Voigt E, Wickesberg A, Wasmuth J-C, Gute P, Locher L, Salzberger B, Wöhrmann A, Adam A, Weitner L, Rockstroh J K
Department of Internal Medicine I, University of Bonn, Germany.
HIV Med. 2002 Oct;3(4):277-82. doi: 10.1046/j.1468-1293.2002.00123.x.
To evaluate safety and efficacy of the protease inhibitor combination ritonavir/indinavir 100/800 mg twice daily plus 2-3 nucleoside reverse transcriptase inhibitors (NRTI) in antiretroviral-naive patients.
Within this open-label, uncontrolled multicentre trial, antiretroviral-naive patients (n = 57) with median baseline HIV-RNA of 308,000 copies/mL (range 170-3.01 million copies/mL) and median CD4 cell count of 50 cells/microL (range 0-853 cells/microL) were started on 2-3 NRTIs plus ritonavir/indinavir 100/800 mg twice daily. CD4 cell counts and HIV-RNA were determined at weeks 0, 4, 8, 12, 16, 20, 24 and 48. Statistical analysis was performed on treatment as well as intent-to-treat.
Viral load decreased by a median of 3.79 log10 copies/mL (range 2.0-4.60 log10 copies/mL) until week 48. At week 48, 23/57 (40%, intent-to-treat) patients showed a viral load </= 80 copies/mL. In parallel, median CD4 cell counts increased by a median of 149 cells/microL (range -60-420 cells/microL). Median triglycerides and cholesterol increased from baseline 160 mg/dL (range 33-364 mg/dL) to 218 mg/dL (range 110-527 mg/dL) at week 48 and from 166 mg/dL (range 63-262 mg/dL) to 233 mg/dL (range 95-359 mg/dL), respectively. Twenty-seven of fifty-seven patients (47%) discontinued study medication, 19 (33%) due to nephrolithiasis. Two patients changed their antiretroviral regimen after failing virologically.
Ritonavir/indinavir 100/800 mg twice daily appears to be effective up to 48 weeks despite high baseline viraemia and low CD4 cell count in antiretroviral-naive patients. However, discontinuation due to adverse events, especially nephrotoxicity, is frequent and limits treatment duration. Therefore, extra hydration appears inevitable with this combination.
评估蛋白酶抑制剂组合利托那韦/茚地那韦每日两次，每次100/800毫克，联合2 - 3种核苷类逆转录酶抑制剂（NRTI）用于初治抗逆转录病毒治疗患者的安全性和有效性。
在这项开放标签、非对照的多中心试验中，对初治抗逆转录病毒治疗患者（n = 57）进行研究，这些患者基线HIV - RNA中位数为308,000拷贝/毫升（范围170 - 301万拷贝/毫升），CD4细胞计数中位数为50个/微升（范围0 - 853个/微升），开始接受2 - 3种NRTI联合利托那韦/茚地那韦每日两次，每次100/800毫克的治疗。在第0、4、8、12、16、20、24和48周测定CD4细胞计数和HIV - RNA。对治疗组和意向性治疗组进行统计分析。
到第48周时，病毒载量中位数下降了3.79 log10拷贝/毫升（范围2.0 - 4.60 log10拷贝/毫升）。在第48周时，23/57（40%，意向性治疗）的患者病毒载量≤80拷贝/毫升。与此同时，CD4细胞计数中位数增加了149个/微升（范围 - 60 - 420个/微升）。甘油三酯和胆固醇中位数在第48周时分别从基线的160毫克/分升（范围33 - 364毫克/分升）增加到218毫克/分升（范围110 - 527毫克/分升），以及从166毫克/分升（范围63 - 262毫克/分升）增加到233毫克/分升（范围95 - 359毫克/分升）。57名患者中有27名（47%）停止了研究用药，19名（33%）是由于肾结石。两名患者在病毒学治疗失败后更改了抗逆转录病毒治疗方案。
对于初治抗逆转录病毒治疗患者，尽管基线病毒血症高且CD4细胞计数低，但利托那韦/茚地那韦每日两次，每次100/800毫克在48周内似乎是有效的。然而，由于不良事件，尤其是肾毒性导致的停药很常见，限制了治疗持续时间。因此，使用这种组合时额外补充水分似乎是不可避免的。
