Literature DB >> 33960939

Real-World Data from Turkey: Is Sofosbuvir/Ledipasvir With or Without Ribavirin Treatment for Chronic Hepatitis C Really Effective?

Neşe Demirtürk1, Bilgehan Aygen2, İlhami Çelik3, Reşit Mıstık4, Sıla Akhan5, Şener Barut6, Onur Ural7, Ayşe Batırel8, Funda Şimşek9, Gülden Ersöz10, Dilara İnan11, Sami Kınıklı12, Nesrin Türker13, Hüseyin Bilgin14, Yunus Gürbüz15, Necla Tülek16, Hüseyin Tarakçı17, Orhan Yıldız2, Emine Türkoğlu1, Deniz Kamalak Güzel3, Sümeyra Şimşek18, Nazan Tuna19, Nazlım Aktuğ Demir7, Atahan Çağatay20, Rıza Aytaç Çetinkaya21, Faruk Karakeçili22, İsmail Necati Hakyemez23, Günay Tuncer Ertem12, Bahar Örmen13, Pınar Korkmaz24, Uluhan Yıldız14, Ziya Kuruüzüm25, Alper Şener26, Selcan Arslan Özel27, Sinan Öztürk28, Kaya Suer29, Mustafa Kemal Çelen30, Petek Konya1, Ali Asan31, Neşe Saltoğlu32, Nurhan Doğan33.   

Abstract

BACKGROUND: In this study, we aimed to investigate the efficacy and safety of sofosbuvir-based therapies in the treatment of chronic hepatitis C in real-world clinical practice.
METHODS: Data from patients with chronic hepatitis C treated with SOF/LDV ± RBV or SOF/RBV in 31 centers across Turkey between April 1, 2017, and August 31, 2018, were recorded in a nationwide database among infectious disease specialists. Demographics, clinical, and virological outcomes were analyzed.
RESULTS: A total of 552 patients were included in the study. The mean age of the patients was 51.28 ± 14.2, and 293 (55.8%) were female. The majority had HCV genotype 1b infection (65%), 75.04% of the patients underwent treatment, and non-cirrhosis was present at baseline in 381 patients (72.6%). SOF/LDV ± RBV treatment was given to 477 patients and 48 patients received SOF/RBV according to HCV genotype. The total SVR12 rate was 99% in all patients. Five patients experienced disease relapse during the study and all of them were genotype 2. In patients infected with HCV GT2, SVR12 was 77.3%. SVR was 100% in all patients infected with other HCV genotypes. All treatments were well tolerated by patients without causing severe adverse events. Side effects and side effects-associated treatment discontinuation rates were 28.2% and 0.4%, respectively. Weakness (13.7%) was the common side effect.
CONCLUSION: The present real-world data of 525 patients with HCV genotypes 1, 1a, 1b, 3, 4, and 5 who underwent SOF/LDV ± RBV treatment in Turkey demonstrated a high efficacy and safety profile. HCV GT2 patients should be treated with more efficacious treatment.

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Year:  2021        PMID: 33960939      PMCID: PMC8975436          DOI: 10.5152/tjg.2020.19569

Source DB:  PubMed          Journal:  Turk J Gastroenterol        ISSN: 1300-4948            Impact factor:   1.852


  22 in total

1.  Efficacy and Safety of Ledipasvir/Sofosbuvir with and without Ribavirin in Patients with Chronic Hepatitis C Virus Genotype 1 Infection: a meta-analysis.

Authors:  Tingting Tao; Xuehua Jiang; Yuehong Chen; Yiran Song
Journal:  Int J Infect Dis       Date:  2016-12-29       Impact factor: 3.623

2.  Sofosbuvir-ledipasvir with or without ribavirin for chronic hepatitis C genotype-1 and 6: real-world experience in Vietnam.

Authors:  Pham Thi Thu Thuy; Chalermrat Bunchorntavakul; Ho Tan Dat; Julia Palecki; K Rajender Reddy
Journal:  Antivir Ther       Date:  2018

3.  EASL Recommendations on Treatment of Hepatitis C 2016.

Authors: 
Journal:  J Hepatol       Date:  2016-09-22       Impact factor: 25.083

4.  EASL Recommendations on Treatment of Hepatitis C 2018.

Authors: 
Journal:  J Hepatol       Date:  2018-04-09       Impact factor: 25.083

5.  A phase 3b study of sofosbuvir plus ribavirin in treatment-naive and treatment-experienced Korean patients chronically infected with genotype 2 hepatitis C virus.

Authors:  S H Ahn; Y S Lim; K S Lee; S W Paik; Y J Lee; S H Jeong; J H Kim; S K Yoon; H J Yim; W Y Tak; S Y Han; J C Yang; H Mo; A Mathias; L Han; S J Knox; D M Brainard; Y J Kim; K S Byun; Y S Kim; J Heo; K H Han
Journal:  J Viral Hepat       Date:  2016-02-10       Impact factor: 3.728

6.  Evaluation of Dual Therapy in Real Life Setting in Treatment-Naïve Turkish Patients with HCV Infection: A Multicenter, Retrospective Study.

Authors:  Yunus Gürbüz; Necla Eren Tülek; Emin Ediz Tütüncü; Süda Tekin Koruk; Bilgehan Aygen; Neşe Demirtürk; Sami Kınıklı; Ali Kaya; Taner Yıldırmak; Kaya Süer; Fatime Korkmaz; Onur Ural; Sıla Akhan; Özgür Günal; Nazan Tuna; Şükran Köse; İbak Gönen; Bahar Örmen; Nesrin Türker; Neşe Saltoğlu; Ayşe Batırel; Günay Tuncer; Cemal Bulut; Fatma Sırmatel; Asım Ulçay; Ergenekon Karagöz; Derviş Tosun; Alper Şener; Aynur Aynıoğlu; Elif Sargın Altunok
Journal:  Balkan Med J       Date:  2016-01-01       Impact factor: 2.021

7.  Real-World Effectiveness and Safety of Oral Combination Antiviral Therapy for Hepatitis C Virus Genotype 4 Infection.

Authors:  Javier Crespo; Jose Luis Calleja; Inmaculada Fernández; Begoña Sacristan; Belén Ruiz-Antorán; Javier Ampuero; Marta Hernández-Conde; Javier García-Samaniego; Francisco Gea; Maria Buti; Joaquin Cabezas; Sabela Lens; Rosa Maria Morillas; Jose Ramon Salcines; Juan Manuel Pascasio; Juan Turnes; Federico Sáez-Royuela; Juan Arenas; Diego Rincón; Martin Prieto; Francisco Jorquera; Juan Jose Sanchez Ruano; Carmen A Navascués; Esther Molina; Adolfo Gallego Moya; José Maria Moreno-Planas
Journal:  Clin Gastroenterol Hepatol       Date:  2017-02-24       Impact factor: 11.382

8.  Real-world effectiveness of ledipasvir/sofosbuvir in 4,365 treatment-naive, genotype 1 hepatitis C-infected patients.

Authors:  Lisa I Backus; Pamela S Belperio; Troy A Shahoumian; Timothy P Loomis; Larry A Mole
Journal:  Hepatology       Date:  2016-06-07       Impact factor: 17.425

9.  Sofosbuvir plus ribavirin in Japanese patients with chronic genotype 2 HCV infection: an open-label, phase 3 trial.

Authors:  Masao Omata; Shuhei Nishiguchi; Yoshiyuki Ueno; Hitoshi Mochizuki; Namiki Izumi; Fusao Ikeda; Hidenori Toyoda; Osamu Yokosuka; Kazushige Nirei; Takuya Genda; Takeji Umemura; Tetsuo Takehara; Naoya Sakamoto; Yoichi Nishigaki; Kunio Nakane; Nobuo Toda; Tatsuya Ide; Mikio Yanase; Keisuke Hino; Bing Gao; Kimberly L Garrison; Hadas Dvory-Sobol; Akinobu Ishizaki; Masa Omote; Diana Brainard; Steven Knox; William T Symonds; John G McHutchison; Hiroshi Yatsuhashi; Masashi Mizokami
Journal:  J Viral Hepat       Date:  2014-09-08       Impact factor: 3.728

Review 10.  The Efficacy and Safety of 12 Weeks of Sofosbuvir and Ledipasvir versus Sofosbuvir, Ledipasvir, and Ribavirin in Patients with Chronic Hepatitis C, Genotype 1, Who Have Cirrhosis and Have Failed Prior Therapy: A Systematic Review and Meta-Analysis.

Authors:  William Stokes; Carol Fenton; Fiona Clement; Matthew James; Paul Ronksley; Karen L Tang
Journal:  Can J Gastroenterol Hepatol       Date:  2017-03-06
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