Bülent Değertekin1, Mehmet Demir2, Ulus S Akarca3, Haluk Tarık Kani4, Enver Üçbilek5, Emre Yıldırım6, Fatih Güzelbulut7, Ayhan Balkan6, Sezgin Vatansever8, Nilay Danış3, Melek Demircan9, Aliye Soylu10, Serkan Yaras5, Aysun Kartal11, Ayşe Kefeli12, Feyza Gündüz4, Kendal Yalçın13, Elife Erarslan14, Murat Aladağ15, Murat Harputluoğlu15, Ayşegül Özakyol9, Tuncer Temel9, Mesut Akarsu16, Hale Sümer17, Mete Akın18, Bülent Albayrak18, İlker Sen19, Hüseyin Alkım19, Ahmet Uyanıkoğlu20, Kader Irak21, Sinem Öztaşkın22, Çağrı Burak Uğurlu22, Şevkican Güneş22, Selim Gürel23, Kenan Nuriyev22, İsmail İnci22, Sabite Kaçar17, Dinç Dinçer18, Levent Doğanay24, Hüseyin Savaş Göktürk25, Ali Mert26, Arif Mansur Coşar27, Hakan Dursun28, Roni Atalay17, Sabiye Akbulut29, Yasemin Balkan30, Hayrettin Koklu31, Halis Şimşek31, Osman Özdoğan5, Mehmet Çoban32. 1. Division of Gastroenterology and Hepatology, Acibadem Mehmet Ali Aydinlar University School of Medicine, İstanbul, Turkey. 2. Division of Gastroenterology Mustafa Kemal University School of Medicine, Hatay, Turkey. 3. Division of Gastroenterology and Hepatology, Ege University School of Medicine, İzmir, Turkey. 4. Division of Gastroenterology and Hepatology, Marmara University School of Medicine, İstanbul, Turkey. 5. Division of Gastroenterology, Mersin University School of Medicine, Mersin, Turkey. 6. Division of Gastroenterology, Gaziantep University School of Medicine, Gaziantep, Turkey. 7. Division of Gastroenterology, Haydarpasa Numune Training and Research Hospital, İstan-bul, Turkey. 8. Division of Gastroenterology, Kâtip Celebi University, İzmir, Turkey. 9. Division of Gastroenterology, Eskisehir Osmangazi University School of Medicine, Eskişehir, Turkey. 10. Division of Gastroenterology, Health Sciences University Bakırkoy Hospital, İstanbul, Turkey. 11. Division of Gastroenterology and Hepatology, Ankara University School of Medicine, Ankara, Turkey. 12. Division of Gastroenterology, Tokat Gaziosmanpasa University School of Medicine, Tokat, Turkey. 13. Division of Gastroenterology and Hepatology, Dicle University School of Medicine, Diyarbakır, Turkey. 14. Division of Gastroenterology, Dışkapı Trainining and Research Hospital, Ankara, Turkey. 15. Division of Gastroenterology and Hepatology, İnonu University School of Medicine, Malatya, Turkey. 16. Division of Gastroenterology and Hepatology, Dokuz Eylül University School of Medicine, İzmir, Turkey. 17. Division of Gastroenterology, Ankara City Hospital, Ankara, Turkey. 18. Division of Gastroenterology, Akdeniz University School of Medicine, Antalya, Turkey. 19. Division of Gastroenterology, Health Sciences University, Şişli Etfal Hospital, İstanbul, Turkey. 20. Division of Gastroenterology, Harran University School of Medicine, Urfa, Turkey. 21. Division of Gastroenterology, Kanuni Sultan Suleyman Training and Research Hospital, İstanbul, Turkey. 22. Division of Gastroenterology and Hepatology, İstanbul University School of Medicine, İstanbul Turkey. 23. Division of Gastroenterology and Hepatology, Uludag University School of Medicine, Bursa, Turkey. 24. Division of Gastroenterology, Umraniye Training and Research Hospital, İstanbul, Turkey. 25. Division of Gastroenterology, Başkent University Hospital, Konya, Turkey. 26. Division of Infectious Diseases, Istanbul Medipol University School of Medicine, İstanbul Turkey. 27. Division of Gastroenterology, Karadeniz Technical University School of Medicine, Trabzon, Turkey. 28. Division of Gastroenterology, Ataturk University, School of Medicine, Erzurum, Turkey. 29. Division of Gastroenterology, Kartal Kosuyolu Yüksek İhtisas Training and Research Hospital, İstanbul, Turkey. 30. Division of İnfectious Diseases, Gaziantep 25 Aralık Government Hospital, Gaziantep, Turkey. 31. Division of Gastroenterology and Hepatology, Hacettepe University School of Medicine, Ankara, Turkey. 32. Division of Gastroenterology, Ufuk University School of Medicine, Ankara, Turkey.
Abstract
BACKGROUND/AIMS: This study aimed to evaluate the real-life efficacy and tolerability of direct-acting antiviral treatments for patients with chronic hepatitis C (CHC) with/without cirrhosis in the Turkish population. MATERIAL AND METHODS: A total of 4,352 patients with CHC from 36 different institutions in Turkey were enrolled. They received ledipasvir (LDV) and sofosbuvir (SOF)±ribavirin (RBV) orombitasvir/paritaprevir/ritonavir±dasabuvir (PrOD)±RBV for 12 or 24 weeks. Sustained virologic response (SVR) rates, factors affecting SVR, safety profile, and hepatocellular cancer (HCC) occurrence were analyzed. RESULTS: SVR12 was achieved in 92.8% of the patients (4,040/4,352) according to intention-to-treat and in 98.3% of the patients (4,040/4,108) according to per-protocol analysis. The SVR12 rates were similar between the treatment regimens (97.2%-100%) and genotypes (95.6%-100%). Patients achieving SVR showed a significant decrease in the mean serum alanine transaminase (ALT) levels (50.90±54.60 U/L to 17.00±14.50 U/L) and model for end-stage liver disease (MELD) scores (7.51±4.54 to 7.32±3.40) (p<0.05). Of the patients, 2 were diagnosed with HCC during the treatment and 14 were diagnosed with HCC 37.0±16.0 weeks post-treatment. Higher initial MELD score (odds ratio [OR]: 1.92, 95% confidence interval [CI]: 1.22-2.38; p=0.023]), higher hepatitis C virus (HCV) RNA levels (OR: 1.44, 95% CI: 1.31-2.28; p=0.038), and higher serum ALT levels (OR: 1.38, 95% CI: 1.21-1.83; p=0.042) were associated with poor SVR12. The most common adverse events were fatigue (12.6%), pruritis (7.3%), increased serum ALT (4.7%) and bilirubin (3.8%) levels, and anemia (3.1%). CONCLUSION: LDV/SOF or PrOD±RBV were effective and tolerable treatments for patients with CHC and with or without advanced liver disease before and after liver transplantation. Although HCV eradication improves the liver function, there is a risk of developing HCC.
BACKGROUND/AIMS: This study aimed to evaluate the real-life efficacy and tolerability of direct-acting antiviral treatments for patients with chronic hepatitis C (CHC) with/without cirrhosis in the Turkish population. MATERIAL AND METHODS: A total of 4,352 patients with CHC from 36 different institutions in Turkey were enrolled. They received ledipasvir (LDV) and sofosbuvir (SOF)±ribavirin (RBV) orombitasvir/paritaprevir/ritonavir±dasabuvir (PrOD)±RBV for 12 or 24 weeks. Sustained virologic response (SVR) rates, factors affecting SVR, safety profile, and hepatocellular cancer (HCC) occurrence were analyzed. RESULTS: SVR12 was achieved in 92.8% of the patients (4,040/4,352) according to intention-to-treat and in 98.3% of the patients (4,040/4,108) according to per-protocol analysis. The SVR12 rates were similar between the treatment regimens (97.2%-100%) and genotypes (95.6%-100%). Patients achieving SVR showed a significant decrease in the mean serum alanine transaminase (ALT) levels (50.90±54.60 U/L to 17.00±14.50 U/L) and model for end-stage liver disease (MELD) scores (7.51±4.54 to 7.32±3.40) (p<0.05). Of the patients, 2 were diagnosed with HCC during the treatment and 14 were diagnosed with HCC 37.0±16.0 weeks post-treatment. Higher initial MELD score (odds ratio [OR]: 1.92, 95% confidence interval [CI]: 1.22-2.38; p=0.023]), higher hepatitis C virus (HCV) RNA levels (OR: 1.44, 95% CI: 1.31-2.28; p=0.038), and higher serum ALT levels (OR: 1.38, 95% CI: 1.21-1.83; p=0.042) were associated with poor SVR12. The most common adverse events were fatigue (12.6%), pruritis (7.3%), increased serum ALT (4.7%) and bilirubin (3.8%) levels, and anemia (3.1%). CONCLUSION:LDV/SOF or PrOD±RBV were effective and tolerable treatments for patients with CHC and with or without advanced liver disease before and after liver transplantation. Although HCV eradication improves the liver function, there is a risk of developing HCC.
Authors: Karin Kozbial; Stephan Moser; Remy Schwarzer; Hermann Laferl; Ramona Al-Zoairy; Rudolf Stauber; Albert F Stättermayer; Sandra Beinhardt; Ivo Graziadei; Clarissa Freissmuth; Andreas Maieron; Michael Gschwantler; Michael Strasser; Markus Peck-Radosalvjevic; Michael Trauner; Harald Hofer; Peter Ferenci Journal: J Hepatol Date: 2016-06-16 Impact factor: 25.083
Authors: H Wedemeyer; A Craxí; E Zuckerman; D Dieterich; R Flisiak; S K Roberts; A Pangerl; Z Zhang; M Martinez; Y Bao; J-L Calleja Journal: J Viral Hepat Date: 2017-07-03 Impact factor: 3.728
Authors: Elizabeth C Verna; Giuseppe Morelli; Norah A Terrault; Anna S Lok; Joseph K Lim; Adrian M Di Bisceglie; Stefan Zeuzem; Charles S Landis; Paul Kwo; Mohamed Hassan; Michael P Manns; Monika Vainorius; Lucy Akushevich; David R Nelson; Michael W Fried; K Rajender Reddy Journal: J Hepatol Date: 2020-03-31 Impact factor: 25.083
Authors: Fred Poordad; Eugene R Schiff; John M Vierling; Charles Landis; Robert J Fontana; Rong Yang; Fiona McPhee; Eric A Hughes; Stephanie Noviello; Eugene S Swenson Journal: Hepatology Date: 2016-03-07 Impact factor: 17.425