293
Views
24
CrossRef citations to date
0
Altmetric
Drug Evaluation

Efficacy and safety of alisporivir for the treatment of hepatitis C infection

, , &
Pages 379-384 | Received 02 Oct 2018, Accepted 14 Dec 2018, Published online: 21 Dec 2018

References

  • Younossi ZM. Hepatitis C infection: a systematic disease. Clin Liver Dis. 2017;21:449–453.
  • Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017;2:161–176.
  • Reddy KR, Bruno S, Rossaro L, et al. Predictors of sustained virologic response among treatment-naïve patients with hepatitis C virus genotype 1 when treated with boreceprevir (boc) plus peginterferon alfa-2b/ribavirin (pr). J Hepatol. 2011;54:S190.
  • Gheorghe L, Iacob S, Curescu M, et al. Real-life use of 3 direct-acting antiviral regimen in a large cohort of patients with genotype-1b HCV compensated cirrhosis. J Gastrointestin Liver Dis. 2017 Sep;26(3):275281.
  • Spengler U. Direct Antiviral Agents (DAAs)- A new age in the treatment of hepatitis C virus infection. Pharmacol Ther. 2018 Mar;183:118–126.
  • Stanciu C, Trifan A. Hepatitis C virus treatment revolution: eastern European story. Hepatitis Mon. 2015;15(7):e28969.
  • Trifan A, Stanciu C, Gheorghe L, et al. Efficacy and safety of paritaprevir/ritonavir, ombitasvir, and dasabuvir with ribavirin for the treatment of HCV genotype 1b compensated cirrhosis in patients aged 70 years or older. Medicine. 2017;96(50):e9271.
  • Au JS, Pockros PJ. Novel therapeutic approaches for hepatitis C. Clin Pharmacol Ther. 2014;95:78–88.
  • Flisiak R, Jaroszewicz J, Parfieniuk-Kowerda A. Emerging treatments for hepatitis C. Expert Opin Emerg Drugs. 2013;18:461–475.
  • Armstrong GL, Wasley A, Simard EP, et al. The prevalence of hepatitis C virus infection in the United States, 1999 through 2002. Ann Intern Med. 2006;144:705–714.
  • Cross TJ, Antoniades CG, Harrison PM. Current and future management of chronic hepatitis C infection. Postgrad Med J. 2008;2008(84):172–176.
  • Crabbe R, Vuagniaux G, Dumont JM, et al. An evaluation of the cyclophilin inhibitor Debio 025 and its potential as a treatment for chronic hepatitis C. Expert Opin Investig Drugs. 2009;18:211–220.
  • Borel JF. History of the discovery of cyclosporin and of its early pharmacological development. Wien Klin Wochenschr. 2002;114:433–437.
  • Inoue K, Sekiyama K, Yamada M, et al. Combined interferon alpha2b and cyclosporin A in the treatment of chronic hepatitis C: controlled trial. J Gastroenterol. 2003;38:567–572.
  • Inoue K, Yoshiba M. Interferon combined with cyclosporine treatment as an effective countermeasure against hepatitis C virus recurrence in liver transplant patients with end-stage hepatitis C virus related disease. Transplant Proc. 2005;37:1233–1234.
  • Paeshuyse J, Kaul A, De Clercq E, et al. The non-immunosuppressive cyclosporin DEBIO-025 is a potent inhibitor of hepatitis C virus replication in vitro. Hepatology. 2006;43:761–770.
  • 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;12:763–773.
  • IDSA/AASLD. Recommendations for testing, managing, and treating hepatitis C. [Internet]; 2017 [cited 2018 Sep 12]. http://www.hcvguidelines.org
  • EASL. Recommendations on treatment of hepatitis C 2016. J Hepatol. 2017;66:153–194.
  • Benitez-Gutierrez L, Barreiro P, Labarga P, et al. Prevention and management of treatment failure to new oral hepatitis C drugs. Expert Opin Pharmacother. 2016;17:1215–1223.
  • Johnson S, Thompson D, Raccor B. Hepatitis C virus genotype 3: update on current and emergent therapeutic interventions. Curr Infect Dis Rep. 2017;19:22.
  • Esposito I, Trinks J, Soriano V. Hepatitis C virus resistance to the new direct-acting antivirals. Expert Opin Drug Metab Toxicol. 2016;12:1197–1209.
  • Sarrazin C. The importance of resistance to direct antiviral drugs in HCV infection in clinical practice. J Hepatol. 2016;64:486–504.
  • Alkhouri N, Lawitz E, Poordad F. Novel treatments for chronic hepatitis C: closing the remaining gaps. Curr Opin Pharmacol. 2017;37:107–111.
  • Flisiak R, Jarowiecz J, Flisiak I, et al. Update on alisporivir in treatment of viral hepatitis C. Expert Opin Investig Drugs. 2012;21:375–382.
  • Flisiak R, Horban A, Gallay P, et al. The cyclophilin inhibitor Debio-025 shows potent anti-HCV effect inpatients coinfected with hepatitis C and human immunodeficiency virus. Hepatology. 2008;47:817–826.
  • Herrmann E, Kafer A, Flisiak R, et al. Modeling of viral kinetics during treatment with Debio-025 plus pegylated interferon alpha-2a in treatment naive HCV patients. J Hepatol. 2009;50(S1):S344.
  • Chatterji U, Bobardt MD, Sevarajah S, et al. The isomerase active site of cyclophilin a is critical for hepatitis C virus replication. J Biol Chem. 2009;284:16998–17005.
  • Liu Z, Yang F, Robotham JM, et al. Critical role of cyclophilin a and its prolyl-peptidyl isomerase activity in the structure and function of the hepatitis C virus replication complex. J Virol. 2009;83:6554–6565.
  • Landrieu I, Hanoulle X, Bonachera F, et al. Structural basis for the non-immunosuppressive character of the cyclosporin A analogue Debio 025. Biochemistry. 2010;49:4679–4686.
  • Fernandes F, I-uH A, Striker R. Cyclosporine inhibits a direct interaction between cyclophilins and hepatitis C NS5A. PLoS ONE. 2010;5(3):e9815.
  • Coelmont L, Hanoulle X, Chatterji U, et al. DEB025 (alisporivir) inhibits hepatitis C virus replication by preventing a cyclophilin a induced Cis-Trans isomerisation in domain II of NS5A. PLoS ONE. 2010;5(10):e13687.
  • Hanoulle X, Badillo A, Wieruszeski JM, et al. Hepatitis C virus NS5A protein is a substrate for the peptidyl-prolyl cis/trans isomerase activity of cyclophilins A and B. J Biol Chem. 2009;284:13589–13601.
  • Gallay PA, Lin K. Profile of alisporivir and its potential in the treatment of hepatitis C. Drug Des Devel Ther. 2013;7:105–115.
  • Crouchet E, Wrensch F, Schuster C, et al. Host-targeting therapies for hepatitis C virus infection: current developments and future applications. Therap Adv Gastroenterol. 2018;11:1756284818759483.
  • Chatterji U, Garcia-Rivera JA, Baugh J, et al. The combination of alisporivir plus an NS5A inhibitor provides additive to synergistic anti-hepatitis C virus activity without detectable cross-resistance. Antimicrob Agents Chemother. 2014;58(6):3327–3334.
  • Flisiak R, Feinman SV, Jablkowski M, et al. The cyclophilin inhibitor Debio 025 combined with PEG IFNalpha2a significantly reduces viral load in treatment-naive hepatitis C patients. Hepatology. 2009;49(5):1460–1468.
  • Flisiak R, Pawlotsky JM, Crabbe R, et al. Once daily alisporivir (DEB025) plus peg-IFN-alfa-2a/ribavirin results in superior sustained virologic response (SVR24) in chronic hepatitis C genotype 1 treatment-naȉve patients-the ESSENTIAL study. J Hepatol. 2011;55(Abstract):190.
  • Nelson DR, Ghalib RH, Sulkowski M, et al. Efficacy and safety of the cyclophilin inhibitor Debio 025 in combination with pegylated interferon alpha-2a and ribavirin in previously null-responder genotype 1 HCV patients. J Hepatol. 2009;49(S1):S40.
  • Pawlotsky JM, Sarin SK, Foster GR, et al. Alisporivir plus ribavirin is highly effective as interferon-free or interferon-add-on regimen in previously untreated HCV-G2 or G3 patients: SVR12 results from VITAL-1 phase 2b study. J Hepatol. 2012;56(Abstract):1405.
  • Pawlotsky JM, Flisiak R, Sarin SK, et al. VITAL-1 study team. Alisporivir plus ribavirin, interferon free or in combination with pegylated interferon, for hepatitis C virus genotype 2 or 3 infection. Hepatology. Oct2015;62(4):1013–1023.
  • Buti M, Flisiak R, Kao JH, et al. Alisporivir with peginterferon/ribavirin in patients with chronic hepatitis C genotype 1 infection who failed to respond to or relapsed after prior interferon-based therapy: fundamental, a phase II trial. J Viral Hepat. Jul2015;22(7):596–606.
  • Buti M, Llaneras J, Riveiro-Barciela M, et al. Therapy for hepatitis C genotype 3: moving forward. J Viral Hepat. 2015 Sep;22(9):683–690.
  • Zeuzem S, Flisiak R, Vierling JM, et al. Essential II study group.Randomised clinical trial: alisporivir combined with peginterferon and ribavirin in treatment-naïve patients with chronic HCV genotype 1 infection (ESSENTIAL II) Aliment Pharmacol Ther. Oct2015;42(7):829–844.
  • Griffel L, Bao W, Orsenigo R, et al. Interferon (IFN)-Free Alisporivir has a better overal safety profile comparde to IFN-containing treatment: a pooled analysis of the ALV development program. J Hepatol. 2013;58:S229–S407.
  • Daito T, Watashi K, Sluder A, et al. Cyclophilin inhibitors reduce phosphorylation of RNA-dependent protein kinase to restore expression of IFN-stimulated genes in HCV-infected cells. Gastroenterology. 2014;147:463–472.
  • Global health sector strategy on viral hepatitis, 2016–2021; 2018 [cited 2018 Sep 14]. http://www.who.int/hepatitis/strategy2016-2021/portal/en/
  • Hézode 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;59:434–441.
  • Ferenci P. Treatment of hepatitis C in difficult-to-treat patients. Nat Rev Gastroenterol Hepatol. 2015;12:284–292.
  • Zeuzem S, Dusheiko GM, Salupere R, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014;370:1993–2001.
  • Nelson DR, Cooper JN, Lalezari JP, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61:1127–1135.
  • Foster GR, Afdhal N, Roberts SK, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. 2015;373:2608–2617.
  • Hull MW, Yoshida EM, Montaner JSG. Update on current evidence for hepatitis C therapeutic options in HCV mono-infected patients. Curr Infect Dis Rep. 2016;18:22.
  • Leroy V, Angus P, Bronowicki JP, et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease: a randomized phase III study (ALLY-3+). Hepatology. 2016;63:1430–1441.
  • Naoumov NV. Cyclophilin inhibition as potential therapy for liver diseases. J Hepatol. 2014;61:1166–1174.
  • Gallay PA, Bobardt MD, Chatterji U, et al. The novel cyclophilin inhibitor CPI-431-32 concurrently blocks HCV and HIV-1 infections via a similar mechanism of action. PLoS ONE. 2015;10(8):e0134707.
  • Lim PJ, Gallay PA. Hepatitis C NS5A protein: two drug targets within the same protein with different mechanisms of resistance. Curr Opin Virol. 2014;30–37. DOI:10.1016/j.coviro.2014.04.012

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.