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2013, Number 1

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Ann Hepatol 2013; 12 (1)

Safety and efficacy of treatment with pegylated interferon alpha-2a with ribavirin in chronic hepatitis C genotype 4

Urquijo JJ, Diago M, Boadas J, Planas R, Solá R, del Olmo JÁ, Crespo J, Erdozaín JC, Antón MD, Arocena C, Suarez D, Giné J, Barrera JM, García-Samaniego J, Perez R, Dalmau B, Montoro M

Language: English
References: 40
Page: 30-35
PDF size: 99.03 Kb.


ABSTRACT

The hepatitis C virus (HCV) genotype is an important predictive outcome parameter for pegylated interferon plus ribavirin therapy. Most published therapeutic trials to date have enrolled mainly patients with HCV genotypes 1, 2 and 3. Limited studies have focused on genotype 4 patients, who have had a poor representation in pivotal trials. Our aim was to evaluate the efficacy and safety of treatment with standard dose pegylated interferon alfa-2a in combination with weight-based ribavirin in patients with chronic hepatitis C genotype 4. In this prospective observational study, 198 patients with HCV-4 were included in this study from February 2004 to August 2005,188 patients who received at least 1 dose of drugs were included in the ITT analysis and they were treated with pegylated interferon alfa-2a and ribavirin for 48 weeks. Baseline and demographic characteristics, response to treatment at weeks 12, 48 and 72, and the nature and frequency of adverse effects were analyzed. Virological response at week 12 was achieved in 144 patients (76.6%). Virological response at the end of treatment was present in 110 patients (58.5%). At week 72, 99 patients presented SVR (52.7%). The reported adverse events were similar to those found in the literature for treatments of similar dose and duration. In conclusion, combined treatment with pegylated interferon alfa-2a and ribavirin was well tolerated and effective in chronic hepatitis C genotype 4, yielding response rates between those reported for genotype 1 and those of genotypes 2-3.


REFERENCES

  1. WHO. Global surveillance and control of hepatitis C. Report of a WHO Consultation organized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepat 1999: 6: 35-47.

  2. WHO. Hepatitis C. WHO Fact sheet Nº 164. Available at: URL.

  3. Fried MW, Hoofnagle JH. Therapy of hepatitis C. Semin Liver Dis 1995: 15: 82-91.

  4. Nguyen MH, Keeffe EB. Prevalence and treatment of hepatitis C virus genotypes 4, 5, and 6. Clin Gastroenterol Hepatol 2005: 3: S97-S101.

  5. Booth JC, Foster GR, Levine T, Thomas HC, Goldin RD. The relationship of histology to genotype in chronic HCV infection. Liver 1997: 17: 144-51.

  6. Chayama K, Tsubota A, Arase Y, Saitoh S, Ikeda K, Matsumoto T, Hashimoto M, et al. Genotype, slow decrease in virus titer during interferon treatment and high degree of sequence variability of hypervariable region are indicative of poor response to interferon treatment in patients with chronic hepatitis type C. J Hepatol 1995: 23: 648-53.

  7. el-Zayadi A, Simmonds P, Dabbous H, Prescott L, Selim O, Ahdy A. Response to interferon-alpha of Egyptian patients infected with hepatitis C virus genotype 4. J Viral Hepat 1996; 3: 261-4.

  8. Hnatyszyn HJ. Chronic hepatitis C and genotyping: the clinical significance of determining HCV genotypes. Antivir Ther 2005; 10: 1-11.

  9. Khattab MA, Ferenci P, Hadziyannis SJ, Colombo M, Manns MP, Almasio PL, Esteban R, et al. Management of hepatitis C virus genotype 4: recommendations of an international expert panel. J Hepatol 2011; 54: 1250-62.

  10. Fernández-Arcás N, López-Siles J, Trapero S, Ferraro A, Ibáñez A, Orihuela F, Maldonado J, et al. High prevalence of hepatitis C virus subtypes 4c and 4d in Malaga (Spain): phylogenetic and epidemiological analyses. J Med Virol 2006; 78: 1429-35.

  11. Martinez SM, Delgado MB, Castroagudin JF, Aguilera A. High rate of infection with hepatitis C virus genotype 4 in a district of galicia, Spain. J Clin Microbiol 2005; 43: 5403-4.

  12. Cenci M, Massi M, Alderisio M, De Soccio G, Recchia O. Prevalence of hepatitis C virus (HCV) genotypes and increase of type 4 in central Italy: an update and report of a new method of HCV genotyping. Anticancer Res 2007; 27: 1219-22.

  13. Castera L, Morice Y, Grando V, Bon C, Deny P, Roulot D. Le virus de l’hepatite C de génotype 4. Caracteristiques épidemiologiques et réponse aux traitments antiviraux. Gastroenterol Clin Biol 2003; 27: 596-604.

  14. Antaki N, Craxi A, Kamal S, Moucari R, Van der Merwe S, Haffar S, Gadano A, et al. The neglected hepatitis C virus genotypes 4, 5 and 6: an international consensus report. Liver Int 2010; 30: 342-55.

  15. Kamal SM, Nasser IA. Hepatitis C genotype 4: What we know and what we don’t yet know. Hepatology 2008; 47: 1371-83.

  16. Martín-Carbonero L, Puoti M, García-Samaniego J, De Luca A, Losada E, Quinzan G, Bruno R, et al. Response to pegylated interferon plus ribavirin in HIV-infected patients with chronic hepatitis C due to genotype 4. J Viral Hepat 2008; 15: 710-5.

  17. Diago-Madrid M. Treatment of genotype 4 patients. Gastroenterol Hepatol 2006; 29: 5.

  18. Ferenci P, Laferl H, Scherzer TM, Gschwantler M, Maieron A, Brunner H, Stauber R, et al. Peginterferon alfa-2a and ribavirin for 24 weeks in hepatitis C type 1 and 4 patients with rapid virological response. Gastroenterology 2008; 135: 451-8.

  19. Ferenci P, Laferl H, Scherzer TM, Maieron A, Hofer H, Stauber R, Gschwantler M, et al. Peginterferon alfa-2a/ribavirin for 48 or 72 weeks in hepatitis C genotypes 1 and 4 patients with slow virologic response. Gastroenterology 2010; 138: 503-12, 512 e1.

  20. Alfaleh FZ, Hadad Q, Khuroo MS, Aljumah A, Algamedi A, Alashgar H, Al-Ahdal MN, et al. Peginterferon alpha-2b plus ribavirin compared with interferon alpha-2b plus ribavirin for initial treatment of chronic hepatitis C in Saudi patients commonly infected with genotype 4. Liver Int 2004; 24: 568-74.

  21. McHutchison JG, Gordon SC, Schiff ER, Shiffman ML, Lee WM, Rustgi VK, Goodman ZD, et al. Interferon alfa-2b alone or in combination with ribavirin as initial treatment for chronic hepatitis C. Hepatitis Interventional Therapy Group. N Engl J Med 1998; 339: 1485-92.

  22. Poynard T, Marcellin P, Lee SS, Niederau C, Minuk GS, Ideo G, Bain V, et al. Randomised trial of interferon alpha2b plus ribavirin for 48 weeks or for 24 weeks versus interferon alpha2b plus placebo for 48 weeks for treatment of chronic infection with hepatitis C virus. International Hepatitis Interventional Therapy Group (IHIT). Lancet 1998; 352: 1426-32.

  23. Sherman M, Marinos G, Sedarati F. Infection with hepatitis C virus genotype 4 is associated with a poor response to interferon-alpha. Ann Intern Med 2001; 135: 927-8.

  24. Esmat G, Abouzied AM, Abdel-Aziz F, Strickland T. Subjects with chronic hepatitis C and genotype 4 have a similarly effective response to standard or pegylated interferon in combination with ribavirin. Hepatology 2003; 38.

  25. Shobokshi OA, Serebour FE, Skakni L, Al-Saffy YH, Ahdal MN. Hepatitis C genotypes and subtypes in Saudi Arabia. J Med Virol 1999; 58: 44-8.

  26. Poynard T, McHutchison J, Goodman Z, Ling MH, Albrecht J. Is an “à la carte” combination interferon alfa-2b plus ribavirin regimen possible for the first line treatment in patients with chronic hepatitis C? The ALGOVIRC Project Group. Hepatology 2000; 31: 211-8.

  27. El Makhzangy H, Esmat G, Said M, Elraziky M, Shouman S, Refai R, Rekacewicz C, et al. Response to pegylated interferon alfa-2a and ribavirin in chronic hepatitis C genotype 4. J Med Virol 2009; 81: 1576-83.

  28. Diago M, Hassanein T, Rodes J, Ackrill AM, Sedarati F. Optimized virologic response in hepatitis C virus genotype 4 with peginterferon-alpha2a and ribavirin. Ann Intern Med 2004; 140: 72-3.

  29. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL Jr, Häussinger D, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002; 347: 975-82.

  30. Hadziyannis SJ, Sette H Jr, Morgan TR, Balan V, Diago M, Marcellin P, Ramadori G, et al. Peginterferon-alpha2a and ribavirin combination therapy in chronic hepatitis C: a randomized study of treatment duration and ribavirin dose. Ann Intern Med 2004; 140: 346-55.

  31. Asselah T, Estrabaud E, Bieche I, Lapalus M, De Muynck S, Vidaud M, Saadoun D, et al. Hepatitis C: viral and host factors associated with non-response to pegylated interferon plus ribavirin. Liver Int 2010; 30: 1259-69.

  32. Davis GL, Lau JY. Factors predictive of a beneficial response to therapy of hepatitis C. Hepatology 1997; 26: 122S-127S.

  33. Ogawa E, Furusyo N, Kajiwara E, Takahashi K, Nomura H, Tanabe Y, Satoh T, et al. An evaluation of the adverse effect of premature discontinuation of pegylated interferon alpha-2b and ribavirin treatment for chronic hepatitis C virus infection: Results from Kyushu University Liver Disease Study (KULDS). J Gastroenterol Hepatol 2011.

  34. Sulkowski MS, Cooper C, Hunyady B, Jia J, Ogurtsov P, Peck-Radosavljevic M, Shiffman ML, et al. Management of adverse effects of Peg-IFN and ribavirin therapy for hepatitis C. Nat Rev Gastroenterol Hepatol 2011; 8: 212-23.

  35. Nogueira Nogueira JB, Santana Sena LC, de Souza Siqueira Quintans J, Guedes da Silva Almeida JR, Vianey Callado Franca A, Quintans Junior LJ. Side Effects of the Therapy With Peginterferon and Ribavirin in Chronic Hepatitis C: A Small Audit. J Pharm Pract 2011.

  36. Fried MW, Hadziyannis SJ, Shiffman ML, Messinger D, Zeuzem S. Rapid virological response is the most important predictor of sustained virological response across genotypes in patients with chronic hepatitis C virus infection. J Hepatol 2011; 55: 69-75.

  37. Yu JW, Wang GQ, Sun LJ, Li XG, Li SC. Predictive value of rapid virological response and early virological response on sustained virological response in HCV patients treated with pegylated interferon alpha-2a and ribavirin. J Gastroenterol Hepatol 2007; 22: 832-6.

  38. Gonzalez SA, Keeffe EB. IL-28B As a Predictor of Sustained Virologic Response in Patients with Chronic Hepatitis C Virus Infection. Gastroenterol Hepatol (NY) 2011; 7: 366-73.

  39. Thompson AJ, Muir AJ, Sulkowski MS, Ge D, Fellay J, Shianna KV, Urban T, 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: 120-9 e18.

  40. Esmat G, El Raziky M, El Kassas M, Hassany M, Gamil ME. The future for the treatment of genotype 4 chronic hepatitis C. Liver Int 2012; 32(Suppl. 1): 146-50.




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