Italian Drug Agency. Dig Liver Dis 2014;46:826–32
  • Soriano V, Peters MG, Zeuzem S. New therapies for hepatitis C virus infection. Clin Infect Dis 2009;48:313–20
  • McHutchison JG, Everson GT, Gordon SC, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med 2009;360:1827–38
  • Poordad F, McCone JJr, Bacon BR, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med 2011;364:1195–206
  • 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 (Baltimore, Md) 2011;54:1433–44
  • Bruno S, Bollani S, Zignego AL, et al. Undetectable HCV-RNA at treatment-week 8 results in high-sustained virological response in HCV G1 treatment-experienced patients with advanced liver disease: the International Italian/Spanish Boceprevir/Peginterferon/Ribavirin Name Patients Program. J Virol Hepat 2015;22:469–80
  • Merck. VICTRELIS™ (boceprevir) [package insert];2012
  • Vertex Pharmaceuticals. INCIVEK™ (telaprevir) [package insert];2012
  • 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;16:1115–21
  • 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
  • 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;21:1391–404
  • Stedman CA. Current prospects for interferon-free treatment of hepatitis C in 2012. J Gastroenterol Hepatol 2013;28:38–45
  • Gallay PA, Lin K. Profile of alisporivir and its potential in the treatment of hepatitis C. Drug Des Devel Ther 2013;7:105–15
  • Gentile I, Buonomo AR, Zappulo E, et al. GS-9669: a novel non-nucleoside inhibitor of viral polymerase for the treatment of hepatitis C virus infection. Expert Rev Anti Infect Ther 2014;12:1179–86
  • Gentile I, Buonomo AR, Zappulo E, et al. Discontinued drugs in 2012 - 2013: hepatitis C virus infection. Exp Opin Invest Drugs 2015;24:239–51
  • Gentile I, Buonomo AR, Borgia G. Ombitasvir: a potent pan-genotypic inhibitor of NS5A for the treatment of hepatitis C virus infection. Expert Rev Anti Infect Ther 2014;12:1033–43
  • 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 Invest Drugs 2014;23(5):719–28
  • Gentile I, Borgia F, Buonomo AR, et al. ABT-450: a novel protease inhibitor for the treatment of hepatitis C virus infection. Curr Med Chem 2014;21:3261–70
  • 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 Invest Drugs 2014;23:719–28
  • Gentile I, Coppola N, Buonomo AR, et al. Investigational nucleoside and nucleotide polymerase inhibitors and their use in treating hepatitis C virus. Expert Opin Invest Drugs 2014;23:1211–23
  • Gentile I, Borgia F, Zappulo E, et al. Efficacy and Safety of Sofosbuvir in Treatment of Chronic Hepatitis C: The Dawn of the a New Era. Rev Recent Clin Trials 2013. [Epub ahead of print]
  • Gentile I, Buonomo AR, Borgia F, et al. Ledipasvir : a novel synthetic antiviral for the treatment of HCV infection. Expert Opin Invest Drugs 2014;23:561–71
  • Gentile I, Buonomo AR, Borgia G. Dasabuvir: a non-nucleoside inhibitor of NS5B for the treatment of hepatitis C virus infection. Rev Recent Clin Trials 2014;9:115–23
  • Kieffer TL, Kwong AD, Picchio GR. Viral resistance to specifically targeted antiviral therapies for hepatitis C (STAT-Cs). J Antimicrob Chemother 2010;65:202–12
  • Kronenberger B, Zeuzem S. Future treatment options for HCV: double, triple, what is the optimal combination? Best practice Res Clin Gastroenterol 2008;22:1123–36
  • Gentile I, Buonomo AR, Zappulo E, et al. Interferon-free therapies for chronic hepatitis C: toward a hepatitis C virus-free world? Expert Rev Anti Infect Ther 2014;12:763–73
  • Gentile I, Borgia G. A pill a day keeps HCV away. Lancet Infect Dis 2015;15:616–17
  • McPhee F, Sheaffer AK, Friborg J, et al. Preclinical Profile and Characterization of the Hepatitis C Virus NS3 Protease Inhibitor Asunaprevir (BMS-650032). Antimicrobial Agents Chemother 2012;56:5387–96
  • Gentile I, Buonomo AR, Zappulo E, et al. Asunaprevir, a protease inhibitor for the treatment of hepatitis C infection. Ther Clin Risk Manag 2014;10:493–504
  • Chayama K, Takahashi S, Toyota J, et al. Dual therapy with the nonstructural protein 5A inhibitor, daclatasvir, and the nonstructural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b-infected null responders. Hepatology (Baltimore, Md) 2012;55:742–8
  • Suzuki Y, Ikeda K, Suzuki F, et al. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol 2013;58:655–62
  • Bronowicki JP, Pol S, Thuluvath PJ, et al. Randomized study of asunaprevir plus pegylated interferon-alpha and ribavirin for previously untreated genotype 1 chronic hepatitis C. Antivir Ther 2013;18:885–93
  • Bristol-Myers-Squibb. Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen. 2014
  • McEwan P, Ward T, Webster S, et al. Estimating the Long-Term Clinical and Economic Outcomes of Daclatasvir Plus Asunaprevir in Difficult-to-Treat Japanese Patients Chronically Infected with Hepatitis C Genotype 1b. Value in Health Regional Issues 2014;3:136–45
  • Gentile I, Carleo MA, Borgia F, et al. The efficacy and safety of telaprevir - a new protease inhibitor against hepatitis C virus. Expert Opin Invest Drugs 2010;19:151–9
  • Scola PM, Sun LQ, Wang AX, et al. The discovery of asunaprevir (BMS-650032), an orally efficacious NS3 protease inhibitor for the treatment of hepatitis C virus infection. J Med Chem 2014;57:1730–52
  • Yan Y, Li Y, Munshi S, et al. Complex of NS3 protease and NS4A peptide of BK strain hepatitis C virus: a 2.2 A resolution structure in a hexagonal crystal form. Protein Sci 1998;7:837–47
  • Germain MA, Chatel-Chaix L, Gagne B, et al. Elucidating Novel Hepatitis C. Virus/Host Interactions Using Combined Mass Spectrometry and Functional Genomics Approaches. Mol Cell Proteomics 2013;29:29
  • McPhee F, Sheaffer AK, Friborg J, et al. Preclinical Profile and Characterization of the Hepatitis C Virus NS3 Protease Inhibitor Asunaprevir (BMS-650032). Antimicrob Agents Chemother 2012;56:5387–96
  • Friborg J, Levine S, Chen C, et al. Combinations of lambda interferon with direct-acting antiviral agents are highly efficient in suppressing hepatitis C virus replication. Antimicrob Agents Chemother 2013;57:1312–22
  • Soumana DI, Ali A, Schiffer CA. Structural analysis of asunaprevir resistance in HCV NS3/4A protease. ACS Chem Biol 2014;9:2485–90
  • McPhee F, Friborg J, Levine S, et al. Resistance analysis of the hepatitis C virus NS3 protease inhibitor asunaprevir. Antimicrob Agents Chemother 2012;56:3670–81
  • Pasquinelli C, Eley T, Villegas C, et al. Safety, tolerability, pharmacokinetics and antiviral activity following single- and multiple-dose administration of BMS-650032, a novel HCV NS3 inhibitor, in subjects with chronic genotype 1 HCV infection. Hepatology 2009;50:411A–2A
  • Shiozaki T, Ueno T, Nagashima H, et al. Single- and multiple-ascending dose studies to evaluate the safety, tolerability, and pharmacokinetics of daclatasvir and asunaprevir in healthy male Japanese subjects. Int J Clin Pharmacol Ther 2015;53:292–302
  • Eley T, Han YH, Huang SP, et al. Organic anion transporting polypeptide-mediated transport of, and inhibition by, asunaprevir, an inhibitor of hepatitis C virus NS3 protease. Clin Pharmacol Ther 2015;97:159–66
  • Mosure KW, Knipe JO, Browning M, et al. Preclinical pharmacokinetics and in vitro metabolism of asunaprevir (BMS-650032), a Potent Hepatitis C Virus NS3 Protease Inhibitor. J Pharmacol Sci 2015
  • Eley T, He B, Chang I, et al. The effect of hepatic impairment on the pharmacokinetics of asunaprevir, an HCV NS3 protease inhibitor. Antivir Ther 2015;20:29–37
  • Garimella T, He B, Luo W-L, et al. Asunaprevir Pharmacokinetics and Safety in Subjects With Impaired Renal Function. Hepatology 2013;58:430A
  • Pasquinelli C, McPhee F, Eley T, et al. Single- and multiple-ascending-dose studies of the NS3 protease inhibitor asunaprevir in subjects with or without chronic hepatitis C. Antimicrob Agents Chemother 2012;56:1838–44
  • Eley T, Sevinsky H, Huang SP, et al. The pharmacokinetics of daclatasvir and asunaprevir administered in combination in studies in healthy subjects and patients infected with hepatitis C virus. Clin Drug Invest 2014;34:661–71
  • Garimella T, Adamczyk R, Hu P, et al. No Clinically-Relevant Interactions Between Asunaprevir and Selective Serotonin Reuptake Inhibitors (Escitalopram and Sertraline) in Healthy Subjects. Hepatology 2013;58:445A–6A
  • Tao X, Sims K, Hesney M, et al. Evaluation Of Drug–Drug Interactions Between The Fixed-Dose Combination Of Daclatasvir/Asunaprevir/Beclabuvir And Methadone Or Buprenorphine/Naloxone In: P0839 P, editor. EASL-50th International Liver Congress. Vienna, 2015
  • Bronowicki JP, Ratziu V, Gadano A, et al. Asunaprevir with Peginterferon-alfa and ribavirin in treatment-naive patients with genotype-1 or-4 chronic hepatitis C: SVR24 results from a randomized phase 2b study (AI447016). J Hepatol 2013;58:S571–S2
  • Vierling JM, Lataillade M, Gane EJ, et al. Sustained Virologic Response (SVR12) in HCV Genotype 1 Patients Receiving Peginterferon Lambda in Combination With Ribavirin and Either Daclatasvir or Asunaprevir: Interim Results From the D-LITE Study. Hepatology 2012;56:1522–3
  • Jensen D, Sherman KE, Hezode C, et al. Daclatasvir and asunaprevir plus peginterferon alfa and ribavirin in HCV genotype 1 or 4 non-responders. J Hepatol 2015
  • Piroth L, Paniez H, Taburet AM, et al. High cure rate with 24 weeks of daclatasvir-based quadruple therapy in treatment-experienced null-responder HIV/HCV genotype 1/4 co-infected patients: the ANRS HC 30 QUADRIH study. Clin Infect Dis 2015;61(5):817–25
  • Lok AS, Gardiner DF, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012;366:216–24
  • Lok AS, Gardiner DF, Hezode C, et al. Randomized trial of daclatasvir and asunaprevir with or without PegIFN/RBV for hepatitis C virus genotype 1 null responders. J Hepatol 2014;60:490–9
  • Suzuki Y, Ikeda K, Suzuki F, et al. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol 2013;58:655–62
  • Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 2014;6:27113
  • Manns M, Pol S, Jacobson I. All-oral dual therapy with daclatasvir and asunaprevir in patients with HCV genotype 1B infection: phase 3 study results. J Hepatol 2014;60:S524–S5
  • Manns M, Pol S, Jacobson IM, et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet 2014;384:1597–605
  • Nakamuta M, Kohjima M, Motomura K, et al. Early HCV kinetics during dual oral therapy with daclatasvir and asunaprevir. Poster 0830. EASL-50th International Liver Congress. Vienna, 2015
  • Everson GT, Sims KD, Rodriguez-Torres M, et al. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterol 2014;146:420–9
  • Everson GT, Thuluvath PJ, Lawitz E, et al. All-Oral Combination of Daclatasvir, Asunaprevir, and BMS-791325 for HCV Genotype 1 Infection. Conference on Retroviruses and Opportunistic Infections (CROI); 3 – 6 March 2014; Boston, MA Oral 25. Boston, MA
  • Everson G, Sims KD, Thuluvath PJ, et al. Daclatasvir in combination with asunaprevir and beclabuvir for prior null responders with chronic HCV genotype 1 infection Poster 1943. Poster presented at The Liver Meeting® 2014, the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 7 – 11 November 2014; Boston, MA
  • Hassanein T, Sims KD, Bennett M, et al. A Randomized Trial of Daclatasvir in Combination With Asunaprevir and Beclabuvir in Patients With Chronic Hepatitis C Virus Genotype 4 Infection. J Hepatol 2015; Epub ahead of print
  • Poordad F, Sievert W, Mollison L. All-oral, fixed-dose combination therapy with daclatasvir/asunaprevir/beclabuvir for non-cirrhotic patients with chronic HCV genotype 1 infection: UNITY-1 phase 3 SVR12 results Poster LB-7. Poster presented at The Liver Meeting 2014, the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 7 – 11 November 2014; Boston, MA
  • Rajender Reddy K, Beavers K, Gordon S, et al. Effect of baseline factors on response to the fixed-dose combination of Daclatasvir (Dcv), Asunaprevir (Asv) And Beclabuvir (Bcv) in non-cirrhotic patients with HCV genotype 1 infection. Poster 0889. EASL-50th International Liver Congress. Vienna; 2015
  • Muir A, Poordad F, Lalezari J, et al. All-oral fixed-dose combination therapy with daclatasvir/asunaprevir/beclabuvir, ± ribavirin, for patients with chronic HCV genotype 1 infection and compensated cirrhosis: UNITY-2 phase 3 SVR12 results Oral LB-2. Oral presentation The Liver Meeting® 2014, the 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD); 7 – 11 November 2014; Boston, MA
  • Hezode C, Herring RJr, Pockros P, et al. Effect of baseline factors on response to the fixed-dose combination of Daclatasvir (Dcv), Asunaprevir (Asv) And Beclabuvir (Bcv), with or without ribavirin (rbv), in patients with HCV genotype 1 infection and cirrhosis.Poster 0888. EASL-50th International Liver Congress. Vienna; 2015
  • Fujii Y, Uchida Y, Mochida S. Drug-induced immunoallergic hepatitis during combination therapy with daclatasvir and asunaprevir. Hepatol (Baltimore, Md) 2015;61:400–1
  • Gentile I, Talamo M, Borgia G. Is the drug-induced hypersensitivity syndrome (DIHS) due to human herpesvirus 6 infection or to allergy-mediated viral reactivation? Report of a case and literature review. BMC Infect Dis 2010;10:49
  • Adamczyk R, Sims K, Hesney M, et al. The Effect of Renal Impairment on Multiple-dose Pharmacokinetics of the Fixed-dose Combination of Daclatasvir/Asunaprevir/Beclabuvir. In: P0790 P, editor. EASL-50th International Liver Congress. Vienna: 2015
  • Borgia G, Reynaud L, Gentile I, et al. Pernicious anemia during IFN-alpha treatment for chronic hepatitis C. J Interferon Cytokine Res 2003;23:11–12
  • Borgia G, Reynaud L, Gentile I, et al. Myasthenia gravis during low-dose IFN-alpha therapy for chronic hepatitis C. J Interferon Cytokine Res 2001;21:469–70
  • Gentile I, Viola C, Reynaud L, et al. Hemolytic anemia during pegylated IFN-alpha2b plus ribavirin treatment for chronic hepatitis C: ribavirin is not always the culprit. J Interferon Cytokine Res 2005;25:283–5
  • Tosone G, Borgia G, Gentile I, et al. A case of pegylated interferon alpha-related diabetic ketoacidosis: can this complication be avoided? Acta Diabetol 2007;44:167–9
  • Hezode C, Fontaine H, Dorival C, et al. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) - NCT01514890. J Hepatol 2013;59:434–41
  • D’Ambrosio R, Colombo M. Safety of direct antiviral agents in real life. Dig Liver Dis 2013;30:012
  • Bristol-Myers. SUNVEPRA™ (asunaprevir) [package insert] 2014
  • Gentile I, Zappulo E, Buonomo AR, et al. Prevention of mother-to-child transmission of hepatitis B virus and hepatitis C virus. Expert Rev Anti Infect Ther 2014;12:775–82
  • Gentile I, Borgia G. Vertical transmission of hepatitis B virus: challenges and solutions. Int J Womens Health 2014;6:605–11
  • Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology (Baltimore, Md) 2014;59:2083–91

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.