جستجوی مقالات مرتبط با کلیدواژه « Tenofovir Alafenamide » در نشریات گروه « پزشکی »

 Tenofovir alafenamide (TAF) has been effective against naïve patients with chronic hepatitis B (CHB) in phase 3 clinical trials. However, its real-world data are still limited.

 This study aimed to investigate the effectiveness and safety of TAF in real-life situations in treatment-naïve (TN) and treatment-experienced (TE) CHB patients in China.

 This retrospective study enrolled TAF-treated patients between January 2019 and October 2020 at the outpatient clinic of West China Hospital. The primary endpoint was the rates of virologic response (VR), and the secondary endpoints were the proportion of normal alanine aminotransferase (ALT) and quantitative hepatitis B surface antigen (qHBsAg) levels. Safety endpoints comprised serum lipid profiles, changes in estimated glomerular filtration rate (eGFR), and serum creatinine (Scr).

 A total of 161 TAF-treated patients were enrolled, including 49 TN patients and 112 TE patients. In the TN group, the VR rate at week 96 was 91.7% (22/24), and the proportion of normal ALT at week 96 was 95.8% (23/24). In the TE group, the VR rate at week 96 was 97.2% (69/71), and the proportion of normal ALT at week 96 was 90.1% (64/71). Serum qHBsAg levels decreased from 2930 to 1292 IU/mL in the TN group and 1158 to 533IU/mL in the TE group during 96 weeks of treatment (P = 0.05). For patients in the TN and TE groups, when compared to baseline measurements, serum creatinine increased (+7.91 vs. +6.62 mL/min/1.73m2, P = 0.52) while eGFR decreased (-11.46 vs. -10.90 µmol/L, P = 0.82) at week 96. Simultaneously, triglycerides (TG) (+ 0.39 vs. + 0.31 mmol/L, P = 0.32), total cholesterol (TC) (+0.65 vs. +0.52 mmol/L, P = 0.02), and low-density lipoprotein cholesterol (LDL-C) (+0.25 vs. +0.25 mmol/L, P = 0.60) increased over time.

 TAF was highly effective in TN and TE CHB patients. However, there are potential risks in eGFR decrease and a continuous increase in lipidemia with the prolongation of medication time.

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) may be the right choice.

This study aimed to present real-life data in terms of the efficacy and safety of a TAF/ETV treatment change while receiving TDF.

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.

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).

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.

 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.

 The purpose of the study was to evaluate the effectiveness and reliability of TAF using real-life data.

 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.

 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%).

 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.