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Kronik hepatit C tedavisinde ikinci kuşak direk etkili oral antivirallerin gerçek yaşam verileri: Tek merkez ve heterojen hasta grubu

Yıl 2020, Cilt: 19 Sayı: 3, 123 - 128, 30.12.2020
https://doi.org/10.17941/agd.843318

Öz

Giriş ve Amaç: Kronik hepatit C enfeksiyonu karaciğer sirozu ve hepatoselüler karsinomun nedenleri arasındadır. Bu çalışmada primer olarak kronik hepatit C’li heterojen bir hasta grubunda güncel olarak kullanılan ikinci kuşak direk etkili oral antivirallerin tedavi etkinliği ve yan etki profillerinin araştırılması amaçlanmıştır. Gereç ve Yöntem: Retrospektif olan bu çalışmaya ikinci kuşak direk etkili oral antiviral tedavi alan 72 hasta dahil edilmiştir. Hastalara ait klinik ve laboratuvar verileri poliklinik takip dosyalarından elde edilmiştir. Bulgular: Hastaların yaş ortalaması 58±14 olup, 39’u (%54) kadın idi. Baskın genotip 1b idi (%74.6). Non-sirotik, kompanse siroz ve dekompanse siroz hastaların sayıları sırasıyla; 56 (%77.8), 14 (%19.4) ve 2 (%2.8) idi. On sekiz hasta (%25) tedavi deneyimli idi. Paritaprevir/ritonavir/ombitasvir + dasabuvir, ledipasvir/sofosbuvir, ledipasvir/sofosbuvir + ribavirin, sofosbuvir + ribavirin, glekaprevir + pibrentasvir ve paritaprevir/ritonavir/ombitasvir + ribavirin alan hasta sayıları sırasıyla; 38 (%52.8), 13 (%18.1), 7 (%9.7), 7 (%9.7), 6 (%8.3) ve 1 (%1.4) idi. Toplam 71 hasta tedaviyi tamamladı ve bunların 69’unda (%97.2) kalıcı viral yanıt elde edildi. Ayrıca başlangıç aspartat aminotransferaz, alanin amimotransferaz, gama glutamil transferaz ve alfa fetoprotein düzeylerinde tedavi ile birlikte anlamlı bir düşüş izlendi (p <0.05). Bilirübin düzeyleri ise tedavi esnasında anlamlı bir şekilde yükselmekle beraber (p <0.05), tedavinin sona ermesiyle birlikte düşüş göstermekteydi. Yan etki profilleri açısından, kullanılan tüm rejimlerde gözlenen yan etkiler hafif şiddette olup, tedaviyi kesecek vasıfta değildi. Sonuç: Ülkemizde kronik hepatit C infeksiyonunda güncel olarak kullanılan ikinci kuşak direk etkili oral antiviraller yüksek etkinlik ve düşük yan etki profiline sahiptirler.

Kaynakça

  • 1. Pardee M. Diagnosis and management of Hepatitis B and C. Nurs Clin North Am 2019;54:277-84.
  • 2. Hyun Kim B, Ray Kim W. Epidemiology of hepatitis B virus infection in the United States. Clin Liver Dis (Hoboken) 2018;12:1-4.
  • 3. World Health Organization. Global hepatitis report 2017. Geneva. Licence: CC BY-NC-SA3.0IGO. Available at: http://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/.Accessed October 23, 2018.
  • 4. Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol 201461(1 Suppl):S45-57.
  • 5. Tozun N, Ozdogan O, Cakaloglu Y, et al. Seroprevalence of hepatitis B and C virus infections and risk factors in Turkey: a fieldwork TURHEP study. Clin Microbiol Infect 2015;21:1020-6.
  • 6. Altuğlu I, Sertöz R, Aksoy A, et al. Possible transmission risks and genotype distribution of hepatitis C virus infection in Western Turkey. Turk J Gastroenterol 2013;24:349-55.
  • 7. Gürbüz Y, Tülek NE, Tütüncü EE, et al. Evaluation of dual therapy in real life setting in treatment-naïve Turkish patients with HCV infection: A multicenter, retrospective study. Balkan Med J 2016;33:18-26.
  • 8. Kırdar S, Yaşa MH, Aydın N, ve ark. The distribution of hepatitis C virus genotypes in patients with chronic hepatitis C infection. Meandros Med Dent J 2015;16:108-13.
  • 9. Tada T, Kumada T, Toyoda H, et al. Viral eradication reduces all-cause mortality in patients with chronic hepatitis C virus infection: a propensity score analysis. Liver Int 2016;36:817-26.
  • 10. Aygen B, Yıldız O, Akhan S, et al. Retreatment of chronic hepatitis C infection with telaprevir: Preliminary results in Turkey. Balkan Med J 2015;32:266-72.
  • 11. Aygen B, Yıldız O, Gökahmetoğlu S, et al. Telaprevir combination therapy in patients infected with hepatitis C virus genotype 4. J Immunol Clin Microbiol 2016;2:57-61.
  • 12. Ahmed H, Abushouk AI, Menshawya A, et al. Safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir with or without ribavirin for treatment of hepatitis C virus genotype 1: A systematic review and meta-analysis. Clin Drug Investig 2017;37:1009-23.
  • 13. Flisiak R, Łucejko M, Mazur W, et al. Effectiveness and safety of ledipasvir/sofosbuvir±ribavirin in the treatment of HCV infection: The real-world HARVEST study. Adv Med Sci 2017;62:387-92.
  • 14. Aygen B, Demirtürk N, Yıldız O, et al. Real-world efficacy, safety, and clinical outcomes of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin combination therapy in patients with hepatitis C virus genotype 1 or 4 infection: The Turkey experience experience. Turk J Gastroenterol 2020;31:305-17.
  • 15. Cakmak E. The real-world efficacy and safety of direct-acting oral antiviral treatment in chronic Hepatitis C Genotype 1 patients in Turkey. Cumhuriyet Medical Journal 2018;40:768-76.
  • 16. Nozaki A, Atsukawa M, Kondo C, et al. The effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients with refractory factors in the real world: a comprehensive analysis of a prospective multicenter study. Hepatol Int 2020;14:225-38.
  • 17. Hsu SJ, Chiu MC, Fang YJ, et al. Real-world effectiveness and safety of glecaprevir/pibrentasvir in Asian patients with chronic hepatitis C. J Formos Med Assoc 2019;118:1187-92.
  • 18. Liu CH, Liu CJ, Hung CC, et al. Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real-world effectiveness and safety in Taiwan. Liver Int 2020;40:758-68.
  • 19. Çakır ÖÖ. The Real-World Outcomes of Virologic Response of Treatment with Direct Acting Antiviral Agents of Chronic Hepatitis C: Single Center Study. Sakarya Tıp Dergisi 2019;9:455-63.
  • 20. Perelló C, Carrión JA, Ruiz-Antorán B, et al. Effectiveness and safety of ombitasvir, paritaprevir, ritonavir±dasabuvir±ribavirin: An early access programme for Spanish patients with genotype 1/4 chronic hepatitis C virus infection. J Viral Hepat 2017;24:226-37.
  • 21. Weil C, Mehta D, Koren G, et al. Sustained virological response to ombitasvir/paritaprevir/ritonavir and dasabuvir treatment for hepatitis C: Real-world data from a large healthcare provider. J Viral Hepat 2018;25:144-51.
  • 22. Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Comparative effectiveness of ledipasvir/sofosbuvir±ribavirin vs. ombitasvir/paritaprevir/ritonavir/dasabuvir±ribavirin in 6961 genotype 1 patients treated in routine medical practice. Aliment Pharmacol Ther 2016;44:400-10.

Real life data of second generation direct acting oral antivirals in the treatment of chronic hepatitis C: A single center and heterogeneous patient group

Yıl 2020, Cilt: 19 Sayı: 3, 123 - 128, 30.12.2020
https://doi.org/10.17941/agd.843318

Öz

Background and Aims: Chronic hepatitis C infection is one of the causes of liver cirrhosis and hepatocellular carcinoma. The purpose of this study was primarily to examine the treatment efficacy and side effect profiles of second-generation direct-acting oral antivirals currently used in a heterogeneous patient group with chronic hepatitis C. Materials and Methods: This retrospective study included 72 patients who received second-generation direct-acting oral antiviral therapy. Clinical and laboratory data of the patients were collected from outpatient follow-up files. Results: The mean age of the patients was 58±14 years, of which 39 (54%) were women. The predominant genotype was 1b (74.6%). Patients with no cirrhosis, compensated cirrhosis, and decompensated cirrhosis were 56 (77.8%), 14 (19.4%), and 2 (2.8%), respectively. Eighteen patients (25%) were treatment experienced. On the other hand, patients treated with paritaprevir/ritonavir/ombitasvir + dasabuvir, ledipasvir/sofosbuvir, ledipasvir/sofosbuvir + ribavirin, sofosbuvir + ribavirin, glecaprevir + pibrentasvir, and paritaprevir/ritonavir/ombitasvir + ribavirin were 38 (52.8%), 13 (18.1%), 7 (9.7%), 7 (9.7%), 6 (8.3%), and 1 (1.4%), respectively. A total of 71 patients completed the treatment and 69 of them (97.2%) was obtained sustained viral response. In addition, a significant decrease was observed in the initial aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, and alpha fetoprotein levels during treatment (p <0.05). Although bilirubin levels increased significantly during treatment (p <0.05), they decreased at the end of treatment. In terms of the side effect profile, side effects observed in all regimes were mild and not severe enough to discontinue treatment. Conclusion: Therefore, the second-generation direct-acting oral antivirals widely used in chronic hepatitis C infection in our country have high efficacy and low side effect profile.

Kaynakça

  • 1. Pardee M. Diagnosis and management of Hepatitis B and C. Nurs Clin North Am 2019;54:277-84.
  • 2. Hyun Kim B, Ray Kim W. Epidemiology of hepatitis B virus infection in the United States. Clin Liver Dis (Hoboken) 2018;12:1-4.
  • 3. World Health Organization. Global hepatitis report 2017. Geneva. Licence: CC BY-NC-SA3.0IGO. Available at: http://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/.Accessed October 23, 2018.
  • 4. Gower E, Estes C, Blach S, Razavi-Shearer K, Razavi H. Global epidemiology and genotype distribution of the hepatitis C virus infection. J Hepatol 201461(1 Suppl):S45-57.
  • 5. Tozun N, Ozdogan O, Cakaloglu Y, et al. Seroprevalence of hepatitis B and C virus infections and risk factors in Turkey: a fieldwork TURHEP study. Clin Microbiol Infect 2015;21:1020-6.
  • 6. Altuğlu I, Sertöz R, Aksoy A, et al. Possible transmission risks and genotype distribution of hepatitis C virus infection in Western Turkey. Turk J Gastroenterol 2013;24:349-55.
  • 7. Gürbüz Y, Tülek NE, Tütüncü EE, et al. Evaluation of dual therapy in real life setting in treatment-naïve Turkish patients with HCV infection: A multicenter, retrospective study. Balkan Med J 2016;33:18-26.
  • 8. Kırdar S, Yaşa MH, Aydın N, ve ark. The distribution of hepatitis C virus genotypes in patients with chronic hepatitis C infection. Meandros Med Dent J 2015;16:108-13.
  • 9. Tada T, Kumada T, Toyoda H, et al. Viral eradication reduces all-cause mortality in patients with chronic hepatitis C virus infection: a propensity score analysis. Liver Int 2016;36:817-26.
  • 10. Aygen B, Yıldız O, Akhan S, et al. Retreatment of chronic hepatitis C infection with telaprevir: Preliminary results in Turkey. Balkan Med J 2015;32:266-72.
  • 11. Aygen B, Yıldız O, Gökahmetoğlu S, et al. Telaprevir combination therapy in patients infected with hepatitis C virus genotype 4. J Immunol Clin Microbiol 2016;2:57-61.
  • 12. Ahmed H, Abushouk AI, Menshawya A, et al. Safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir with or without ribavirin for treatment of hepatitis C virus genotype 1: A systematic review and meta-analysis. Clin Drug Investig 2017;37:1009-23.
  • 13. Flisiak R, Łucejko M, Mazur W, et al. Effectiveness and safety of ledipasvir/sofosbuvir±ribavirin in the treatment of HCV infection: The real-world HARVEST study. Adv Med Sci 2017;62:387-92.
  • 14. Aygen B, Demirtürk N, Yıldız O, et al. Real-world efficacy, safety, and clinical outcomes of ombitasvir/paritaprevir/ritonavir±dasabuvir±ribavirin combination therapy in patients with hepatitis C virus genotype 1 or 4 infection: The Turkey experience experience. Turk J Gastroenterol 2020;31:305-17.
  • 15. Cakmak E. The real-world efficacy and safety of direct-acting oral antiviral treatment in chronic Hepatitis C Genotype 1 patients in Turkey. Cumhuriyet Medical Journal 2018;40:768-76.
  • 16. Nozaki A, Atsukawa M, Kondo C, et al. The effectiveness and safety of glecaprevir/pibrentasvir in chronic hepatitis C patients with refractory factors in the real world: a comprehensive analysis of a prospective multicenter study. Hepatol Int 2020;14:225-38.
  • 17. Hsu SJ, Chiu MC, Fang YJ, et al. Real-world effectiveness and safety of glecaprevir/pibrentasvir in Asian patients with chronic hepatitis C. J Formos Med Assoc 2019;118:1187-92.
  • 18. Liu CH, Liu CJ, Hung CC, et al. Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real-world effectiveness and safety in Taiwan. Liver Int 2020;40:758-68.
  • 19. Çakır ÖÖ. The Real-World Outcomes of Virologic Response of Treatment with Direct Acting Antiviral Agents of Chronic Hepatitis C: Single Center Study. Sakarya Tıp Dergisi 2019;9:455-63.
  • 20. Perelló C, Carrión JA, Ruiz-Antorán B, et al. Effectiveness and safety of ombitasvir, paritaprevir, ritonavir±dasabuvir±ribavirin: An early access programme for Spanish patients with genotype 1/4 chronic hepatitis C virus infection. J Viral Hepat 2017;24:226-37.
  • 21. Weil C, Mehta D, Koren G, et al. Sustained virological response to ombitasvir/paritaprevir/ritonavir and dasabuvir treatment for hepatitis C: Real-world data from a large healthcare provider. J Viral Hepat 2018;25:144-51.
  • 22. Backus LI, Belperio PS, Shahoumian TA, Loomis TP, Mole LA. Comparative effectiveness of ledipasvir/sofosbuvir±ribavirin vs. ombitasvir/paritaprevir/ritonavir/dasabuvir±ribavirin in 6961 genotype 1 patients treated in routine medical practice. Aliment Pharmacol Ther 2016;44:400-10.
Toplam 22 adet kaynakça vardır.

Ayrıntılar

Birincil Dil Türkçe
Konular Sağlık Kurumları Yönetimi
Bölüm Makaleler
Yazarlar

Mustafa Akar Bu kişi benim 0000-0002-5589-2849

Tevfik Solakoğlu Bu kişi benim 0000-0002-5735-4200

Yayımlanma Tarihi 30 Aralık 2020
Yayımlandığı Sayı Yıl 2020 Cilt: 19 Sayı: 3

Kaynak Göster

APA Akar, M., & Solakoğlu, T. (2020). Kronik hepatit C tedavisinde ikinci kuşak direk etkili oral antivirallerin gerçek yaşam verileri: Tek merkez ve heterojen hasta grubu. Akademik Gastroenteroloji Dergisi, 19(3), 123-128. https://doi.org/10.17941/agd.843318

test-5