Real-world efficacy and safety of Ledipasvir + Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir [+ or -] Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience

• Published in: Turkish Journal of Gastroenterology 2020, Vol.31 (12), p.883
• Main Authors: 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
• Format: Report
• Language: English
• Subjects: Antiviral agents; Dosage and administration; Drug therapy; Drug therapy, Combination; Hepatitis C; Patient outcomes
• ISSN: 1300-4948
• DOI: 10.5152/tjg.2020.20696

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