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在资源有限的环境中,齐多夫定一线治疗在病毒学方面与替诺福韦相当吗?

Is zidovudine first-line therapy virologically comparable to tenofovir in resource-limited settings?

作者信息

Labhardt Niklaus D, Bader Joëlle, Lejone Thabo Ismael, Ringera Isaac, Puga Daniel, Glass Tracy R, Klimkait Thomas

机构信息

Medical Services and Diagnostics, Clinical Research Unit, Swiss Tropical and Public Health Institute, Basel, Switzerland.

University of Basel, Basel, Switzerland.

出版信息

Trop Med Int Health. 2015 Jul;20(7):914-8. doi: 10.1111/tmi.12509. Epub 2015 Apr 2.

Abstract

OBJECTIVE

To compare virologic success between adult patients on tenofovir (TDF) and zidovudine (AZT)-containing first-line antiretroviral (ART) regimens in 10 rural clinics in Lesotho, Southern Africa.

METHODS

Multicentre cross-sectional study, patients ≥16 years, on first-line ART ≥6 months, receiving AZT/lamivudine (3TC) or TDF/3TC combined with efavirenz (EFV) or nevirapine (NVP). Patient characteristics and clinical/therapeutic history were collected on the day of blood draw for viral load (VL). Analysis was stratified for non-nucleoside reverse transcriptase inhibitor (EFV or NVP). A logistic regression model weighted for patients' baseline characteristics was used to assess the likelihood of virologic success (<80 copies/ml) in patients with TDF- as compared to AZT-backbones.

RESULTS

In total 1539 patients were included in the analysis. Most were clinically and immunologically stable (clinical failure: 2.7% (AZT) and 2.8% (TDF); immunological failure: 4.6% (AZT) and 4.8% (TDF)). In EFV-based regimens (n = 1162), TDF was significantly associated with higher rates of virologic suppression than AZT (93.8% vs. 88.1%; weighted odds ratio: 2.15 (95% CI: 1.29-3.58; P = 0.003)). In NVP-based regimens, a similar trend was observed, but not significant (89.4% vs. 86.7%; 1.99 (0.83-4.75, P = 0.121)).

CONCLUSION

These findings support the WHO recommendation to use TDF/3TC/EFV as first-line regimen. They do, however, not support the recommendation that patients who are clinically stable on AZT should continue on this first-line regimen.

摘要

目的

比较在南非莱索托的10家农村诊所中,接受含替诺福韦(TDF)和含齐多夫定(AZT)的一线抗逆转录病毒(ART)方案的成年患者的病毒学治疗成功率。

方法

多中心横断面研究,患者年龄≥16岁,接受一线ART治疗≥6个月,服用AZT/拉米夫定(3TC)或TDF/3TC联合依非韦伦(EFV)或奈韦拉平(NVP)。在采集病毒载量(VL)血样当天收集患者特征及临床/治疗史。分析按非核苷类逆转录酶抑制剂(EFV或NVP)进行分层。使用根据患者基线特征加权的逻辑回归模型评估与以AZT为基础的治疗方案相比,以TDF为基础的治疗方案中患者病毒学治疗成功(<80拷贝/毫升)的可能性。

结果

共有1539例患者纳入分析。大多数患者临床和免疫状况稳定(临床失败:AZT组为2.7%,TDF组为2.8%;免疫失败:AZT组为4.6%,TDF组为4.8%)。在以EFV为基础的治疗方案(n = 1162)中,与AZT相比,TDF与更高的病毒学抑制率显著相关(93.8%对88.1%;加权比值比:2.15(95% CI:1.29 - 3.58;P = 0.003))。在以NVP为基础的治疗方案中,观察到类似趋势,但不显著(89.4%对86.7%;1.99(0.83 - 4.75,P = 0.121))。

结论

这些研究结果支持世界卫生组织使用TDF/3TC/EFV作为一线治疗方案的建议。然而,它们不支持关于在AZT治疗下临床稳定的患者应继续使用该一线治疗方案的建议。

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