Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey

Yıl: 2015 Cilt: 32 Sayı: 3 Sayfa Aralığı: 266 - 272 Metin Dili: İngilizce İndeks Tarihi: 29-07-2022

Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey

Öz:
Background: The use of pegylated interferon alpha andribavirin (PegIFN/RBV) for the retreatment of chronichepatitis C virus (HCV) infection without a sustainedvirological response (SVR) prior to PegIFN/RBV treat- ment has resulted in low success rates.Aims: To investigate the efficacy and safety of telaprevir(TVR) in combination with PegIFN/RBV in patients in- fected with HCV genotypes 1 and 4 who were previous- ly treated with PegIFN/RBV and failed to achieve SVR.Study Design: Multi-center, retrospective, cross-sec- tional study. Methods: The study included 111 patients: 80 prior re- lapsers, 25 prior null responders, and six prior partial re- sponders to PegIFN/RBV treatment. The patients weregiven TVR/PegIFN/RBV for 12 weeks, followed by a12-week PegIFN/RBV treatment; virological responseresults were assessed at weeks 4, 12, and 24. Treatmentwas discontinued in patients with HCV RNA >1000 IU/ mL at week 4 or with negative RNA results at week 4 but>1000 IU/mL at week 12. Rapid virological response(RVR), early virological response (EVR), extended rap- id virological response (eRVR), and virological responseat 24th week of treatment were evaluated. The side ef- fects of combination therapy and the rates of treatmentdiscontinuation were investigated. Results: The mean age of the patients was 56.02±9.96years and 45.9% were male. Ninety-one percent of thepatients were infected with viral genotype 1, 69.6% withthe interleukin (IL) 28B genotype CT and 20.2% werecirrhotic. The RVR rate was 86.3% in prior relapsers,56% in prior null responders, and 50% in prior partialresponders (p=0.002). EVR rates in those groups were91.3%, 56%, and 83.3%, respectively (p<0.001). eRVRrates were 83.8% in prior relapsers, 48% in prior null re- sponders, and 50% in prior partial responders (<0.001).The virological response at the 24th week of treatmentwas found to be the highest in prior relapsers (88.8%);it was 56% in prior null responders and 66.7% in priorpartial responders (p<0.001). Common side effects werefatigue, headache, anorexia, malaise, anemia, pruritus,dry skin, rash, dyspepsia, nausea, pyrexia, stomachache,and anorectal discomfort. All treatments were discontin- ued due to side effects in 9.9% of patients. Conclusion: High virological response rates were ob- tained with TVR/PegIFN/RBV treatment. Although sideeffects were frequently observed, the discontinuationrate of combination therapy was low.
Anahtar Kelime:

Konular: Cerrahi
Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
  • 1. Hepatitis C. Geneva: World Health Organization, 2011. (http:// www.who.int/vaccine_research/diseases/hepatitis_c/en/.)
  • 2. World Health Organization. Global surveillance and control of hepatitis C: report of a WHO consultation organized in collabo- ration with the Viral Hepatitis Prevention Board, Antwerp, Bel- gium. J Viral Hepat 1999;6:35-47. [CrossRef]
  • 3. Thomas MB, Jaffe D, Choti MM, Belghiti J, Curley S, Fong Y, et al. Hepatocellular carcinoma: consensus recommendations of the National Cancer Institute Trials Planning Meeting. J Clin Oncol 2010;28:3994-4005. [CrossRef]
  • 4. Aygen B. Hepatitis C. Turkiye Klinikleri J Int Med Sci 2006;2:21-33.
  • 5. Bozkurt I, Aygen B, Gökahmetoglu S, Yildiz O. Hepatitis C and occult hepatitis C infection among hemodialysis patients from Central Anatolia. J Pure Appl Microbiol 2014:8:435-40.
  • 6. Aygen B, Deniz K, Akhan S, Çelen MK, Yıldız O, Ayaz C, et al. Frequency and epidemiologic characteristics of hepatitis C virus infection in patients receiving hemodialysis in our region. Klimik Journal 2012;25:19-23. [CrossRef]
  • 7. Gökahmetoğlu S, Bozdayı M, Özbakır Ö, Aygen B, Özbal Y, Soyuer I, et al. Hepatitis C virus genotypes detected in Erci- yes University. Journal of Turkish Society of Microbiology 2007;37:35-8.
  • 8. Gökahmetoğlu S, Atalay MA, Kılınç A. Determination of the hepatitis C virus genotypes with “pyrosequencing” method. Erciyes Medical Journal 2011;33:99-102.
  • 9. Fried MW, Shiffman ML, Reddy KR, Smith C, Marinos G, Gonçales FL Jr, et al. Peginterferon alfa-2a plus ribavirin for chronic hepatitis C virus infection. N Engl J Med 2002;347:975-82. [CrossRef]
  • 10. Manns MP, McHutchison JG, Gordon SC, Rustgi VK, Shiffman M, Reindollar R, et al. Peginterferon alfa-2b plus ribavirin com- pared with interferon alfa-2b plus ribavirin for initial treatment of chronic hepatitis C: a randomised trial. Lancet 2001;358:958-65. [CrossRef]
  • 11. Kamal SM, Nasser IA. Hepatitis C genotype 4: what we know and what we don’t yet know. Hepatology 2008;47:1371-83. [CrossRef]
  • 12. McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, et al. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med 2009;360:1827-38. [CrossRef]
  • 13. McHutchison JG, Manns MP, Muir AJ, Terrault NA, Jacobson IM, Afdhal NH, et al; PROVE3 Study Team. Telaprevir for previously treated chronic HCV infection. N Engl J Med 2010; 362:1292-303. [CrossRef]
  • 14. Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, et al; ADVANCE Study Team. Telapre- vir for previously untreated chronic hepatitis C virus infection. N Engl J Med 2011;364:2405-16. [CrossRef]
  • 15. Sherman KE, Flamm SL, Afdhal NH, Nelson DR, Sulkowski MS, Everson GT, et al; ILLUMINATE Study Team. Response- guided telaprevir combination treatment for hepatitis C virus infection. N Engl J Med 2011;365:1014-24. [CrossRef]
  • 16. Zeuzem S, Andreone P, Pol S, Lawitz E, Diago M, Roberts S, et al; REALIZE Study Team. Telaprevir for retreatment of HCV infection. N Engl J Med 2011;364:2417-28. [CrossRef]
  • 17. Benhamou Y, Moussalli J, Ratziu V, Lebray P, De Backer K, De Meyer S, et al. Telaprevir activity in treatment-naive patients infected hepatitis C virus genotype 4: a randomized trial. J Inf ect Dis 2013;208:1000-7. [CrossRef]
  • 18. Ishak K, Baptisa A, Bianchi L, Callea F, De Groote J, Gudat F, et al. Histological grading and staging of chronic hepatitis. J Hepatol 1995;22:696-9. [CrossRef]
  • 19. Omata M, Kanda T, Yu ML, Yokosuka O, Lim SG, Jafri W, et al. APASL consensus statements and management algorithms for hep- atitis C virus infection. Hepatol Int 2012;6:409-35. [CrossRef]
  • 20. Ghany MG, Strader DB, Thomas DL, Seeff LB; American Association for the Study of Liver Diseases. Diagnosis, man- agement, and treatment of hepatitis C: an update. Hepatology 2009;49:1335-74. [CrossRef]
  • 21. Sung H, Chang M, Saab S. Management of hepatitis C antiviral ther- apy adverse effects. Curr Hepat Rep 2011;10:33-40. [CrossRef]
  • 22. European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of hepatitis C virus infection. J Hepatol 2011;55:245-64. [CrossRef]
  • 23. El Awady MK, Bader El Din NG, Tabll A, El Hosary Y, Abdel Aziz AO, El Khayat H, et al. IL28B polymorphism and cytomeg- alovirus predict response to treatment in Egyptian HCV type 4 patients. World J Gastroenterol 2013;19:290-8. [CrossRef]
  • 24. Muir AJ, Poordad FF, McHutchison JG, Shiffman ML, Berg T, Ferenci P, et al. Retreatment with telaprevir combination therapy in hepatitis C patients with well-characterized prior treatment response. Hepatology 2011;54:1538-46. [CrossRef]
  • 25. Poynard T, Colombo M, Bruix J, Schiff E, Terg R, Flamm S, et al. Peginterferon alfa-2b and ribavirin: effective in patients with hepatitis C who failed interferon alfa/ribavirin therapy. Gastro- enterology 2009;136:1618-28. [CrossRef]
  • 26. Shiffman ML, Di Bisceglie AM, Lindsay KL, Morishima C, Wright EC, Everson GT, et al; Hepatitis C Antiviral Long-Term Treatment Against Cirrhosis Trial Group. Peginterferon alfa-2a and ribavirin in patients with chronic hepatitis C who have failed prior treatment. Gastroenterology 2004;126:1015-23. [CrossRef]
  • 27. Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB. An up- date on treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the American Association for the Study of Liver Diseases. Hepatology 2011;54:1433-44. [CrossRef] Balkan Med J, Vol. 32, No. 3, 2015
APA AYGEN B, YILDIZ O, AKHAN S, CELEN M, URAL O, KORUK TEKİN S, köse ş, KORKMAZ F, Kuruüzüm Z, TUNA N, taheri s, SAYAN M, DEMİR ATKUĞ N, SÜMER Ş, ALTINOK SARGIN E (2015). Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. , 266 - 272.
Chicago AYGEN Bilgehan,YILDIZ Orhan,AKHAN Sıla,CELEN MUSTAFA,URAL Onur,KORUK TEKİN Süda,köse şükran,KORKMAZ Fatime,Kuruüzüm Ziya,TUNA Nazan,taheri serpil,SAYAN Murat,DEMİR ATKUĞ Nazlım,SÜMER Şua,ALTINOK SARGIN Elif Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. (2015): 266 - 272.
MLA AYGEN Bilgehan,YILDIZ Orhan,AKHAN Sıla,CELEN MUSTAFA,URAL Onur,KORUK TEKİN Süda,köse şükran,KORKMAZ Fatime,Kuruüzüm Ziya,TUNA Nazan,taheri serpil,SAYAN Murat,DEMİR ATKUĞ Nazlım,SÜMER Şua,ALTINOK SARGIN Elif Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. , 2015, ss.266 - 272.
AMA AYGEN B,YILDIZ O,AKHAN S,CELEN M,URAL O,KORUK TEKİN S,köse ş,KORKMAZ F,Kuruüzüm Z,TUNA N,taheri s,SAYAN M,DEMİR ATKUĞ N,SÜMER Ş,ALTINOK SARGIN E Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. . 2015; 266 - 272.
Vancouver AYGEN B,YILDIZ O,AKHAN S,CELEN M,URAL O,KORUK TEKİN S,köse ş,KORKMAZ F,Kuruüzüm Z,TUNA N,taheri s,SAYAN M,DEMİR ATKUĞ N,SÜMER Ş,ALTINOK SARGIN E Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. . 2015; 266 - 272.
IEEE AYGEN B,YILDIZ O,AKHAN S,CELEN M,URAL O,KORUK TEKİN S,köse ş,KORKMAZ F,Kuruüzüm Z,TUNA N,taheri s,SAYAN M,DEMİR ATKUĞ N,SÜMER Ş,ALTINOK SARGIN E "Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey." , ss.266 - 272, 2015.
ISNAD AYGEN, Bilgehan vd. "Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey". (2015), 266-272.
APA AYGEN B, YILDIZ O, AKHAN S, CELEN M, URAL O, KORUK TEKİN S, köse ş, KORKMAZ F, Kuruüzüm Z, TUNA N, taheri s, SAYAN M, DEMİR ATKUĞ N, SÜMER Ş, ALTINOK SARGIN E (2015). Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. Balkan Medical Journal, 32(3), 266 - 272.
Chicago AYGEN Bilgehan,YILDIZ Orhan,AKHAN Sıla,CELEN MUSTAFA,URAL Onur,KORUK TEKİN Süda,köse şükran,KORKMAZ Fatime,Kuruüzüm Ziya,TUNA Nazan,taheri serpil,SAYAN Murat,DEMİR ATKUĞ Nazlım,SÜMER Şua,ALTINOK SARGIN Elif Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. Balkan Medical Journal 32, no.3 (2015): 266 - 272.
MLA AYGEN Bilgehan,YILDIZ Orhan,AKHAN Sıla,CELEN MUSTAFA,URAL Onur,KORUK TEKİN Süda,köse şükran,KORKMAZ Fatime,Kuruüzüm Ziya,TUNA Nazan,taheri serpil,SAYAN Murat,DEMİR ATKUĞ Nazlım,SÜMER Şua,ALTINOK SARGIN Elif Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. Balkan Medical Journal, vol.32, no.3, 2015, ss.266 - 272.
AMA AYGEN B,YILDIZ O,AKHAN S,CELEN M,URAL O,KORUK TEKİN S,köse ş,KORKMAZ F,Kuruüzüm Z,TUNA N,taheri s,SAYAN M,DEMİR ATKUĞ N,SÜMER Ş,ALTINOK SARGIN E Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. Balkan Medical Journal. 2015; 32(3): 266 - 272.
Vancouver AYGEN B,YILDIZ O,AKHAN S,CELEN M,URAL O,KORUK TEKİN S,köse ş,KORKMAZ F,Kuruüzüm Z,TUNA N,taheri s,SAYAN M,DEMİR ATKUĞ N,SÜMER Ş,ALTINOK SARGIN E Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey. Balkan Medical Journal. 2015; 32(3): 266 - 272.
IEEE AYGEN B,YILDIZ O,AKHAN S,CELEN M,URAL O,KORUK TEKİN S,köse ş,KORKMAZ F,Kuruüzüm Z,TUNA N,taheri s,SAYAN M,DEMİR ATKUĞ N,SÜMER Ş,ALTINOK SARGIN E "Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey." Balkan Medical Journal, 32, ss.266 - 272, 2015.
ISNAD AYGEN, Bilgehan vd. "Retreatment of Chronic Hepatitis C Infection with Telaprevir: Preliminary Results in Turkey". Balkan Medical Journal 32/3 (2015), 266-272.