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- Title
Tenofovir alafenamide in HBV: Real life data from Turkey.
- Authors
Tabak, Fehmi; Yörük, Gülşen; Köksal, Iftihar; Erdem, Hazal; Yıldız, Dilek; Ince, Nevin; Yamazhan, Tansu; Sürme, Serkan; Batırel, Ayşe; Günal, Özgür; Yıldız, Ilknur Esen; Sırmatel, Fatma; Koç, Meliha Meriç; Çeken, Sabahat; Bozkurt, Ilkay; Görenek, Levent; Senel, Alper; Kose, Sukran; Turker, Kamuran; Inan, Dilara
- Abstract
INTRODUCTION: Tenofovir alafenamide (TAF) is a novel nucleotide reverse transcriptase inhibitor used for the treatment of HIV-1 and HBV infections. It provides higher intracellular tenofovir concentrations and lower serum levels. TAF is expected to have efficacy similar to that of tenofovir disoproxil fumarate (TDF) while reducing tenofovir-associated nephrotoxicity and bone mineral density losses. Following the launch of TAF in Turkey, it has been used widely in HBV treatment and prophylaxis. We studied TAF use in HBV patients in a real life setting across the country. PATIENTS & METHODS: Treatment-naïve, treatment-experienced chronic HBV patients, and HBV carriers given prophylaxis were included. Twenty-six centers from 15 cities were enrolled. Patients' demographics, laboratory studies at baseline (or before TAF) and during TAF treatment were recorded. Data at baseline, in 6th month and in 12th month were compared.. RESULTS: The study included 521 patients: 71 treatment-naïve, 391 treatment-experienced, and 58 given prophylaxis. Among naïve patients, median age was 48 years, male 35 (48.6%), HBeAg-negative 43 (84.3%), median ALT 33 U/L, median fibrosis score 2, and median histologic activity index (HAI) 7. HBV-DNA <20 IU/mL was achieved in 79.4% in 6th month and 84.7% in 12th month. ALT normalization (<35 U/L for men, <25 for women) was 45.6% at baseline, 76.3% in 6th month and 77.8% in 12th month. Creatinine levels and eGFR remained stable from baseline to 6th and 12th months (0.8 mg/dl, 0.97 mg/dl, and 0.78 mg/dl; 90.5 mL/min, 89.5 mL/min, and 101 ml/min, respectively). Among experienced patients, median age was 44 years, male 235 (60.1%), HBeAg-negative 238 (85%), median ALT 23 U/L, median fibrosis score 2, and HAI 7. They were previously using TDF (81.6%), entecavir (8.2%), lamivudine (6.1%), telbivudine (2.9%), and adefovir (1.1%). HBV-DNA <20 IU/mL was 80.7% at baseline. It became 89% in 6th month and 91.5% in 12th month. ALT normalization was 71.6% at baseline, 81.5% in 6th month and 83.9% in 12th month. Creatinine levels and eGFR remained stable from baseline to 6th and 12th months (0.86 mg/dl, 0.86 mg/dl, and 0.88 mg/dl; 92 mL/min, 84.2 mL/min, and 87.2 ml/min, respectively). Among patients given TAF prophylaxis, median age was 57 years, male 24 (41.4%), HBeAg-negative 90.3%, HBsAg-negative 64.3%, and median ALT 20 U/L. ALT normalization was 74.5% at baseline, 73.5% in 6th month and 72% in 12th month. Creatinine levels and eGFR remained stable from baseline to 6th and 12th months (0.97 mg/dl, 0.85 mg/dl, and 0.77 mg/dl; 58 mL/min, 96 mL/min, and 92.5 ml/min, respectively). Among all patients, TAF was tolerated well. Side effects were headache (42, 8.1%), nausea (20, 3.8%), fatigue (19, 3.6%), and rash (6, 1.2%).. CONCLUSION: Real life data confirmed the efficacy and safety of TAF in treatment-naïve, treatment-experienced HBV patients and those given TAF prophylaxis.
- Subjects
TENOFOVIR; REVERSE transcriptase inhibitors; HEPATITIS B virus; PREVENTIVE medicine; CREATININE
- Publication
Hepatology Forum, 2021, p22
- ISSN
1307-5888
- Publication type
Article