佳息患联合施多宁治疗HIV感染者/AIDS患者6个月效果及耐药性初步观察

Pilot study on efficacy and drug resistnace of highly active antiretroviral therapy combining Indinavir with Efavirenz in Chinese HIV/AIDS patients

目的探讨规范化应用蛋白酶抑制剂茚地那韦(Indinavir,佳息患)联合非核苷类逆转录酶抑制剂依非韦仑(Efavirenz,施多宁)治疗艾滋病病毒(HIV)感染者/AIDS患者的疗效和耐药情况。方法用施多宁联合佳息患对10例HIV感染者/AIDS患者进行为期6个月的治疗,于治疗前,治疗第1、3、6个月随访,监测病毒学和免疫学参数[病毒载量(VL)、CD4+细胞绝对计数、CD4+和CD8+免疫活化标志HLA-DR、CD3+8],药物毒副作用,基因型耐药变异情况,临床表现和依从性。结果10例HIV感染者/AIDS患者治疗前平均VL为5.17log拷贝/ml(3.58×105拷贝/ml),治疗6个月后平均下降3.25log拷贝/ml(P<0.001),其中9例达到检测不出的水平(<400拷贝/ml)。CD4+T细胞绝对计数平均上升178个/μl(P<0.001)。CD3+8HLA-DR+CD4+细胞平均百分比和CD3+8HLA-DR+CD8+细胞平均百分比分别降低了14.9%(P<0.01)和22.9%(P<0.001)。病人临床症状缓解且耐受性良好,无严重不良反应发生。10例患者在治疗前和治疗6个月后均未出现原发耐药变异。结论佳息患联合施多宁规范化治疗不同感染阶段的中国HIV感染者/AIDS患者6个月,可有效抑制HIV-1复制,促进机体免疫重建,改善临床症状,提高生活质量,副作用在可接受范围内,无原发耐药变异发生。

Objective To evaluate efficacy and drug resistance of regimen combining Indinavir with Efavirenz in Chinese HIV/AIDS patients. Methods Ten HIV-1 sero-positive individuals were recruited and treated with Indinavir and Efavirenz for six months. Viral load, CD4^＋ T lymphocyte absolute count and expression of HLA-DR and CD38^＋ on CD4^＋ and CD8 T cells,drug resistance genes, clinical manifestations, drug related adverse events and adherence were monitored before and 1,3,6 months after treatment. Results The average level of viral load was 5.17 log copies/ml（3.58×10^5 copies/ml） at baseline and decreased by 3.25 log copies/ml after 6-month treatment （ P〈0. 001 ）. The viral load level of 90 percent of the subjects became undetectable（〈400 copies/ml）.The mean CD4T celll counts of the ten patients increased significantly from 165 cells/μl to 343 cells/μl （P〈0.001）. The mean percentage of CD4^＋ and CD8^＋ T cells expressing CD38^＋ HLA-DR^＋ decreased by 14.9% （P〈0.01） and 22.9% （P〈0.001） respectively. Symptom of some patients was relieved. Drug related adverse reactions were mild and no severe side effects occurred to make the subjects＇ discontinue the therapy. No primary resistance mutation was observed during follow up. Conclusions The combination of Indinavir and Efavirenz showed excellent efficacy at 24 weeks with suppression of HIV-RNA, recovery of immune functions and improvement of life quality. The regimen is well tolerated without discontinuations due to adverse reactions and no primary resistance mutation was observed during the follow up.