Servet KÖLGELİER, Nazlım Aktuğ DEMİR, Serap ÖZÇİMEN, Şua SÜMER

Evaluation of 48-week response of treatment-naive chronic hepatitis B patients to 0.5 mg/day entecavir

The hepatitis B virus (HBV) is an important healthcare problem. Chronic hepatitis B infection may present with a wide range of manifestations from inactive carrier state to cirrhosis and hepatocellular cancer. Therefore, treatment is very important in chronic hepatitis B. In this study, the treatment results of 199 chronic hepatitis B patients taking entecavir 0.5 mg/day for 48 weeks were evaluated. Materials and methods: This study retrospectively evaluated data of 199 treatment-naive chronic hepatitis B patients who were treated with entecavir. Results: Of the 199 treatment-naive chronic hepatitis B patients, 141 (70.9%) were males and 58 (29.1%) were females, and mean age of the whole group was 37.5 ± 12.1 years. HBeAg was positive in 91 (45.7%) and antiHBe was positive in 108 (54.3%) patients. Mean HBV DNA value was 666,449,365.5 ± 2,759,013,996.9 IU/mL, mean ALT value was 112.1 ± 95.7 U/L, and mean AST value was 95.3 ± 71.2 U/L. At week 24 of the treatment, HBV DNA levels were below 50 IU/mL in 56% of the HBeAg-positive and 76% of the HBeAg-negative patients. At week 48 of the treatment, HBV DNA levels were below 50 IU/mL in 79% of the HBeAg-positive and 87% of the HBeAg-negative patients. At week 24, ALT had normalized in 72% of the HBeAg-positive and 79% of the HBeAg-negative patients. At week 48, ALT had normalized in 89% of the HBeAg-positive and 88% of the HBeAg-negative patients. AntiHBe seroconversion was seen in 2 of 91 patients (2.2%), but the loss of HBsAg was never observed. Conclusion: The 48-week entecavir treatment at a dose of 0.5 mg/day was shown to be effective both for HBeAg-positive and negative patients.

Anahtar Kelimeler:

Key words: Chronic hepatitis B, entecavir, entecavir efficacy

Evaluation of 48-week response of treatment-naive chronic hepatitis B patients to 0.5 mg/day entecavir

Keywords:

Key words: Chronic hepatitis B, entecavir, entecavir efficacy,

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Ustaçelebi Ş, Ergünay K. Hepatit B virüsünün moleküler virolojisi. In: Tabak F, Balık İ, Tekeli E, editors. Viral Hepatit 200 İstanbul: Viral Hepatitle Savaşım Derneği; 2007. pp. 96–
Vyas GN, Yen TSB. Hepatitis B virus: Biology, pathogenesis, epidemiology, clinical description, and diagnosis. In: Specter S, editor. Viral Hepatitis. Diagnosis, Therapy and Prevention. New Jersey, USA: Humana Press; 1999. pp. 35.
Hoofnagle JH, Doo E, Liang TJ, Fleischer R, Lok AS. Management of hepatitis B: summary of a clinical research workshop. Hepatology 2007; 45: 1056–75.
Lok AS, McMahon BJ. AASLD practice guidelines. Chronic Hepatitis B: Update 2009. Hepatology 2009; 50: 661–2.
Lok AS, McMahon BJ. AASLD practice guidelines: Chronic hepatitis B. Hepatology 2007; 45: 507–539.
European Association for the Study of the Liver. EASL clinical practice guidelines: Management of chronic hepatitis B. J Hepat 2009; 50: 227–242.
Saltoğlu N. B tipi kronik hepatitin güncel tedavisi. In: Tabak F, Balık İ, Tekeli E, editors. Viral Hepatit 2005. İstanbul: Viral Hepatitle Savaşım Derneği; 2005. p. 214–32.
Nguyen MH, Keeffe EB. Chronic hepatitis B and hepatitis C in Asian Americans. Rev Gastroenterol Dis 2003; 3: 125–34.
Yamazhan T. Kronik hepatit B tedavisinde antiviral ile uzun vadeli sonuçlar. In: Tabak F, Balık İ, editors. Viral Hepatit 2009. İstanbul: Viral Hepatitle Savaşım Derneği; 2009. pp. 31–44.
Chang TT, Gish RG, de Man R, Gadano A, Sollano J, Chao YC, Lok AS, Han KH, Goodman Z, Zhu J et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006; 354: 1001–10.
Zheng MH, Shi KQ, Dai ZJ, Ye C, Chen YP. A 24-week, parallelgroup, open-label, randomized clinical trial comparing the early antiviral efficacy of telbivudine and entecavir in the treatment of hepatitis B e antigen-positive chronic hepatitis B virus infection in adult Chinese patients. Clin Ther 2010; 32: 649–58.
Song CJ, Min BY, Kim JW, Kim JY, Kim YM, Shin CM, Lee SH, Hwang JH, Jeong SH, Kim N et al. Pretreatment serum HBsAgto-HBV DNA ratio predicts a virologic response to entecavir in chronic hepatitis B. Korean J Hepat 2011; 17: 268–273.
Buti M, Morillas RM, Prieto M, Diago M, Perz J, Sola R, Bonet L, Palau A, Testillano M, Garcia-Samaniego J et al. Efficacy and safety of entecavir in clinical practice in treatment-naive Caucasian chronic hepatitis B patients. Eur J Gastroenterol Hepat 2012; 24: 535–42.
Chen EQ, Zhou TY, Liu L, Liu C, Lei M, Tang H. A comparison of treatment with adefovir and entecavir for chronic hepatitis B in China: The 2-year results of a prospective study. Hepat Mon 2011; 11: 27–31.
Kwon JH, Jang JW, Lee S, Lee J, Chung KW, Lee YS, Choi JY. Pretreatment HBeAg level and an early decrease in HBeAg level predict virologic response to entecavir treatment for HBeAg-positive chronic hepatitis B. J Viral Hepat 2012; 19: 41–
Gish RG, Lok AS, Chang TT, Man RA, Gadano A, Sollano J, Han KH, Chao YC, Lee SD, Harris M et al. Entecavir therapy for up to 96 weeks in patients with HBeAg-positive chronic hepatitis B. Gastroenterology 2007; 133: 1437–44.
Köklü S, Tuna Y, Gülşen MT, Demir M, Köksal AŞ, Koçkar MC, Aygün C, Çoban Ş, Özdil K, Ataseven H et al. Long-term efficacy and safety of lamivudine, entecavir and tenofovir for treatment of hepatitis B virus-related cirrhosis. Clin Gastroenterol Hepatol 2013; 11: 88–94.
Sims KA, Woodland AM. Entecavir: a new nucleoside analog for the treatment of chronic hepatitis B infection. Pharmacotherapy 2006; 26: 1745–57.