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    First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort
    (Kare Publishing, 2023) Karaşahin, Ömer; Kalkan, İrem Akdemir; Dal, Tuba; Toplu, Sibel Altunışık; Harputluoğlu, Murat; Mete, Ayşe Özlem; Aktar, Fesih; Demir, Yakup; Çelen, Mustafa Kemal
    Background and Aim: In chronic hepatitis B infection, antiviral therapy significantly reduces the incidence of complications. This study aimed to present real-life 12-month effectiveness and safety data for TAF. Materials and Methods: This Pythagoras Retrospective Cohort Study included patients from 14 centers in Turkiye. The study presents 12-month results of 480 patients treated with TAF as initial therapy or after switching from another antiviral drug. Results: The study shows treatment of about 78.1% patients with at least one antiviral agent (90.6% tenofovir disoproxil [TDF]). The rate of unde-tectable HBV DNA increased in both treatment-experienced and naive pa-tients. In TDF-experienced patients, the rate of alanine transaminase (ALT) normalization increased slightly (1.6%) within 12 months, but the change was not statistically significant (p=0.766). Younger age, low albumin, and high body mass index and cholesterol were identified as risk factors for abnormal ALT after 12 months, but no linear relationship was detected. In TDF-experienced patients, renal and bone function indicators showed significant improvement three months after the transition to TAF and remained stable for 12 months. Conclusion: Real-life data demonstrated effective virological and biochemical responses with TAF therapy. After switching to TAF treat-ment, gains in kidney and bone functions were achieved in the early period.
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    Real-life data for tenofovir alafenamide fumarate treatment of hepatitis B: The pythagoras cohort
    (Kowsar Publication, 2021) Karaşahin, Ömer; Kalkan, İrem Akdemir; Dal, Tuba; Toplu, Sibel Altunışık; Harputoğlu, Murat; Mete, Ayşe Özlem; Kömür, Süheyla; Sarigül, Figen; Yıldız, Yeşim; Esmer, Fatih; Kandemir, Özlem; Nazik, Selçuk; İnan, Dilara; Akgül, Fethiye; Kaya, Şafak; Tunç, Nurettin; Balin, Şafak Özer; Bayındır, Yaşar; Taşova, Yeşim; Aktar, Fesih; Ören, Meryem Merve; Ayhan, Merve; Demir, Yakup; Çelen, Mustafa Kemal
    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-DNApolymerase 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 gastroenterology 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 tot = 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.