Rate and predictors of treatment failure to all-oral HCV regimens outside clinical trials

Antiviral Therapy

Volumn 22, Issue 4, 2017, Pages 307-312

  Arias, Ana ^a   Aguilera, Antonio ^b   Soriano, Vicente ^c   Benítez Gutiérrez, Laura ^a   Lledó, Gemma ^a   Navarro, Daniel ^b   Treviño, Ana ^a   Otero, Esteban ^b   Peña, José M ^c   Cuervas Mons, Valentín ^a   De Mendoza, Carmen ^a  

^a HOSPITAL UNIVERSITARIO PUERTA DE HIERRO   (Spain)

^b HOSPITAL DE CONXO   (Spain)

^c HOSPITAL UNIVERSITARIO LA PAZ   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIVIRUS AGENT; DASABUVIR; LEDIPASVIR; OMBITASVIR; PARITAPREVIR; RIBAVIRIN; RITONAVIR; SIMEPREVIR; SOFOSBUVIR; BENZIMIDAZOLE DERIVATIVE; FLUORENE DERIVATIVE; LEDIPASVIR, SOFOSBUVIR DRUG COMBINATION; URIDINE PHOSPHATE; VIRUS RNA;

ADULT; ARTICLE; CLINICAL TRIAL (TOPIC); DISEASE ASSOCIATION; DISEASE SEVERITY; DRUG TREATMENT FAILURE; FEMALE; HEPATITIS C; HUMAN; LIVER FIBROSIS; MAJOR CLINICAL STUDY; MALE; PREDICTION; PRIORITY JOURNAL; RELAPSE; RETROSPECTIVE STUDY; SPAIN; SUSTAINED VIROLOGIC RESPONSE; TREATMENT DURATION; TREATMENT OUTCOME; AGED; ANALOGS AND DERIVATIVES; ANTAGONISTS AND INHIBITORS; CHRONIC HEPATITIS C; CLASSIFICATION; CLINICAL TRIAL; DRUG EFFECT; GENETICS; GENOTYPE; HEPACIVIRUS; HUMAN IMMUNODEFICIENCY VIRUS; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; ISOLATION AND PURIFICATION; LIVER CIRRHOSIS; METABOLISM; MIDDLE AGED; MIXED INFECTION; MULTICENTER STUDY; ORAL DRUG ADMINISTRATION; PATHOLOGY; PROGNOSIS; RECURRENT DISEASE; RISK FACTOR; TREATMENT FAILURE; VIROLOGY;

ADMINISTRATION, ORAL; ADULT; AGED; ANTIVIRAL AGENTS; BENZIMIDAZOLES; COINFECTION; FEMALE; FLUORENES; GENOTYPE; HEPACIVIRUS; HEPATITIS C, CHRONIC; HIV; HIV INFECTIONS; HUMANS; LIVER CIRRHOSIS; MALE; MIDDLE AGED; PROGNOSIS; RECURRENCE; RIBAVIRIN; RISK FACTORS; RNA, VIRAL; TREATMENT FAILURE; URIDINE MONOPHOSPHATE;

EID: 85032454562     PISSN: 13596535     EISSN: 20402058     Source Type: Journal    
DOI: 10.3851/IMP3061     Document Type: Article

References (40)

1. Del Bello D, Cha A, Sorbera M, et al. Real-world sustained virologic response rates of sofosbuvir-containing regimens in patients coinfected with hepatitis C and HIV. Clin Infect Dis 2016; 62:1497–1504.
2. Zhu G, Zou Z-L, Zheng J-N, et al. Systematic review and network meta-analysis of randomized controlled trials - comparative effectiveness and safety of DAA for treatment-naive hepatitis C genotype 1. Medicine (Baltimore) 2016; 95:e3004.
3. Soriano V, Labarga P, de Mendoza C, et al. New hepatitis C therapies for special patient populations. Expert Opin Pharmacother 2016; 17:217–229.
4. 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 Suppl S1:219A.
5. 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 S1:220A.
6. Afdhal N, Bacon B, Dieterich D, et al. Failure with all-oral DAA regimens: academic and community treatment of a real world population from the TRIO network. 66th Annual Meeting of the American Association for the Study of Liver Diseases. 13–17 November 2015, San Francisco, CA, USA. Abstract LB17.
7. Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Effectiveness of sofosbuvir-based regimens in genotype 1 and 2 hepatitis C virus infection in 4026 U.S. Veterans. Aliment Pharmacol Ther 2015; 42:559–573.
8. Sulkowski MS, Vargas HE, Di Bisceglie AM, et al. Effectiveness of simeprevir plus sofosbuvir, with or without ribavirin, in real-world patients with HCV genotype 1 infection. Gastroenterology 2016; 150:419–429.
9. Soriano V, Vispo E, Poveda E, Labarga P, Barreiro P. Treatment failure with new hepatitis C drugs. Expert Opin Pharmacother 2012; 13:313–323.
10. Buti M, Riveiro-Barciela M, Esteban R. Management of direct antiviral agent failures. J Hepatol 2015; 63:1511–1522.
11. Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014; 370:1879–1888.
12. 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.
13. Lawitz E, Poordad FF, Pong PS, et al. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label Phase 2 trial. Lancet 2014; 383:515–523.
14. Benítez-Gutiérrez 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.
15. 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.
16. Ziol M, Handra-Luca A, Kettaneh A, et al. Non-invasive assessment of liver fibrosis by measurement of stiffness in patients with chronic hepatitis C. Hepatology 2005; 41:48–54.
17. Castéra L, Vergniol J, Foucher J, et al. Prospective comparison of transient elastography, Fibrotest, APRI, and liver biopsy for the assessment of fibrosis in chronic hepatitis C. Gastroenterology 2005; 128:343–350.
18. de Lédinghen V, Douvin C, Kettaneh A, et al. Diagnosis of hepatic fibrosis and cirrhosis by transient elastography in HIV/hepatitis C virus-coinfected patients. J Acquir Immune Defic Syndr 2006; 41:175–179.
19. Rallón NI, Naggie S, Benito JM, et al. Association of a single nucleotide polymorphism near the interleukin-28B gene with response to hepatitis C therapy in HIV/hepatitis C virus-coinfected patients. AIDS 2010; 24:F23–F29.
20. Deeks ED. Cobas AmpliPrep/Cobas Taqman HCV quantitative test version 2.0: an in vitro test for hepatitis C virus RNA quantification. Mol Diagn Ther 2015; 19:1–7.
21. Verbeeck J, Stanley M, Celis M, et al. Evaluation of Versant hepatitis C virus genotype assay (LiPA) 2.0. J Clin Microbiol 2008; 46:1901–1906.
22. EASL. Recommendations on treatment of hepatitis C 2015. J Hepatol 2015; 63:199–236.
23. Backus LI, Balpeiro PS, Shahoumian T, et al. Effectiveness of ledipasvir/sofosbuvir in treatment naive genotype 1 patients treated in routine medical practice. Hepatology 2015; 62 Suppl S1:255A.
24. Terrault N, Zeuzem S, Di Bisceglie A, et al. Treatment outcomes with 8, 12 and 24 weeks regimens of ledipasvir/ sofosbuvir for the treatment of hepatitis C infection. Analysis of a multicentre prospective observational study (TARGET). Hepatology 2015; 62 Suppl S1:256A.
25. Zayed N, Gamal H, Elmakhzangy H, et al. Therapeutic outcome of 6198 interferon-naive Egyptian patients with chronic hepatitis C: a real-life experience and lessons in DAAs’ era. J Viral Hepat; 23:506–511.
26. Esmat G, El Raziky M, Gomaa A, et al. High virologic response rate in Egyptian HCV genotype 4 patients treated with ravidasvir (PPI-668) and sofosbuvir: results of a large multicenter Phase 3 registrational trial. Hepatology 2015; 62 Suppl S1:1381A.
27. Fontaine H, Duboc D, Pol S, et al. Bradyarrhythmias associated with sofosbuvir treatment. N Engl J Med 2015; 373:1886–1888.
28. 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.
29. Dyson JK, Hutchinson J, Harrison L, et al. Liver toxicity associated with sofosbuvir, an NS5A inhibitor and ribavirin use. J Hepatol 2016; 64:234–238.
30. Stine JG, Intagliata N, Shah NL, et al. Hepatic decompensation likely attributable to simeprevir in patients with advanced cirrhosis. Dig Dis Sci 2015; 60:1031–1035.
31. Soriano V, Barreiro P, de Mendoza C, Peña JM. Hepatic decompensation with sofosbuvir plus simeprevir in a patient with Child-Pugh B compensated cirrhosis. Antivir Ther 2016; 21:91–92.
32. Shibata S, Umemura T, Komatsu M, Tanaka E. Severe hepatotoxicity associated with asunaprevir and daclatasvir in chronic hepatitis C. Hepatology 2016; 63:2063–2064.
33. Marchan-Lopez A, Dominguez L, Kessler-Saiz P, Jarrin-Estupiñan E. Liver failure in HIV-HCV coinfection treated with sofosbuvir, ledipasvir and antiretroviral therapy. J Hepatol 2016; 64:752–753.
34. Helmers RA, Byme TJ, Wesselius LJ, et al. Serious pulmonary toxicity secondary to novel hepatitis C antiviral therapy in a liver transplant recipient. Mayo Clin Proc 2015; 90:1294–1297.
35. Renard S, Borentain P, Salaun E, et al. Severe pulmonary arterial hypertension in patients treated for hepatitis C with sofosbuvir. Chest 2016; 149:e69–e73.
36. Banerjee D, Reddy K. Safety and tolerability of direct-acting antiviral agents in the new era of hepatitis C therapy. Aliment Pharmacol Ther 2016; 43:674–696.
37. Welker M-W, Luhne S, Lange C, et al. Lactic acidosis in patients with hepatitis C virus related cirrhosis and combined ribavirin/sofosbuvir treatment. J Hepatol 2016; 64:790–799.
38. Hoofnagle JH. Hepatic decompensation during direct-acting antiviral therapy of chronic hepatitis C. J Hepatol 2016; 64:763–765.
39. Soriano V, Barreiro P, de Mendoza C. Hypoglycemia in a diabetic patient during hepatitis C therapy. Hepatology 2016; 63:2065–2066.
40. De Monte A, Courjon J, Anty R, et al. Direct-acting antiviral treatment with HCV: reactivation of hepatitis B virus coinfection as a further challenge. J Clin Virol 2016; 78:27–30.