Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience

Öz:

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) ombitasvir/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.

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APA	Degertekin B, Demir M, Akarca U, Kani H, Ucbilek E, YILDIRIM E, Güzelbulut F, Balkan A, vatansever s, Danis N, DEMİRCAN m, Soylu A, Yaraş S, ÇALISKAN KARTAL A, Kefeli A, Dilber F, Yalçın K, Erarslan E, Aladag M, HARPUTLUOĞLU M, OZAKYOL A, Temel T, akarsu m, Gokcan H, Akin M, albayrak b, SEN I, Alkim H, Uyanikoglu A, Irak K, ÖZTAŞKIN S, uğurlu ç, GÜNEŞ Ş, GUREL S, NURİYEV K, İNCİ i, Kaçar S, Dincer D, DOGANAY H, GOKTURK H, Mert A, COSAR A, Dursun H, Atalay R, akbulut s, BALKAN Y, ÇETİN H, simsek h, özdoğan o, Coban M, Poturoglu S, ayyıldız t, Yapali S, Günşar F, Akdogan M, ÖZENİRLER S, AKYILDIZ M, Sezgin O, Kaymakoglu S, Beşışık F, karasu z, Idilman R, GROUP T (2020). Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. , 883 - 893. 10.5152/tjg.2020.20696
Chicago	Degertekin Bulent,Demir Mehmet,Akarca Ulus Salih,Kani Haluk Tarik,Ucbilek Enver,YILDIRIM EMRE,Güzelbulut Fatih,Balkan Ayhan,vatansever sezgin,Danis Nilay,DEMİRCAN melek,Soylu Aliye,Yaraş Serkan,ÇALISKAN KARTAL AYSUN,Kefeli Ayşe,Dilber Feyza,Yalçın Kendal,Erarslan Elife,Aladag Murat,HARPUTLUOĞLU MURAT,OZAKYOL AYSEGÜL,Temel Tuncer,akarsu mesut,Gokcan Hale,Akin Mete,albayrak bulent,SEN ILKER,Alkim Huseyin,Uyanikoglu Ahmet,Irak Kader,ÖZTAŞKIN SİNEM,uğurlu çağrı burak,GÜNEŞ Şevki,GUREL SELIM,NURİYEV Kenan,İNCİ ismail,Kaçar Sabite,Dincer Dinc,DOGANAY HAMDI LEVENT,GOKTURK HUSEYIN SAVAS,Mert Ali,COSAR Arif Mansur,Dursun Hakan,Atalay Roni,akbulut sabiye,BALKAN YASEMIN,ÇETİN Hayrettin,simsek halis,özdoğan osman,Coban Mehmet,Poturoglu Sule,ayyıldız talat,Yapali Suna,Günşar Fulya,Akdogan Meral,ÖZENİRLER Seren,AKYILDIZ Murat,Sezgin Orhan,Kaymakoglu Sabahattin,Beşışık Fatih,karasu zeki,Idilman Ramazan,GROUP TASL Viral Hepatitis Special Interest Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. (2020): 883 - 893. 10.5152/tjg.2020.20696
MLA	Degertekin Bulent,Demir Mehmet,Akarca Ulus Salih,Kani Haluk Tarik,Ucbilek Enver,YILDIRIM EMRE,Güzelbulut Fatih,Balkan Ayhan,vatansever sezgin,Danis Nilay,DEMİRCAN melek,Soylu Aliye,Yaraş Serkan,ÇALISKAN KARTAL AYSUN,Kefeli Ayşe,Dilber Feyza,Yalçın Kendal,Erarslan Elife,Aladag Murat,HARPUTLUOĞLU MURAT,OZAKYOL AYSEGÜL,Temel Tuncer,akarsu mesut,Gokcan Hale,Akin Mete,albayrak bulent,SEN ILKER,Alkim Huseyin,Uyanikoglu Ahmet,Irak Kader,ÖZTAŞKIN SİNEM,uğurlu çağrı burak,GÜNEŞ Şevki,GUREL SELIM,NURİYEV Kenan,İNCİ ismail,Kaçar Sabite,Dincer Dinc,DOGANAY HAMDI LEVENT,GOKTURK HUSEYIN SAVAS,Mert Ali,COSAR Arif Mansur,Dursun Hakan,Atalay Roni,akbulut sabiye,BALKAN YASEMIN,ÇETİN Hayrettin,simsek halis,özdoğan osman,Coban Mehmet,Poturoglu Sule,ayyıldız talat,Yapali Suna,Günşar Fulya,Akdogan Meral,ÖZENİRLER Seren,AKYILDIZ Murat,Sezgin Orhan,Kaymakoglu Sabahattin,Beşışık Fatih,karasu zeki,Idilman Ramazan,GROUP TASL Viral Hepatitis Special Interest Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. , 2020, ss.883 - 893. 10.5152/tjg.2020.20696
AMA	Degertekin B,Demir M,Akarca U,Kani H,Ucbilek E,YILDIRIM E,Güzelbulut F,Balkan A,vatansever s,Danis N,DEMİRCAN m,Soylu A,Yaraş S,ÇALISKAN KARTAL A,Kefeli A,Dilber F,Yalçın K,Erarslan E,Aladag M,HARPUTLUOĞLU M,OZAKYOL A,Temel T,akarsu m,Gokcan H,Akin M,albayrak b,SEN I,Alkim H,Uyanikoglu A,Irak K,ÖZTAŞKIN S,uğurlu ç,GÜNEŞ Ş,GUREL S,NURİYEV K,İNCİ i,Kaçar S,Dincer D,DOGANAY H,GOKTURK H,Mert A,COSAR A,Dursun H,Atalay R,akbulut s,BALKAN Y,ÇETİN H,simsek h,özdoğan o,Coban M,Poturoglu S,ayyıldız t,Yapali S,Günşar F,Akdogan M,ÖZENİRLER S,AKYILDIZ M,Sezgin O,Kaymakoglu S,Beşışık F,karasu z,Idilman R,GROUP T Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. . 2020; 883 - 893. 10.5152/tjg.2020.20696
Vancouver	Degertekin B,Demir M,Akarca U,Kani H,Ucbilek E,YILDIRIM E,Güzelbulut F,Balkan A,vatansever s,Danis N,DEMİRCAN m,Soylu A,Yaraş S,ÇALISKAN KARTAL A,Kefeli A,Dilber F,Yalçın K,Erarslan E,Aladag M,HARPUTLUOĞLU M,OZAKYOL A,Temel T,akarsu m,Gokcan H,Akin M,albayrak b,SEN I,Alkim H,Uyanikoglu A,Irak K,ÖZTAŞKIN S,uğurlu ç,GÜNEŞ Ş,GUREL S,NURİYEV K,İNCİ i,Kaçar S,Dincer D,DOGANAY H,GOKTURK H,Mert A,COSAR A,Dursun H,Atalay R,akbulut s,BALKAN Y,ÇETİN H,simsek h,özdoğan o,Coban M,Poturoglu S,ayyıldız t,Yapali S,Günşar F,Akdogan M,ÖZENİRLER S,AKYILDIZ M,Sezgin O,Kaymakoglu S,Beşışık F,karasu z,Idilman R,GROUP T Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. . 2020; 883 - 893. 10.5152/tjg.2020.20696
IEEE	Degertekin B,Demir M,Akarca U,Kani H,Ucbilek E,YILDIRIM E,Güzelbulut F,Balkan A,vatansever s,Danis N,DEMİRCAN m,Soylu A,Yaraş S,ÇALISKAN KARTAL A,Kefeli A,Dilber F,Yalçın K,Erarslan E,Aladag M,HARPUTLUOĞLU M,OZAKYOL A,Temel T,akarsu m,Gokcan H,Akin M,albayrak b,SEN I,Alkim H,Uyanikoglu A,Irak K,ÖZTAŞKIN S,uğurlu ç,GÜNEŞ Ş,GUREL S,NURİYEV K,İNCİ i,Kaçar S,Dincer D,DOGANAY H,GOKTURK H,Mert A,COSAR A,Dursun H,Atalay R,akbulut s,BALKAN Y,ÇETİN H,simsek h,özdoğan o,Coban M,Poturoglu S,ayyıldız t,Yapali S,Günşar F,Akdogan M,ÖZENİRLER S,AKYILDIZ M,Sezgin O,Kaymakoglu S,Beşışık F,karasu z,Idilman R,GROUP T "Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience." , ss.883 - 893, 2020. 10.5152/tjg.2020.20696
ISNAD	Degertekin, Bulent vd. "Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience". (2020), 883-893. https://doi.org/10.5152/tjg.2020.20696

APA	Degertekin B, Demir M, Akarca U, Kani H, Ucbilek E, YILDIRIM E, Güzelbulut F, Balkan A, vatansever s, Danis N, DEMİRCAN m, Soylu A, Yaraş S, ÇALISKAN KARTAL A, Kefeli A, Dilber F, Yalçın K, Erarslan E, Aladag M, HARPUTLUOĞLU M, OZAKYOL A, Temel T, akarsu m, Gokcan H, Akin M, albayrak b, SEN I, Alkim H, Uyanikoglu A, Irak K, ÖZTAŞKIN S, uğurlu ç, GÜNEŞ Ş, GUREL S, NURİYEV K, İNCİ i, Kaçar S, Dincer D, DOGANAY H, GOKTURK H, Mert A, COSAR A, Dursun H, Atalay R, akbulut s, BALKAN Y, ÇETİN H, simsek h, özdoğan o, Coban M, Poturoglu S, ayyıldız t, Yapali S, Günşar F, Akdogan M, ÖZENİRLER S, AKYILDIZ M, Sezgin O, Kaymakoglu S, Beşışık F, karasu z, Idilman R, GROUP T (2020). Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. Turkish Journal of Gastroenterology, 31(12), 883 - 893. 10.5152/tjg.2020.20696
Chicago	Degertekin Bulent,Demir Mehmet,Akarca Ulus Salih,Kani Haluk Tarik,Ucbilek Enver,YILDIRIM EMRE,Güzelbulut Fatih,Balkan Ayhan,vatansever sezgin,Danis Nilay,DEMİRCAN melek,Soylu Aliye,Yaraş Serkan,ÇALISKAN KARTAL AYSUN,Kefeli Ayşe,Dilber Feyza,Yalçın Kendal,Erarslan Elife,Aladag Murat,HARPUTLUOĞLU MURAT,OZAKYOL AYSEGÜL,Temel Tuncer,akarsu mesut,Gokcan Hale,Akin Mete,albayrak bulent,SEN ILKER,Alkim Huseyin,Uyanikoglu Ahmet,Irak Kader,ÖZTAŞKIN SİNEM,uğurlu çağrı burak,GÜNEŞ Şevki,GUREL SELIM,NURİYEV Kenan,İNCİ ismail,Kaçar Sabite,Dincer Dinc,DOGANAY HAMDI LEVENT,GOKTURK HUSEYIN SAVAS,Mert Ali,COSAR Arif Mansur,Dursun Hakan,Atalay Roni,akbulut sabiye,BALKAN YASEMIN,ÇETİN Hayrettin,simsek halis,özdoğan osman,Coban Mehmet,Poturoglu Sule,ayyıldız talat,Yapali Suna,Günşar Fulya,Akdogan Meral,ÖZENİRLER Seren,AKYILDIZ Murat,Sezgin Orhan,Kaymakoglu Sabahattin,Beşışık Fatih,karasu zeki,Idilman Ramazan,GROUP TASL Viral Hepatitis Special Interest Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. Turkish Journal of Gastroenterology 31, no.12 (2020): 883 - 893. 10.5152/tjg.2020.20696
MLA	Degertekin Bulent,Demir Mehmet,Akarca Ulus Salih,Kani Haluk Tarik,Ucbilek Enver,YILDIRIM EMRE,Güzelbulut Fatih,Balkan Ayhan,vatansever sezgin,Danis Nilay,DEMİRCAN melek,Soylu Aliye,Yaraş Serkan,ÇALISKAN KARTAL AYSUN,Kefeli Ayşe,Dilber Feyza,Yalçın Kendal,Erarslan Elife,Aladag Murat,HARPUTLUOĞLU MURAT,OZAKYOL AYSEGÜL,Temel Tuncer,akarsu mesut,Gokcan Hale,Akin Mete,albayrak bulent,SEN ILKER,Alkim Huseyin,Uyanikoglu Ahmet,Irak Kader,ÖZTAŞKIN SİNEM,uğurlu çağrı burak,GÜNEŞ Şevki,GUREL SELIM,NURİYEV Kenan,İNCİ ismail,Kaçar Sabite,Dincer Dinc,DOGANAY HAMDI LEVENT,GOKTURK HUSEYIN SAVAS,Mert Ali,COSAR Arif Mansur,Dursun Hakan,Atalay Roni,akbulut sabiye,BALKAN YASEMIN,ÇETİN Hayrettin,simsek halis,özdoğan osman,Coban Mehmet,Poturoglu Sule,ayyıldız talat,Yapali Suna,Günşar Fulya,Akdogan Meral,ÖZENİRLER Seren,AKYILDIZ Murat,Sezgin Orhan,Kaymakoglu Sabahattin,Beşışık Fatih,karasu zeki,Idilman Ramazan,GROUP TASL Viral Hepatitis Special Interest Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. Turkish Journal of Gastroenterology, vol.31, no.12, 2020, ss.883 - 893. 10.5152/tjg.2020.20696
AMA	Degertekin B,Demir M,Akarca U,Kani H,Ucbilek E,YILDIRIM E,Güzelbulut F,Balkan A,vatansever s,Danis N,DEMİRCAN m,Soylu A,Yaraş S,ÇALISKAN KARTAL A,Kefeli A,Dilber F,Yalçın K,Erarslan E,Aladag M,HARPUTLUOĞLU M,OZAKYOL A,Temel T,akarsu m,Gokcan H,Akin M,albayrak b,SEN I,Alkim H,Uyanikoglu A,Irak K,ÖZTAŞKIN S,uğurlu ç,GÜNEŞ Ş,GUREL S,NURİYEV K,İNCİ i,Kaçar S,Dincer D,DOGANAY H,GOKTURK H,Mert A,COSAR A,Dursun H,Atalay R,akbulut s,BALKAN Y,ÇETİN H,simsek h,özdoğan o,Coban M,Poturoglu S,ayyıldız t,Yapali S,Günşar F,Akdogan M,ÖZENİRLER S,AKYILDIZ M,Sezgin O,Kaymakoglu S,Beşışık F,karasu z,Idilman R,GROUP T Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. Turkish Journal of Gastroenterology. 2020; 31(12): 883 - 893. 10.5152/tjg.2020.20696
Vancouver	Degertekin B,Demir M,Akarca U,Kani H,Ucbilek E,YILDIRIM E,Güzelbulut F,Balkan A,vatansever s,Danis N,DEMİRCAN m,Soylu A,Yaraş S,ÇALISKAN KARTAL A,Kefeli A,Dilber F,Yalçın K,Erarslan E,Aladag M,HARPUTLUOĞLU M,OZAKYOL A,Temel T,akarsu m,Gokcan H,Akin M,albayrak b,SEN I,Alkim H,Uyanikoglu A,Irak K,ÖZTAŞKIN S,uğurlu ç,GÜNEŞ Ş,GUREL S,NURİYEV K,İNCİ i,Kaçar S,Dincer D,DOGANAY H,GOKTURK H,Mert A,COSAR A,Dursun H,Atalay R,akbulut s,BALKAN Y,ÇETİN H,simsek h,özdoğan o,Coban M,Poturoglu S,ayyıldız t,Yapali S,Günşar F,Akdogan M,ÖZENİRLER S,AKYILDIZ M,Sezgin O,Kaymakoglu S,Beşışık F,karasu z,Idilman R,GROUP T Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience. Turkish Journal of Gastroenterology. 2020; 31(12): 883 - 893. 10.5152/tjg.2020.20696
IEEE	Degertekin B,Demir M,Akarca U,Kani H,Ucbilek E,YILDIRIM E,Güzelbulut F,Balkan A,vatansever s,Danis N,DEMİRCAN m,Soylu A,Yaraş S,ÇALISKAN KARTAL A,Kefeli A,Dilber F,Yalçın K,Erarslan E,Aladag M,HARPUTLUOĞLU M,OZAKYOL A,Temel T,akarsu m,Gokcan H,Akin M,albayrak b,SEN I,Alkim H,Uyanikoglu A,Irak K,ÖZTAŞKIN S,uğurlu ç,GÜNEŞ Ş,GUREL S,NURİYEV K,İNCİ i,Kaçar S,Dincer D,DOGANAY H,GOKTURK H,Mert A,COSAR A,Dursun H,Atalay R,akbulut s,BALKAN Y,ÇETİN H,simsek h,özdoğan o,Coban M,Poturoglu S,ayyıldız t,Yapali S,Günşar F,Akdogan M,ÖZENİRLER S,AKYILDIZ M,Sezgin O,Kaymakoglu S,Beşışık F,karasu z,Idilman R,GROUP T "Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience." Turkish Journal of Gastroenterology, 31, ss.883 - 893, 2020. 10.5152/tjg.2020.20696
ISNAD	Degertekin, Bulent vd. "Real-world efficacy and safety of Ledipasvir + Sofosbuvir andOmbitasvir/Paritaprevir/Ritonavir ± Dasabuvir combinationtherapies for chronic hepatitis C: A Turkish experience". Turkish Journal of Gastroenterology 31/12 (2020), 883-893. https://doi.org/10.5152/tjg.2020.20696