Abe Kensuke, Obara Taku, Kamio Satomi, Kondo Asahi, Imamura Junji, Goto Tatsuya, Ito Toshihiro, Sato Hiroshi, Takahashi Nobuyuki
Division of Clinical Pharmacology and Therapeutics, Graduate School of Pharmaceutical Sciences, Tohoku University, Sendai, Japan.
Department of Pharmacy, National Hospital Organization Sendai Medical Center, 2-11-12 Miyagino, Miyagino-ku, Sendai, Miyagi, 983-8520, Japan.
AIDS Res Ther. 2021 Dec 7;18(1):94. doi: 10.1186/s12981-021-00420-5.
Tenofovir disoproxil fumarate (TDF) has a strong antiviral effect, but TDF is known to cause renal dysfunction. Therefore, we are investigating preventing renal dysfunction by replacing TDF with tenofovir alafenamide fumarate (TAF), which is known to be relatively safe to the kidneys. However, the changes in renal function under long-term use of TAF are not known. In this study, we evaluated renal function in Japanese HIV-1-positive patients switching to TAF after long-term treatment with TDF.
A single-center observational study was conducted in Japanese HIV-1-positive patients. TDF was switched to TAF after at least 48 weeks of the treatment so we could evaluate the long-term use of TDF. The primary endpoint was the estimated glomerular filtration rate (eGFR) at 144 weeks of TAF administration. In addition, we predicted the factors that would lead to changes in eGFR after long-term use of TAF.
Of the 125 HIV-1-positive patients who were prescribed TAF at our hospital during the study period, 70 fulfilled the study criteria. The eGFR at the time of switching from TDF to TAF was 81.4 ± 21.1 mL/min/1.73 m. eGFR improved significantly after 12 weeks of taking TAF but significantly decreased at 96 and 144 weeks. The factors significantly correlated with the decrease in eGFR at 144 weeks on TAF were eGFR and weight at the start of TAF.
In this study, it was confirmed that switching to TAF was effective for Japanese HIV-1-positive patients who had been taking TDF for a long period of time and had a reduced eGFR. It was also found that the transition status depended on the eGFR and weight at the time of switch. Since HIV-1-positive patients in Japan are expected to continue taking TAF for a long time, renal function and body weight should be carefully monitored.
替诺福韦酯(TDF)具有强大的抗病毒作用,但已知TDF会导致肾功能障碍。因此,我们正在研究用对肾脏相对安全的富马酸替诺福韦艾拉酚胺(TAF)替代TDF来预防肾功能障碍。然而,长期使用TAF时肾功能的变化尚不清楚。在本研究中,我们评估了长期接受TDF治疗后改用TAF的日本HIV-1阳性患者的肾功能。
对日本HIV-1阳性患者进行了一项单中心观察性研究。在至少48周的治疗后将TDF换为TAF,以便我们能够评估TDF的长期使用情况。主要终点是TAF给药144周时的估计肾小球滤过率(eGFR)。此外,我们预测了长期使用TAF后导致eGFR变化的因素。
在研究期间,我院125例接受TAF治疗的HIV-1阳性患者中,70例符合研究标准。从TDF转换为TAF时的eGFR为81.4±21.1 mL/min/1.73m²。服用TAF 12周后eGFR显著改善,但在96周和144周时显著下降。与TAF治疗144周时eGFR下降显著相关的因素是开始使用TAF时的eGFR和体重。
在本研究中,证实改用TAF对长期服用TDF且eGFR降低的日本HIV-1阳性患者有效。还发现转换状态取决于转换时的eGFR和体重。由于预计日本的HIV-1阳性患者将长期服用TAF,应仔细监测肾功能和体重。