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Review

Prevention and management of treatment failure to new oral hepatitis C drugs

, , , , , , & show all
Pages 1215-1223 | Received 07 Mar 2016, Accepted 15 Apr 2016, Published online: 09 May 2016

References

  • Mohd-Hanafiah K, Groeger J, Flaxman A, et al. Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013;57:1333–1342.
  • Messina J, Humphreys I, Flaxman A, et al. Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61:77–87.
  • Gower E, Estes C, Blach S, et al. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014;61(suppl):45–57.
  • Wedemeyer H, Dore G, Ward J. Estimates on HCV disease burden worldwide - filling the gaps. J Viral Hepat. 2015;22(suppl 1):1–5.
  • Riou J, Aït-Ahmed M, Blake A, et al. Hepatitis C virus seroprevalence in adults in Africa: a systematic review and meta-analysis. J Viral Hepat. Forthcoming.
  • Wiese M, Fisher J, Lobermann M, et al. Evaluation of liver disease progression in the German Hepatitis C virus (1b)-contaminated anti-D cohort at 35 years after infection. Hepatology. 2014;59:49–57.
  • Lingala S, Ghany M. Natural history of hepatitis C. Gastroenterol Clin North Am. 2015;44:717–734.
  • Lim S, Vos T, Flaxman A, et al. A comparative risk assessment of burden of disease and injury attributable to 67 risk factor and risk factors cluster in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2224–2260.
  • EASL. Recommendations on treatment of hepatitis C 2015. J Hepatol. 2015;63:199–236.
  • Vispo E, Barreiro P, Soriano V. Pharmacokinetics of new oral hepatitis C antiviral drugs. Expert Opin Drug Metab Toxicol. 2013;9:5–16.
  • Bartenschlager R, Lohmann V, Penin F. The molecular and structural basis of advanced antiviral therapy for hepatitis C virus infection. Nat Rev Microbiol. 2013;11:482–496.
  • Gentile I, Buonomo A, 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.
  • Pawlotsky JM. New hepatitis C therapies: the toolbox, strategies, and challenges. Gastroenterology. 2014;146:1176–1192.
  • Convjeevaram H. Continued progress against hepatitis C infection. JAMA. 2015;313:1716–1717.
  • Muir A, Naggie S. HCV treatment: is it possible to cure all HCV patients? Clin Gastroenterol Hepatol. 2015;13:2166–2172.
  • Fontaine H, Duboc D, Pol S. Bradyarrhythmias associated with sofosbuvir treatment. N Engl J Med. 2015;373:1886–1888.
  • Ahmad T, Yin P, Saffitz J, et al. Cardiac dysfunction associated with a nucleotide polymerase inhibitor for treatment of hepatitis C. Hepatology. 2015;62:409–416.
  • Dyson J, Hutchinson J, Harrison L, et al. Liver toxicity associated with sofosbuvir, an NS5A inhibitor and ribavirin use. J Hepatol. 2016;64:234–238.
  • Soriano V, Barreiro P, De Mendoza C, et al. Hepatic decompensation with sofosbuvir plus simeprevir in a patient with Child–Pugh B compensated cirrhosis. Antivir Ther. Forthcoming.
  • Soriano V, Barreiro P, De Mendoza C. Hypoglycemia in a diabetic patient during hepatitis C therapy. Hepatology. Forthcoming.
  • Helmers R, Byme T, Wesselius L, et al. Serious pulmonary toxicity secondary to novel hepatitis C antiviral therapy in a liver transplant recipient. Mayo Clin Proc. 2015;90:1294–1297.
  • Banerjee D, Reddy K. Safety and tolerability of direct-acting antiviral agents in the new era of hepatitis C therapy. Aliment Pharmacol Therap. Forthcoming.
  • Sarrazin C. The importance of resistance to direct antiviral drugs in HCV infection in clinical practice. J Hepatol. 2016;64:486–504.
  • Terrault N. Difficult-to-cure populations with chronic hepatitis C: vanishing in the direct-acting antiviral era? Hepatology. 2015;62:4–7.
  • Barreiro P, Labarga P, Fernandez-Montero JV, et al. Rate and predictors of serum HCV-RNA >6 million IU/mL in patients with chronic hepatitis C. J Clin Virol. 2015;71:63–66.
  • Soriano V, Labarga P, De Mendoza C, et al. New hepatitis C therapies for special patient populations. Exp Opin Pharmacother. 2016;17:217–229.
  • Patiño-Galindo J, Salvatierra K, González-Candelas F, et al. Comprehensive screening for naturally-occurring hepatitis C virus resistance to direct-acting antivirals in the NS3, NS5A and NS5B genes in worldwide isolates from viral genotypes 1-6. Antimicrob Agents Chemother. Forthcoming.
  • Treviño A, De Mendoza C, Parra P, et al. Natural polymorphisms associated with resistance to new antivirals against HCV in newly diagnosed HIV-HCV coinfected patients. Antiviral Ther. 2011;16:413–416.
  • Nguyen L, Gray E, Dean J, et al. Baseline prevalence and emergence of protease inhibitors resistance mutations following treatment in chronic HCV genotype 1 infected individuals. Antivir Ther. Forthcoming.
  • Sarrazin C, Lathouwers E, Peeters M, et al. Prevalence of the hepatitis C virus NS3 polymorphism Q80K in genotype 1 patients in the European region. Antivir Res. 2015;116:10–16.
  • Poveda E, Wyles D, Mena A, et al. Update on hepatitis C virus resistance to direct-acting antiviral agents. Antivir Res. 2014;108:181–191.
  • Vallet S, Viron F, Henquell C, et al. NS3 protease polymorphism and natural resistance to protease inhibitors in French patients infected with HCV genotypes 1-5. Antivir Ther. 2011;16:1093–1102.
  • Bartels D, Sullivan J, Zhang E, et al. Hepatitis C virus variants with decreased sensitivity to direct-acting antivirals (DAAs) were rarely observed in DAA-naive patients prior to treatment. J Virol. 2013;87:1544–1553.
  • Plaza Z, Soriano V, Vispo E, et al. Prevalence of natural polymorphisms at the HCV NS5A gene associated with resistance to daclatasvir, and NS5A inhibitor. Antivir Ther. 2012;17:921–926.
  • Hernandez D, Zhou N, Ueland J, et al. Natural prevalence of NS5A polymorphisms in subjects infected with hepatitis C virus genotype 3 and their effects on the antiviral activity of NS5A inhibitors. J Clin Virol. 2013;57:13–18.
  • Nguyen L, Hall N, Sheerin D, et al. Naturally occurring HCV NS5A/B inhibitor resistance-associated mutations to direct-acting antivirals. Antivir Ther. Forthcoming.
  • Chen Z, Li H, Ren H, et al. Global prevalence of pre-existing HCV variants resistant to direct-acting antiviral agents (DAAs): mining the GenBank HCV genome data. Sci Rep. Forthcoming.
  • Kuntzen T, Timm J, Berical A, et al. Naturally occurring dominant resistance mutations to hepatitis C virus protease and polymerase inhibitors in treatment-naive patients. Hepatology. 2008;48:1769–1778.
  • Di Maio V, Cento V, Mirabelli C, et al. Hepatitis C virus genetic variability and the presence of NS5B resistance-associated mutations as natural polymorphisms in selected genotypes could affect the response to NS5B inhibitors. Antimicrob Agents Chemother. 2014;58:2781–2797.
  • Wyles D. Antiviral resistance and the future landscape of hepatitis C virus infection therapy. J Infect Dis. 2013;207(suppl 1):33–39.
  • Lenz O, Verbinnen T, Fevery B, et al. Virology analyses of HCV isolates from genotype 1-infected patients treated with simeprevir plus peginterferon/ribavirin in Phase IIb/III studies. J Hepatol. 2015;62:1008–1014.
  • Krishnan P, Tripathi R, Schnell G, et al. Resistance analysis of baseline and treatment-emergent variants in hepatitis C virus genotype 1 in the AVIATOR study with paritaprevir-ritonavir, ombitasvir and dasabuvir. Antimicrob Agents Chemother. 2015;59:5445–5454.
  • Black S, Pak I, Ingravallo P, et al. Resistance analysis of virologic failure in hepatitis C genotype 1 infected patients treated with grazoprevir/elbasvir ± ribavirin: the C-WORTHY study. J Hepatol. 2015;62(suppl):677–678.
  • Svarovskaia E, Dvory-Sobol H, Parkin H, et al. Infrequent development of resistance in genotype 1-6 hepatitis C virus-infected subject treated with sofosbuvir in phase 2 and 3 clinical trials. Clin Infect Dis. 2014;59:1666–1674.
  • Hedskog C, Dvory-Sobol H, Gontcharova V, et al. Evolution of the HCV viral population from a patient with S282T detected at relapse after sofosbuvir monotherapy. J Viral Hepat. 2015;22:871–881.
  • Donaldson E, Harrington P, O´Rear J, et al. Clinical evidence and bioinformatics characterization of potential hepatitis C virus resistance pathways for sofosbuvir. Hepatology. 2015;61:56–65.
  • Lontok E, Harrington P, Howe A, et al. Hepatitis C virus drug resistance-associated substitutions: state of the art summary. Hepatology. 2015;62:1623–1632.
  • Krishnan P, Tripathi R, Schnell G, et al. Long-term follow-up of treatment-emergent resistance-associated variants in NS3, NS5A and NS5B with paritaprevir/r, ombitasvir- and dasabuvir based-regimens. J Hepatol. 2015;62:1008–1014.
  • Sullivan J, De Meyer S, Bartels D, et al. Evolution of treatment-emergent resistant variants in telaprevir phase 3 clinical trials. Clin Infect Dis. 2013;57:221–229.
  • Jensen D, O´Leary J, Pockros P, et al. Safety and efficacy of sofosbuvir-containing regimens for hepatitis C: real world experience. Hepatology. 2014;60(supp l):219A.
  • Dieterich D, Bacon B, Flamm S, et al. Evaluation of sofosbuvir and simeprevir –based regimens in the TRIO network: academic and community treatment of a real world, heterogeneous population. Hepatology. 2014;60(suppl):220A.
  • Soriano V, Vispo E, Poveda E, et al. Treatment failure with new hepatitis C drugs. Expert Opin Pharmacother. 2012;13:313–323.
  • Buti M, Riveiro-Barciela M, Esteban R. Management of direct antiviral agent failures. J Hepatol. 2015;63:1511–1522.
  • Afdhal N, Zeuzem S, Kwo P, et al. ION-1 Investigators. Ledipasvir and sofosbuvir for untreated genotype 1 infection. N Engl J Med. 2014;370:1889–1898.
  • Afdhal N, Reddy K, Nelson D, et al. ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl Med. 2014;370:1483–1493.
  • Everson G, Towner W, Davis M, et al. Sofosbuvir with velpatasvir in treatment-naive non-cirrhotic patients with genotype 1 to 6 hepatitis C virus infection: a randomized trial. Ann Intern Med. 2015;163:818–826.
  • Lok A, Gardiner D, Lawitz E, et al. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med. 2012;366:216–224.
  • Manns M, Pol S, Jacobson I, et al. All oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet. 2014;384:1597–1605.
  • Lawitz E, Poordad F, Pangs P, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naïve and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014;383:515–523.
  • Sulkowski M, Gardiner D, Rodriguez-Torres M, et al. Daclatasvir plus sosfosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370:211–221.
  • Nelson D, Cooper J, Lalezari J, et al. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase 3 study. Hepatology. 2015;61:1127–1135.
  • Landaverde C, Wells J, Hamner R, et al. Dual therapy of grazoprevir and elbasvir for the treatment of hepatitis C infection. Expert Rev Gastroenterol Hepatol. Forthcoming.
  • Wyles D, Ruane P, Sulkowski M, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015;373:714–725.
  • Kohli A, Osinusi A, Sims Z, et al. Virological response after 6 week triple drug regimens for hepatitis C: a proof-of-concept phase 2 cohort study. Lancet. 2015;385:1107–1113.
  • Lam B, Jeffers T, Younoszai Z, et al. The changing landscape of hepatitis C virus therapy: focus on interferon-free treatment. Ther Adv Gastroenterol. 2015;8:298–312.
  • Günthard H, Aberg J, Eron J, et al. Antiretroviral treatment of adult HIV infection: 2014 recommendations of the International Antiviral Society-USA Panel. JAMA. 2014;312:410–425.
  • Dietz J, Susser S, Berkowski C, et al. Consideration of viral resistance for optimization of direct antiviral therapy of hepatitis C virus genotype 1-infected patients. PLoS One. 2015;10:e0134395.
  • Sarrazin C, Dvory-Sobol H, Svarovskaia E, et al. The prevalence and the effect of HCV NS5A resistance associated variants in subjects with compensated cirrhosis treated with ledipasvir/sofosbuvir +/- ribavirin. J Hepatol. 2015;62(suppl):620.
  • Ozeki I, Nakajima T, Yamaguchi M, et al. Successful achievement of sustained virological response to triple combination therapy containing simeprevir in two patients with chronic hepatitis C who had failed asunaprevir-daclatasvir combination therapy. Hepatol Res. Forthcoming.
  • Hézode C, Chevaliez S, Scoazec G, et al. Retreatment with sofosbuvir and simeprevir of patients with HCV GT1 or 4 who previously failed a daclatasvir-containing regimen. Hepatology. Forthcoming.
  • Soriano V, Perelson A, Zoulim F. Why are there different dynamics in the selection of drug resistance in HIV and hepatitis B and C viruses? J Antimicrob Chemother. 2008;62:1–4.
  • McCloskey R, Liang R, Joy J, et al. Global origin and transmission of HCV non-structural protein 3 Q80K polymorphism. J Infect Dis. 2015;211:1288–1295.
  • Tong X, Le Pogam S, Li L, et al. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014;209:668–675.
  • Svarovskaia E, Gane E, Dvory-Sobol H, et al. L159F and V321A sofosbuvir-associated hepatitis C virus NS5B substitutions. J Infect Dis. Forthcoming.
  • Tapper E, Afdhal N. Is 3 the new 1: perspectives on virology, natural history and treatment for hepatitis C genotype 3. J Viral Hepat. 2013;20:669–677.
  • Gao N. Antiviral activity and resistance of HCV NS5A replication complex inhibitors. Curr Op Virol. 2013;5:514–520.
  • Zeuzem S, Dusheiko G, Salupere R, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med. 2014;370:1993–2001.
  • 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. Forthcoming.
  • Foster G, Afdhal N, Roberts S, et al. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. 2015;373:2608–2617.
  • Ferenci P, Kozbial K, Mandorfer M, et al. HCV targeting of patients with cirrhosis. J Hepatol. 2015;63:1015–1022.
  • Gambato M, Lens S, Navasa M, et al. Treatment options in patients with decompensated cirrhosis, pre- and post-transplantation. J Hepatol. 2014;61(suppl 1):120–131.
  • Foster G, Irving W, Cheung M, et al. Cohort study of the impact of direct acting antiviral therapy in patients with chronic hepatitis C and decompensated cirrhosis. J Hepatol. Forthcoming.
  • Saxena V, Nyberg L, Pauly M, et al. Safety and efficacy of simeprevir/sofosbuvir in hepatitis C infected patients with compensated and decompensated cirrhosis: a matched analysis. Hepatology. 2015;62:715–725.
  • Reddy K, Bourlière M, Sulkowski M, et al. Ledipasvir and sofosbuvir in patients with genotype 1 HCV and compensated cirrhosis: an integrated safety and efficacy analysis. Hepatology. 2015;62:79–86.
  • Zeuzem S, Ghalib R, Reddy K, et al. Grazoprevir-elbasvir combination therapy for treatment-naive cirrhotic and non-cirrhotic patients with chronic hepatitis C virus genotype 1, 4 or 6 Infection: a randomized trial. Ann Intern Med. 2015;163:1–13.
  • Manns M, Samuel D, Gane E, et al. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicenter, open-label, randomized, phase 2 study. Lancet Infect Dis. Forthcoming.
  • Fernandez-Montero JV, Soriano V. SOLAR-2: the sun also rises for cirrhotics. Lancet Infect Dis. Forthcoming.
  • Stine J, Intagliata N, Shah N, et al. Hepatic decompensation likely attributable to simeprevir in patients with advanced cirrhosis. Dig Dis Sci. 2015;60:1031–1035.
  • Shibata S, Umemura T, Komatsu M, et al. Severe hepatotoxicity associated with asunaprevir and daclatasvir in chronic hepatitis. C Hepatol. Forthcoming.
  • 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;370:1973–1982.
  • Marchan A, Dominguez L, Kessler P, et al. Liver failure in HIV-HCV coinfection treated with sofosbuvir, ledipasvir and antiretroviral therapy. J Hepatol. Forthcoming.
  • Esposito I, Labarga P, Barreiro P, et al. Dual antiviral therapy for HIV and hepatitis C: drug interactions and side effects. Expert Opin Drug Saf. 2015;14:1421–1434.
  • Kau A, Vermehren J, Sarrazin C. Treatment predictors of a sustained virologic response in hepatitis B and C. J Hepatol. 2008;49:634–651.
  • Medrano J, Neukam K, Rallón N, et al. Modelling the probability of sustained virological response to therapy with pegylated interferon plus ribavirin in patients coinfected with HCV and HIV. Clin Infect Dis. 2010;51:1209–1216.
  • Poordad F, McCone J, Bacon B, et al. Boceprevir for untreated chronic HCV genotype 1 infection. N Engl J Med. 2011;364:1195–1206.
  • Poordad F, Bronowicki J, Gordon S, et al. Factors that predict response of patients with hepatitis C virus infection to boceprevir. Gastroenterology. 2012;143:608–618.
  • FDA Package insert for HARVONI. Available from: www.accessdata.fda.gov
  • Kowdley K, Gordon S, Reddy K, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med. 2014;370:1879–1888.
  • Kwo P, Gitlin N, Nahass R, et al. A phase 3 randomized open-label study to evaluate the efficacy and safety of 8 and 12 weeks of simeprevir plus sofosbuvir in treatment-naïve and –experienced patients with chronic HCV genotype 1 infection without cirrhosis: OPTIMIST-1. J Hepatol. 2015;62(suppl 2):270 [abstract LP14].
  • Hoofnagle J, Sherker A. Therapy for hepatitis C – the costs of success. N Engl J Med. 2014;370:1552–1553.
  • McCaughan G, Zekry A. Impact of immunosuppression on immunopathogenesis of liver damage in HCV-infected recipients following liver transplantation. Liver Transpl. 2003;9(suppl):21–27.
  • Barreiro P, Labarga P, de Mendoza C, et al. High serum HCV-RNA in chronic hepatitis C patients coinfected with HIV despite successful antiretroviral therapy. Antivir Ther. Forthcoming.
  • Soriano V, Gallego L. Viral hepatitis: treating hepatitis C in injection drug users. Nat Rev Gastroenterol Hepatol. 2013;10:568–569.
  • Barreiro P, Fernandez-Montero JV, de Mendoza C, et al. Towards hepatitis C eradication from the HIV-infected population. Antivir Res. 2014;105:1–7.
  • Alqahtani S, Sulkowski M. Current and evolving treatments of genotype 1 hepatitis C virus. Gastroenterol Clin N Am. 2015;44:825–843.
  • Barreiro P, Labarga P, Fernández-Montero JV, et al. Longitudinal changes in viral RNA concentration in patients with chronic hepatitis C and/or HIV infection in the absence of antiviral therapy. J Clin Virol. 2013;58:391–395.
  • Vermehren J, Maasoumy B, Maan R, et al. Applicability of HCV RNA viral load thresholds for 8-week treatments in patients with chronic hepatitis C genotype 1 infection. Clin Infect Dis. Forthcoming.
  • Bourliere M, Bronowicki J, de Ledinghen V, et al. Ledipasvir-sofosbuvir with or without ribavirin to treat patients with HCV genotype 1 infection and cirrhosis non-responsive to previous protease inhibitor therapy: a randomized, double-blind, phase 2 trial (SIRIUS). Lancet Infect Dis. 2015;15:397–404.
  • Foster G, Afdhal N, Roberts S, et al. Sofosbuvir and velpatasvir for HCV genotypes 2 and 3. N Engl J Med. 2015;373:2608–2617.
  • Lacombe K. Hepatitis C therapeutics: pangenotypic therapeutics on the horizon. CROI 2016. Boston, MA; 2016 Feb 22–25. [abstract 56].
  • Pawlotsky JM. Avoiding treatment failures associated with HCV resistance. Nature Rev Gastroenterol Hepatol. 2015;12:673–674.

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