Real-world efficacy and safety of Ledipasvir plus Sofosbuvir and

Abstract

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.

C1 [Degertekin, Bulent; Yapali, Suna] Acibadem Mehmet Ali Aydinlar Univ, Div Gastroenterol & Hepatol, Sch Med, Istanbul, Turkey.

[Demir, Mehmet] Mustafa Kemal Univ, Div Gastroenterol, Sch Med, Antakya, Turkey.

[Akarca, Ulus S.; Danis, Nilay; Gunsar, Fulya; Karasu, Zeki] Ege Univ, Div Gastroenterol & Hepatol, Sch Med, Izmir, Turkey.

[Kani, Haluk Tarik; Gunduz, Feyza; Ozdogan, Osman] Marmara Univ, Div Gastroenterol & Hepatol, Sch Med, Istanbul, Turkey.

[Ucbilek, Enver; Yaras, Serkan; Ozdogan, Osman; Sezgin, Orhan] Mersin Univ, Div Gastroenterol, Sch Med, Mersin, Turkey.

[Yildirim, Emre; Balkan, Ayhan] Gaziantep Univ, Div Gastroenterol, Sch Med, Gaziantep, Turkey.

[Guzelbulut, Fatih] Haydarpasa Numune Training & Res Hosp, Div Gastroenterol, Istanbul, Turkey.

[Vatansever, Sezgin] Katip Celebi Univ, Div Gastroenterol, Izmir, Turkey.

[Demircan, Melek; Ozakyol, Aysegul; Temel, Tuncer] Eskisehir Osmangazi Univ, Div Gastroenterol, Sch Med, Eskisehir, Turkey.

[Soylu, Aliye] Hlth Sci Univ Bakirkoy Hosp, Div Gastroenterol, Istanbul, Turkey.

[Kartal, Aysun; Idilman, Ramazan] Ankara Univ, Div Gastroenterol & Hepatol, Sch Med, Ankara, Turkey.

[Kefeli, Ayse] Tokat Gaziosmanpasa Univ, Div Gastroenterol, Sch Med, Tokat, Turkey.

[Yalcin, Kendal] Dicle Univ, Div Gastroenterol & Hepatol, Sch Med, Diyarbakir, Turkey.

[Erarslan, Elife] Diskapi Trainining & Res Hosp, Div Gastroenterol, Ankara, Turkey.

[Aladag, Murat; Harputluoglu, Murat] Inonu Univ, Div Gastroenterol & Hepatol, Sch Med, Malatya, Turkey.

[Akarsu, Mesut] Dokuz Eylul Univ, Div Gastroenterol & Hepatol, Sch Med, Izmir, Turkey.

[Sumer, Hale; Kacar, Sabite; Atalay, Roni; Akdogan, Meral] Ankara City Hosp, Div Gastroenterol, Ankara, Turkey.

[Akin, Mete; Albayrak, Bulent; Dincer, Dinc] Akdeniz Univ, Div Gastroenterol, Sch Med, Antalya, Turkey.

[Sen, Ilker; Alkim, Huseyin] Hlth Sci Univ, Sisli Etfal Hosp, Div Gastroenterol, Istanbul, Turkey.

[Uyanikoglu, Ahmet] Harran Univ, Div Gastroenterol, Sch Med, Urfa, Turkey.

[Irak, Kader] Kanuni Sultan Suleyman Training & Res Hosp, Div Gastroenterol, Istanbul, Turkey.

[Oztaskin, Sinem; Ugurlu, Cagri Burak; Gunes, Sevkican; Nuriyev, Kenan; Inci, Ismail; Kaymakoglu, Sabahattin; Besisik, Fatih] Istanbul Univ, Div Gastroenterol & Hepatol, Sch Med, Istanbul, Turkey.

[Gurel, Selim] Uludag Univ, Div Gastroenterol & Hepatol, Sch Med, Bursa, Turkey.

[Doganay, Levent] Umraniye Training & Res Hosp, Div Gastroenterol, Istanbul, Turkey.

[Gokturk, Huseyin Savas] Baskent Univ Hosp, Div Gastroenterol, Konya, Turkey.

[Mert, Ali] Istanbul Medipol Univ, Div Infect Dis, Sch Med, Istanbul, Turkey.

[Cosar, Arif Mansur] Karadeniz Tech Univ, Div Gastroenterol, Sch Med, Trabzon, Turkey.

[Dursun, Hakan] Ataturk Univ, Sch Med, Div Gastroenterol, Erzurum, Turkey.

[Akbulut, Sabiye] Kartal Kosuyolu Yuksek Ihtisas Training & Res Hos, Div Gastroenterol, Istanbul, Turkey.

[Balkan, Yasemin] Gaziantep 25 Aralik Govt Hosp, Div Infect Dis, Gaziantep, Turkey.

[Koklu, Hayrettin; Simsek, Halis] Hacettepe Univ, Div Gastroenterol & Hepatol, Sch Med, Ankara, Turkey.

[Coban, Mehmet] Ufuk Univ, Div Gastroenterol, Sch Med, Ankara, Turkey.

[Poturoglu, Sule] Haseki Training & Res Hosp, Div Gastroenterol, Istanbul, Turkey.

[Ayyildiz, Talat] Ondokuz Mayis Univ, Div Gastroenterol, Sch Med, Samsun, Turkey.

[Ozenirler, Seren] Gazi Univ, Div Gastroenterol, Sch Med, Ankara, Turkey.

[Akyildiz, Murat] Mem Atasehir Hosp, Organ Transplantat Ctr, Dept Gastroenterol, Istanbul, Turkey.