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Results of Entecavir treatment in patients with chronic hepatitis B

Yıl 2013, Cilt: 3 Sayı: 04, 176 - 180, 01.12.2013
https://doi.org/10.5799/ahinjs.02.2013.04.0104
https://izlik.org/JA36RJ45NY

Öz

Objective: This study was designed to determine the efficacy and safety of Entecavir (ETV) after 96 weeks treatment in patients with chronic viral hepatitis B (CHB). Methods: Thirty-eight patients were included into the study. The criteria for starting ETV treatment were as follows: elevated ALT levels >upper limit of normal (ULN) two times, with HBV-DNA levels ≥5 log10 copies/ml (≥20000 IU/mL), in HBe Ag positive patients, ≥4log10 copies/ml (≥2000IU/mL) in HBe Ag negative patients and liver damage was confirmed by histopathology (Knodell HAI ≥4 or fibrosis ≥1). Patients were followed up every 12 weeks by virological and biochemical tests. Results: Twenty-four of 38 patients (63.2%) were male. Mean age of patients were 38.6 years, 14 of them were HBeAg positive (36.8%). At baseline, median ALT level was detected as 106.7 IU/ml, median HBV DNA levels were 4.8 x 107 copy/ml, and mean Knodell HAI score was nine. Eleven of 14 HBe Ag positive patients (78.6%) were treatment-naïve. No resistance mutation was determined during treatment. Biochemical responses (BR) at 48th and 96th week were 100% and virologic response (VR) were 57.1%, and 50%, respectively. Serological response (SR) at 48th and 96th weeks were 35.7% and 42.8% respectively. Fifteen (62.5%) of 24 HBe Ag negative patients were treatment-naïve; two patients were detected to have lamivudine resistance mutation. At 48th and 96th week, BR was 95.8%, and 100%, respectively; and VR were 83.3% both. Conclusion: In our study, virologic response was significantly high after two years of therapy with Entecavir in HBe Ag negative patients.

Kaynakça

  • World Health Organization. HepatitisB fact sheet WHO/204. Geneva: World Health Organization, October 2000. (Ac- cessed February 10, 2006, at http://www. who.int/mediacen- tre/factsheets/fs204/en.)
  • Lee WM. Hepatitis B virus infection. N Engl J Med 1997;337:1733-1745.
  • Liaw YF, Leung N, Kao JH et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int 2008;2:263-283.
  • European Association for the Study of the Liver. EASL clini- cal practice guidelines: management of chronic hepatitis B. J Hepatol 2009;50:227–242.
  • Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hep- atology 2009;50:661-662.
  • European Association For The Study Of The Liver. EASL Clini- cal Practice Guidelines: management of chronic hepatitis B. J Hepatol 2009;50:227-42.
  • Niu C, Murakami E, Furman PA. Clevudine is efficiently phos- phorylated to the active triphosphate form in primary human hepatocytes. Antivir Ther 2008;13:263-269.
  • Baraclude Package Insert. Wallingford, CT: Bristol-Myers Squibb.
  • http://packageinserts.bms.com/pi/pi_baraclude.pdf. Accessed December 4, 2010.
  • Seifer M, Hamatake RK, Colonno RJ, Standring DN. In vitro inhibition of hepadnavirus polymerases by the triphosphates of BMS-200475 and lobucavir. Antimicrob Agents Chemoth- er1998;42:3200–3208.
  • Chang TT, Lai CL, Kew Yoon S, et al. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology 2010;51:422–430.
  • Tenney DJ, Rose RE, Baldick CJ, et al. Long-term monitoring shows hepatitis B virus resistance to Entecavir in nucleoside naive patients is rare through 5 years of therapy. Hepatology. 2009;49:1503–1514.
  • Buster EH, van Erpecum KJ , Schalm SW. Treatment of chronic hepatitis B virus infection- Dutch national guidelines. Neth J Med 2008;66:292-306.
  • Nagasaki F, Niitsuma H, Ueno Y. The high incidence of the emergence of Entecavir-resistant mutants among patients infected with Lamuvidine-resistant hepatitis B virus. Tohoku J Exp Med 2007;213:181-186.
  • Dimou E, Papadimitropoulos V, Hadziyannis SJ. The role of Entecavir in the treatment of chronic hepatitis B. Therapeu- tics and Clinical Risk Management 2007;3:1077-1086.
  • Chang TT, Gish RG, Man RD. A comparison of Entecavir and Lamuvidine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354:1001-1010.
  • Lai CL, Shouval D, Lok AS. Entecavir versus lamuvidine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med.2006;354:1011-1020.
  • Tillmann HL. Antiviral therapy and resistance with hepatitis B virus infection. World J Gastroenterol 2007;13:125-140.
  • Sherman M, Yurdaydin C, Sollano. Entecavir for treatment of Lamuvidine- refractory, HBeAg-positive chronic hepatitis B. Gastroenterology 2006;130:2039-2049.
  • Yao GB, Ren H, Xu DZ, et al. Virological, serological and bio- chemical outcomes through 3 years of Entecavir treatment in nucleoside-naive Chinese chronic hepatitis B patients. J Viral Hepat 2010;17 Suppl 1:51-58.
  • Buti M, Morillas RM, Prieto M, et al. Efficacy and safety of Entecavir in clinical practice in treatment-naive Caucasian chronic hepatitis B patients. Eur J Gastroenterol Hepatol 2012;24:535-542.
  • Chen EQ, Wang TT, Bai L, et al. Quantitative hepatitis B sur- face antigen titres in Chinese chronic hepatitis B patients over 4 years of Entecavir treatment. Antivir Ther 2013;2.

Results of Entecavir treatment in patients with chronic hepatitis B

Yıl 2013, Cilt: 3 Sayı: 04, 176 - 180, 01.12.2013
https://doi.org/10.5799/ahinjs.02.2013.04.0104
https://izlik.org/JA36RJ45NY

Öz

Amaç: Bu çalışmada kronik hepatit B hastalarında 96 haftalık Entekavir (ETV) tedavi etkinliğinin ve güvenliğinin değerlendirilmesi amaçlandı.Yöntemler: Kronik Hepatit B tanısıyla 38 hasta çalışmaya alındı. Entekavir tedavisine başlama kriterleri: yükselmiş ALT düzeyleri, (>normalin iki katında fazla), HBe Ag pozitif hastalarda HBV DNA ≥5 log10 kopya/ml (≥20000 IU/ml), HBe Ag negatif hastalarda ≥4 log10 kopya/ml (≥ 2000 IU/ml) karaciğer hasarının histopatolojik olarak gösterilmesi (Knodell HAİ ≥4, fibrozis ≥1). Hastalar 12 haftada bir biyokimyasal ve virolojik testlerle takip edildi. Bulgular: Hastaların 24’ü (%63,2) erkekti. Yaş ortalaması 38,6 yıldı. Tüm hastaların 14’ünde (%36,8) HBe Ag pozitifti. Başlangıç ortalama ALT düzeyleri 106,7 IU/ml, HBV DNA düzeyleri 4,8 x 107 kopya/ml ve Knodell HAI skoru dokuz idi. HBe Ag pozitif hastaların 11’i (%78,6) naivdi. Hiçbirinde direnç mutasyonu yoktu. Biyokimyasal yanıt (BY) 48. ve 96. haftalarda %100, virolojik yanıt (VY) sırasıyla %57,1 ve %50 idi. Serolojik yanıt (SY) sırasıyla %35,7 ve %42,8 olarak saptandı. HBeAg negatif hastaların 15’i (%62,5) naivdi; iki hastada lamuvidin direnç mutasyonu saptandı. Kırksekizinci ve 96. haftalarda sırasıyla BY %95,8 ve %100, VY %83,3 saptandı.Sonuç: Çalışmamızda iki yıllık entakavir tedavisi sonucunda, özellikle HBe Ag negatif hastalarda tedaviye yüksek oranda yanıt sağlanmıştır

Kaynakça

  • World Health Organization. HepatitisB fact sheet WHO/204. Geneva: World Health Organization, October 2000. (Ac- cessed February 10, 2006, at http://www. who.int/mediacen- tre/factsheets/fs204/en.)
  • Lee WM. Hepatitis B virus infection. N Engl J Med 1997;337:1733-1745.
  • Liaw YF, Leung N, Kao JH et al. Asian-Pacific consensus statement on the management of chronic hepatitis B: a 2008 update. Hepatol Int 2008;2:263-283.
  • European Association for the Study of the Liver. EASL clini- cal practice guidelines: management of chronic hepatitis B. J Hepatol 2009;50:227–242.
  • Lok AS, McMahon BJ. Chronic hepatitis B: update 2009. Hep- atology 2009;50:661-662.
  • European Association For The Study Of The Liver. EASL Clini- cal Practice Guidelines: management of chronic hepatitis B. J Hepatol 2009;50:227-42.
  • Niu C, Murakami E, Furman PA. Clevudine is efficiently phos- phorylated to the active triphosphate form in primary human hepatocytes. Antivir Ther 2008;13:263-269.
  • Baraclude Package Insert. Wallingford, CT: Bristol-Myers Squibb.
  • http://packageinserts.bms.com/pi/pi_baraclude.pdf. Accessed December 4, 2010.
  • Seifer M, Hamatake RK, Colonno RJ, Standring DN. In vitro inhibition of hepadnavirus polymerases by the triphosphates of BMS-200475 and lobucavir. Antimicrob Agents Chemoth- er1998;42:3200–3208.
  • Chang TT, Lai CL, Kew Yoon S, et al. Entecavir treatment for up to 5 years in patients with hepatitis B e antigen-positive chronic hepatitis B. Hepatology 2010;51:422–430.
  • Tenney DJ, Rose RE, Baldick CJ, et al. Long-term monitoring shows hepatitis B virus resistance to Entecavir in nucleoside naive patients is rare through 5 years of therapy. Hepatology. 2009;49:1503–1514.
  • Buster EH, van Erpecum KJ , Schalm SW. Treatment of chronic hepatitis B virus infection- Dutch national guidelines. Neth J Med 2008;66:292-306.
  • Nagasaki F, Niitsuma H, Ueno Y. The high incidence of the emergence of Entecavir-resistant mutants among patients infected with Lamuvidine-resistant hepatitis B virus. Tohoku J Exp Med 2007;213:181-186.
  • Dimou E, Papadimitropoulos V, Hadziyannis SJ. The role of Entecavir in the treatment of chronic hepatitis B. Therapeu- tics and Clinical Risk Management 2007;3:1077-1086.
  • Chang TT, Gish RG, Man RD. A comparison of Entecavir and Lamuvidine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354:1001-1010.
  • Lai CL, Shouval D, Lok AS. Entecavir versus lamuvidine for patients with HBeAg-negative chronic hepatitis B. N Engl J Med.2006;354:1011-1020.
  • Tillmann HL. Antiviral therapy and resistance with hepatitis B virus infection. World J Gastroenterol 2007;13:125-140.
  • Sherman M, Yurdaydin C, Sollano. Entecavir for treatment of Lamuvidine- refractory, HBeAg-positive chronic hepatitis B. Gastroenterology 2006;130:2039-2049.
  • Yao GB, Ren H, Xu DZ, et al. Virological, serological and bio- chemical outcomes through 3 years of Entecavir treatment in nucleoside-naive Chinese chronic hepatitis B patients. J Viral Hepat 2010;17 Suppl 1:51-58.
  • Buti M, Morillas RM, Prieto M, et al. Efficacy and safety of Entecavir in clinical practice in treatment-naive Caucasian chronic hepatitis B patients. Eur J Gastroenterol Hepatol 2012;24:535-542.
  • Chen EQ, Wang TT, Bai L, et al. Quantitative hepatitis B sur- face antigen titres in Chinese chronic hepatitis B patients over 4 years of Entecavir treatment. Antivir Ther 2013;2.
Toplam 22 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Yazarlar

Şükran Köse Bu kişi benim

Melda Turken Bu kişi benim

Bengu Gireniz Tatar Bu kişi benim

Yayımlanma Tarihi 1 Aralık 2013
DOI https://doi.org/10.5799/ahinjs.02.2013.04.0104
IZ https://izlik.org/JA36RJ45NY
Yayımlandığı Sayı Yıl 2013 Cilt: 3 Sayı: 04

Kaynak Göster

APA Köse, Ş., Turken, M., & Tatar, B. G. (2013). Results of Entecavir treatment in patients with chronic hepatitis B. Journal of Microbiology and Infectious Diseases, 3(04), 176-180. https://doi.org/10.5799/ahinjs.02.2013.04.0104
AMA 1.Köse Ş, Turken M, Tatar BG. Results of Entecavir treatment in patients with chronic hepatitis B. Journal of Microbiology and Infectious Diseases. 2013;3(04):176-180. doi:10.5799/ahinjs.02.2013.04.0104
Chicago Köse, Şükran, Melda Turken, ve Bengu Gireniz Tatar. 2013. “Results of Entecavir treatment in patients with chronic hepatitis B”. Journal of Microbiology and Infectious Diseases 3 (04): 176-80. https://doi.org/10.5799/ahinjs.02.2013.04.0104.
EndNote Köse Ş, Turken M, Tatar BG (01 Aralık 2013) Results of Entecavir treatment in patients with chronic hepatitis B. Journal of Microbiology and Infectious Diseases 3 04 176–180.
IEEE [1]Ş. Köse, M. Turken, ve B. G. Tatar, “Results of Entecavir treatment in patients with chronic hepatitis B”, Journal of Microbiology and Infectious Diseases, c. 3, sy 04, ss. 176–180, Ara. 2013, doi: 10.5799/ahinjs.02.2013.04.0104.
ISNAD Köse, Şükran - Turken, Melda - Tatar, Bengu Gireniz. “Results of Entecavir treatment in patients with chronic hepatitis B”. Journal of Microbiology and Infectious Diseases 3/04 (01 Aralık 2013): 176-180. https://doi.org/10.5799/ahinjs.02.2013.04.0104.
JAMA 1.Köse Ş, Turken M, Tatar BG. Results of Entecavir treatment in patients with chronic hepatitis B. Journal of Microbiology and Infectious Diseases. 2013;3:176–180.
MLA Köse, Şükran, vd. “Results of Entecavir treatment in patients with chronic hepatitis B”. Journal of Microbiology and Infectious Diseases, c. 3, sy 04, Aralık 2013, ss. 176-80, doi:10.5799/ahinjs.02.2013.04.0104.
Vancouver 1.Şükran Köse, Melda Turken, Bengu Gireniz Tatar. Results of Entecavir treatment in patients with chronic hepatitis B. Journal of Microbiology and Infectious Diseases. 01 Aralık 2013;3(04):176-80. doi:10.5799/ahinjs.02.2013.04.0104