HBV抗病毒治疗没有增加肾功能的影响风险

StephenW

Anti-viral regimens did not increase risk for renal effects in HBV

Koklu S. Aliment Pharmacol Ther. 2014;doi:10.1111/apt.13036.  
January 20, 2015

   
Anti-viral therapy did not increase any risk for renal disease among patients with hepatitis B virus infection, with or without renal risk factors before treatment, according to study data.

“Renal impairment during the course of anti-viral treatment of hepatitis B still needs to be clarified whether it is related to anti-viral nephrotoxicity or pre-existing risk factors for renal disease,” the researchers wrote.

To determine any risk factors for renal impairment during anti-viral treatment for HBV, researchers enrolled 2,221 treatment-naive patients with chronic HBV from various centers in Turkey, who were receiving treatment with lamivudine, telbivudine (Tyzeka, Novartis), entecavir, tenofovir (Viread, Gilead Sciences) or adefovir. The Modification of Diet in Renal Disease formula was used to calculate the glomerular filtration rate (GFR) of each patient. Approximately 895 patients underwent anti-viral treatment for at least 24 months and had “repeated measures” at baseline and 1, 6, 12 and 24 months of follow-up, according to the research. The patients in the telbivudine and adefovir groups were excluded from the final analyses due to a low number of patients receiving those anti-virals.

Overall, 239 patients (27.9%) with repeated measures had cirrhosis and 65 had decompensated cirrhosis. In patients without cirrhosis and those with compensated cirrhosis, GFR decreased over time among patients who received therapy with tenofovir (P=.001), but remained unchanged among all other groups. In addition, creatinine levels increased over time in the tenofovir group (P=.001), but did not change in any other anti-viral therapy group. Calcium and phosphate serum levels did not change over time in any group. Five patients in the tenofovir group and three patients in the lamivudine group developed transient hypophosphataemia.

Among patients with decompensated cirrhosis, GFR decreased among patients receiving tenofovir therapy (P=.001) and creatinine levels increased in the tenofovir group (P=.001), but remained unchanged in the lamivudine and entecavir groups. Very few patients with decompensated cirrhosis had repeated measures of calcium and phosphate serum, so they were not used in the statistical analysis among this group of patients, according to the research.  

GFR difference was higher in the tenofovir patients compared with other groups at 1 month, but were comparable at other months.

Risk factors for renal disease, including diabetes, coinfection with HIV and active glomerulonephritis, were not found to be independent risk factors for renal dysfunction, according to the research.

“Tenofovir caused a decline in GFR at both short- and long-term follow-ups,” the researchers concluded. “However, that decline was mild and seemed to give a minimal clinical effect.”

The researchers added, “Continuous renal monitoring, including GFR and serum creatinine and phosphate, is necessary while using any anti-viral drug against hepatitis B.”

Disclosure: The researchers report no relevant financial disclosures.

StephenW

抗病毒治疗方案没有增加风险的HBV肾功能的影响

Koklu S. ALIMENT药理有。 2014年，DOI：10.1111/ apt.13036。
2015年1月20日

   
根据研究数据的抗病毒疗法没有增加对肾脏疾病的风险的患者中乙型肝炎病毒感染，有或没有治疗前肾风险因素，。

“抗病毒治疗乙肝的过程中，肾功能损害仍然需要澄清是否与抗病毒的肾毒性或预先存在的危险因素，肾脏疾病，”研究人员写道。

为了在抗病毒治疗HBV确定任何风险因素，肾功能损害，研究人员招收2221治疗过的患者与土耳其各中心，谁是拉米夫定，替比夫定（Tyzeka，诺华公司），恩替卡韦，替诺福韦（接受治疗的慢性HBV Viread的，Gilead Sciences公司）或阿德福韦。饮食的肾脏疾病的式的变形例是用来计算每个患者的肾小球滤过率（GFR）。大约有895例患者接受抗病毒治疗至少24个月，在基线和1，6，12和随访24个月内曾“反复措施”，根据研究。被排除在最终的替比夫定和阿德福韦组病人进行分析，由于接收这些抗病毒剂的患者数低。

总体而言，239例（27.9％）与重复测量了肝硬化和65有失代偿性肝硬化。患者无肝硬化和那些代偿性肝硬化，GFR下降随着时间的推移之间谁接受治疗替诺福韦（P =0.001）的患者，但仍保持所有其他群体之间不变。此外，肌酸酐水平随时间增加的替诺福韦组（P =0.001）中，但在任何其它抗病毒治疗组并没有改变。钙和磷酸盐血清水平没有随时间推移，在任何组中发生变化。五名病人的替诺福韦组3例拉米夫定组开发的瞬时低磷酸盐血症。

其中失代偿性肝硬化，肾小球滤过率下降在接受替诺福韦治疗（P =0.001）的患者和肌酐水平的替诺福韦组（P =0.001）增加，但仍维持在拉米夫定和恩替卡韦组不变。极少数病人有肝硬化失代偿期曾多次钙，磷血清措施，所以他们并没有在本组患者中的统计分析中，根据研究。

GFR差异有较高的替诺福韦的病人与其他组1个月时相比，但具有可比性的其他月份。

风险因素为肾脏疾病，包括糖尿病，共感染与HIV和活跃性肾小球肾炎，均未发现是独立的危险因素为肾功能不全，根据研究。

“替诺福韦造成GFR下降，在短期和长期的随访，”研究人员得出结论。 “不过，这种下降是温和，似乎给了一个最小的临床治疗效果。”

研究人员补充说，“连续性肾脏监测，包括GFR和血清肌酐和磷酸盐，而使用任何抗病毒的药物对乙肝是必要的”

披露：研究人员报告没有相关财务披露。

战天斗hbv

好事，核苷类很安全