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Evaluation of potent antiviral therapy in chronic hepatitis B patients

Year 2020, Volume: 13 Issue: 2, 189 - 199, 26.08.2020
https://doi.org/10.26559/mersinsbd.558948

Abstract

References

  • 1. Papatheodoridis, G., Buti, M., Cornberg, M., Janssen, H., Mutimer, D., Pol, S., & Raimondo, G. EASL clinical practice guidelines: management of chronic hepatitis B virus infection (2012); Journal of hepatology, 57(1), 167-185.
  • 2. European Association for the study of the liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370-398.
  • 3. Gordon SC, Krastev Z, Horban A,et al. Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load. Hepatology 2013;58:505-513.
  • 4. Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1981;1:431-435.
  • 5. Chang TT, Gish RG, de Man R, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354(10):1001-1010.
  • 6. Woo G, Tomlinson G, Nishikawa Y.et al. Tenofovir and entecavir are the most effective aniviral agents for chronic hepatitis B: A systematic rewiev and Bayesian meta-analyses. Gastroenterology 2010:139(4);1218-1229.
  • 7. 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
  • 8. Güzelbulut F, Ovünç AO, Oetinkaya ZA, et al. Comparison of the efficacy of entecavir and tenofovir in chronic hepatitis B. Hepatogastroenterology. 2012;59(114):477-480. doi:10.5754/hge11426
  • 9. Doğan Ü.B, Kara B, Gümürdülü Y, et al. Comparison of the efficacy of tenofovir and entecavir for the treatment of nucleos(t)ide-naive patients with chronic hepatitis B. Turk J Gastroenterol 2012;23(3):247-252.
  • 10. Lampertico, Pietro, et al. Entecavir monotherapy in 418 nuc-naive patients with chronic hepatitis B from field practice: high efficacy and favorable safety profile over 3 years of treatment. In: Annual meeting of the American association for the study of liver diseases: the liver meeting. Wiley, 2011. p. 1043A-1043A.
  • 11. Ridruejo E, Adrovar R, Cocozella D et al. Effectiveness of entecavir in chronic hepatitis B NUC-naive patients in routine clinical practice. Int J Clin Pract 2011;65:866–870.
  • 12. Zoutendijk R, Reijnders JG, Brown A, et al. Entecavir treatment for chronic hepatitis B: adaptation is not needed for the majority of naïve patients with a partial virological response [published correction appears in Hepatology. 2011 Dec;54(6):2280]. Hepatology. 2011;54(2):443-451.
  • 13. 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. 14. Lampertico P, Soffredini R, Facchetti F, et al. Tenofovir monotherapy suppressed viral suppression in most field practice, treatmentnaive patients with chronic hepatitis B followed for 3 years in a multicenter European study. Hepatology 2012; 56 Suppl 1: Abstract 401
  • 15. Marcellin P, Heathcote E,Buti M,et al. Tenofovir disoproxilfumarate versus Adefovir dipivoxil chronic hepatitis B. N Eng J Med 2008;359:2442-55.
  • 16. Heathcote EJ, Marcellin P, Buti M.et al. Three-year efficacy and safety of TDF disoproxil fumarate treatment for chronic hepatitis B. Gastroenterology 2011;140:132-143. 17. Heathcote, E. J., et al. "Long term (4 year) efficacy and safety of tenofovir disoproxil fumarate (TDF) treatment in HBeAg-positive patients (HBeAg+) with chronic hepatitis B (study 103): preliminary analysis." Hepatology 52.4 (2010): 556A.
  • 18. Carey, Ivana, et al. P47 De-novo antiviral therapy with nucleos (t) ide analogues in ‘real-life’patients with chronic hepatitis B infection: comparison of virological responses between lamivudine+ adefovir vs entecavir vs tenofovir therapy. Gut, 2011, 60.Suppl 2: A22-A23.
  • 19. Ceylan B, Yardimci C, Fincanci M, Eren G, Tozalgan U, Muderrisoglu C, Akkoyunlu Y. Comparison of tenofovir and entecavir in patients with chronic HBV infection. Eur Rev Med Pharmacol Sci. 2013;17(18):2467-2473.
  • 20. Kayaaslan B, Akinci E, Ari A, Tufan ZK, Alpat SN, Gunal O, Tosun S, Guner R, Tabak F. A long-term multicenter study: Entecavir versus Tenofovir in treatment of nucleos(t)ide analogue-naive chronic hepatitis B patients. Clin Res Hepatol Gastroenterol. 2018;42(1):40-47.
  • 21. Miquel M, Núñez Ó, Trapero-Marugán M, et al. Efficacy and safety of entecavir and/or tenofovir in hepatitis B compensated and decompensated cirrhotic patients in clinical practice. Ann Hepatol 2013;12:205-212.
  • 22. Ecin, Seval Müzeyyen, Nursel Çalık Başaran, and Murat Aladağ. "Evaluation of the Effectiveness of Tenofovir in Chronic Hepatitis B Patients." Acta Medica 2020; 51.1, 9-14.
  • 23. Cai, Dachuan, et al. "Comparison of the long-term efficacy of tenofovir and entecavir in nucleos (t) ide analogue-naive HBeAg-positive patients with chronic hepatitis B: A large, multicentre, randomized controlled trials." Medicine 2019;98.1
  • 24. Seto WK, Lai CL, Fung J, Yuen JC, Wong DK, Yuen MF. Outcome of4-year treatment of entecavir for treatment-naıve chronic hepatitis B.J Hepatol 2011;54: S301
  • 25. Song, Jeong Eun; LEE, Chang Hyeong; KIM, Byung Seok. Efficacy of long-term tenofovir disoproxil fumarate therapy in chronic hepatitis B patients with partial virologic response in real practice. The Korean journal of internal medicine, 2019, 34.4: 802.
  • 26. Marcellin, Patrick, et al. "Ten year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection." Liver International 2019;39.10 , 1868-1875.
  • 27. Karaagac, Mustafa, et al. Assessment of Efficacy, Reliability, Side Effects and Patient Compliance of Entecavir in Turkish Patients with Nukleos (t) ide Analogues Naive Chronic Hepatitis B." EJMI 2019;3(4):322–326.

Kronik hepatit B hastalarında potent antiviral tedavinin değerlendirilmesi

Year 2020, Volume: 13 Issue: 2, 189 - 199, 26.08.2020
https://doi.org/10.26559/mersinsbd.558948

Abstract

Amaç: Kronik Hepatit B (KHB) enfeksiyonunda tedavinin amacı; kalıcı viral süpresyon, biyokimyasal ve histolojik düzelmenin sağlanması, siroz ve/veya hepatosellüler karsinom gibi uzun dönem komplikasyonlarını önlemektir. Güncel tedavide Tenofovir disoproksil, Tenofovir alafenamid ve Entekavir en potent ilaçlardır. Bu ilaçların uzun süre etkinliğine yönelik gerçek yaşam verilerinin sunulduğu çalışmalar sınırlıdır. Bu çalışmada uzun süre Tenofovir disoproksil ve Entekavir tedavisi alan hastaların geriye yönelik etkinliğinin değerlendirilmesi planlandı. Yöntem: Çalışmada 2007-2015 yılları arasında KHB tanısı almış olan, oral antiviral tedavi almamış olan ve Entekavir (0.5 mg/gün) veya Tenofovir disoproksil (245 mg/gün) alan hastaların dosyaları retrospektif olarak değerlendirildi. Hastalarda en az altı ay tedavi almaları ölçüt olarak alındı. Dekompanze sirozu, malignite ve diğer altta yatan hastalığı olanlar değerlendirilme dışı bırakıldı. Tedavi yanıtlarının değerlendirilmesinde; HBV DNA düzeyi, ALT değerleri, serokonversiyon durumu analiz edildi. Bulgular: Tek merkezde takip edilen, KHB tanılı daha önce antiviral tedavi almamış olan 111 hasta TDF (n=54, %57 erkek, yaş ortalaması 44±14 y, %27 HBeAg pozitif, takip süresi median 38 ay) ve ETV (n=57, %51 erkek, ortalama yaş 46±13 y,% 18 HBeAg pozitif, takip süresi median 48 ay) olmak üzere iki farklı grup tedavi rejimi almıştır. TDF grubunda başlangıçtaki HBV DNA değeri (8.0±1,1 kopya/mL) ETV grubundan (7.7±1.1 kopya/mL) daha büyük ve anlamlıydı (p=0.02). İki tedavi grubunda tedavinin altıncı ve 12. aylarında HBV DNA negatifliği karşılaştırıldığında, ETV grubunda istatistiksel olarak anlamlı HBV DNA negatifliğinin elde edildiği görüldü (p<0.05). Tedavinin 36. ayından sonra TDF grubunda bütün hastalarda HBV DNA negatifleşirken, ETV grubunda %90 hastada HBV DNA negatif idi. Gruplardaki HBeAg pozitif hastalardaki HBV DNA negatifliği oranı anlamlı olmamasına rağmen HBeAg negatif, ETV alan hastalarda DNA negatifliği anlamlı olarak yüksekti. Tedavinin altıncı yılında, TDF grubunda HBeAg serokonversiyon oranı daha yüksekti. ETV grubunda hastaların birinde (%1.7) HBsAg kaybı ve antiHBs pozitifleşmesi gerçekleşti. TDF grubunda ise HBsAg kaybı ve antiHBs pozitifleşmesi görülmedi. Sonuç: KHB tedavisinde, ETV ve TDF ilaçlarının uzun süre kullanımı ile benzer klinik ve laboratuar sonuçları alındığı görülmektedir. Daha kesin sonuçlara ulaşabilmek için fazla sayıda hasta ile karşılaştırılmalı, prospektif klinik çalışmalara ihtiyaç olduğu kanaatindeyiz.

References

  • 1. Papatheodoridis, G., Buti, M., Cornberg, M., Janssen, H., Mutimer, D., Pol, S., & Raimondo, G. EASL clinical practice guidelines: management of chronic hepatitis B virus infection (2012); Journal of hepatology, 57(1), 167-185.
  • 2. European Association for the study of the liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol. 2017;67(2):370-398.
  • 3. Gordon SC, Krastev Z, Horban A,et al. Efficacy of tenofovir disoproxil fumarate at 240 weeks in patients with chronic hepatitis B with high baseline viral load. Hepatology 2013;58:505-513.
  • 4. Knodell RG, Ishak KG, Black WC, Chen TS, Craig R, Kaplowitz N, et al. Formulation and application of a numerical scoring system for assessing histological activity in asymptomatic chronic active hepatitis. Hepatology 1981;1:431-435.
  • 5. Chang TT, Gish RG, de Man R, et al. A comparison of entecavir and lamivudine for HBeAg-positive chronic hepatitis B. N Engl J Med 2006;354(10):1001-1010.
  • 6. Woo G, Tomlinson G, Nishikawa Y.et al. Tenofovir and entecavir are the most effective aniviral agents for chronic hepatitis B: A systematic rewiev and Bayesian meta-analyses. Gastroenterology 2010:139(4);1218-1229.
  • 7. 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
  • 8. Güzelbulut F, Ovünç AO, Oetinkaya ZA, et al. Comparison of the efficacy of entecavir and tenofovir in chronic hepatitis B. Hepatogastroenterology. 2012;59(114):477-480. doi:10.5754/hge11426
  • 9. Doğan Ü.B, Kara B, Gümürdülü Y, et al. Comparison of the efficacy of tenofovir and entecavir for the treatment of nucleos(t)ide-naive patients with chronic hepatitis B. Turk J Gastroenterol 2012;23(3):247-252.
  • 10. Lampertico, Pietro, et al. Entecavir monotherapy in 418 nuc-naive patients with chronic hepatitis B from field practice: high efficacy and favorable safety profile over 3 years of treatment. In: Annual meeting of the American association for the study of liver diseases: the liver meeting. Wiley, 2011. p. 1043A-1043A.
  • 11. Ridruejo E, Adrovar R, Cocozella D et al. Effectiveness of entecavir in chronic hepatitis B NUC-naive patients in routine clinical practice. Int J Clin Pract 2011;65:866–870.
  • 12. Zoutendijk R, Reijnders JG, Brown A, et al. Entecavir treatment for chronic hepatitis B: adaptation is not needed for the majority of naïve patients with a partial virological response [published correction appears in Hepatology. 2011 Dec;54(6):2280]. Hepatology. 2011;54(2):443-451.
  • 13. 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. 14. Lampertico P, Soffredini R, Facchetti F, et al. Tenofovir monotherapy suppressed viral suppression in most field practice, treatmentnaive patients with chronic hepatitis B followed for 3 years in a multicenter European study. Hepatology 2012; 56 Suppl 1: Abstract 401
  • 15. Marcellin P, Heathcote E,Buti M,et al. Tenofovir disoproxilfumarate versus Adefovir dipivoxil chronic hepatitis B. N Eng J Med 2008;359:2442-55.
  • 16. Heathcote EJ, Marcellin P, Buti M.et al. Three-year efficacy and safety of TDF disoproxil fumarate treatment for chronic hepatitis B. Gastroenterology 2011;140:132-143. 17. Heathcote, E. J., et al. "Long term (4 year) efficacy and safety of tenofovir disoproxil fumarate (TDF) treatment in HBeAg-positive patients (HBeAg+) with chronic hepatitis B (study 103): preliminary analysis." Hepatology 52.4 (2010): 556A.
  • 18. Carey, Ivana, et al. P47 De-novo antiviral therapy with nucleos (t) ide analogues in ‘real-life’patients with chronic hepatitis B infection: comparison of virological responses between lamivudine+ adefovir vs entecavir vs tenofovir therapy. Gut, 2011, 60.Suppl 2: A22-A23.
  • 19. Ceylan B, Yardimci C, Fincanci M, Eren G, Tozalgan U, Muderrisoglu C, Akkoyunlu Y. Comparison of tenofovir and entecavir in patients with chronic HBV infection. Eur Rev Med Pharmacol Sci. 2013;17(18):2467-2473.
  • 20. Kayaaslan B, Akinci E, Ari A, Tufan ZK, Alpat SN, Gunal O, Tosun S, Guner R, Tabak F. A long-term multicenter study: Entecavir versus Tenofovir in treatment of nucleos(t)ide analogue-naive chronic hepatitis B patients. Clin Res Hepatol Gastroenterol. 2018;42(1):40-47.
  • 21. Miquel M, Núñez Ó, Trapero-Marugán M, et al. Efficacy and safety of entecavir and/or tenofovir in hepatitis B compensated and decompensated cirrhotic patients in clinical practice. Ann Hepatol 2013;12:205-212.
  • 22. Ecin, Seval Müzeyyen, Nursel Çalık Başaran, and Murat Aladağ. "Evaluation of the Effectiveness of Tenofovir in Chronic Hepatitis B Patients." Acta Medica 2020; 51.1, 9-14.
  • 23. Cai, Dachuan, et al. "Comparison of the long-term efficacy of tenofovir and entecavir in nucleos (t) ide analogue-naive HBeAg-positive patients with chronic hepatitis B: A large, multicentre, randomized controlled trials." Medicine 2019;98.1
  • 24. Seto WK, Lai CL, Fung J, Yuen JC, Wong DK, Yuen MF. Outcome of4-year treatment of entecavir for treatment-naıve chronic hepatitis B.J Hepatol 2011;54: S301
  • 25. Song, Jeong Eun; LEE, Chang Hyeong; KIM, Byung Seok. Efficacy of long-term tenofovir disoproxil fumarate therapy in chronic hepatitis B patients with partial virologic response in real practice. The Korean journal of internal medicine, 2019, 34.4: 802.
  • 26. Marcellin, Patrick, et al. "Ten year efficacy and safety of tenofovir disoproxil fumarate treatment for chronic hepatitis B virus infection." Liver International 2019;39.10 , 1868-1875.
  • 27. Karaagac, Mustafa, et al. Assessment of Efficacy, Reliability, Side Effects and Patient Compliance of Entecavir in Turkish Patients with Nukleos (t) ide Analogues Naive Chronic Hepatitis B." EJMI 2019;3(4):322–326.
There are 25 citations in total.

Details

Primary Language Turkish
Journal Section Articles
Authors

Zehra Beştepe Dursun 0000-0002-6736-0380

İlhami Çelik 0000-0002-2604-3776

Publication Date August 26, 2020
Submission Date April 29, 2019
Acceptance Date May 16, 2020
Published in Issue Year 2020 Volume: 13 Issue: 2

Cite

APA Beştepe Dursun, Z., & Çelik, İ. (2020). Kronik hepatit B hastalarında potent antiviral tedavinin değerlendirilmesi. Mersin Üniversitesi Sağlık Bilimleri Dergisi, 13(2), 189-199. https://doi.org/10.26559/mersinsbd.558948
AMA Beştepe Dursun Z, Çelik İ. Kronik hepatit B hastalarında potent antiviral tedavinin değerlendirilmesi. Mersin Univ Saglık Bilim derg. August 2020;13(2):189-199. doi:10.26559/mersinsbd.558948
Chicago Beştepe Dursun, Zehra, and İlhami Çelik. “Kronik Hepatit B hastalarında Potent Antiviral Tedavinin değerlendirilmesi”. Mersin Üniversitesi Sağlık Bilimleri Dergisi 13, no. 2 (August 2020): 189-99. https://doi.org/10.26559/mersinsbd.558948.
EndNote Beştepe Dursun Z, Çelik İ (August 1, 2020) Kronik hepatit B hastalarında potent antiviral tedavinin değerlendirilmesi. Mersin Üniversitesi Sağlık Bilimleri Dergisi 13 2 189–199.
IEEE Z. Beştepe Dursun and İ. Çelik, “Kronik hepatit B hastalarında potent antiviral tedavinin değerlendirilmesi”, Mersin Univ Saglık Bilim derg, vol. 13, no. 2, pp. 189–199, 2020, doi: 10.26559/mersinsbd.558948.
ISNAD Beştepe Dursun, Zehra - Çelik, İlhami. “Kronik Hepatit B hastalarında Potent Antiviral Tedavinin değerlendirilmesi”. Mersin Üniversitesi Sağlık Bilimleri Dergisi 13/2 (August 2020), 189-199. https://doi.org/10.26559/mersinsbd.558948.
JAMA Beştepe Dursun Z, Çelik İ. Kronik hepatit B hastalarında potent antiviral tedavinin değerlendirilmesi. Mersin Univ Saglık Bilim derg. 2020;13:189–199.
MLA Beştepe Dursun, Zehra and İlhami Çelik. “Kronik Hepatit B hastalarında Potent Antiviral Tedavinin değerlendirilmesi”. Mersin Üniversitesi Sağlık Bilimleri Dergisi, vol. 13, no. 2, 2020, pp. 189-9, doi:10.26559/mersinsbd.558948.
Vancouver Beştepe Dursun Z, Çelik İ. Kronik hepatit B hastalarında potent antiviral tedavinin değerlendirilmesi. Mersin Univ Saglık Bilim derg. 2020;13(2):189-9.

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