학술논문
Real-World Data from Turkey: Is Sofosbuvir/Ledipasvir With or Without Ribavirin Treatment for Chronic Hepatitis C Really Effective?
ORIGINAL ARTICLE
ORIGINAL ARTICLE
Document Type
Report
Author
Demirturk, Nese; Aygen, Bilgehan; Celik, Ilhami; Mistik, Resit; Akhan, Sila; Barut, Sener; Uralv, Onur; Batirelv, Ayse; Simsek, Funda; Ersoz, Gulden; Inan, Dilara; Kinikli, Sami; Turker, Nesrin; Bilgin, Huseyin; Gurbuz, Yunus; Tulek, Necla; Tarakci, Huseyin; Yildiz, Orhan; Turkoglu, Emine; Guzel, Deniz Kamalak; Simsek, Sumeyra; Tuna, Nazan; Demir, Nazlim Aktug; Cagatay, Atahan; Cetinkaya, Riza Aytac; Karakecili, Faruk; Hakyemez, Ismail Necati; Ertem, Gunay Tuncer; Ormen, Bahar; Korkmaz, Pinar; Sili, Uluhan; Kuruuzum, Ziya; Sener, Alper; Ozel, Selcan Arslan; Ozturk, Sinan; Suer, Kaya; Celen, Mustafa Kemal; Konya, Petek; Asan, Ali; Saltoglu, Nese; Dogan, Nurhan
Source
The Turkish Journal of Gastroenterology. February 2021, Vol. 32 Issue 2, p155, 9 p.
Subject
Language
English
ISSN
1300-4948
Abstract
INTRODUCTION Hepatitis C virus infection is an important public health problem. It is a leading cause of chronic liver disease and hepatocellular carcinoma. According to the data of the World [...]
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 [+ or -] 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 [+ or -] 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 [+ or -] 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 [+ or -] RBV treatment in Turkey demonstrated a high efficacy and safety profile. HCV GT2 patients should be treated with more efficacious treatment. Keywords: Chronic hepatitis C, sofosbuvir, ledipasvir, sustained virological response, genotype, real-world data
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 [+ or -] 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 [+ or -] 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 [+ or -] 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 [+ or -] RBV treatment in Turkey demonstrated a high efficacy and safety profile. HCV GT2 patients should be treated with more efficacious treatment. Keywords: Chronic hepatitis C, sofosbuvir, ledipasvir, sustained virological response, genotype, real-world data