Winston A, McAllister J, Amin J, Cooper D A, Carr A
Department of Immunology, HIV and Infectious Diseases, St Vincent's Hospital, National Centre for HIV Epidemiology and Clinical Research, Sydney, NSW, Australia.
HIV Med. 2005 May;6(3):191-7. doi: 10.1111/j.1468-1293.2005.00288.x.
Nonoccupational post-exposure prophylaxis (NPEP) for HIV is recommended after high-risk sexual exposure. Because of the high incidence of intolerable side effects observed with protease inhibitor- and zidovudine-based NPEP regimens, our unit changed standard NPEP treatment to 28 days of tenofovir-lamivudine-stavudine (TDF-3TC-d4T). The aim of this study was to compare side effects and numbers of individuals completing NPEP before and after this change.
Parameters were compared amongst individuals commencing the following NPEP regimens: zidovudine-lamivudine (ZDV-3TC), zidovudine-lamivudine-nelfinavir (ZDV-3TC-NFV) and TDF-3TC-d4T.
A total of 385 individuals received ZDV-3TC (n = 36), ZDV-3TC-NFV (n = 225) or TDF-3TC-d4T (n = 137) as NPEP for the first time between June 1999 and November 2003. Noncompletion rates were 25%, 32% and 15%, respectively (P = 0.001), with odds ratios for noncompletion being 2.0 [95% confidence interval (CI) 0.8-4.8] and 2.7 (95% CI 1.6-4.8) in the first two groups compared with the TDF-3TC-d4T group (P = 0.008). Adverse events were less common in the TDF-3TC-d4T group, with significantly lower rates of nausea and headache, but significantly higher rates of peripheral neuropathy and asymptomatic raised transaminases. There was no HIV seroconversion in any group.
TDF-3TC-d4T is significantly better tolerated than ZDV-3TC or ZDV-3TC-NFV as NPEP and results in greater numbers of individuals completing 28 days of treatment.
对于高危性接触后,建议进行非职业性暴露后预防(NPEP)以预防HIV感染。鉴于基于蛋白酶抑制剂和齐多夫定的NPEP方案出现难以耐受的副作用的发生率较高,我们单位将标准NPEP治疗改为使用替诺福韦-拉米夫定-司他夫定(TDF-3TC-d4T)进行28天治疗。本研究的目的是比较这一改变前后的副作用以及完成NPEP治疗的个体数量。
对开始使用以下NPEP方案的个体的参数进行比较:齐多夫定-拉米夫定(ZDV-3TC)、齐多夫定-拉米夫定-奈非那韦(ZDV-3TC-NFV)和TDF-3TC-d4T。
1999年6月至2003年11月期间,共有385名个体首次接受ZDV-3TC(n = 36)、ZDV-3TC-NFV(n = 225)或TDF-3TC-d4T(n = 137)作为NPEP治疗。未完成治疗率分别为25%、32%和15%(P = 0.001),与TDF-3TC-d4T组相比,前两组未完成治疗的比值比分别为2.0 [95%置信区间(CI)0.8 - 4.8]和2.7(95% CI 1.6 - 4.8)(P = 0.008)。TDF-3TC-d4T组不良事件较少见,恶心和头痛发生率显著较低,但外周神经病变和无症状转氨酶升高发生率显著较高。任何组均未发生HIV血清转化。
作为NPEP治疗,TDF-3TC-d4T的耐受性明显优于ZDV-3TC或ZDV-3TC-NFV,且能使更多个体完成28天的治疗。