Immunological outcomes of Tenofovir versus Zidovudine-based regimens among people living with HIV/AIDS: a two years retrospective cohort study
Immunological outcomes of Tenofovir versus Zidovudine-based regimens among people living with HIV/AIDS: a two years retrospective cohort study
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DOI：
10.1186/s12981-017-0132-4
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发表时间：
2017-02-01
影响因子：
2.2
通讯作者：
Mamo, Girma
中科院分区：
文献类型：
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作者：
Ayele, Teshale;Jarso, Habtemu;Mamo, Girma
背景：据报道，以替诺福韦（TDF）为基础的方案具有更好的免疫结果。不幸的是，由于该方案自2013年开始在埃塞俄比亚常规使用，因此关于该方案的免疫结果的信息有限。方法：在埃塞俄比亚亚的斯亚贝巴西南346公里的吉马大学专科医院进行了一项为期2年的回顾性队列研究。从2015年2月10日至2015年3月10日的病历中提取2012年9月至2014年7月的280例患者数据。使用简单的随机抽样技术选择记录。收集社会人口、临床和药物相关变量的数据；输入EpiData 3.1，并通过STATA 13.1进行分析。采用混合效应线性回归评估各组间CD4+变化的差异，调整基线特征。预测CD4计数的变化归因于每个方案也通过边际分析进行评估。随机效应线性回归斜率P < 0.05作为相关性存在的指标。结果：TDF组和AZT组的平均随访时间（SD）分别为714.2（69.6）天和708.8（78.9）天（P = 0.753）。TDF组和AZT组的最短随访时间分别为7.4个月和8.9个月。大多数TDF组（93.6%）和AZT组（91.4%）完成随访，TDF组5例（3.6%）和AZT组6例（4.3%）死亡，TDF组4例（2.9%）和AZT组6例（4.3%）失访（P = 0.769）。两组患者免疫功能恢复随时间的变化差异有统计学意义（B = + 34.08, 95% CI [7.8, 60.35], P = 0.027）。预测TDF/3TC/EFV CD4+计数为（B = + 347.65 cells/mm(3), P < 0.001）， AZT/3TC/EFV CD4+计数为（B = + 281.54 cells/mm(3), P < 0.001）。结论：基于TDF的方案比基于AZT的方案更有效，尽管基于AZT的方案在埃塞俄比亚等低收入国家更负担得起。然而，我们建议在TDF使用者中进行进一步的质量设计研究，以评估这种情况下CD4+次优反应（CD4净增益< 50个细胞/ μ l/6个月）的发生率。
Background: Tenofovir (TDF) based regimen was reported to have better immunological outcomes. Unfortunately, there is limited information regarding the immunologic outcome associated with this regimen in Ethiopia, as its routine utilization in this setting begun since 2013.Methods: A 2 years retrospective cohort study was conducted at Jimma University Specialized Hospital, 346 km Southwest of Addis Ababa, Ethiopia. A total of 280 patients' data from September 2012 to July 2014 was extracted from records from February 10, 2015 to March 10, 2015. Records were selected using a simple random sampling technique. Data on socio-demographic, clinical and drug related variables were collected; entered into EpiData 3.1 and analyzed by STATA 13.1. Mixed effect linear regression was performed to assess difference in CD4+ change between groups adjusting for baseline characteristics. The change in predicted CD4 count attributed to each regimen was also assessed by marginal analysis. P < 0.05 for slopes of the random effect linear regression was used as indicators for presence of association.Results: The mean (SD) duration of cohort follow up was 714.2 (69.6) and 708.8 (78.9) days (P = 0.753) for TDF and AZT groups respectively. The minimum follow up duration was 7.4 and 8.9 months for TDF and AZT groups respectively. Most of TDF (93.6%) and AZT (91.4%) groups completed their follow up, 5 (3.6%) TDF and 6 (4.3%) AZT groups died and 4 (2.9%) TDF and 6 (4.3%) AZT groups were lost for follow-up (P = 0.769). There was statistically significant difference in immunologic recovery between the groups (B = + 34.08, 95% CI [7.8, 60.35], P = 0.027) over time. The predicted CD4+ count for TDF/3TC/EFV was (B = + 347.65 cells/mm(3), P < 0.001) whereas that of AZT/3TC/EFV was (B = + 281.54 cells/mm(3), P < 0.001).Conclusions: TDF based regimens have shown more efficacy compared to AZT based regimens though AZT based regimens are more affordable in low income countries like Ethiopia. However, we recommend further study with quality design to assess the prevalence of sub-optimal CD4+ response (net CD4 gain < 50 cells/mu l/6 month) in this set-up among TDF users.