Journals / Turkish Journal of Gastroenterology / 2020 / Cilt: 31 - Sayı: 12

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

Pages
883–893
DOI
—
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

Although HCV eradication improves the liver function, there is a risk of developing HCC.

📌 3 Key Takeaways

🎯
Objective & Hypothesis: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.
📊
Key Findings & Data:They received ledipasvir (LDV) and sofosbuvir (SOF)±ribavirin (RBV) ombitasvir/paritaprevir/ritonavir±dasabuvir (PrOD)±RBV for 12 or 24 weeks.
💡
Conclusion & Impact:Although HCV eradication improves the liver function, there is a risk of developing HCC.
🔬Design:Modeling & Simulation
📍Scope:Comprehensive Sample
⚙️Variables:Domain Parameters

Özet

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.

🔖

Cite This Article

DEĞERTEKİN, B., DEMİR, M., AKARCA, U. S., KANİ, H. T., ÜÇBİLEK, E., YILDIRIM, E., GÜZELBULUT, F., BALKAN, A., VATANSEVER, S., DANIŞ, N., DEMİRCAN, M., SOYLU, A., YARAŞ, S., KARTAL, A. Ç., KEFELİ, A., GÜNDÜZ, F., YALÇIN, K., ERASLAN, E., ALADAĞ, M., HARPUTLUOĞLU, M. (2020). Real-world efficacy and safety of Ledipasvir + Sofosbuvir and Ombitasvir/Paritaprevir/Ritonavir ± Dasabuvir combination therapies for chronic hepatitis C: A Turkish experience. Turkish Journal of Gastroenterology, Cilt: 31 - Sayı: 12, 883–893. https://ajindex.com/articles/408714

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (15)

  1. WHO Global Hepatitis Report. 2017
  2. Lanini S, Easterbrook PJ, Zumla A, Ippolito G. Hepatitis C: global epidemiology and strategies for control. Clin Microbiol Infect 2016; 22: 833-8
  3. Bertino G, Ardiri A, Proiti M, et al. Chronic hepatitis C: This and the new era of treatment. World J Hepatol 2016; 8: 92-106
  4. Panel A-IHG. Hepatitis C Guidance 2018 Update: AASLD-IDSA Recommendations for Testing, Managing, and Treating Hepatitis C Virus Infection. Clin Infect Dis 2018; 67: 1477-92
  5. European Association for the Study of the Liver. Electronic ad dress eee, European Association for the Study of the L. EASL Rec ommendations on Treatment of Hepatitis C 2018. J Hepatol 2018; 69: 461-511
  6. Alshuwayk O, Kwo PY. HCV treatment in 2020: How to translate highly effective therapies into elimination strategies. Hepatology Forum 2020; 2: 72-4
  7. Yang Y, Wu FP, Wang WJ, et al. Real-life efficacy and safety of di rect-acting antiviral therapy for treatment of patients infected with hepatitis C virus genotypes 1, 2 and 3 in northwest China. World J Gastroenterol 2019; 25: 6551-60
  8. Liu CH, Liu CJ, Hung CC, et al. Glecaprevir/pibrentasvir for patients with chronic hepatitis C virus infection: Real-world effectiveness and safety in Taiwan. Liver Int 2020; 40: 758-68
  9. Huang CF, Iio E, Jun DW, et al. Direct-acting antivirals in East Asian hepatitis C patients: real-world experience from the REAL-C Consortium. Hepatol Int 2019; 13: 587-98
  10. Lobato CMO, Codes L, Silva GF, et al. Direct antiviral therapy for treatment of hepatitis C: A real-world study from Brazil. Ann Hepatol 2019; 18: 849-54
  11. Tozun N, Ozdogan O, Cakaloglu Y, et al. Seroprevalence of hep atitis B and C virus infections and risk factors in Turkey: a fieldwork TURHEP study. Clin Microbiol Infect 2015; 21: 1020-6
  12. Ormeci N, Gulsen MT, Sezgin O, et al. Treatment of HCV infection with direct-acting antiviral agents. Real life experiences from the Euro-Asian region. Turk J Gastroenterol 2020; 31: 148-55
  13. Danis N, Toz H, Unal N, et al. Paritaprevir, ritonavir, ombitasvir, and dasabuvir treatment in renal transplant patients with hepatitis C virus infection. Turk J Gastroenterol 2019; 30: 695-701
  14. Ormeci N, Sezgin O, Karaali R, et al. Effectiveness of fixed-dose combination of paritaprevir, ritonavir, ombitasvir, and dasabuvir in patients with chronic hepatitis C virus infection and chronic kidney diseases: real-life experiences. Eur J Gastroenterol Hepatol 2019; 31: 534-9
  15. Yaras