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Öğe Comparison of Tenofovir Alafenamide and Entecavir Therapy in Patients with Chronic Hepatitis B Initially Treated with Tenofovir Disoproxil: A Retrospective Observational Survey(Briefland, 2021) Kalkan, Irem Akdemir; Karasahin, Omer; Sarigul, Figen; Toplu, Sibel Altunisik; Aladag, Murat; Akgul, Fethiye; Mete, Ayse OzlemBackground: In chronic hepatitis B patients with or exposed to the risk of osteoporosis or renal dysfunction, switching from tenofovir disoproxil fumarate (TDF) to tenofovir alafenamide fumarate (TAF) or entecavir (ETV) maybe the right choice. Objectives: This study aimed to present real-life data in terms of the efficacy and safety of a TAF/ETV treatment change while receiving TDF. Methods: This retrospective study was conducted on 344 adult patients from 10 centers. The data of patients who had changed to ETV (n = 107) and TAF (n = 237) while receiving TDF were analyzed. The data collected at 0 and 6 months of treatment were analyzed. The virological response was assessed based on undetected hepatitis B virus (HBV) DNA. Serum alanine aminotransferase (ALT) values were used to evaluate the biochemical response. For renal function, serum creatinine and phosphorus, as well as estimated glomerular filtration rate (eGFR), were recorded. Moreover, lumbar spine and hip T-scores along with the serum lipid profile were evaluated. Results: The mean age of patients was 41.14 +/- 13.46 years, and 224 (65.1%) of the participants were male. The treatment arms were not significantly different in terms of demographic characteristics, comorbid diseases, infection duration, family history of HBV infection, blood platelet count, serum biomarkers, such as ALT, phosphorus, creatinine, total bilirubin, albumin, lipid profile, and HBV DNA levels at the beginning. No statistically significant difference was found between the proportion of undetectable HBV DNA of the two treatment groups after 6 months (P = 0.221). The ALT normalization in the ETV and TAF groups at the sixth month compared to the baseline levels was not significantly different (P = 0.853, P = 0.330, respectively). There was no statistically significant difference between the two treatment arms regarding changes in eGFR, creatinine, phosphorus, hip, and spine T-scores from baseline to 6 months (P = 0.296, P = 0.78, P = 0.141, P = 0.832, P = 0.947, respectively). In those who switched to TAF or ETV, low-density lipoproteins cholesterol were observed to be significantly higher after 6 months compared to baseline values (P = 0.002, P = 0.049, respectively). The TC increased significantly in the TAF group (P = 0.035). Conclusions: Our study showed that switching to ETV and TAF sustained the viral suppression and biochemical response achieved by TDF therapy. The treatment switch to TAF of ETV can control renal dysfunction and reduce bone mineral density caused by TDF.Öğe First year real life experience with tenofovir alafenamide fumarate: The pythagorean cohort(Kare Publ, 2023) Karasahin, Omer; Kalkan, Irem Akdemir; Dal, Tuba; Toplu, Sibel Altunisik; Harputluoglu, Murat; Mete, Ayse Ozlem; Komur, SuheylaBackground 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 undetectable HBV DNA increased in both treatment-experienced and naive patients. 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 treatment, gains in kidney and bone functions were achieved in the early period.Öğe Real-life Data for Tenofovir Alafenamide Fumarate Treatment of Hepatitis B: the Pythagoras Cohort(Briefland, 2021) Karasahin, Omer; Kalkan, Irem Akdemir; Dal, Tuba; Toplu, Sibel Altunisik; Harputoglu, Murat; Mete, Ayse Ozlem; Komur, SuheylaBackground: 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.Öğe REAL-LIFE EXPERIENCE OF TENOFOVIR ALAFENAMIDE FUMARATE: THE PYTHAGOREAN COHORT(Wiley, 2021) Karasahin, Omer; Kalkan, Irem Akdemir; Dal, Tuba; Toplu, Sibel Altunisik; Harputoglu, Murat; Mete, Ayse Ozlem; Komur, Suheyla[Abstract Not Available]
