Treatment of Chronic Hepatitis B Virus Infection with Tenofovir Formamide
Articles: Clinical Pharmacology Expert Comments
Introduction: In April 2017 tenofovir alafenamide (TAF) was added to the list of first-line therapies recommended for chronic hepatitis B (CHB). TAF has pharmacology similar to tenofovir disoproxil fumarate (TDF) with higher cell delivery to the hepatocytes but less systemic exposure.
Areas covered: We review here studies leading to TAF’s approval and comparing it to TDF. In two major clinical trials, TAF was non-inferior to TDF in achieving HBV DNA levels below 29 IU/ml. TAF-treated patients had significantly smaller decreases in bone mineral density (BMD) at the hip and spine in both HBeAg-positive and HBeAg-negative patients, and smaller mean increases in serum creatinine, although the difference was only statistically significant in HBeAg-positive patients. Patients treated with TDF for 96 weeks and then switched to TAF had improvements in renal and BMD measures only 24 weeks after switchin
Expert commentary: With clear evidence from major studies showing that TAF is safe, tolerable, and non-inferior to TDF, its recommendation as a first-line therapy is appropriate. Longer term follow up will be required to determine if the differences in adverse bone and kidney effects seen with TAF in comparison to TDF will be clinically relevant.
Citation: Syed Abdul Basit, Altaf Dawood, John Ryan & Robert Gish (2017) Tenofoviralafenamide for the treatment of chronic hepatitis B virus infection, Expert Review of ClinicalPharmacology, 10:7, 707-716, DOI: 10.1080/17512433.2017.1323633 作者: StephenW 时间: 2017-6-16 18:31
覆盖范围:我们在这里审查导致TAF批准并与TDF进行比较的研究。在两项主要临床试验中,TAF在实现HBV DNA水平低于29 IU / ml的情况下不逊于TDF。在HBeAg阳性和HBeAg阴性患者中,TAF治疗的患者的髋关节和脊柱骨矿物质密度(BMD)显着降低,血清肌酐平均升高较小,但HBeAg阳性率差异无统计学意义耐心。用TDF治疗96周,然后切换到TAF的患者在切换后24周仅改善肾和BMD测量。
引用:Syed Abdul Basit,Altaf Dawood,John Ryan&Robert Gish(2017)Tenofoviralafenamide for the treatment of chronic hepatitis B virus infection,Expert Review of ClinicalPharmacology,10:7,707-716,DOI:10.1080 / 17512433.2017.1323633作者: StephenW 时间: 2017-6-16 18:37