학술논문
Real-world efficacy and safety of Ledipasvir + Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir [+ or -] Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience
ORIGINAL ARTICLE
ORIGINAL ARTICLE
Document Type
Report
Author
Degertekin, Bulent; Demir, Mehmet; Akarca, Ulus S.; Kani, Haluk Tarik; Ucbilek, Enver; Yildirim, Emre; Guzelbulut, Fatih; Balkan, Ayhan; Vatansever, Sezgin; Danis, Nilay; Demircan, Melek; Soylu, Aliye; Yaras, Serkan; Kartal, Aysun; Kefeli, Ayse; Gunduz, Feyza; Yalcin, Kendal; Erarslan, Elife; Aladag, Murat; Harputluoglu, Murat; Ozakyol, Aysegul; Temel, Tuncer; Akarsu, Mesut; Sumer, Hale; Akin, Mete; Albayrak, Bulent; Sen, Ilker; Alkim, Huseyin; Uyanikoglu, Ahmet; Irak, Kader; Oztaskin, Sinem; Ugurlu, Cagri Burak; Gunes, Sevkican; Gurel, Selim; Nuriyev, Kenan; Inci, Ismail; Kacar, Sabite; Dincer, Dinc; Doganay, Levent; Gokturk, Huseyin Savas; Mert, Ali; Cosar, Arif Mansur; Dursun, Hakan; Atalay, Roni; Akbulut, Sabiye; Balkan, Yasemin; Koklu, Hayrettin; Imsek, Halis G.; Ozdogan, Osman; Coban, Mehmet; Poturoglu, Sule; Ayyildiz, Talat; Yapali, Suna; Gunsar, Fulya; Akdoan, Meral; Ozenirler, Seren; Akyildiz, Murat; Sezgin, Orhan; Kaymakoglu, Sabahattin; Besisik, Fatih; Karasu, Zeki; Idilman, Ramazan
Source
The Turkish Journal of Gastroenterology. December 2020, Vol. 31 Issue 12, p883, 11 p.
Subject
Language
English
ISSN
1300-4948
Abstract
INTRODUCTION Hepatitis C virus (HCV) infection is one of the leading causes of progressive liver disease, cirrhosis, and hepatocellular cancer (HCC). According to recent epidemiological studies, the global rate of [...]
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)[+ or -]ribavirin (RBV) ombitasvir/paritaprevir/ritonavir[+ or -]dasabuvir (PrOD)[+ or -]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[+ or -]54.60 U/L to 17.00[+ or -]14.50 U/L) and model for end-stage liver disease (MELD) scores (7.51[+ or -]4.54 to 7.32[+ or -]3.40) (p Conclusion: LDV/SOF or PrOD[+ or -]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. Keywords: HCV, treatment, direct-acting antiviral, Turkey
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)[+ or -]ribavirin (RBV) ombitasvir/paritaprevir/ritonavir[+ or -]dasabuvir (PrOD)[+ or -]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[+ or -]54.60 U/L to 17.00[+ or -]14.50 U/L) and model for end-stage liver disease (MELD) scores (7.51[+ or -]4.54 to 7.32[+ or -]3.40) (p Conclusion: LDV/SOF or PrOD[+ or -]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. Keywords: HCV, treatment, direct-acting antiviral, Turkey