基线CD4＜50个细胞/立方毫米与CD4≥50个细胞/立方毫米的HIV感染患者之间，司他夫定、拉米夫定和奈韦拉平抗逆转录病毒疗法通用固定剂量组合的安全性和疗效。
Safety and efficacy of a generic fixed-dose combination of stavudine, lamivudine and nevirapine antiretroviral therapy between HIV-infected patients with baseline CD4 <50 versus CD4 > or = 50 cells/mm3.
作者信息
Manosuthi Weerawat, Chimsuntorn Sukanya, Likanonsakul Sirirat, Sungkanuparph Somnuek
机构信息
Bamrasnaradura Infectious Diseases Institute, Ministry of Public Health, Nonthaburi, 11000, Thailand.
出版信息
AIDS Res Ther. 2007 Mar 13;4:6. doi: 10.1186/1742-6405-4-6.
BACKGROUND
Antiretroviral therapy (ART) with a generic fixed-dose combination (FDC) of stavudine (d4T)/lamivudine (3TC)/nevirapine (NVP) is widely used in developing countries. The clinical data of this FDC among very advanced HIV-infected patients is limited.
METHODS
A retrospective cohort study was conducted among ART-naïve HIV-infected patients who were initiated a generic FDC of d4T/3TC/NVP between May 2004 and October 2005. Patients were categorized into 2 groups according to the baseline CD4 (group A: <50 cell/mm3 and group B: > or = 50 cell/mm3).
RESULTS
There were 204 patients with a mean +/- SD age of 37.1 +/- 8.9 years, 120 (58.8%) in group A and 84 (41.2%) in group B. Median (IQR) CD4 cell count was 6 (16-29) cells/mm3 in group A and 139 (92-198) cells/mm3 in group B. Intention-to-treat analysis at 48 weeks, 71.7% (86/120) of group A and 75.0% (63/84) of group B achieved plasma HIV RNA <50 copies/ml (P = 0.633). On-treatment analysis, 90.5% (87/96) in group A and 96.9% (63/65) in group B achieved plasma HIV RNA <50 copies/ml (P = 0.206). At 12, 24, 36 and 48 weeks of ART, mean CD4 were 98, 142, 176 and 201 cells/mm3 in group A and 247, 301, 336 and 367 cells/mm3 in group B, respectively. There were no differences of probabilities to achieve HIV RNA <50 copies/ml (P = 0.947) and CD4 increment at 48 weeks between the two groups (P = 0.870). Seven (9.6%) patients in group A and 4 (8.5%) patients in group B developed skin reactions grade II or III (P = 1.000). ALT at 12 weeks was not different from that at baseline in both groups (P > 0.05).
CONCLUSION
Initiation of FDC of d4T/3TC/NVP in HIV-infected patients with CD4 <50 and > or = 50 cells/mm3 has no different outcomes in terms of safety and efficacy. FDC of d4T/3TC/NVP can be effectively used in advance HIV-infected patients with CD4 <50 cells/mm3.
背景
由司他夫定（d4T）/拉米夫定（3TC）/奈韦拉平（NVP）组成的通用型固定剂量复方（FDC）抗逆转录病毒疗法（ART）在发展中国家广泛应用。该FDC在极晚期HIV感染患者中的临床数据有限。
方法
对2004年5月至2005年10月间开始使用d4T/3TC/NVP通用型FDC的初治HIV感染患者进行回顾性队列研究。根据基线CD4水平将患者分为两组（A组：<50个细胞/mm3，B组：≥50个细胞/mm3）。
结果
共204例患者，平均年龄为37.1±8.9岁，A组120例（58.8%），B组84例（41.2%）。A组CD4细胞计数中位数（IQR）为6（16 - 29）个细胞/mm3，B组为139（92 - 198）个细胞/mm3。48周意向性分析时，A组71.7%（86/120）和B组75.0%（63/84）的血浆HIV RNA<50拷贝/ml（P = 0.633）。治疗中分析时，A组90.5%（87/96）和B组96.9%（63/65）的血浆HIV RNA<50拷贝/ml（P = 0.206）。在ART的12、24、36和48周时，A组平均CD4分别为98、142、176和201个细胞/mm3，B组分别为247、301、336和367个细胞/mm3。两组在48周时实现HIV RNA<50拷贝/ml的概率（P = 0.947）和CD4增加量（P = 0.870）无差异。A组7例（9.6%）和B组4例（8.5%）患者发生II级或III级皮肤反应（P = 1.000）。两组12周时的ALT与基线时无差异（P>0.05）。
结论
对于CD4<50和≥50个细胞/mm3的HIV感染患者，起始使用d4T/3TC/NVP FDC在安全性和疗效方面无差异。d4T/3TC/NVP FDC可有效用于CD4<50个细胞/mm3的晚期HIV感染患者。
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