Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection

Hepatology

Volumn 68, Issue 4, 2018, Pages 1298-1307

  Reau, Nancy ^a   Kwo, Paul Y ^b   Rhee, Susan ^c   Brown, Robert S ^d   Agarwal, Kosh ^e   Angus, Peter ^f   Gane, Edward ^g   Kao, Jia Horng ^h   Mantry, Parvez S ⁱ   Mutimer, David ^j   Reddy, K Rajender ^k   Tran, Tram T ^l   Hu, Yiran B ^c   Gulati, Abhishek ^c   Krishnan, Preethi ^c   Dumas, Emily O ^c   Porcalla, Ariel ^c   Shulman, Nancy S ^c   Liu, Wei ^c   Samanta, Suvajit ^c   Trinh, Roger ^c   Forns, Xavier ^m   more..

^a RUSH UNIVERSITY MEDICAL CENTER   (United States)

^b STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^c ABBVIE INC   (United States)

^d WEILL CORNELL MEDICAL COLLEGE   (United States)

^e KING'S COLLEGE HOSPITAL NHS FOUNDATION TRUST   (United Kingdom)

^f UNIVERSITY OF MELBOURNE   (Australia)

^g AUCKLAND CITY HOSPITAL   (New Zealand)

^h NATIONAL TAIWAN UNIVERSITY HOSPITAL   (Taiwan)

ⁱ Liver Instirtue at Methodist Dallas   (United States)

^j University of Birmingham   (United Kingdom)

^k UNIVERSITY OF PENNSYLVANIA   (United States)

^l CEDARS SINAI MEDICAL CENTER   (United States)

^m UNIVERSITY OF BARCELONA   (Spain)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; AMINO ACID; BILIRUBIN; CLARITHROMYCIN; CREATININE; CYCLOSPORINE; EVEROLIMUS; GLECAPREVIR PLUS PIBRENTASVIR; PEGINTERFERON; RAPAMYCIN; RIBAVIRIN; SOFOSBUVIR; TACROLIMUS; VIRUS RNA; ABT-493; BENZIMIDAZOLE DERIVATIVE; PIBRENTASVIR; QUINOXALINE DERIVATIVE; SULFONAMIDE;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANTICOAGULANT THERAPY; ANTIVIRAL THERAPY; ARTICLE; BILIRUBIN BLOOD LEVEL; CEREBROVASCULAR ACCIDENT; CHRONIC HEPATITIS C; COMBINATION DRUG THERAPY; CREATININE BLOOD LEVEL; CREATININE CLEARANCE; DIARRHEA; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; ESTIMATED GLOMERULAR FILTRATION RATE; FATIGUE; FEMALE; HEADACHE; HEALTH CARE QUALITY; HEPATITIS C VIRUS GENOTYPE 1; HEPATITIS C VIRUS GENOTYPE 2; HEPATITIS C VIRUS GENOTYPE 3; HEPATITIS C VIRUS GENOTYPE 4; HEPATITIS C VIRUS GENOTYPE 5; HEPATITIS C VIRUS GENOTYPE 6; HUMAN; IMMUNOSUPPRESSIVE TREATMENT; IMMUNOTHERAPY; INTERNATIONAL NORMALIZED RATIO; KIDNEY GRAFT; KIDNEY GRAFT REJECTION; LIVER GRAFT; LIVER GRAFT REJECTION; MAJOR CLINICAL STUDY; MALE; MEDICATION COMPLIANCE; MULTICENTER STUDY; NAUSEA; OPEN STUDY; PATIENT COMPLIANCE; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PRURITUS; RELAPSE; SIDE EFFECT; SUSTAINED VIROLOGIC RESPONSE; URINARY TRACT INFECTION; CLINICAL TRIAL; DOSE RESPONSE; DRUG ADMINISTRATION; GRAFT RECIPIENT; GRAFT REJECTION; GRAFT SURVIVAL; INTERNATIONAL COOPERATION; KIDNEY TRANSPLANTATION; LIVER TRANSPLANTATION; MIDDLE AGED; PROGNOSIS; RISK ASSESSMENT; TREATMENT OUTCOME;

ADULT; AGED; BENZIMIDAZOLES; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; DRUG THERAPY, COMBINATION; FEMALE; GRAFT REJECTION; GRAFT SURVIVAL; HEPATITIS C, CHRONIC; HUMANS; INTERNATIONALITY; KIDNEY TRANSPLANTATION; LIVER TRANSPLANTATION; MALE; MIDDLE AGED; PROGNOSIS; QUINOXALINES; RISK ASSESSMENT; SULFONAMIDES; TRANSPLANT RECIPIENTS; TREATMENT OUTCOME;

EID: 85054321603     PISSN: 02709139     EISSN: 15273350     Source Type: Journal    
DOI: 10.1002/hep.30046     Document Type: Article

References (38)

1. Petruzziello A, Marigliano S, Loquercio G, Cozzolino A, Cacciapuoti C. Global epidemiology of hepatitis C virus infection: an up-date of the distribution and circulation of hepatitis C virus genotypes. World J Gastroenterol 2016;22:7824-7840.
2. American Association for the Study of Liver Diseases, Infectious Diseases Society of America. Recommendations for testing, managing, and treating hepatitis C. http://www.hcvguidelines.org. Published 2017. Accessed November 14, 2017.
3. Organ Procurement and Transplantation Network, Scientific Registry of Transplant Recipients. United States organ transplantation. OPTN/SRTR 2012 annual data report. https://srtr.transplant.hrsa.gov/annual_reports/2012/pdf/2012_SRTR_ADR_updated_full_intro.pdf. Published June 2014. Accessed June 14, 2017.
4. Gane EJ, Portmann BC, Naoumov NV, Smith HM, Underhill JA, Donaldson PT, et al. Long-term outcome of hepatitis C infection after liver transplantation. N Engl J Med 1996;334:815-820.
5. Garcia-Retortillo M, Forns X, Feliu A, Moitinho E, Costa J, Navasa M, et al. Hepatitis C virus kinetics during and immediately after liver transplantation. Hepatology 2002;35:680-687.
6. Crespo G, Marino Z, Navasa M, Forns X. Viral hepatitis in liver transplantation. Gastroenterology 2012;142:1373-1383.
7. Blasco A, Forns X, Carrion JA, Garcia-Pagan JC, Gilabert R, Rimola A, et al. Hepatic venous pressure gradient identifies patients at risk of severe hepatitis C recurrence after liver transplantation. Hepatology 2006;43:492-499.
8. Forman LM, Lewis JD, Berlin JA, Feldman HI, Lucey MR. The association between hepatitis C infection and survival after orthotopic liver transplantation. Gastroenterology 2002;122:889-896.
9. Fabrizi F, Martin P, Dixit V, Messa P. Meta-analysis of observational studies: hepatitis C and survival after renal transplant. J Viral Hepat 2014;21:314-324.
10. Kliem V, Michel U, Burg M, Bock A, Chapman J, Dussol B, et al. Geographical prevalence, risk factors and impact of hepatitis B and C after renal transplantation. Clin Nephrol 2009;71:423-429.
11. Santos L, Alves R, Macario F, Parada B, Campos M, Mota A. Impact of hepatitis B and C virus infections on kidney transplantation: a single center experience. Transplant Proc 2009;41:880-882.
12. Goodkin DA, Bieber B, Jadoul M, Martin P, Kanda E, Pisoni RL. Mortality, hospitalization, and quality of life among patients with hepatitis C infection on hemodialysis. Clin J Am Soc Nephrol 2017;12:287-297.
13. de Oliveira Uehara SN, Emori CT, da Silva Fucuta Pereira P, Perez RM, Pestana JO, Lanzoni VP, et al. Histological evolution of hepatitis C virus infection after renal transplantation. Clin Transplant 2012;26:842-848.
14. Fabrizi F, Martin P, Ponticelli C. Hepatitis C virus infection and renal transplantation. Am J Kidney Dis 2001;38:919-934.
15. Morales JM, Fabrizi F. Hepatitis C and its impact on renal transplantation. Nat Rev Nephrol 2015;11:172-182.
16. Berenguer M, Palau A, Aguilera V, Rayon JM, Juan FS, Prieto M. Clinical benefits of antiviral therapy in patients with recurrent hepatitis C following liver transplantation. Am J Transplant 2008;8:679-687.
17. Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver D. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology 2009;49:1335-1374.
18. Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, et al. Ledipasvir and sofosbuvir plus ribavirin for treatment of HCV infection in patients with advanced liver disease. Gastroenterology 2015;149:649-659.
19. Fontana RJ, Brown RS Jr, Moreno-Zamora A, Prieto M, Joshi S, Londono MC, et al. Daclatasvir combined with sofosbuvir or simeprevir in liver transplant recipients with severe recurrent hepatitis C infection. Liver Transpl 2016;22:446-458.
20. Kwo PY, Mantry PS, Coakley E, Te HS, Vargas HE, Brown R Jr, et al. An interferon-free antiviral regimen for HCV after liver transplantation. N Engl J Med 2014;371:2375-2382.
21. O'Leary JG, Fontana RJ, Brown K, Burton JR Jr, Firpi-Morell R, Muir A, et al. Efficacy and safety of simeprevir and sofosbuvir with and without ribavirin in subjects with recurrent genotype 1 hepatitis C postorthotopic liver transplant: the randomized GALAXY study. Transpl Int 2017;30:196-208.
22. Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, et al. Daclatasvir with sofosbuvir and ribavirin for hepatitis C virus infection with advanced cirrhosis or post–liver transplantation recurrence. Hepatology 2016;63:1493-1505.
23. Colombo M, Aghemo A, Liu H, Zhang J, Dvory-Sobol H, Hyland R, et al. Treatment with ledipasvir-sofosbuvir for 12 or 24 weeks in kidney transplant recipients with chronic hepatitis C virus genotype 1 or 4 infection: a randomized trial. Ann Intern Med 2017;166:109-117.
24. Saxena V, Khungar V, Verna EC, Levitsky J, Brown RS Jr, Hassan MA, et al. Safety and efficacy of current direct-acting antiviral regimens in kidney and liver transplant recipients with hepatitis C: results from the HCV-TARGET study. Hepatology 2017;66:1090-1101.
25. Kamar N, Marion O, Rostaing L, Cointault O, Ribes D, Lavayssiere L, et al. Efficacy and safety of sofosbuvir-based antiviral therapy to treat hepatitis C virus infection after kidney transplantation. Am J Transplant 2016;16:1474-1479.
26. Sawinski D, Kaur N, Ajeti A, Trofe-Clark J, Lim M, Bleicher M, et al. Successful treatment of hepatitis C in renal transplant recipients with direct-acting antiviral agents. Am J Transplant 2016;16:1588-1595.
27. Azmi AN, Tan SS, Mohamed R. Hepatitis C and kidney disease: an overview and approach to management. World J Hepatol 2015;7:78-92.
28. Ng TI, Krishnan P, Pilot-Matias T, Kati W, Schnell G, Beyer J, et al. In vitro antiviral activity and resistance profile of the next-generation hepatitis C virus NS5A inhibitor pibrentasvir. Antimicrob Agents Chemother 2017;61:e02558-02516.
29. Ng TI, Reisch T, Middleton T, McDaniel K, Kempf D, Lu L, et al. ABT-493, a potent HCV NS3/4A protease inhibitor with broad genotype coverage. Presented at: 21st Annual Conference on Retroviruses and Opportunistic Infections (CROI); March 3-6, 2014; Boston, MA. Poster 636.
30. Gane E, Poordad F, Wang S, Asatryan A, Kwo PY, Lalezari J, et al. High efficacy of ABT-493 and ABT-530 treatment in patients with HCV genotype 1 or 3 infection and compensated cirrhosis. Gastroenterology 2016;151:651-659.
31. Kwo PY, Poordad F, Asatryan A, Wang S, Wyles DL, Hassanein T, et al. Glecaprevir and pibrentasvir yield high response rates in patients with HCV genotype 1-6 without cirrhosis. J Hepatol 2017;67:263-271.
32. Asselah T, Kowdley KV, Zadeikis N, Wang S, Hassanein T, Horsmans Y, et al. Efficacy of glecaprevir/pibrentasvir for 8 or 12 weeks in patients with hepatitis C virus genotype 2, 4, 5, or 6 infection without cirrhosis. Clin Gastroenterol Hepatol 2017;16:417-426.
33. Zeuzem S, Foster GR, Wang S, Asatryan A, Gane E, Feld JJ, et al. Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med 2018;378:354-369.
34. Poordad F, Felizarta F, Asatryan A, Sulkowski MS, Reindollar RW, Landis CS, et al. Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment. Hepatology 2017;66:389-397.
35. Forns X, Lee SS, Valdes J, Lens S, Ghalib R, Aguilar H, et al. Glecaprevir plus pibrentasvir for chronic hepatitis C virus genotype 1, 2, 4, 5, or 6 infection in adults with compensated cirrhosis (EXPEDITION-1): a single-arm, open-label, multicentre phase 3 trial. Lancet Infect Dis 2017;17:1062-1068.
36. Gane E, Lawitz E, Pugatch D, Papatheodoridis G, Brau N, Brown A, et al. Glecaprevir and pibrentasvir in patients with HCV and severe renal impairment. N Engl J Med 2017;377:1448-1455.
37. Manns M, Samuel D, Gane EJ, Mutimer D, McCaughan G, Buti M, et al. Ledipasvir and sofosbuvir plus ribavirin in patients with genotype 1 or 4 hepatitis C virus infection and advanced liver disease: a multicentre, open-label, randomised, phase 2 trial. Lancet Infect Dis 2016;16:685-697.
38. Krishnan P, Schnell G, Tripathi R, Ng TI, Reisch T, Beyer J, et al. Pooled resistance analysis in HCV genotype 1-6-infected patients treated with glecaprevir/pibrentasvir in phase 2 and 3 clinical trials. J Hepatol 2017;66(Suppl.):S500.