FREQUENCY OF END OF TREATMENT RESPONSE IN GENOTYPE 3 CIRRHOTIC PATIENTS TAKING SOFOSBUVIR, RIBAVIRIN AND DACLATASVIR
Main Article Content
Keywords
Liver Cirrhosis, Sofosbuvir, Ribavirin and Daclatasvir, Genotype 3.
Abstract
A descriptive (case series) study was conducted to find the frequency of end of treatment response in genotype 3 cirrhotic patients taking Sofosbuvir, Ribavirin and Daclatasvir. Triple therapy in combination with daclatasvir leads to a higher rate of SVR both in previously untreated genotype 3 cirrhotic patients and in those who have failed prior antiviral treatment. Study was conducted in the Department of Gastroenterology, Fatima Memorial Hospital, Shadman, Lahore.
Method: A total of 381 of genotype 3 cirrhotic patients’ age (18-80) years of both genders were studied with mean age of 47.57 ± 11.49 years who started on Sofosbuvir (400mg once daily), weight-based ribavirin 1200 or 1000 mg/day if ≥75 or <75 kg body weight, respectively) Ribavirin (and Daclatasvir (60mg once daily). Data was analyzed with the help of SPSS version 21. Categorical variables such as gender and achieved end treatment response were expressed in the form of frequency and percentages.
Analysis: Age, BMI and duration of hep C were calculated as mean and standard deviation. Effect modifiers (age, gender, BMI and duration of HCV) were handled by stratification. Post-stratification chi square test was applied and P value less than or equal to 0.05 was considered significant. Results: After 6 months 24 weeks treatment, HCV was checked for ETR. Out of 381 patients, 238 (62.57%) male and 143 (27.43%) females with the ratio of 1.6:1; the frequency of end treatment was found in 366 (96.06%) patients which was very high.
Conclusion: Sofosbuvir, Ribavirin and Daclatasvir recommended for use in routine for genotype 3 cirrhotic patients to achieve end treatment response that will in turn reduce the morbidity and mortality of our population.
References
1. Lian J, Zeng L, Chen J, Jia H, Zhang Y, Xiang D, et al. De novo combined lamivudine and adefovir dipivoxil therapy vs entecavir monotherapy for hepatitis B virus-related decompensated cirrhosis. World J Gastroenterol. 2013;19: 6278-83.
2. Berzigotti A. Advances and challenges in cirrhosis and portal hypertension. BMC Med. 2017; 15:200.
3. Stephen L. Chen & Timothy R. Morgan. The Natural History of Hepatitis C Virus (HCV) Infection. International Journal of Medical Sciences.2006; 3(2): 47–52.
4. Tatiana Martins, Janaína LuzNarciso-Schiavon, Leonardo de Lucca Schiavon. Epidemiology of hepatitis C virus infection. The Lancet Infectious Diseases. 2005; 5: 9: 558-567.
5. Higuchi M, Tanaka E, Kiyosawa K. Epidemiology and clinical aspects on hepatitis C. Jpn J Infect Dis. 2002;55: 69-77.
6. Hamid S, Umar M, Alam A, Siddiqui A, Qureshi H, Butt J; Pakistan Society of Gastroenterology. PSG consensus statement on management of hepatitis C virus infection-- 2003. J Pak Med Assoc. 2004; 54:146-50.
7. Global Burden of Disease (GBD) for Hepatitis C. The Global Burden of Hepatitis C Working Group. 8 March 2013.
8. Raja and Janjua. Epidemiology of hepatitis C virus infection in Pakistan. Journal of Microbiology, Immunology and Infection. 2008 Feb; 41(1):4-8.
9. Hamid S, Umar M, Alam A, Siddiqui A, Qureshi H, Butt J; Pakistan Society of Gastroenterology. PSG consensus statement on management of hepatitis C virus infection-- 2003. J Pak Med Assoc. 2004;54: 146-50.
10. Frank C, Mohamed MK, Stickland GT, Lavanchy D, Arthur PR, Magder LS, et al. The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt. Lancet. 2000; 355:887-91.
11. Morton TA, Kelen GD. Hepatitis C. Ann Emerg Med. 1998; 31:381-90.
12. Butt AK, Khan AA, Khan SY, Sharea I. Dentistry as a possible route of hepatitis C transmission in Pakistan. Int Dent J. 2003; 53:141-4.
13. Hofmann WP, Sarrazin C, Zeuzem S. Current Standards in the Treatment of Chronic Hepatitis C. Deutsches Arzteblatt International. 2012; 109(19): 352–358.
14. Siddique, S.M et al. Rapid virological & End treatment response of patients treated with Sofosbuvir in Chronic Hepatitis C. Pak J Med Sci. 2017 Jul-Aug; 33(4): 813– 817.
15. Zanga LP. Treatment of hepatitis C virus genotype 3 infection with direct-acting antiviral agents. Braz J Med Biol Res. 2016; 49(11): e5504.
16. Stanislas Pol, Marion Corouge, and Anaïs Vallet-Pichard. Daclatasvir–sofosbuvir combination therapy with or without ribavirin for hepatitis C virus infection: from the clinical trials to real life. Hepat Med. 2016; 8: 21–26.
17. Fattovich G, Farci P, Rugge M. A randomized controlled trial of lymphoblastic interferon alpha in patients with chronic hepatitis B lacking HBeAg. Hepatology. 1992; 15(4):584-9.
18. Nafees M, Abbas G, Saqib M. Validity of Ultrasound in Diagnosis of Liver Fibrosis Resulting from Chronic Viral Hepatitis. Pak J Armed Forces. 2011; 61(4):585-89.
19. Rege A, Berho M,Jeffer LJ, Mili Kowski C,Molina EG,Pyrso Poulos NT,et al. Sampling error and intra observer variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002; 97:2614-8.
20. Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol. 2006; 45(4):529–38.
21. Longo DL. Harrison's principles of internal medicine. (18th Ed.). New York: McGraw-Hill. 2012; pp. 308.
22. Friedman LS. Current medical diagnosis and treatment 2014. [S.l.]: Mcgraw-Hill. 2014; pp. Chapter 16
23. Edwards CQ, Kushner JP. Screening for hemochromatosis. New England J Med. 1993; 328(22):1616–20.
24. Tanner MS. Role of copper in Indian childhood cirrhosis. Am J Clin Nutrition. 1998; 67(5 Suppl):1074S–81S.
25. Crawford JM. Cirrhosis. In MacSween RNM, Anthony PP, Scheuer PJ, Burt AD, Portmann BC (eds): Pathology of the Liver, 4th ed. Philadelphia, WB Saunders, 2001;pp.575–619.
26. Iredale JP. Cirrhosis: new research provides a basis for rational and targeted treatments. Br Med J. 2003;327(7407):143–7.
27. Li CP, Lee FY, Hwang SJ. Spider angiomas in patients with liver cirrhosis: role of alcoholism and impaired liver function. Scand J Gastroenterol. 1999; 34(5):520–3.
28. Rodríguez-Roisin R, Krowka MJ, Hervé P, Fallon MB. Pulmonary-Hepatic vascular Disorders (PHD). Eur Respir J. 2004;24(5):861–80.
29. Kim MY, Choi H, Baik SK. Portal Hypertensive Gastropathy: Correlation with Portal Hypertension and Prognosis in Cirrhosis. Dig Dis Sci. 2010; 55(12):3561–7.
30. Tangerman A, Meuwese-Arends MT, Jansen JB. Cause and composition of foetor hepaticus. Lancet. 1994; 343(8895):483.
31. Suurmond D. Color Atlas and Synopsis of Clinical Dermatology: Common and Serious Diseases. McGraw-Hill. pp. Section 33: Disorders of the nail apparatus. 2009.
32. Halfon P, Munteanu M, Poynard T. Fibro Test-ActiTest as a non-invasive marker of liver fibrosis. Gastroenterol Clin Biol. 2008; 32(6):22–39.
33. Rosen HR. Clinical practice. Chronic hepatitis C infection". N Eng J Med. 2011; 364(25):2429–38.
34. Goodman ZD, Ishak, KG. Hepatic Histopathology. In: Schiff ER, Sorrell MF, Maddrey WC. Schiff’s Diseases of the Liver. 9th edition. Philadelphia: Lippincott Williams & Wilkins 2003; 69-134.
35. Regev A, Berho M, Jeffers LJ. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002; 97: 2614-2618.
36. Bonis PAL. Up To Date [CD-ROM]. Rose BD, editor. Version 15.3. Wellesley (MA), USA: Up To Date Inc.; 2007 Oct. Histologic scoring systems for chronic hepatitis. 3 CD-ROMs: sound, color, 4 ¾ in.
37. Honkoop P, de man RA, Zondervan PE. Histological improvement in patients with chronic hepatitis B virus infection treated with lamivudine. Liver. 1997; 17:103.
38. Mattsson L, Weiland O, Glaumann H. Application of a numerical scoring system for assessment of histological outcome in patients with chronic post transfusion non-A non-B hepatitis with or without antibodies to hepatitis C. Liver. 1990; 10:257.
39. Vaquer P, Canet R, Liompart A, et al. Histological evolution of chronic hepatitis C. factors related to progression. Liver. 1994; 14:265.
40. The French METAVIR Cooperative Study Group. Intraobserver and interobserver variations in liver biopsy interpretation in patients with chronic hepatitis C. Hepatology. 1994; 20(1 pt 1):15-20.
41. Bedossa P, Dargère D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatology. 2003; 38:1449-57.
42. Marcellin P, Asselah T, Nathalie Boyer. Fibrosis and Disease Progression in Hepatitis C. Hepatology. 2002; 36:S47-S56.
43. American College of Radiology. Liver Imaging Reporting and Data System version 2013.1. Available at http://www.acr.org/Quality-Safety/Resources/LIRADS/. Accessed August 2013.
44. Nino-Murcia M, Olcott EW, Jeffrey RB Jr, Lamm RL, Beaulieu CF, Jain KA. Focal liver lesions: pattern-based classification scheme for enhancement at arterial phase CT. Radiology. 2000; 215(3):746-51.
45. Takayasu K, Muramatsu Y, Mizuguchi Y, et al. CT Evaluation of the progression of hypoattenuating nodular lesions in virus-related chronic liver disease. AJR Am J Roentgenol. 2006; 187(2):454-63.
46. Kim YK, Lee WJ, Park MJ, Kim SH, Rhim H, Choi D. Hypovascular hypointense nodules on hepatobiliary phase gadoxetic acid-enhanced MR images in patients with cirrhosis: potential of DW imaging in predicting progression to hypervascular HCC. Radiology. 2012; 265(1):104-14.
47. Kim SH, Kim SH, Lee J, et al. Gadoxetic acid-enhanced MRI versus triple-phase MDCT for the preoperative detection of hepatocellular carcinoma. AJR Am J Roentgenol. 2009; 192(6):1675-81.
48. Kim HJ, Kim AY, Kim TK, Byun JH, Won HJ, Kim KW. Transient hepatic attenuation differences in focal hepatic lesions: dynamic CT features. AJR Am J Roentgenol. 2005; 184(1):83-90.
49. Young ST, Paulson EK, Washington K, Gulliver DJ, Vredenburgh JJ, Baker ME. CT of the liver in patients with metastatic breast carcinoma treated by chemotherapy: findings simulating cirrhosis. AJR Am J Roentgenol. 1994; 163(6):1385-8.
50. Kim TK, Choi BI, Han JK, Chung JW, Park JH, Han MC. Nontumorous arterioportal shunt mimicking hypervascular tumor in cirrhotic liver: two-phase spiral CT findings. Radiology. Sep 1998; 208(3):597-603.
51. Ichikawa T, Nakajima H, Nanbu A, Hori M, Araki T. Effect of injection rate of contrast material on CT of hepatocellular carcinoma. AJR Am J Roentgenol. May 2006; 186(5):1413-8.
52. Ito K, Mitchell DG, Hann HW, Outwater EK, Kim Y. Compensated cirrhosis due to viral hepatitis: using MR imaging to predict clinical progression. AJR Am J Roentgenol. 1997; 169(3):801-5.
53. Kondo H, Kanematsu M, Hoshi H, et al. Preoperative detection of malignant hepatic tumors: comparison of combined methods of MR imaging with combined methods of CT. AJR Am J Roentgenol. 2000; 174(4):947-54.
54. Di Martino M, Marin D, Guerrisi A. Intraindividual comparison of gadoxetate disodium-enhanced MR imaging and 64-section multidetector CT in the Detection of hepatocellular carcinoma in patients with cirrhosis. Radiology. Sep 2010;256(3):806-16.
55. Tani I, Kurihara Y, Kawaguchi A, et al. MR imaging of diffuse liver disease. AJR Am J Roentgenol. 2000; 174(4):965-71.
56. Bartolozzi C, Donati F, Cioni D, Crocetti L, Lencioni R. MnDPDP-enhanced MRI vs dual-phase spiral CT in the detection of hepatocellular carcinoma in cirrhosis. Eur Radiol. 2000; 10(11):1697-702.
57. Mori K, Yoshioka H, Itai Y, et al. Arterioportal shunts in cirrhotic patients: evaluation of the difference between tumorous and nontumorous arterioportal shunts on MR imaging with superparamagnetic iron oxide. AJR Am J Roentgenol. 2000; 175(6):1659-64.
58. Kim T, Baron RL, Nalesnik MA. Infarcted regenerative nodules in cirrhosis: CT and MR imaging findings with pathologic correlation. AJR Am J Roentgenol. 2000; 175(4):1121-5.
59. Kim BS, Hayashi PH, Kim SH, Angthong W, Srirattanapong S, Woosley JT. Outcomes of patients with elevated a-fetoprotein level and initial negative findings at MR imaging. Radiology. 2013; 268(1):109-19.
60. Wu W, Chen MH, Yin SS. The role of contrast-enhanced sonography of focal liver lesions before percutaneous biopsy. AJR Am J Roentgenol. 2006;187(3):752-61.
61. Livraghi T. Percutaneous ethanol injection in the treatment of hepatocellular carcinoma in cirrhosis. Hepatogastroenterology. 2001; 48(37):20-4.
62. Trojan J, Schroeder O, Raedle J. Fluorine-18 FDG positron emission tomography for imaging of hepatocellular carcinoma. Am J Gastroenterol. 1999; 94(11):3314-9.
63. Choi D, Lim HK, Kim SH. Hepatocellular carcinoma treated with percutaneous radio-frequency ablation: usefulness of power Doppler US with a microbubble contrast agent in evaluating therapeutic response-preliminary results. Radiology. 2000; 217(2):558-63.
64. Khan MA, Combs CS, Brunt EM. Positron emission tomography scanning in the evaluation of hepatocellular carcinoma. J Hepatol. 2000; 32(5):792-7.
65. Kim YS, Cho SW, Lee KJ. Tc-99m MIBI SPECT is useful for noninvasively predicting the presence of MDR1 gene-encoded P-glycoprotein in patients with hepatocellular carcinoma. Clin Nucl Med. 1999; 24(11):874-9.
66. Cohen EB, Afdhal NH. Ultrasound-based hepatic elastography: origins, limitations, and applications. J Clin Gastroenterol. 2010;44(9):637-45.
67. Smith PA, Klein AS, Heath DG, Chavin K, Fishman EK. Dual-phase spiral CT angiography with volumetric 3D rendering for preoperative liver transplant evaluation: preliminary observations. J Comput Assist Tomogr. 1998;22(6):868-74.
68. Escorsell A, Bordas JM, Castaneda B. Predictive value of the variceal pressure response to continued pharmacological therapy in patients with cirrhosis and portal hypertension. Hepatology. 2000;31(5):1061-7.
69. Bosch J, García-Pagán JC. Complications of cirrhosis. I. Portal hypertension. J Hepatol. 2000; 32(1 Suppl):141-56.
70. Pannu HK, Maley WR, Fishman EK. Liver transplantation: preoperative CT evaluation. Radiographics. 2001; 21 Spec No: S133-46.
71. Malik SM, Gupte PA, de Vera ME, Ahmad J. Liver transplantation in patients with nonalcoholic steatohepatitis-related hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2009;7(7):800-6.
72. Shanbhogue AK, Prasad SR, Takahashi N, Vikram R, Sahani DV. Recent advances in cytogenetics and molecular biology of adult hepatocellular tumors: implications for imaging and management. Radiology. 2011; 258(3):673-93.
73. Paradis V, Zalinski S, Chelbi E, Guedj N, Degos F, Vilgrain V. Hepatocellular carcinomas in patients with metabolic syndrome often develop without significant liver fibrosis: a pathological analysis. Hepatology. 2009;49(3):851-9.
74. Armitage J. The safety of statins in clinical practice. Lancet. 2007;370(9601):1781-90.
75. Lewis JH, Mortensen ME, Zweig S. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatol. 2007;46(5):1453-63.
76. Rajab MA, Kaplan MM. Statins in primary biliary cirrhosis: are they safe?. Dig Dis Sci. Oct 1 2009.
77. Zaman A. Which Drugs Are Safe in Patients With Cirrhosis? NEJM Journal Watch. Jun 21 2013. Available at http://www.jwatch.org/na31329/2013/06/21/which-drugs-are-safe-patients-with-cirrhosis. Accessed July 30 2013.
78. Lewis JH, Stine JG. Review article: prescribing medications in patients with cirrhosis - a practical guide. Aliment Pharmacol Ther. 2013; 37(12):1132-56.
79. Peterlik M, Cross HS. Vitamin D and calcium deficits predispose for multiple chronic diseases. Eur J Clin Invest. 2005; 35: 290–304.
80. Rode A, Fourlanos S, Nicoll A. Oral vitamin D replacement is effective in chronic liver disease. Gastroenterol Clin Biol. 2010; 34: 618–620.
81. Hepatitis C. Fact Sheet. [Last accessed on 17 May 2018]. Available at http://www.who.int/en/news-room/fact-sheets/detail/hepatitis-c.
82. Gower E, Estes C, Blach S, Shearer KR, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014; 61(1Suppl):S45–57.
83. Arshad A, Ashfaq UA. Epidemiology of Hepatitis C Infection in Pakistan: Current Estimate and Major Risk Factors. Crit Rev Eukaryot Gene Expr. 2017;27(1):63–77.
84. Prevalence of Hepatitis B &C in Pakistan. [(Last accessed on 8th January 2019)]. Available at http://phrc.org.pk/assets/hepatitis-national-survey. pdf .
85. Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001; 345: 41–52.
86. Hepatitis. WHO urges countries to scale up hepatitis C treatment [(Last accessed on 18 May 2018)]. Available at http://www.who.int/hepatitis/news-events/hep-c-access-report-2018-story/en/
87. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;16;370(3):211–221.
88. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, 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(4):1127–1135.
89. Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease:A randomized phase III study (ALLY3+). Hepatology. 2016;63(5):1430–1441.
90. AASLD-IDSA. [(Last accessed on 18 May 2018)];HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. Available at https://www.hcvguidelines.org . [Google Scholar]
91. European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018;69(2):461–511.
92. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370: 211–21.
93. Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015; 373: 714–25.
94. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al. Alloral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61: 1127–35.
95. Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, 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; 63:1430–41
96. Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, et al. Daclatasvir with sofosbuvir and ribavirin for HCV infection with advanced cirrhosis or post-liver transplant recurrence. Hepatology. 2016;63: 1493–505.
97. Coilly A, Fougerou-Leurent C, de Ledinghen V, Houssel-Debry P, Duvoux C, Di Martino V, et al. Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence - The ANRS CUPILT study. J Hepatol. 2016; 65: 711–8.
98. Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, et al. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. 2016;65: 1861–70.
99. Hezode C, De Ledinghen V, Fontaine H, Zoulim F, Lebray P, Boyer N, et al. Daclatasvir plus sofosbuvir with or without ribavirin in patients with HCV genotype 3 infection: interim analysis of a French multicenter compassionate use program (abstract LP05). J Hepatol. 2015;62: S265–6.
100. Butt Z, Shah SMA. Daclatasvir plus Sofosbuvir with or without ribavirin in patients with chronic Hepatitis C genotype 3a in Pakistani population - A real world experience. Pak J Med Sci. 2019 Mar-Apr; 35(2): 409–413.
101. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol. 2015; 63: 199‐ 236.
102. Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, et al.; ASTRAL‐2 Investigators; ASTRAL‐3 Investigators. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. 2015; 373: 2608‐ 2617.
103. Del Rio-Valencia JC, Asensi-Diez R, Madera-Pajin R, Yunquera-Romero L, Muñoz-Castillo I. Interferon-free treatments in patients with hepatitis C genotype 3 infection in a tertiary hospital. Rev Esp Quimioter. 2018;31(1):35–42.
104. Tao YC, Deng R, Wang ML, Lv DD, Yuan M, Wang YH, Chen EQ, Tang H. Satisfactory virological response and fibrosis improvement of sofosbuvir-based regimens for Chinese patients with hepatitis C virus genotype 3 infections: results of a real-world cohort study. Virol J. 2018; 15(1):150.
2. Berzigotti A. Advances and challenges in cirrhosis and portal hypertension. BMC Med. 2017; 15:200.
3. Stephen L. Chen & Timothy R. Morgan. The Natural History of Hepatitis C Virus (HCV) Infection. International Journal of Medical Sciences.2006; 3(2): 47–52.
4. Tatiana Martins, Janaína LuzNarciso-Schiavon, Leonardo de Lucca Schiavon. Epidemiology of hepatitis C virus infection. The Lancet Infectious Diseases. 2005; 5: 9: 558-567.
5. Higuchi M, Tanaka E, Kiyosawa K. Epidemiology and clinical aspects on hepatitis C. Jpn J Infect Dis. 2002;55: 69-77.
6. Hamid S, Umar M, Alam A, Siddiqui A, Qureshi H, Butt J; Pakistan Society of Gastroenterology. PSG consensus statement on management of hepatitis C virus infection-- 2003. J Pak Med Assoc. 2004; 54:146-50.
7. Global Burden of Disease (GBD) for Hepatitis C. The Global Burden of Hepatitis C Working Group. 8 March 2013.
8. Raja and Janjua. Epidemiology of hepatitis C virus infection in Pakistan. Journal of Microbiology, Immunology and Infection. 2008 Feb; 41(1):4-8.
9. Hamid S, Umar M, Alam A, Siddiqui A, Qureshi H, Butt J; Pakistan Society of Gastroenterology. PSG consensus statement on management of hepatitis C virus infection-- 2003. J Pak Med Assoc. 2004;54: 146-50.
10. Frank C, Mohamed MK, Stickland GT, Lavanchy D, Arthur PR, Magder LS, et al. The role of parenteral antischistosomal therapy in the spread of hepatitis C virus in Egypt. Lancet. 2000; 355:887-91.
11. Morton TA, Kelen GD. Hepatitis C. Ann Emerg Med. 1998; 31:381-90.
12. Butt AK, Khan AA, Khan SY, Sharea I. Dentistry as a possible route of hepatitis C transmission in Pakistan. Int Dent J. 2003; 53:141-4.
13. Hofmann WP, Sarrazin C, Zeuzem S. Current Standards in the Treatment of Chronic Hepatitis C. Deutsches Arzteblatt International. 2012; 109(19): 352–358.
14. Siddique, S.M et al. Rapid virological & End treatment response of patients treated with Sofosbuvir in Chronic Hepatitis C. Pak J Med Sci. 2017 Jul-Aug; 33(4): 813– 817.
15. Zanga LP. Treatment of hepatitis C virus genotype 3 infection with direct-acting antiviral agents. Braz J Med Biol Res. 2016; 49(11): e5504.
16. Stanislas Pol, Marion Corouge, and Anaïs Vallet-Pichard. Daclatasvir–sofosbuvir combination therapy with or without ribavirin for hepatitis C virus infection: from the clinical trials to real life. Hepat Med. 2016; 8: 21–26.
17. Fattovich G, Farci P, Rugge M. A randomized controlled trial of lymphoblastic interferon alpha in patients with chronic hepatitis B lacking HBeAg. Hepatology. 1992; 15(4):584-9.
18. Nafees M, Abbas G, Saqib M. Validity of Ultrasound in Diagnosis of Liver Fibrosis Resulting from Chronic Viral Hepatitis. Pak J Armed Forces. 2011; 61(4):585-89.
19. Rege A, Berho M,Jeffer LJ, Mili Kowski C,Molina EG,Pyrso Poulos NT,et al. Sampling error and intra observer variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002; 97:2614-8.
20. Perz JF, Armstrong GL, Farrington LA, Hutin YJ, Bell BP. The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide. J Hepatol. 2006; 45(4):529–38.
21. Longo DL. Harrison's principles of internal medicine. (18th Ed.). New York: McGraw-Hill. 2012; pp. 308.
22. Friedman LS. Current medical diagnosis and treatment 2014. [S.l.]: Mcgraw-Hill. 2014; pp. Chapter 16
23. Edwards CQ, Kushner JP. Screening for hemochromatosis. New England J Med. 1993; 328(22):1616–20.
24. Tanner MS. Role of copper in Indian childhood cirrhosis. Am J Clin Nutrition. 1998; 67(5 Suppl):1074S–81S.
25. Crawford JM. Cirrhosis. In MacSween RNM, Anthony PP, Scheuer PJ, Burt AD, Portmann BC (eds): Pathology of the Liver, 4th ed. Philadelphia, WB Saunders, 2001;pp.575–619.
26. Iredale JP. Cirrhosis: new research provides a basis for rational and targeted treatments. Br Med J. 2003;327(7407):143–7.
27. Li CP, Lee FY, Hwang SJ. Spider angiomas in patients with liver cirrhosis: role of alcoholism and impaired liver function. Scand J Gastroenterol. 1999; 34(5):520–3.
28. Rodríguez-Roisin R, Krowka MJ, Hervé P, Fallon MB. Pulmonary-Hepatic vascular Disorders (PHD). Eur Respir J. 2004;24(5):861–80.
29. Kim MY, Choi H, Baik SK. Portal Hypertensive Gastropathy: Correlation with Portal Hypertension and Prognosis in Cirrhosis. Dig Dis Sci. 2010; 55(12):3561–7.
30. Tangerman A, Meuwese-Arends MT, Jansen JB. Cause and composition of foetor hepaticus. Lancet. 1994; 343(8895):483.
31. Suurmond D. Color Atlas and Synopsis of Clinical Dermatology: Common and Serious Diseases. McGraw-Hill. pp. Section 33: Disorders of the nail apparatus. 2009.
32. Halfon P, Munteanu M, Poynard T. Fibro Test-ActiTest as a non-invasive marker of liver fibrosis. Gastroenterol Clin Biol. 2008; 32(6):22–39.
33. Rosen HR. Clinical practice. Chronic hepatitis C infection". N Eng J Med. 2011; 364(25):2429–38.
34. Goodman ZD, Ishak, KG. Hepatic Histopathology. In: Schiff ER, Sorrell MF, Maddrey WC. Schiff’s Diseases of the Liver. 9th edition. Philadelphia: Lippincott Williams & Wilkins 2003; 69-134.
35. Regev A, Berho M, Jeffers LJ. Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Am J Gastroenterol. 2002; 97: 2614-2618.
36. Bonis PAL. Up To Date [CD-ROM]. Rose BD, editor. Version 15.3. Wellesley (MA), USA: Up To Date Inc.; 2007 Oct. Histologic scoring systems for chronic hepatitis. 3 CD-ROMs: sound, color, 4 ¾ in.
37. Honkoop P, de man RA, Zondervan PE. Histological improvement in patients with chronic hepatitis B virus infection treated with lamivudine. Liver. 1997; 17:103.
38. Mattsson L, Weiland O, Glaumann H. Application of a numerical scoring system for assessment of histological outcome in patients with chronic post transfusion non-A non-B hepatitis with or without antibodies to hepatitis C. Liver. 1990; 10:257.
39. Vaquer P, Canet R, Liompart A, et al. Histological evolution of chronic hepatitis C. factors related to progression. Liver. 1994; 14:265.
40. The French METAVIR Cooperative Study Group. Intraobserver and interobserver variations in liver biopsy interpretation in patients with chronic hepatitis C. Hepatology. 1994; 20(1 pt 1):15-20.
41. Bedossa P, Dargère D, Paradis V. Sampling variability of liver fibrosis in chronic hepatitis C. Hepatology. 2003; 38:1449-57.
42. Marcellin P, Asselah T, Nathalie Boyer. Fibrosis and Disease Progression in Hepatitis C. Hepatology. 2002; 36:S47-S56.
43. American College of Radiology. Liver Imaging Reporting and Data System version 2013.1. Available at http://www.acr.org/Quality-Safety/Resources/LIRADS/. Accessed August 2013.
44. Nino-Murcia M, Olcott EW, Jeffrey RB Jr, Lamm RL, Beaulieu CF, Jain KA. Focal liver lesions: pattern-based classification scheme for enhancement at arterial phase CT. Radiology. 2000; 215(3):746-51.
45. Takayasu K, Muramatsu Y, Mizuguchi Y, et al. CT Evaluation of the progression of hypoattenuating nodular lesions in virus-related chronic liver disease. AJR Am J Roentgenol. 2006; 187(2):454-63.
46. Kim YK, Lee WJ, Park MJ, Kim SH, Rhim H, Choi D. Hypovascular hypointense nodules on hepatobiliary phase gadoxetic acid-enhanced MR images in patients with cirrhosis: potential of DW imaging in predicting progression to hypervascular HCC. Radiology. 2012; 265(1):104-14.
47. Kim SH, Kim SH, Lee J, et al. Gadoxetic acid-enhanced MRI versus triple-phase MDCT for the preoperative detection of hepatocellular carcinoma. AJR Am J Roentgenol. 2009; 192(6):1675-81.
48. Kim HJ, Kim AY, Kim TK, Byun JH, Won HJ, Kim KW. Transient hepatic attenuation differences in focal hepatic lesions: dynamic CT features. AJR Am J Roentgenol. 2005; 184(1):83-90.
49. Young ST, Paulson EK, Washington K, Gulliver DJ, Vredenburgh JJ, Baker ME. CT of the liver in patients with metastatic breast carcinoma treated by chemotherapy: findings simulating cirrhosis. AJR Am J Roentgenol. 1994; 163(6):1385-8.
50. Kim TK, Choi BI, Han JK, Chung JW, Park JH, Han MC. Nontumorous arterioportal shunt mimicking hypervascular tumor in cirrhotic liver: two-phase spiral CT findings. Radiology. Sep 1998; 208(3):597-603.
51. Ichikawa T, Nakajima H, Nanbu A, Hori M, Araki T. Effect of injection rate of contrast material on CT of hepatocellular carcinoma. AJR Am J Roentgenol. May 2006; 186(5):1413-8.
52. Ito K, Mitchell DG, Hann HW, Outwater EK, Kim Y. Compensated cirrhosis due to viral hepatitis: using MR imaging to predict clinical progression. AJR Am J Roentgenol. 1997; 169(3):801-5.
53. Kondo H, Kanematsu M, Hoshi H, et al. Preoperative detection of malignant hepatic tumors: comparison of combined methods of MR imaging with combined methods of CT. AJR Am J Roentgenol. 2000; 174(4):947-54.
54. Di Martino M, Marin D, Guerrisi A. Intraindividual comparison of gadoxetate disodium-enhanced MR imaging and 64-section multidetector CT in the Detection of hepatocellular carcinoma in patients with cirrhosis. Radiology. Sep 2010;256(3):806-16.
55. Tani I, Kurihara Y, Kawaguchi A, et al. MR imaging of diffuse liver disease. AJR Am J Roentgenol. 2000; 174(4):965-71.
56. Bartolozzi C, Donati F, Cioni D, Crocetti L, Lencioni R. MnDPDP-enhanced MRI vs dual-phase spiral CT in the detection of hepatocellular carcinoma in cirrhosis. Eur Radiol. 2000; 10(11):1697-702.
57. Mori K, Yoshioka H, Itai Y, et al. Arterioportal shunts in cirrhotic patients: evaluation of the difference between tumorous and nontumorous arterioportal shunts on MR imaging with superparamagnetic iron oxide. AJR Am J Roentgenol. 2000; 175(6):1659-64.
58. Kim T, Baron RL, Nalesnik MA. Infarcted regenerative nodules in cirrhosis: CT and MR imaging findings with pathologic correlation. AJR Am J Roentgenol. 2000; 175(4):1121-5.
59. Kim BS, Hayashi PH, Kim SH, Angthong W, Srirattanapong S, Woosley JT. Outcomes of patients with elevated a-fetoprotein level and initial negative findings at MR imaging. Radiology. 2013; 268(1):109-19.
60. Wu W, Chen MH, Yin SS. The role of contrast-enhanced sonography of focal liver lesions before percutaneous biopsy. AJR Am J Roentgenol. 2006;187(3):752-61.
61. Livraghi T. Percutaneous ethanol injection in the treatment of hepatocellular carcinoma in cirrhosis. Hepatogastroenterology. 2001; 48(37):20-4.
62. Trojan J, Schroeder O, Raedle J. Fluorine-18 FDG positron emission tomography for imaging of hepatocellular carcinoma. Am J Gastroenterol. 1999; 94(11):3314-9.
63. Choi D, Lim HK, Kim SH. Hepatocellular carcinoma treated with percutaneous radio-frequency ablation: usefulness of power Doppler US with a microbubble contrast agent in evaluating therapeutic response-preliminary results. Radiology. 2000; 217(2):558-63.
64. Khan MA, Combs CS, Brunt EM. Positron emission tomography scanning in the evaluation of hepatocellular carcinoma. J Hepatol. 2000; 32(5):792-7.
65. Kim YS, Cho SW, Lee KJ. Tc-99m MIBI SPECT is useful for noninvasively predicting the presence of MDR1 gene-encoded P-glycoprotein in patients with hepatocellular carcinoma. Clin Nucl Med. 1999; 24(11):874-9.
66. Cohen EB, Afdhal NH. Ultrasound-based hepatic elastography: origins, limitations, and applications. J Clin Gastroenterol. 2010;44(9):637-45.
67. Smith PA, Klein AS, Heath DG, Chavin K, Fishman EK. Dual-phase spiral CT angiography with volumetric 3D rendering for preoperative liver transplant evaluation: preliminary observations. J Comput Assist Tomogr. 1998;22(6):868-74.
68. Escorsell A, Bordas JM, Castaneda B. Predictive value of the variceal pressure response to continued pharmacological therapy in patients with cirrhosis and portal hypertension. Hepatology. 2000;31(5):1061-7.
69. Bosch J, García-Pagán JC. Complications of cirrhosis. I. Portal hypertension. J Hepatol. 2000; 32(1 Suppl):141-56.
70. Pannu HK, Maley WR, Fishman EK. Liver transplantation: preoperative CT evaluation. Radiographics. 2001; 21 Spec No: S133-46.
71. Malik SM, Gupte PA, de Vera ME, Ahmad J. Liver transplantation in patients with nonalcoholic steatohepatitis-related hepatocellular carcinoma. Clin Gastroenterol Hepatol. 2009;7(7):800-6.
72. Shanbhogue AK, Prasad SR, Takahashi N, Vikram R, Sahani DV. Recent advances in cytogenetics and molecular biology of adult hepatocellular tumors: implications for imaging and management. Radiology. 2011; 258(3):673-93.
73. Paradis V, Zalinski S, Chelbi E, Guedj N, Degos F, Vilgrain V. Hepatocellular carcinomas in patients with metabolic syndrome often develop without significant liver fibrosis: a pathological analysis. Hepatology. 2009;49(3):851-9.
74. Armitage J. The safety of statins in clinical practice. Lancet. 2007;370(9601):1781-90.
75. Lewis JH, Mortensen ME, Zweig S. Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease: Results of a prospective, randomized, double-blind, placebo-controlled, multicenter trial. Hepatol. 2007;46(5):1453-63.
76. Rajab MA, Kaplan MM. Statins in primary biliary cirrhosis: are they safe?. Dig Dis Sci. Oct 1 2009.
77. Zaman A. Which Drugs Are Safe in Patients With Cirrhosis? NEJM Journal Watch. Jun 21 2013. Available at http://www.jwatch.org/na31329/2013/06/21/which-drugs-are-safe-patients-with-cirrhosis. Accessed July 30 2013.
78. Lewis JH, Stine JG. Review article: prescribing medications in patients with cirrhosis - a practical guide. Aliment Pharmacol Ther. 2013; 37(12):1132-56.
79. Peterlik M, Cross HS. Vitamin D and calcium deficits predispose for multiple chronic diseases. Eur J Clin Invest. 2005; 35: 290–304.
80. Rode A, Fourlanos S, Nicoll A. Oral vitamin D replacement is effective in chronic liver disease. Gastroenterol Clin Biol. 2010; 34: 618–620.
81. Hepatitis C. Fact Sheet. [Last accessed on 17 May 2018]. Available at http://www.who.int/en/news-room/fact-sheets/detail/hepatitis-c.
82. Gower E, Estes C, Blach S, Shearer KR, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol. 2014; 61(1Suppl):S45–57.
83. Arshad A, Ashfaq UA. Epidemiology of Hepatitis C Infection in Pakistan: Current Estimate and Major Risk Factors. Crit Rev Eukaryot Gene Expr. 2017;27(1):63–77.
84. Prevalence of Hepatitis B &C in Pakistan. [(Last accessed on 8th January 2019)]. Available at http://phrc.org.pk/assets/hepatitis-national-survey. pdf .
85. Lauer GM, Walker BD. Hepatitis C virus infection. N Engl J Med. 2001; 345: 41–52.
86. Hepatitis. WHO urges countries to scale up hepatitis C treatment [(Last accessed on 18 May 2018)]. Available at http://www.who.int/hepatitis/news-events/hep-c-access-report-2018-story/en/
87. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;16;370(3):211–221.
88. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, 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(4):1127–1135.
89. Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, et al. Daclatasvir, sofosbuvir, and ribavirin for hepatitis C virus genotype 3 and advanced liver disease:A randomized phase III study (ALLY3+). Hepatology. 2016;63(5):1430–1441.
90. AASLD-IDSA. [(Last accessed on 18 May 2018)];HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. Available at https://www.hcvguidelines.org . [Google Scholar]
91. European Association for the Study of the Liver. EASL Recommendations on Treatment of Hepatitis C 2018. J Hepatol. 2018;69(2):461–511.
92. Sulkowski MS, Gardiner DF, Rodriguez-Torres M, Reddy KR, Hassanein T, Jacobson I, et al. Daclatasvir plus sofosbuvir for previously treated or untreated chronic HCV infection. N Engl J Med. 2014;370: 211–21.
93. Wyles DL, Ruane PJ, Sulkowski MS, Dieterich D, Luetkemeyer A, Morgan TR, et al. Daclatasvir plus sofosbuvir for HCV in patients coinfected with HIV-1. N Engl J Med. 2015; 373: 714–25.
94. Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, et al. Alloral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015;61: 1127–35.
95. Leroy V, Angus P, Bronowicki JP, Dore GJ, Hezode C, Pianko S, 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; 63:1430–41
96. Poordad F, Schiff ER, Vierling JM, Landis C, Fontana RJ, Yang R, et al. Daclatasvir with sofosbuvir and ribavirin for HCV infection with advanced cirrhosis or post-liver transplant recurrence. Hepatology. 2016;63: 1493–505.
97. Coilly A, Fougerou-Leurent C, de Ledinghen V, Houssel-Debry P, Duvoux C, Di Martino V, et al. Multicentre experience using daclatasvir and sofosbuvir to treat hepatitis C recurrence - The ANRS CUPILT study. J Hepatol. 2016; 65: 711–8.
98. Welzel TM, Petersen J, Herzer K, Ferenci P, Gschwantler M, Wedemeyer H, et al. Daclatasvir plus sofosbuvir, with or without ribavirin, achieved high sustained virological response rates in patients with HCV infection and advanced liver disease in a real-world cohort. Gut. 2016;65: 1861–70.
99. Hezode C, De Ledinghen V, Fontaine H, Zoulim F, Lebray P, Boyer N, et al. Daclatasvir plus sofosbuvir with or without ribavirin in patients with HCV genotype 3 infection: interim analysis of a French multicenter compassionate use program (abstract LP05). J Hepatol. 2015;62: S265–6.
100. Butt Z, Shah SMA. Daclatasvir plus Sofosbuvir with or without ribavirin in patients with chronic Hepatitis C genotype 3a in Pakistani population - A real world experience. Pak J Med Sci. 2019 Mar-Apr; 35(2): 409–413.
101. European Association for the Study of the Liver. EASL recommendations on treatment of hepatitis C 2015. J Hepatol. 2015; 63: 199‐ 236.
102. Foster GR, Afdhal N, Roberts SK, Brau N, Gane EJ, Pianko S, et al.; ASTRAL‐2 Investigators; ASTRAL‐3 Investigators. Sofosbuvir and velpatasvir for HCV genotype 2 and 3 infection. N Engl J Med. 2015; 373: 2608‐ 2617.
103. Del Rio-Valencia JC, Asensi-Diez R, Madera-Pajin R, Yunquera-Romero L, Muñoz-Castillo I. Interferon-free treatments in patients with hepatitis C genotype 3 infection in a tertiary hospital. Rev Esp Quimioter. 2018;31(1):35–42.
104. Tao YC, Deng R, Wang ML, Lv DD, Yuan M, Wang YH, Chen EQ, Tang H. Satisfactory virological response and fibrosis improvement of sofosbuvir-based regimens for Chinese patients with hepatitis C virus genotype 3 infections: results of a real-world cohort study. Virol J. 2018; 15(1):150.
Article Sidebar
Published
Sep 25, 2024
Article Details
How to Cite
Muhammad Zohaib Khan. (2024). FREQUENCY OF END OF TREATMENT RESPONSE IN GENOTYPE 3 CIRRHOTIC PATIENTS TAKING SOFOSBUVIR, RIBAVIRIN AND DACLATASVIR. Journal of Population Therapeutics and Clinical Pharmacology, 31(9), 4104-4128. https://doi.org/10.53555/vgped651
Section
Articles
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
Author Biography
Muhammad Zohaib Khan
Department of Gastroenterology and Hepatology, Bahria International Hospital, Lahore, Pakistan.
How to Cite
Muhammad Zohaib Khan. (2024). FREQUENCY OF END OF TREATMENT RESPONSE IN GENOTYPE 3 CIRRHOTIC PATIENTS TAKING SOFOSBUVIR, RIBAVIRIN AND DACLATASVIR. Journal of Population Therapeutics and Clinical Pharmacology, 31(9), 4104-4128. https://doi.org/10.53555/vgped651