Wintergerst U, Hoffmann F, Sölder B, Notheis G, Petropoulou T, Eberle J, Gürtler L, Belohradsky B H
Children's Hospital, Ludwig Maximilians-University Munich, Germany.
Pediatr Infect Dis J. 1998 Jun;17(6):495-9. doi: 10.1097/00006454-199806000-00012.
The effects of two antiretroviral triple combinations including the protease inhibitor indinavir on the surrogate markers, viral load and CD4 cells were evaluated.
Fifteen patients with high viral load or disease progression under their prior antiretroviral therapy were switched to zidovudine/lamivudine/indinavir (Group A, n = 10) or stavudine/lamivudine/indinavir (Group B, n = 5). Serial determinations of viral load and CD4 cells were performed.
The median reduction of the viral load was 0.6 log after 3 months and 0.8 log after 6 months in Group A and 2.5 and 2.4 log after 3 and 6 months in Group B, respectively. After 3 and 6 months 3 of 10 patients in Group A and 3 of 5 patients in Group B had viral load reductions below the detection limit of the assay. Patients with an additional switch of nucleoside analogues at start of indinavir therapy (regardless of the specific reverse transcriptase inhibitor used) had significantly better reductions of the viral load than patients without such a switch (median 2.3 log vs. 0.2 log after 6 months, P < 0.05). In Group A the median of the relative increase of CD4 cells was 37% after 3 months and 57% after 6 months (P = 0.002); in Group B the medians of the relative increase of CD4 cells were 145 and 163% (not significant), respectively. Two patients from Group A and 1 from Group B developed renal calculi, which resolved after adequate hydration. One patient was withdrawn because of intractable vomiting attributed to indinavir.
In a small cohort of HIV-infected pediatric patients with extensive prior antiretroviral treatment, triple therapy including indinavir had a sustained effect on the decrease of the viral load and the increase of CD4 cells similar to results obtained in antiretrovirally experienced adults. This effect was significantly better in patients with an additional switch of a nucleoside analogue at start of triple therapy with indinavir than in patients without such a change.
评估两种包含蛋白酶抑制剂茚地那韦的抗逆转录病毒三联疗法对替代指标、病毒载量和 CD4 细胞的影响。
15 例在先前抗逆转录病毒治疗下病毒载量高或疾病进展的患者，转用齐多夫定/拉米夫定/茚地那韦（A 组，n = 10）或司他夫定/拉米夫定/茚地那韦（B 组，n = 5）。对病毒载量和 CD4 细胞进行系列测定。
A 组病毒载量在 3 个月后中位数下降 0.6 log，6 个月后下降 0.8 log；B 组在 3 个月和 6 个月后分别下降 2.5 和 2.4 log。3 个月和 6 个月后，A 组 10 例患者中有 3 例、B 组 5 例患者中有 3 例病毒载量下降至检测限以下。在茚地那韦治疗开始时额外换用核苷类似物的患者（无论使用何种特定逆转录酶抑制剂），其病毒载量下降明显优于未进行此类换药的患者（6 个月后中位数分别为 2.3 log 和 0.2 log，P < 0.05）。A 组 CD4 细胞相对增加的中位数在 3 个月后为 37%，6 个月后为 57%（P = 0.002）；B 组 CD4 细胞相对增加的中位数分别为 145%和 163%（无统计学意义）。A 组 2 例患者和 B 组 1 例患者出现肾结石，经充分补液后结石溶解。1 例患者因茚地那韦引起的顽固性呕吐而退出研究。
在一小群先前接受广泛抗逆转录病毒治疗的 HIV 感染儿科患者中，包含茚地那韦的三联疗法对病毒载量降低和 CD4 细胞增加具有持续作用，类似于在有抗逆转录病毒治疗经验的成人中获得的结果。在茚地那韦三联疗法开始时额外换用核苷类似物的患者，其效果明显优于未进行此类改变的患者。
