Real-life data for tenofovir alafenamide fumarate treatment of hepatitis B: The pythagoras cohort


KARAŞAHİN Ö., Kalkan I. A., Dal T., ALTUNIŞIK TOPLU S., Harputoğlu M., Mete A. O., ...Daha Fazla

Hepatitis Monthly, cilt.21, sa.2, 2021 (SCI-Expanded, Scopus)

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 21 Sayı: 2
  • Basım Tarihi: 2021
  • Doi Numarası: 10.5812/hepatmon.104943
  • Dergi Adı: Hepatitis Monthly
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, CAB Abstracts, CINAHL, EMBASE, Veterinary Science Database
  • Anahtar Kelimeler: Bone Mineral Density, Hepatitis B, Chronic Hepatitis B, Glomerular Filtration Rate, Tenofovir Alafenamide, Real Life, Tenofovir Disoproxil
  • Sağlık Bilimleri Üniversitesi Adresli: Evet

Özet

Background: Chronic hepatitis B (CHB) is a viral infection that can result in life-threatening conditions, such as hepatocellular carcinoma and cirrhosis. Tenofovir, which is used for the treatment of CHB, is a nucleotide analog that inhibits HBV-DNA polymerase and has two formulations: disoproxil and alafenamide. In contrast to tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF) penetrates the whole hepatocyte without being eliminated due to its longer plasma half-life and greater plasma stability. As a result, side effects such as proximal renal tubulopathy and loss of bone density are less common in the treatment of TAF and have similar efficacy to TDF. Objectives: The purpose of the study was to evaluate the effectiveness and reliability of TAF using real-life data. Methods: This retrospective cohort study was carried out in secondary or tertiary healthcare centers in southern Turkey. A total of 480 patients aged 18 years and older were administered TAF for an appropriate indication by the infectious diseases and gastroen-terology clinics of the healthcare centers participating in this study. The data collected at t = 0, t = 3, and t = 6 months of treatment were analyzed. The chi-square, Mann-Whitney U, Friedman, Wilcoxon, Cochran’s Q, and McNemar’s tests were used. Results: The mean age of the patients was 47.40 ± 14.5, and 327 of them (68.1%) were male. A total of 78.1% of the 480 patients who underwent the TAF treatment had previous antiviral therapy experience (TDF, n = 340; 70.8 %), and 21.9% were treatment-naive. The most common reasons for the initiation of TAF treatment were the use of drugs affecting bone mineral density (BMD) (42.9%) and osteoporosis (22.3%). Patients who had taken TDF experienced a significant improvement in glomerular filtration rate (GFR), hip and spine T-scores, and phosphorus levels from t = 0 months to t = 6 months after switching to TAF (P < 0.05). For this group, no statistically significant difference was observed concerning LDL and cholesterol levels from t = 0 months to t = 6 months. Side effects were reported by 5.7% of patients in the third month and 7.1% in the sixth month, with the most common side effect being hair loss (1%). Conclusions: TAF was found to be an effective and safe alternative to TDF with lower incidences of its long-term effects, such as nephrotoxicity and decreased bone density.