APASL consensus statements and recommendation on treatment of hepatitis C

Hepatology International

Volumn 10, Issue 5, 2016, Pages 702-726

  Omata, Masao ^a,b   Kanda, Tatsuo ^c   Wei, Lai ^d   Yu, Ming Lung ^e   Chuang, Wang Long ^f   Ibrahim, Alaaeldin ^g   Lesmana, Cosmas Rinaldi Adithya ^h   Sollano, Jose ⁱ   Kumar, Manoj ^j   Jindal, Ankur ^j   Sharma, Barjesh Chander ^k   Hamid, Saeed S ^l   Dokmeci, A Kadir ^m   Mamun Al Mahtab, ⁿ   McCaughan, Geofferey W ^o   Wasim, Jafri ^l   Crawford, Darrell H G ^p   Kao, Jia Horng ^q   Yokosuka, Osamu ^c   Lau, George K K ^r   Sarin, Shiv Kumar ^j   more..

^a Yamanashi Prefectural Central Hospital   (Japan)

^b UNIVERSITY OF TOKYO   (Japan)

^c CHIBA UNIVERSITY   (Japan)

^d PEKING UNIVERSITY   (China)

^e KAOHSIUNG MUNICIPAL TA TUNG HOSPITAL   (Taiwan)

^f KAOHSIUNG MEDICAL UNIVERSITY HOSPITAL   (Taiwan)

^g BENHA UNIVERSITY   (Egypt)

^h UNIVERSITY OF INDONESIA   (Indonesia)

ⁱ UNIVERSITY OF SANTO TOMAS HOSPITAL   (Philippines)

^j INSTITUTE OF LIVER AND BILIARY SCIENCES   (India)

^k G B PANT HOSPITAL   (India)

^l AGA KHAN UNIVERSITY HOSPITAL   (Pakistan)

^m ANKARA UNIVERSITY   (Turkey)

ⁿ BANGABANDHU SHEIKH MUJIB MEDICAL UNIVERSITY   (Bangladesh)

^o ROYAL PRINCE ALFRED HOSPITAL   (Australia)

^p UNIVERSITY OF QUEENSLAND   (Australia)

^q NATIONAL TAIWAN UNIVERSITY   (Taiwan)

^r BEIJING 302 HOSPITAL   (China)

more..

Author keywords

APASL; DAAs; HCV; Interferon free; Turkey

Indexed keywords

ASUNAPREVIR; BECLABUVIR; DACLATASVIR; DASABUVIR; ELBASVIR; GRAZOPREVIR; LEDIPASVIR PLUS SOFOSBUVIR; OMBITASVIR; PARITAPREVIR; PEGINTERFERON; PROTEINASE INHIBITOR; RIBAVIRIN; RITONAVIR; ANTIVIRUS AGENT;

ADULT; ANTIVIRAL THERAPY; CANCER RECURRENCE; CHRONIC KIDNEY DISEASE; DECOMPENSATED LIVER CIRRHOSIS; DRUG APPROVAL; EGYPT; FEMALE; GENE; GRAFT RECIPIENT; HEALTH CARE ORGANIZATION; HEPATITIS B; HEPATITIS C; 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; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; IL28B GENE; INDONESIA; INFECTION CONTROL; KIDNEY FAILURE; LICENCE; LIVER CELL CARCINOMA; LIVER TRANSPLANTATION; MAJOR CLINICAL STUDY; MALE; MIXED INFECTION; MULTICENTER STUDY (TOPIC); PAKISTAN; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PORTAL HYPERTENSION; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SINGLE NUCLEOTIDE POLYMORPHISM; CHRONIC HEPATITIS C; CLINICAL TRIAL (TOPIC); CONSENSUS DEVELOPMENT; DISEASE MANAGEMENT; DRUG EFFECT; GENETICS; HEPACIVIRUS; TREATMENT OUTCOME; VIROLOGY; VIRUS LOAD;

ANTIVIRAL AGENTS; CLINICAL TRIALS AS TOPIC; DISEASE MANAGEMENT; HEPACIVIRUS; HEPATITIS C, CHRONIC; HUMANS; PRACTICE GUIDELINES AS TOPIC; TREATMENT OUTCOME; VIRAL LOAD;

EID: 84964691124     PISSN: 19360533     EISSN: 19360541     Source Type: Journal    
DOI: 10.1007/s12072-016-9717-6     Document Type: Review

References (137)

1. Omata M, Kanda T, Yu ML, Yokosuka O, Lim SG, Jafri W, Tateishi R, Hamid SS, Chuang WL, Chutaputti A, Wei L, Sollano J, Sarin SK, Kao JH, McCaughan GW. APASL consensus statements and management algorithms for hepatitis C virus infection. Hepatol Int 2012;6:409–435
2. Asian-Pacific Association for the Study of the Liver (APASL) Hepatitis C Working Party, McCaughan GW, Omata M, Amarapurkar D, Bowden S, Chow WC, Chutaputti A, Dore G, Gane E, Guan R, Hamid SS, Hardikar W, Hui CK, Jafri W, Jia JD, Lai MY, Wei L, Leung N, Piratvisuth T, Sarin S, Sollano J, Tateishi R. Asian-Pacific Association for the Study of the Liver consensus statements on the diagnosis, management and treatment of hepatitis C virus infection. J Gastroenterol Hepatol 2007;22:615–633
3. Kanda T, Imazeki F, Yokosuka O. New antiviral therapies for chronic hepatitis C. Hepatol Int 2010;4:548–561
4. Zeuzem S, Hultcrantz R, Bourliere M, Goeser T, Marcellin P, Sanchez-Tapias J, et al. Peginterferon alfa-2b plus ribavirin for treatment of chronic hepatitis C in previously untreated patients infected with HCV genotypes 2 or 3. J Hepatol 2004;40:993–999
5. Mangia A, Santoro R, Minerva N, Ricci GL, Carretta V, Persico M, et al. Peginterferon alfa-2b and ribavirin for 12 vs. 24 weeks in HCV genotype 2 or 3. N Engl J Med 2005;352:2609–2617
6. Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, et al. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med 2007;357:124–134
7. Dalgard O, Bjoro K, Ring-Larsen H, Bjornsson E, Holberg-Petersen M, Skovlund E, et al. Pegylated interferon alfa and ribavirin for 14 versus 24 weeks in patients with hepatitis C virus genotype 2 or 3 and rapid virological response. Hepatology 2008;47:35–42
8. Lagging M, Langeland N, Pedersen C, Farkkila M, Buhl MR, Morch K, et al. Randomized comparison of 12 or 24 weeks of peginterferon alpha-2a and ribavirin in chronic hepatitis C virus genotype 2/3 infection. Hepatology 2008;47:1837–1845
9. Yu ML, Dai CY, Huang JF, Hou NJ, Lee LP, Hsieh MY, Chiu CF, et al. A randomised study of peginterferon and ribavirin for 16 versus 24 weeks in patients with genotype 2 chronic hepatitis C. Gut 2007;56:553–559
10. Jensen DM, Morgan TR, Marcellin P, Pockros PJ, Reddy KR, Hadziyannis SJ, et al. Early identification of HCV genotype 1 patients responding to 24 weeks peginterferon alpha-2a (40 kd)/ribavirin therapy. Hepatology 2006;43:954–960
11. Yu ML, Dai CY, Huang JF, Chiu CF, Yang YH, Hou NJ, Lee LP, et al. Rapid virological response and treatment duration for chronic hepatitis C genotype 1 patients: a randomized trial. Hepatology 2008;47:1884–1893
12. Zeuzem S, Buti M, Ferenci P, Sperl J, Horsmans Y, Cianciara J, et al. Efficacy of 24 weeks treatment with peginterferon alfa-2b plus ribavirin in patients with chronic hepatitis C infected with genotype 1 and low pretreatment viremia. J Hepatol 2006;44:97–103
13. Liu CH, Liu CJ, Lin CL, Liang CC, Hsu SJ, Yang SS, et al. Pegylated interferon-alpha-2a plus ribavirin for treatment-naïve Asian patients with hepatitis C virus genotype 1 infection: a multicenter, randomized controlled trial. Clin Infect Dis 2008;47:1260–1269
14. Berg T, Weich V, Teuber G, Klinker H, Möller B, Rasenack J, et al. Individualized treatment strategy according to early viral kinetics in hepatitis C virus type 1-infected patients. Hepatology 2009;50:369–377
15. Pearlman BL, Ehleben C. Hepatitis C genotype 1 virus with low viral load and rapid virologic response to peginterferon/ribavirin obviates a protease inhibitor. Hepatology 2014;59:71–77
16. Ge D, Fellay J, Thompson AJ, Simon JS, Shianna KV, Urban TJ, Heinzen EL, et al. Genetic variation in IL28B predicts hepatitis C treatment-induced viral clearance. Nature 2009;461:399–401
17. Tanaka Y, Nishida N, Sugiyama M, Kurosaki M, Matsuura K, Sakamoto N, Nakagawa M, et al. Genome-wide association of IL28B with response to pegylated interferon-alpha and ribavirin therapy for chronic hepatitis C. Nat Genet 2009;41:1105–1109
18. Suppiah V, Moldovan M, Ahlenstiel G, Berg T, Weltman M, Abate ML, et al. IL28B is associated with response to chronic hepatitis C interferon-alpha and ribavirin therapy. Nat Genet 2009;41:1100–1104
19. Huang CF, Huang JF, Yang JF, Hsieh MY, Lin ZY, Chen SC, Wang LY, et al. Interleukin-28B genetic variants in identification of hepatitis C virus genotype 1 patients responding to 24 weeks peginterferon/ribavirin. J Hepatol 2012;56:34–40
20. Thompson AJ, Muir AJ, Sulkowski MS, Ge D, Fellay J, Shianna KV, et al. Interleukin-28B polymorphism improves viral kinetics and is the strongest pretreatment predictor of sustained virologic response in genotype 1 hepatitis C virus. Gastroenterology 2010;139(120–129):e18
21. Huang CF, Yeh ML, Huang JF, Yang JF, Hsieh MY, Lin ZY, et al. Host interleukin-28B genetic variants versus viral kinetics in determining responses to standard-of-care for Asians with hepatitis C genotype 1. Antiviral Res 2012;93:239–244
22. Yu ML, Huang CF, Huang JF, Chang NC, Yang JF, Lin ZY, Chen SC, et al. Role of interleukin-28B polymorphisms in the treatment of hepatitis C virus genotype 2 infection in Asian patients. Hepatology 2011;53:7–13
23. Mangia A, Thompson AJ, Santoro R, Piazzolla V, Tillmann HL, Patel K, et al. An IL28B polymorphism determines treatment response of hepatitis C virus genotype 2 or 3 patients who do not achieve a rapid virologic response. Gastroenterology 2010;139:821–827 (827. e1)
24. Sarrazin C, Susser S, Doehring A, Lange CM, Müller T, Schlecker C, et al. Importance of IL28B gene polymorphisms in hepatitis C virus genotype 2 and 3 infected patients. J Hepatol 2011;54:415–421
25. Huang CF, Yeh ML, Hsieh MH, Hsieh MY, Lin ZY, Chen SC, Wang LY, et al. Clinical utility of host genetic IL-28B variants in hepatitis C virus genotype 1 Asian patients retreated with pegylated interferon plus ribavirin. J Gastroenterol Hepatol 2013;28:1515–1520
26. Huang CF, Dai CY, Yeh ML, Huang JF, Huang CI, Hsieh MY, et al. Virological predictors of response to retreatment in hepatitis C genotype 2 infected patients. PLoS One 2013;8:e58882
27. Yu M-L, Chuang W-L. New treatments for HCV: perspective from Asia. Clin Liver Dis 2015;5:17–21
28. Feld JJ, Kowdley KV, Coakley E, et al. Treatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370(17):1594–1603
29. Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, et al. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med 2014;370:1483–1493
30. Afdhal N, Zeuzem S, Kwo P, et al. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med 2014;370(20):1889–1898
31. George SL, Bacon BR, Brunt EM, Mihindukulasuriya KL, Hoffmann J, Di Bisceglie AM. Clinical, virological, histologic, and biochemical outcomes after successful HCV therapy: a 5-year follow-up of 150 patients. Hepatology 2009;49(3):729–738
32. Lindsay KL, Trepo C, Heintges T, Shiffman ML, Gordon SC, Hoels JC, et al. A randomized, double-blind trial comparing pegylated interferon alfa-2b to interferon alfa-2b as initial treatment for chronic Hepatitis C. Hepatology 2001;34(2):395–403
33. Manns MP, McHutchison JG, Gordon SC, et al. Peginterferon alfa-2b plus ribavirin compared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001;358:958–965
34. RiDruejo R. Predictors of response to chronic hepatitis C treatment. Fut Virol 2012;7(ii):1089–1101
35. Wedemeyer H, Dore GJ, Ward JW. Estimates on HCV disease burden worldwide—filling the gaps. J Viral Hepatitis 2015;22(Suppl.S1):1–5
36. Kowdley KV, Gordon SC, Reddy KR, Rossaro L, Bernstein DE, Lawitz E, Shiffman ML, et al. Ledipasvir and sofosbuvir for 8 or 12 weeks for chronic HCV without cirrhosis. N Engl J Med 2014;370:1879–1888
37. Charlton M, Gane E, Manns MP, Brown RS Jr, Curry MP, Kwo PY, et al. Sofosbuvir and ribavirin for treatment of compensated recurrent hepatitis C virus infection after liver transplantation. Gastroenterology 2015;148:108–117
38. Curry MP, Forns X, Chung RT, Terrault NA, Brown R Jr, Fenkel JM, et al. Sofosbuvir and ribavirin prevent recurrence of HCV infection after liver transplantation: an open-label study. Gastroenterology 2015;148:100–107
39. Poordad F, Hezode C, Trinh R, Kowdley KV, Zeuzem S, Agarwal K, Shiffman ML, et al. ABT-450/r-ombitasvir and dasabuvir with ribavirin for hepatitis C with cirrhosis. N Engl J Med 2014;370:1973–1982
40. Zeuzem S, Jacobson IM, Baykal T, et al. Retreatment of HCV with ABT-450/r-ombitasvir and dasabuvir with ribavirin. N Engl J Med 2014;370(17):1604–1614
41. Hezode C, Asselah T, Reddy KR, et al. Ombitasvir plus paritaprevir plus ritonavir with or without ribavirin in treatment-naive and treatment-experienced patients with genotype 4 chronic hepatitis C virus infection (PEARL-I): a randomised, open-label trial. Lancet 2015;385:2502–2509
42. Molina JM, Orkin C, Iser DM, et al. Sofosbuvir plus ribavirin for treatment of hepatitis C virus in patients co-infected with HIV (PHOTON-2): a multicentre, open-label, non-randomised, phase 3 study. Lancet 2015;385:1098–1106
43. Lim SG. Chronic hepatitis C genotype 1 treatment roadmap for resource constrained settings. World J Gastroenterol 2015;21(6):1972–1981
44. Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, et al. Telaprevir for retreatment of HCV infection. N Engl J Med 2011;364:2417–2428
45. Manns M, Marcellin P, Poordad F, de Araujo ES, Buti M, Horsmans Y, Janczewska E, Villamil F, Scott J, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a or 2b plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-2): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet 2014;384:414–426
46. Jacobson IM, Dore GJ, Foster GR, Fried MW, Radu M, Rafalsky VV, Moroz L, Craxi A, Peeters M, Lenz O, Ouwerkerk-Mahadevan S, De La Rosa G, Kalmeijer R, Scott J, Sinha R, Beumont-Mauviel M. Simeprevir with pegylated interferon alfa 2a plus ribavirin in treatment-naive patients with chronic hepatitis C virus genotype 1 infection (QUEST-1): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet 2014;384:403–413
47. Lawitz E, Sulkowski MS, Ghalib R, Rodriguez-Torres M, Younossi ZM, Corregidor A, DeJesus E, Pearlman B, Rabinovitz M, Gitlin N, Lim JK, Pockros PJ, Scott JD, Fevery B, Lambrecht T, Ouwerkerk-Mahadevan S, Callewaert K, Symonds WT, Picchio G, Lindsay KL, Beumont M, Jacobson IM. Simeprevir plus sofosbuvir, with or without ribavirin, to treat chronic infection with hepatitis C virus genotype 1 in non-responders to pegylated interferon and ribavirin and treatment-naive patients: the COSMOS randomised study. Lancet 2014;384:1756–1765
48. Reddy KR, Zeuzem S, Zoulim F, Weiland O, Horban A, Stanciu C, Villamil FG, Andreone P, George J, Dammers E, Fu M, Kurland D, Lenz O, Ouwerkerk-Mahadevan S, Verbinnen T, Scott J, Jessner W. Simeprevir versus telaprevir with peginterferon and ribavirin in previous null or partial responders with chronic hepatitis C virus genotype 1 infection (ATTAIN): a randomised, double-blind, non-inferiority phase 3 trial. Lancet Infect Dis 2015;15:27–35
49. Fellay J, Thompson AJ, Ge D, Gumbs CE, Urban TJ, Shianna KV, Little LD, Qiu P, Bertelsen AH, Watson M, Warner A, Muir AJ, Brass C, Albrecht J, Sulkowski M, McHutchison JG, Goldstein DB. ITPA gene variants protect against anaemia in patients treated for chronic hepatitis C. Nature 2010;464:405–408
50. Muir AJ, Poordad FF, McHutchison JG, Shiffman ML, Berg T, Ferenci P, Heathcote EJ, Pawlotsky JM, Zeuzem S, Reesink HW, Dusheiko G, Martin EC, George S, Kauffman RS, Adda N. Retreatment with telaprevir combination therapy in hepatitis C patients with well-characterized prior treatment response. Hepatology 2011;54:1538–1546
51. Thompson AJ, McHutchison JG. Will IL28B polymorphism remain relevant in the era of direct-acting antiviral agents for hepatitis C virus? Hepatology 2012;56:373–381
52. Gane EJ, Roberts SK, Stedman CA, Angus PW, Ritchie B, Elston R, Ipe D, Morcos PN, Baher L, Najera I, Chu T, Lopatin U, Berrey MM, Bradford W, Laughlin M, Shulman NS, Smith PF. Oral combination therapy with a nucleoside polymerase inhibitor (RG7128) and danoprevir for chronic hepatitis C genotype 1 infection (INFORM-1): a randomised, double-blind, placebo-controlled, dose-escalation trial. Lancet 2010;376:1467–1475
53. Lawitz EJ, Gruener D, Hill JM, Marbury T, Moorehead L, Mathias A, Cheng G, Link JO, Wong KA, Mo H, McHutchison JG, Brainard DM. A phase 1, randomized, placebo-controlled, 3-day, dose-ranging study of GS-5885, an NS5A inhibitor, in patients with genotype 1 hepatitis C. J Hepatol 2012;57:24–31
54. Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. 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, randomised, phase 2 trial. Lancet 2014;383:515–523
55. Mizokami M, Yokosuka O, Takehara T, Sakamoto N, Korenaga M, Mochizuki H, Nakane K, Enomoto H, Ikeda F, Yanase M, Toyoda H, Genda T, Umemura T, Yatsuhashi H, Ide T, Toda N, Nirei K, Ueno Y, Nishigaki Y, Betular J, Gao B, Ishizaki A, Omote M, Mo H, Garrison K, Pang PS, Knox SJ, Symonds WT, McHutchison JG, Izumi N, Omata M. Ledipasvir and sofosbuvir fixed-dose combination with and without ribavirin for 12 weeks in treatment-naive and previously treated Japanese patients with genotype 1 hepatitis C: an open-label, randomised, phase 3 trial. Lancet Infect Dis 2015;15(6):645–653
56. 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
57. Chayama K, Notsumata K, Kurosaki M, Sato K, Rodrigues L Jr, Setze C, Badri P, Pilot-Matias T, Vilchez RA, Kumada H. Randomized trial of interferon- and ribavirin-free ombitasvir/paritaprevir/ritonavir in treatment-experienced hepatitis C virus-infected patients. Hepatology 2015;61:1523–1532
58. Ferenci P, Bernstein D, Lalezari J, Cohen D, Luo Y, Cooper C, Tam E, Marinho RT, Tsai N, Nyberg A, Box TD, Younes Z, Enayati P, Green S, Baruch Y, Bhandari BR, Caruntu FA, Sepe T, Chulanov V, Janczewska E, Rizzardini G, Gervain J, Planas R, Moreno C, Hassanein T, Xie W, King M, Podsadecki T, Reddy KR. PEARL-III study; PEARL-IV study. ABT-450/r-ombitasvir and dasabuvir with or without ribavirin for HCV. N Engl J Med 2014;370:1983–1992
59. Lok AS, Gardiner DF, Lawitz E, Martorell C, Everson GT, Ghalib R, Reindollar R, Rustgi V, McPhee F, Wind-Rotolo M, Persson A, Zhu K, Dimitrova DI, Eley T, Guo T, Grasela DM, Pasquinelli C. Preliminary study of two antiviral agents for hepatitis C genotype 1. N Engl J Med 2012;366:216–224
60. Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, Kawakami Y, Ido A, Yamamoto K, Takaguchi K, Izumi N, Koike K, Takehara T, Kawada N, Sata M, Miyagoshi H, Eley T, McPhee F, Damokosh A, Ishikawa H, Hughes E. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology 2014;59:2083–2091
61. Fujii Y, Uchida Y, Mochida S. Drug-induced immunoallergic hepatitis during combination therapy with daclatasvir and asunaprevir. Hepatology 2015;61:400–401
62. Manns M, Pol S, Jacobson IM, Marcellin P, Gordon SC, Peng CY, Chang TT, et al. All-oral daclatasvir plus asunaprevir for hepatitis C virus genotype 1b: a multinational, phase 3, multicohort study. Lancet 2014;384:1597–1605
63. Suda G, Kudo M, Nagasaka A, Furuya K, Yamamoto Y, Kobayashi T, Shinada K, Tateyama M, Konno J, Tsukuda Y, Yamasaki K, Kimura M, Umemura M, Izumi T, Tsunematsu S, Sato F, Terashita K, Nakai M, Horimoto H, Sho T, Natsuizaka M, Morikawa K, Ogawa K, Sakamoto N (2016) Efficacy and safety of daclatasvir and asunaprevir combination therapy in chronic hemodialysis patients with chronic hepatitis C. J Gastroenterol. doi:10.1007/s00535-016-1162-8
64. Everson GT, Sims KD, Rodriguez-Torres M, Hézode C, Lawitz E, Bourlière M, Loustaud-Ratti V, Rustgi V, Schwartz H, Tatum H, Marcellin P, Pol S, Thuluvath PJ, Eley T, Wang X, Huang SP, McPhee F, Wind-Rotolo M, Chung E, Pasquinelli C, Grasela DM, Gardiner DF. Efficacy of an interferon- and ribavirin-free regimen of daclatasvir, asunaprevir, and BMS-791325 in treatment-naive patients with HCV genotype 1 infection. Gastroenterology 2014;146:420–429
65. Lawitz E, Gane E, Pearlman B, Tam E, Ghesquiere W, Guyader D, Alric L, Bronowicki JP, Lester L, Sievert W, Ghalib R, Balart L, Sund F, Lagging M, Dutko F, Shaughnessy M, Hwang P, Howe AY, Wahl J, Robertson M, Barr E, Haber B. Efficacy and safety of 12 weeks versus 18 weeks of treatment with grazoprevir (MK-5172) and elbasvir (MK-8742) with or without ribavirin for hepatitis C virus genotype 1 infection in previously untreated patients with cirrhosis and patients with previous null response with or without cirrhosis (C-WORTHY): a randomised, open-label phase 2 trial. Lancet 2015;385:1075–1086
66. Roth D, Nelson DR, Bruchfeld A, Liapakis A, Silva M, Monsour H Jr, et al. Grazoprevir plus elbasvir in treatment-naive and treatment-experienced patients with hepatitis C virus genotype 1 infection and stage 4–5 chronic kidney disease (the C-SURFER study): a combination phase 3 study. Lancet 2015;386:1537–1545
67. Hirotsu Y, Kanda T, Matsumura H, Moriyama M, Yokosuka O, Omata M. HCV NS5A resistance-associated variants in a group of real-world Japanese patients chronically infected with HCV genotype 1b. Hepatol Int 2015;9:424–430
68. Zeuzem S, Dusheiko GM, Salupere R, Mangia A, Flisiak R, Hyland RH, Illeperuma A, et al. Sofosbuvir and ribavirin in HCV genotypes 2 and 3. N Engl J Med 2014;370:1993–2001
69. Gane EJ, Stedman CA, Hyland RH, et al. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med 2013;368:34–44
70. Lawitz E, Mangia A, Wyles D, et al. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med 2013;368:1878–1887
71. Jacobson IM, Gordon SC, Kowdley KV, et al. Sofosbuvir for hepatitis C genotype 2 or 3 in patients without treatment options. N Engl J Med 2013;368:1867–1877
72. Omata M, Nishiguchi S, Ueno Y, Mochizuki H, Izumi N, Ikeda F, Toyoda H, Yokosuka O, Nirei K, Genda T, Umemura T, Takehara T, Sakamoto N, Nishigaki Y, Nakane K, Toda N, Ide T, Yanase M, Hino K, Gao B, Garrison KL, Dvory-Sobol H, Ishizaki A, Omote M, Brainard D, Knox S, Symonds WT, McHutchison JG, Yatsuhashi H, Mizokami M. Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open-label, phase 3 trial. J Viral Hepatol 2014;21:762–768
73. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med 2014;370:211–221
74. Gane EJ, Hyland RH, Yang Y, Svarovskaia E, Pang PS, McHutchison JG, et al. Ledipasvir/Sofosbuvir single tablet regimen is effective in patients with HCV Genotype 2 Infection. In: 15th international symposium on viral hepatitis and liver disease (ISVHLD), Berlin, Germany, on 26–28 Jun 2015. http://www.natap.org/2015/HCV/070215_02.htm. Accessed on 11 Feb 2016
75. Everson GT, Tran TT, Towner WJ, et al. Safety and efficacy of treatment with the interferon-free, ribavirin-free combination of sofosbuvir + GS-5816 for 12 weeks in treatment naive patients with genotype 1-6 HCV patients (Abstract). J Hepatol 2014;60(Suppl.):S46
76. Nelson DR, Cooper JN, Lalezari JP et al. All-oral 12-week combination treatment with daclatasvir (DCV) and sofosbuvir (SOF) in patients infected with HCV genotype (GT) 3: ALLY-3 phase 3 study. In: Abstract LB-3. 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). 7–11 Nov 2014; Boston, MA
77. Ruane P, Ain D, Meshrekey R, Stryker R. Sofosbuvir plus ribavirin in the treatment of chronic HCV genotype 4 infection in patients of Egyptian ancestry. In: 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). 1–5 Nov 2013; Washington DC
78. Esmat GE, Shiha G, Omar RF et al. Sofosbuvir plus ribavirin in the treatment of egyptian patients with chronic genotype 4 HCV infection. In: Abstract 959. 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). 7–11 Nov 2014; Boston, MA
79. Molina JM, Orkin C, Iser DM et al. All-oral therapy with sofosbuvir plus ribavirin for the treatment of HCV genotypes 1, 2, 3 and 4 infection in patients co-infected with HIV (PHOTON-2). In: Abstract MOAB0105LB. 20th International AIDS Conference. 20–25 July 2014; Melbourne, Australia
80. Kapoor R, Kohli A, Sidharthan S et al. all-oral treatment for genotype 4 chronic hepatitis C infection with sofosbuvir and ledipasvir: interim results from the NIAID SYNERGY trial. In: Abstract 240. 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). 7–11 Nov 2014; Boston, MA
81. Pol S, Reddy KR, Baykal T et al. Interferon-free regimens of ombitasvir and ABT-450/r with or without ribavirin in patients with HCV genotype 4 infection: PEARL-I study results. In: Abstract 1928. 65th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). 7–11 Nov 2014; Boston, MA
82. Gane EJ, Hyland RH, An D, Svarovskaia ES, Pang PS, Symonds WT, et al. High efficacy of LDV/SOF regimens for 12 weeks for patients with HCV genotype 3 or 6 infection. Hepatology 2014;60:1274A
83. Moreno C, Hezode C, Marcellin P et al. Simeprevir with peginterferon/ribavirin for treatment of chronic HCV genotype 4 infection in treatment-naïve or -experienced patients: interim results of a phase III trial. In: Abstract 60. Hep DAART. 8–12 Dec 2013; Big Island, Hawaii
84. Zeuzem S, Ghalib R, Reddy KR, et al. Grazoprevir–Elbasvir combination therapy for treatment-naive cirrhotic and noncirrhotic patients with chronic HCV genotype 1, 4, or 6 infection: a randomized trial. Ann Intern Med 2015;163:1–13
85. Everson G et al. Safety and efficacy of treatment with the interferon-free, ribavirin-free combination of sofosbuvir + GS-5816 for 12 weeks in treatment naive patients with genotype 1–6 HCV infection. In: 49th Annual Meeting of the European Association for the Study of the Liver (EASL), abstract O111, London, 2014
86. Clinicaltrials.gov NCT02201940; Gilead press release. Sept 21, 2015
87. Hill A, Khoo S, Fortunak J, et al. Minimum costs for producing hepatitis C direct-acting antivirals for use in large-scale treatment access programs in developing countries. Clin Infect Dis 2014;58:928–936
88. Kohli A, Osinusi A, Sims Z, et al. Virological response after 6 week triple-drug regimens for hepatitis C: a proof-of-concept phase 2A cohort study. Lancet 2015;385:1107–1113
89. Qureshi H, Bile KM, Jooma R, Alam SE, Afridi HU. Prevalence of hepatitis B and C viral infections in Pakistan: findings of a national survey appealing for effective prevention and control measures. East Mediterr Health J 2010;16(Suppl):S15–S23
90. Janjua NZ, Hamza HB, Islam M, Tirmizi SF, Siddiqui A, Jafri W, et al. Health care risk factors among women and personal behaviors among men explain the high prevalence of hepatitis C virus infection in Karachi, Pakistan. J Viral Hepat 2010;17:317–326
91. Mumtaz K, Hamid SS, Moatter T, Abid S, Shah HA, Jafri W. Distribution of hepatitis C virus genotypes and its response to treatment in Pakistani patients. Saudi Med J 2008;29:1671
92. Abergel A, Loustaud-Ratti V, Metivier S, Jiang D, Kersey K, Knox SJ, et al. Ledipasvir/sofosbuvir treatment results in high SVR rates in patients with chronic genotype 4 and 5 HCV infection. J Hepatol 2015;62:S219
93. Wehmeyer MH, Jordan S, Eißing C, Hartl J, Stohr A, Petersen J, et al. Sofosbuvir in combination with peginterferon and ribavirin for patients chronically infected with hepatitis C virus genotype 4: “real-life” experience of two large viral hepatitis centers in northern Germany. J Hepatol 2015;62:S219
94. Reddy R, Lim JK, Kuo A, Di Bisceglie AM, Vargas HE, Galati JS, et al. all-oral HCV therapy is safe and effective in patients with decompensated cirrhosis: interim report from the HCV-target real world experience. J Hepatol 2015;62:S193
95. Samuel D, Manns M, Forns X, Flamm SL, Reddy KR, Denning J, et al. Ledipasvir/sofosbuvir with ribavirin is safe in >600 decompensated and post liver transplantation patients with HCV infection: an integrated safety analysis of the solar 1 and solar 2 trials D. J Hepatol 2015;62:S620–S662
96. Waked I, Doss W, El-Sayed MH, Razavi H, Shiha G, Yosry A, Esmat G. The current and future disease burden of chronic hepatitis C virus infection in Egypt. Arab J Gastroenterol 2014;15:45–52
97. Doss W, Esmat G, El Serafy M, El Sayed M, Hassany M, Aymen Yousry A, El Akel W, and waked I:(National Committee for Control of Viral Hepatitis (NCCVH), Ministry of Health and Population, Egypt): Interim analysis for Sofosbuvir National treatment Program in Egypt, 15th International symposium on viral hepatitis and liver (ISVHL), Poster 149, 26–28 June 2015
98. Gani RA, Hasan I, Sanityoso A, Lesmana CRA, Waspodo AS, Siregar L, et al. National consensus of hepatitis C infection management in Indonesia. Jakarta: Indonesia Association of the Study for the Liver; 2014
99. Akbar N, Sulaiman A, Hasan I, Lesmana LA, Gani RA, Sanityoso A, et al. Efficacy and safety of In-Asia-manufactured Interferon α -2b in combination with Ribavirin for therapy of naïve chronic hepatitis C patients: a multicenter, prospective, open-label trial. Indones J Gastroenterol Hepatol Dig Endosc 2009;10(1):7–13
100. Juniastuti K, Wibowo BP, Wibawa IDN, Utsumi T, Mustika S, Amin M, et al. Interleukin-28B polymorphisms and response of chronic hepatitis C patients from Indonesia to Pegylated Interferon/Ribavirin treatment. J Clin Microbiol 2014;52:2193–2195
101. Navasa M, Forns X. Antiviral therapy in HCV decompensated cirrhosis: to treat or not to treat. J Hepatol 2007;46:185–188
102. Berenguer M, Palau A, Aguilera V, Rayón 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
103. 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
104. Foster GR, McLauchlan J, W. Irving, M. Cheung, B. Hudson, S. Verma, K. Agarwal, HCV Research UK EAP Group. Treatment of decompensated HCV cirrhosis in patients with diverse genotypes: 12 weeks sofosbuvir and NS5A inhibitors with/without ribavirin is effective in HCV Genotypes 1 and 3. EASL - The International Liver Congress 2015 50th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, 22–26 April 2015
105. Afdhal N, Everson G, McCaughan G, et al. Sofosbuvir and ribavirin for the treatment of chronic HCV with cirrhosis and portal hypertension with and without decompensation: early virologic response and safety. J Hepatol 2014;60:S28
106. Reddy KR, Lim J, Kuo A, et al. all-oral HCV therapy is safe and effective in patients with decompensated cirrhosis: report from HCV-TARGET. EASL - the international liver congress 2015 50th annual meeting of the European Association for the Study of the Liver, Vienna, Austria, 22–26 April 2015
107. Bashar A, Pungpapong S, et al. The use of simeprevir and sofosbuvir to treat HCV G1 in the liver transplant setting: the experience in 3 US Centres. Hepatology 2014;60:260A
108. Reddy KR, Everson GT, Flamm SL, Denning JM, Arterburn S, Brandt-Sarif T, et al. Ledipasvir/sofosbuvir with ribavirin for the treatment of HCV in patients with post-transplant recurrence: preliminary results of a prospective, multicenter study. Hepatology 2014;60:200A–201A
109. Jensen DM, O’Leary JG, Pockros P, et al. Safety and efficacy of sofosbuvir-containing regimens for hepatitis C: real-world experience in a diverse, longitudinal observational cohort. J Hepatol 2014;60:219A
110. Brown RS, Reddy KRJ, O’Leary JG, Kuo A, Morelli G, Stravitz RT, Durand CM, et al. Safety and efficacy of new DAA-based therapy for hepatitis C post-transplant: interval results from the HCV-TARGET longitudinal, observational study. Hepatology 2014;60:1269A
111. Forns X, Berenguer M, Herzer K, et al. On-treatment virologic response and tolerability of simeprevir, daclatasvir and ribavirin in patients with recurrent hepatitis C virus genotype 1b infection after orthotopic liver transplantation (OLT): interim data from the Phase II SATURN study. In: EASL - The International Liver Congress 2015 50th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, 22–26 April
112. Forns X, Charlton M, Denning J, et al. Sofosbuvir compassionate use program for patients with severe recurrent hepatitis C after liver transplantation. Hepatology 2015;61:1485–1494
113. Leroy V, Dumortier J, Coilly A, Sebagh M, Fougerou-Leurenl C, Radenne S, Bolla D, et al. High rates of virological response and major clinical improvement during sofosbuvir and daclatasvir-based regimens for the treatment of fibrosing cholestatic HCV recurrence after liver transplantation: the ANRS CO23 CUPILT study. Hepatology 2014;60:207A
114. Coilly A, Fougerou C, De Ledinghen V, et al. The association of sofosbuvir and daclatasvir for treating severe recurrence of HCV infection after liver transplantation. EASL - The International Liver Congress 2015 50th Annual Meeting of the European Association for the Study of the Liver, Vienna, Austria, 22–26 April 2015
115. Fissel RB, Bragg-Gresham JL, Woods JD, Jadoul M, Gillespie B, Heddewick SA, et al. Patterns of hepatitis C prevalence and seroconversion in hemodialysis units from three continents: the DOPPS. Kidney Int 2004;65:2335–2342
116. Kidney Disease: Improving Global Outcomes (2008) KDIGO clinical practice guidelines for the prevention, diagnosis, evaluation, and treatment of hepatitis C in chronic kidney disease. Kidney Int Suppl (109):S1-99
117. Butt AA, Skanderson M, McGinnis KA, Ahuja T, Bryce CL, Barnato AE, et al. Impact of hepatitis C virus infection and other comorbidities on survival in patients on dialysis. J Viral Hepat 2007;14:688–696
118. Henderson WA, Shankar R, Gill JM, Kim KH, Ghany MG, Skanderson M, et al. Hepatitis C progressing to hepatocellular carcinoma: the HCV dialysis patient in dilemma. J Viral Hepat 2010;17:59–64
119. Pineda JA, Romero-Gómez M, Díaz-García F, Girón-González JA, Montero JL, Torre-Cisneros J, et al. HIV co-infection shortens the survival of patients with hepatitis C virus-related decompensated cirrhosis. Hepatology 2005;41(4):779–789
120. Macías J, Márquez M, Téllez F, Merino D, Jiménez-Aguilar P, López-Cortés LF, et al. Risk of liver decompensation among HIV/hepatitis C virus-co-infected individuals with advanced fibrosis: implications for the timing of therapy. Clin Infect Dis 2013;57:1401–1408
121. Alves JP, Peres S, Borges F, Miranda AC, Baptista T, Ventura F, et al. Risk of liver decompensation assessed in HIV/HCV co-infected individuals with advanced liver fibrosis: a faster countdown experience. J Int AIDS Soc 2014;17(4 Suppl 3):19641
122. Osinusi A, Townsend K, Kohli A, Nelson A, Seamon C, Meissner EG, et al. Virologic response following combined ledipasvir and sofosbuvir administration in patients with HCV genotype 1 and HIV co-infection. JAMA 2015;313:1232–1239
123. Coppola N, Martini S, Pisaturo M, Sagnelli C, Filippini P, Sagnelli E. Treatment of chronic hepatitis C in patients with HCV/HIV co-infection. World J Virol 2015;4:1–12
124. Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services. Available at http://www.aidsinfo.nih.gov/ContentFiles/AdultandAdolescentGL.pdf. Accessed 25 April 2015
125. Sharma SA, Feld JJ. Management of HCV in cirrhosis-a rapidly evolving landscape. Curr Gastroenterol Rep 2015;17:443
126. Limketkai BN, Mehta SH, Sutcliffe CG, et al. Relationship of liver disease stage and antiviral therapy with liver-related events and death in adults co-infected with HIV/HCV. JAMA 2012;308:370–378
127. Mira JA, Rivero-Juárez A, López-Cortes LF, et al. Benefits from sustained virologic response to pegylated interferon plus ribavirin in HIV/hepatitis C virus co-infected patients with compensated cirrhosis. Clin Infect Dis 2013;56:1646–1653
128. Nunez M, Marino A, Miralles C, Berdun MA, Sola J, Hernandez-Burruezo JJ, et al. Baseline serum hepatitis C virus (HCV) RNA level and response at week 4 are the best predictors of relapse after treatment with pegylated interferon plus ribavirin in HIV/HCV-co-infected patients. J Acquir Immune Defic Syndr 2007;45:439–444
129. Martin-Carbonero L, Nunez M, Marino A, Alcocer F, Bonet L, Garcia-Samaniego J, et al. Undetectable hepatitis C virus RNA at week 4 as predictor of sustained virological response in HIV patients with chronic hepatitis C. AIDS 2008;22:15–21
130. Berenguer J, Alvarez-Pellicer J, Martin PM, Lopez-Aldeguer J, Von-Wichmann MA, Quereda C, et al. Sustained virological response to interferon plus ribavirin reduces liver-related complications and mortality in patients co-infected with human immunodeficiency virus and hepatitis C virus. Hepatology 2009;50:407–413
131. Pineda JA, Caruz A, Rivero A, Neukam K, Salas I, Camacho A, et al. Prediction of response to pegylated interferon plus ribavirin by IL28B gene variation in patients co-infected with HIV and hepatitis C virus. Clin Infect Dis 2010;51:788–795
132. Clausen LN, Weis N, Astvad K, Schonning K, Fenger M, Krarup H, et al. Interleukin-28B polymorphisms are associated with hepatitis C virus clearance and viral load in a HIV-1-infected cohort. J Viral Hepat 2011;18:e66–e74
133. Rallon NI, Naggie S, Benito JM, Medrano J, Restrepo C, Goldstein D, et al. Association of a single nucleotide polymorphism near the interleukin-28B gene with response to hepatitis C therapy in HIV/hepatitis C virus-co-infected patients. AIDS 2010;24:F23–F29
134. Liu CJ, Chuang WL, Lee CM, Yu ML, Lu SN, Wu SS, et al. Peginterferon alfa-2a plus ribavirin for the treatment of dual chronic infection with hepatitis B and C viruses. Gastroenterology 2009;136:496–504
135. Potthoff A, Berg T, Wedemeyer H. Late hepatitis B virus relapse in patients co-infected with hepatitis B virus and hepatitis C virus after antiviral treatment with pegylated interferon-a2b and ribavirin. Scand J Gastroenterol 2009;44:1487–1490
136. Yeh ML, Hung CH, Huang JF, Liu CJ, Lee CM, Dai CY, et al. Long-term effect of interferon plus ribavirin on hepatitis B surface antigen seroclearance in patients dually infected with hepatitis B and C viruses. PLoS One 2011;6:e20752
137. Yu ML, Lee CM, Chuang WL, Lu SN, Dai CY, Huang JF, et al. HBsAg profiles in patients receiving peginterferon alfa-2a plus ribavirin for the treatment of dual chronic infection with hepatitis B and C viruses. J Infect Dis 2010;202:86–92