Turkish Journal of Gastroenterology
Liver - Original Article

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

1.

Division of Gastroenterology and Hepatology, Acibadem Mehmet Ali Aydinlar University School of Medicine, İstanbul, Turkey

2.

Division of Gastroenterology Mustafa Kemal University School of Medicine, Hatay, Turkey

3.

Division of Gastroenterology and Hepatology, Ege University School of Medicine, İzmir, Turkey

4.

Division of Gastroenterology and Hepatology, Marmara University School of Medicine, İstanbul, Turkey

5.

Division of Gastroenterology, Mersin University School of Medicine, Mersin, Turkey

6.

Division of Gastroenterology, Gaziantep University School of Medicine, Gaziantep, Turkey

7.

Division of Gastroenterology, Haydarpasa Numune Training and Research Hospital, İstan-bul, Turkey

8.

Division of Gastroenterology, Kâtip Celebi University, İzmir, Turkey

9.

Division of Gastroenterology, Eskisehir Osmangazi University School of Medicine, Eskişehir, Turkey

10.

Division of Gastroenterology, Health Sciences University Bakırkoy Hospital, İstanbul, Turkey

11.

Division of Gastroenterology and Hepatology, Ankara University School of Medicine, Ankara, Turkey

12.

Division of Gastroenterology, Tokat Gaziosmanpasa University School of Medicine, Tokat, Turkey

13.

Division of Gastroenterology and Hepatology, Dicle University School of Medicine, Diyarbakır, Turkey

14.

Division of Gastroenterology, Dışkapı Trainining and Research Hospital, Ankara, Turkey

15.

Division of Gastroenterology and Hepatology, İnonu University School of Medicine, Malatya, Turkey

16.

Division of Gastroenterology and Hepatology, Dokuz Eylül University School of Medicine, İzmir, Turkey

17.

Division of Gastroenterology, Ankara City Hospital, Ankara, Turkey

18.

Division of Gastroenterology, Akdeniz University School of Medicine, Antalya, Turkey

19.

Division of Gastroenterology, Health Sciences University, Şişli Etfal Hospital, İstanbul, Turkey

20.

Division of Gastroenterology, Harran University School of Medicine, Urfa, Turkey

21.

Division of Gastroenterology, Kanuni Sultan Suleyman Training and Research Hospital, İstanbul, Turkey

22.

Division of Gastroenterology and Hepatology, İstanbul University School of Medicine, İstanbul Turkey

23.

Division of Gastroenterology and Hepatology, Uludag University School of Medicine, Bursa, Turkey

24.

Division of Gastroenterology, Umraniye Training and Research Hospital, İstanbul, Turkey

25.

Division of Gastroenterology, Başkent University Hospital, Konya, Turkey

26.

Division of Infectious Diseases, Istanbul Medipol University School of Medicine, İstanbul Turkey

27.

Division of Gastroenterology, Karadeniz Technical University School of Medicine, Trabzon, Turkey

28.

Division of Gastroenterology, Ataturk University, School of Medicine, Erzurum, Turkey

29.

Division of Gastroenterology, Kartal Kosuyolu Yüksek İhtisas Training and Research Hospital, İstanbul, Turkey

30.

Division of İnfectious Diseases, Gaziantep 25 Aralık Government Hospital, Gaziantep, Turkey

31.

Division of Gastroenterology and Hepatology, Hacettepe University School of Medicine, Ankara, Turkey

32.

Division of Gastroenterology, Ufuk University School of Medicine, Ankara, Turkey

Turk J Gastroenterol 2020; 31: 883-893
DOI: 10.5152/tjg.2020.20696
Read: 251 Downloads: 204 Published: 28 January 2021

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) orombitasvir/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.

Cite this article as: Değertekin B, Demir M, Akarca US, et al. Real-world efficacy and safety of Ledipasvir + Sofosbuvir and Om-bitasvir/Paritaprevir/Ritonavir ± Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience. Turk J Gastroenterol 2020; 31(12): 883-93.

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