Skip to main content
Erschienen in: Drugs 13/2014

01.09.2014 | R & D INSIGHT REPORT

Daclatasvir + Asunaprevir: First Global Approval

verfasst von: Raewyn M. Poole

Erschienen in: Drugs | Ausgabe 13/2014

Einloggen, um Zugang zu erhalten

Abstract

The combination of daclatasvir + asunaprevir [Daklinza® + Sunvepra® (Japan)], two direct-acting antiviral agents, has been developed by Bristol–Myers Squibb for the treatment of patients with chronic hepatitis C virus (HCV) genotype 1 infections, including those with compensated cirrhosis. Daclatasvir + asunaprevir has received its first global approval in this indication in Japan. Daclatasvir + asunaprevir is the first all-oral, interferon- and ribavirin-free regimen for this indication. This article summarizes the milestones in the development of daclatasvir + asunaprevir leading to this first approval for the treatment of chronic HCV genotype 1 infections.
Literatur
1.
Zurück zum Zitat Gonzalez SA. Management of recurrent hepatitis C following liver transplantation. Gastroenterol Hepatol. 2010;6(10):637–45. Gonzalez SA. Management of recurrent hepatitis C following liver transplantation. Gastroenterol Hepatol. 2010;6(10):637–45.
2.
Zurück zum Zitat Perz JF, Armstrong GL, Farrington LA, et al. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol. 2006;45(4):529–38.PubMedCrossRef Perz JF, Armstrong GL, Farrington LA, et al. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol. 2006;45(4):529–38.PubMedCrossRef
3.
Zurück zum Zitat Gottwein JM, Jensen SB, Li Y-P, et al. Combination treatment with hepatitis C virus protease and NS5A inhibitors is effective against recombinant genotype 1a, 2a, and 3a viruses. Antimicrob Agents Chemother. 2013;57(3):1291–303.PubMedCentralPubMedCrossRef Gottwein JM, Jensen SB, Li Y-P, et al. Combination treatment with hepatitis C virus protease and NS5A inhibitors is effective against recombinant genotype 1a, 2a, and 3a viruses. Antimicrob Agents Chemother. 2013;57(3):1291–303.PubMedCentralPubMedCrossRef
4.
Zurück zum Zitat Shah N, Pierce T, Kowdley KV. Review of direct-acting antiviral agents for the treatment of chronic hepatitis C. Expert Opin Investig Drugs. 2013;22(9):1107–21.PubMedCrossRef Shah N, Pierce T, Kowdley KV. Review of direct-acting antiviral agents for the treatment of chronic hepatitis C. Expert Opin Investig Drugs. 2013;22(9):1107–21.PubMedCrossRef
5.
6.
Zurück zum Zitat Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49(4):1335–74.PubMedCrossRef Ghany MG, Strader DB, Thomas DL, et al. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology. 2009;49(4):1335–74.PubMedCrossRef
7.
Zurück zum Zitat 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.PubMedCentralPubMedCrossRef 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.PubMedCentralPubMedCrossRef
8.
Zurück zum Zitat European Association for the Study of the L. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011;55(2):245–64.CrossRef European Association for the Study of the L. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol. 2011;55(2):245–64.CrossRef
9.
Zurück zum Zitat Chae HB, Park SM, Youn SJ. Direct-acting antivirals for the treatment of chronic hepatitis C: open issues and future perspectives. Sci World J. 2013;2013:704912.CrossRef Chae HB, Park SM, Youn SJ. Direct-acting antivirals for the treatment of chronic hepatitis C: open issues and future perspectives. Sci World J. 2013;2013:704912.CrossRef
10.
Zurück zum Zitat De Clercq E. Current race in the development of DAAs (direct-acting antivirals) against HCV. Biochem Pharmacol. 2014;89(4):441–52.PubMedCrossRef De Clercq E. Current race in the development of DAAs (direct-acting antivirals) against HCV. Biochem Pharmacol. 2014;89(4):441–52.PubMedCrossRef
11.
Zurück zum Zitat Martel-Laferrière V, Bichoupan K, Dieterich D. Interferon-free regimens for hepatitis C: combine and conquer. BioDrugs. 2014;28(2):161–9.PubMedCrossRef Martel-Laferrière V, Bichoupan K, Dieterich D. Interferon-free regimens for hepatitis C: combine and conquer. BioDrugs. 2014;28(2):161–9.PubMedCrossRef
12.
Zurück zum Zitat Lange CM, Zeuzem S. Perspectives and challenges of interferon-free therapy for chronic hepatitis C. J Hepatol. 2013;58(3):583–92.PubMedCrossRef Lange CM, Zeuzem S. Perspectives and challenges of interferon-free therapy for chronic hepatitis C. J Hepatol. 2013;58(3):583–92.PubMedCrossRef
13.
Zurück zum Zitat Stedman CAM. Current prospects for interferon-free treatment of hepatitis C in 2012. J Gastroenterol Hepatol. 2013;28(1):38–45.PubMedCrossRef Stedman CAM. Current prospects for interferon-free treatment of hepatitis C in 2012. J Gastroenterol Hepatol. 2013;28(1):38–45.PubMedCrossRef
14.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
15.
Zurück zum Zitat Kramer JR, Kanwal F, Richardson P, et al. Gaps in the achievement of effectiveness of HCV treatment in national VA practice. J Hepatol. 2012;56(2):320–5.PubMedCrossRef Kramer JR, Kanwal F, Richardson P, et al. Gaps in the achievement of effectiveness of HCV treatment in national VA practice. J Hepatol. 2012;56(2):320–5.PubMedCrossRef
16.
Zurück zum Zitat Ferenci P. Treatment of chronic hepatitis C–are interferons really necessary? Liver Int. 2012;32(Suppl 1):108–12.PubMedCrossRef Ferenci P. Treatment of chronic hepatitis C–are interferons really necessary? Liver Int. 2012;32(Suppl 1):108–12.PubMedCrossRef
17.
Zurück zum Zitat Pockros PJ. Interferon-free hepatitis C therapy: how close are we? Drugs. 2012;72(14):1825–31.PubMedCrossRef Pockros PJ. Interferon-free hepatitis C therapy: how close are we? Drugs. 2012;72(14):1825–31.PubMedCrossRef
18.
19.
Zurück zum Zitat Pockros PJ. New direct-acting antivirals in the development for hepatitis C virus infection. Ther Adv Gastroenterol. 2010;3(3):191–202.CrossRef Pockros PJ. New direct-acting antivirals in the development for hepatitis C virus infection. Ther Adv Gastroenterol. 2010;3(3):191–202.CrossRef
20.
Zurück zum Zitat Asselah T, Marcellin P. Interferon free therapy with direct acting antivirals for HCV. Liver Int. 2013;33:93–104.PubMedCrossRef Asselah T, Marcellin P. Interferon free therapy with direct acting antivirals for HCV. Liver Int. 2013;33:93–104.PubMedCrossRef
21.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
22.
Zurück zum Zitat Sulkowski M, Gardiner D, 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.PubMedCrossRef Sulkowski M, Gardiner D, 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.PubMedCrossRef
24.
Zurück zum Zitat Bristol–Myers Squibb Company. Daklinza Tablets (tavaborole) Japanese Prescribing Information. 2014. Bristol–Myers Squibb Company. Daklinza Tablets (tavaborole) Japanese Prescribing Information. 2014.
25.
Zurück zum Zitat Bristol–Myers Squibb Company. Sunvepra Capsules (asunaprevir) Japanese Prescribing Information. 2014. Bristol–Myers Squibb Company. Sunvepra Capsules (asunaprevir) Japanese Prescribing Information. 2014.
26.
Zurück zum Zitat Bristol–Myers Squibb Company. Bristol–Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C. [media release]. 2014. http://www.bms.com. Bristol–Myers Squibb Company. Bristol–Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C. [media release]. 2014. http://​www.​bms.​com.
30.
Zurück zum Zitat McPhee F, Toyota J, Chayama K, et al. Analysis of HCV resistance variants in a phase 3 trial of daclatasvir combined with asunaprevir for Japanese patients with genotype 1b infection. Hepatology. 2013;58(4 suppl 1):749A. McPhee F, Toyota J, Chayama K, et al. Analysis of HCV resistance variants in a phase 3 trial of daclatasvir combined with asunaprevir for Japanese patients with genotype 1b infection. Hepatology. 2013;58(4 suppl 1):749A.
31.
Zurück zum Zitat McPhee F, Hernandez D, Yu F, et al. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013;58(3):902–11.PubMedCrossRef McPhee F, Hernandez D, Yu F, et al. Resistance analysis of hepatitis C virus genotype 1 prior treatment null responders receiving daclatasvir and asunaprevir. Hepatology. 2013;58(3):902–11.PubMedCrossRef
32.
Zurück zum Zitat Karino Y, Toyota J, Ikeda K, et al. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol. 2013;58(4):646–54.PubMedCrossRef Karino Y, Toyota J, Ikeda K, et al. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol. 2013;58(4):646–54.PubMedCrossRef
33.
Zurück zum Zitat Kosaka K, Imamura M, Hayes CN, et al. Emergence of resistant variants detected by ultra-deep sequencing after asunaprevir and daclatasvir combination therapy in patients infected with hepatitis C virus genotype 1. J Viral Hepat. 2014;. doi:10.1111/jvh.12271.PubMed Kosaka K, Imamura M, Hayes CN, et al. Emergence of resistant variants detected by ultra-deep sequencing after asunaprevir and daclatasvir combination therapy in patients infected with hepatitis C virus genotype 1. J Viral Hepat. 2014;. doi:10.​1111/​jvh.​12271.PubMed
34.
Zurück zum Zitat McPhee F, Hernandez D, Zhou N, et al. Comparison of pre-existing and emerging resistance-associated variants in US, EU and Japanese HCV genotype 1b prior interferon alfa (IFN-alpha) non responders and IFN-alpha ineligible patients treated with daclatasvir and asunaprevir. Hepatology. 2012;56:559A–60A. McPhee F, Hernandez D, Zhou N, et al. Comparison of pre-existing and emerging resistance-associated variants in US, EU and Japanese HCV genotype 1b prior interferon alfa (IFN-alpha) non responders and IFN-alpha ineligible patients treated with daclatasvir and asunaprevir. Hepatology. 2012;56:559A–60A.
35.
Zurück zum Zitat Bifano M, Sevinsky H, Bedford BR, et al. Co-Administration of Bms-790052 and Bms-650032 does not result in a clinically meaningful pharmacokinetic interaction in healthy subjects [abstract no. 827]. In: 61st Annual Meeting of the American Association for the Study of Liver Diseases; 29 Oct–02 Nov 2010; Boston. Bifano M, Sevinsky H, Bedford BR, et al. Co-Administration of Bms-790052 and Bms-650032 does not result in a clinically meaningful pharmacokinetic interaction in healthy subjects [abstract no. 827]. In: 61st Annual Meeting of the American Association for the Study of Liver Diseases; 29 Oct–02 Nov 2010; Boston.
36.
Zurück zum Zitat Chan P, Tafoya E, Eley T, et al. Exposure-response analyses of asunaprevir in combination with daclatasvir peginterferon/ ribavirin among patients with genotype 1 chronic Hcv infection: dose selection for phase 3 clinical trials [abstract no. 804]. J Hepatol. 2013;58:S328–9.CrossRef Chan P, Tafoya E, Eley T, et al. Exposure-response analyses of asunaprevir in combination with daclatasvir peginterferon/ ribavirin among patients with genotype 1 chronic Hcv infection: dose selection for phase 3 clinical trials [abstract no. 804]. J Hepatol. 2013;58:S328–9.CrossRef
37.
Zurück zum Zitat Bifano M, Sevinsky H, Hwang C, et al. Effect of the coadministration of daclatasvir on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate. Antivir Ther. 2013. doi:10.3851/IMP2718. Bifano M, Sevinsky H, Hwang C, et al. Effect of the coadministration of daclatasvir on the pharmacokinetics of a combined oral contraceptive containing ethinyl estradiol and norgestimate. Antivir Ther. 2013. doi:10.​3851/​IMP2718.
38.
Zurück zum Zitat Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014;59(6):2083–91.PubMedCrossRef Kumada H, Suzuki Y, Ikeda K, et al. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014;59(6):2083–91.PubMedCrossRef
39.
Zurück zum Zitat 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. doi:10.1016/S0140-6736(14)61059-X. 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. doi:10.​1016/​S0140-6736(14)61059-X.
40.
Zurück zum Zitat 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.PubMedCrossRef 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.PubMedCrossRef
41.
Zurück zum Zitat Lok A, Gardiner D, Hezode C, et al. Confirmation that quadruple therapy with daclatasvir (NS5A inhibitor), asunaprevir (NS3 inhibitor) and peginterferon/ribavirin results in high rate of SVR4 in HCV genotype 1 null responders. J Hepatol. 2012;56:S557.CrossRef Lok A, Gardiner D, Hezode C, et al. Confirmation that quadruple therapy with daclatasvir (NS5A inhibitor), asunaprevir (NS3 inhibitor) and peginterferon/ribavirin results in high rate of SVR4 in HCV genotype 1 null responders. J Hepatol. 2012;56:S557.CrossRef
42.
Zurück zum Zitat 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(4):655–62.PubMedCrossRef 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(4):655–62.PubMedCrossRef
43.
Zurück zum Zitat Chayama K, Takahashi S, Toyota J, et al. Dual therapy with the non-structural protein 5A inhibitor, daclatasvir, and the non-structural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b-infected null responders. Hepatology. 2012;55(3):742–8.PubMedCrossRef Chayama K, Takahashi S, Toyota J, et al. Dual therapy with the non-structural protein 5A inhibitor, daclatasvir, and the non-structural protein 3 protease inhibitor, asunaprevir, in hepatitis C virus genotype 1b-infected null responders. Hepatology. 2012;55(3):742–8.PubMedCrossRef
44.
Zurück zum Zitat Kamae I, Ward T, Webster S, et al. Estimating the long-term clinical effectiveness of daclatasvir plus asunaprevir in Japanese patients chronically infected with HCV genotype 1b: a subgroup analysis. Hepatol Int 2014;8(1 suppl.):S156. Kamae I, Ward T, Webster S, et al. Estimating the long-term clinical effectiveness of daclatasvir plus asunaprevir in Japanese patients chronically infected with HCV genotype 1b: a subgroup analysis. Hepatol Int 2014;8(1 suppl.):S156.
45.
Zurück zum Zitat 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 Health Reg Issues. 2014;3:136–45.CrossRef 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 Health Reg Issues. 2014;3:136–45.CrossRef
Metadaten
Titel
Daclatasvir + Asunaprevir: First Global Approval
verfasst von
Raewyn M. Poole
Publikationsdatum
01.09.2014
Verlag
Springer International Publishing
Erschienen in
Drugs / Ausgabe 13/2014
Print ISSN: 0012-6667
Elektronische ISSN: 1179-1950
DOI
https://doi.org/10.1007/s40265-014-0279-4

Weitere Artikel der Ausgabe 13/2014

Drugs 13/2014 Zur Ausgabe