Akademik Veri Yönetim Sistemi
The Liver Meeting Digital Experience-AASLD, Washington, Amerika Birleşik Devletleri, 12 - 15 Kasım 2021, cilt.74, ss.490-491
Real Life Efficacy and Tolerability of Tenofovir alafenamide fumarate in patients with hepatitis B virus-related cirrhosis and liver transplant recipients. A-Preliminary result
Suna Yapali1, Hale Gokcan2, Murat Harputluoglu3, Zeynep Melekoglu Ellik2, Pinar Gokcen4, Haydar Adanır5, Arif Mansur6, Serdar Durak6, Derya Arı7, Shahin Mehdiyev8, Elif Sitre Koç1, Fatih Guzelbulut9, Huseyin Alkım10, Nergis Ekmen11, Emre Yildirim12, Yasemin Unsal11, Tufan Teker13, Dıgdem Ozer Etik14, Sezgin Vatansever15, Yasemin Balaban16, Kamil Ozdil4, Mehmet Arslan6, Meral Akdogan Kayhan7, Feyza Gunduz8, Murat Kiyici13, Sabite Kacar7, Sedat Boyacioglu14, Halis Simsek16, Şebnem Gürsoy17, Nurdan Tozun1, Dinç Dinçer5, Ramazan Idilman2
1Acıbadem University School of Medicine, Istanbul, Turkey, 2Ankara University, Gastroenterology and Hepatology, Ankara, Turkey, 3İnönü University School of Medicine, Malatya, Turkey, 4Umraniye Training and Research Hospital, Gastroenterology, Istanbul, Turkey, 5Akdeniz University , Gastroenterology, Antalya, Turkey, 6Karadeniz Technical University School of Medicine, Gastroenterology, Trabzon, Turkey, 7Ankara City Hospital, Ankara, Turkey, 8Marmara University, Gastroenterology and Hapatology, Istanbul, Turkey, 9Health Sciences University, Haydarpasa Numune Training and Research Hospital, Istanbul, Turkey, 10Health Sciences University, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey, 11Gazi University School of Medicine , Ankara, Turkey, 12Gaziantep University School of Medicine, Gaziantep, Turkey, 13Uludağ University School of Medicine, Gastroenterology, Bursa, Turkey, 14Başkent University School of Medicine, Gastroenterology, Istanbul, Turkey, 15Katip Celebi University Ataturk Training and Research Hospital, Gastroenterology, Izmir, Turkey, 16Hacettepe University Medical School I, Gastroenterology, Ankara, Turkey, 17Erciyes University School of Medicine, Gastroenterology, Kayseri, Turkey
Background and Aims: We aimed to determine the real‐life efficacy and tolerability of tenofovir alafenamide fumarate (TAF) in patients with hepatitis B virus (HBV)-induced cirrhosis and LT recipients.
Methods: This is a multicenter prospective study. A total of 287 HBV-related cirrhotic patients and liver transplant recipients from 17 centers in Turkey were enrolled into study. The primary endpoints were virological and biochemical response at week 24 and 48 of the treatment, the secondary endpoint was tolerability of TAF. Mean follow-up period for cirrhotics and LT recipients were 13.7±5.7 and 11.6±4.2 months, respectively.
Results: A total of 146 patients (38 cirrhotics and 108 LT recipients), who had at least 6 months follow-up were included in the analysis. Mean age of cirrhotics and LT recipients were 63±10 years and 58±10 years, respectively. Male gender was predominant (61% vs 74%, respectively). Five percent of the HBV-infected patients were HBeAg-positive, and 12% of the cirrhotic patients were decompensated. Median duration from LT to TAF initiation was 24.5 months (range:0–252 months). Twenty-two patients received TAF treatment as first-line therapy, whereas 124 patients had switched to TAF treatment. Renal dysfunction and osteoporosis were the most common indications for TAF treatment. Baseline median serum ALT levels of cirrhotics and LT-recipients were 25 IU/L (range: 10-96 U/L) and 25 IU/L (range: 5-322 IU/L), respectively. The baseline median HBV DNA level was 51000 IU/mL in cirrhotics and 890 IU/m in LT recipients. Among the LT-recipients, 80% were on tacrolimus-based and 38% on everolimus-based treatments.
Virological response and biochemical response in treatment-naïve patients was 70% and 62% at week 24 and 100% and 85% at week 48, respectively. Overall, serum ALT normalization was achieved in 93% of patients with baseline abnormal ALT level, with a median of 3 months (range 1-16 months). Change in mean ALT levels were compared by linear mixed models. Mean ALT decrease in every 24 week follow-up was - 1.13 IU/ml [95% CI: (-1.8) - (- 0.45), p=0.005] in patients with cirrhosis and - 3.226 IU/ml [95% CI: (- 5.62) - (- 0.84); p=0.009] in the LT recipients. After the switch to TAF treatment, none of the patients experienced HBV reactivation. TAF treatment was well tolerated. No serious adverse events were reported. No graft rejection was observed. From baseline to the last follow-up ALT decrease at every 24 weeks compared by linear mixed model in cirrhotics and LT recipients was significant; -1.13 IU/ml (95% CI: - 1.8- -0.45; p: 0.005) and -3.226 IU/ml (95% CI: - 5.62- -0.84; p: 0.009) respectively.
Conclusion: Based on the preliminary results of this study, TAF is effective and tolerable in HBV-related cirrhotic patients and in liver transplant recipients.