Omeje Innocent, Okwundu Charles I
Community Medicine, UNTH/Comprehensive Health Centre, Nsukka, Nigeria.
Cochrane Database Syst Rev. 2012 Feb 15(2):CD007276. doi: 10.1002/14651858.CD007276.pub2.
The current recommended antiretroviral treatment is a highly active antiretroviral therapy (HAART). Although HAART has been associated with improved clinical response to treatment, issues of adherence and viral resistance are major challenges limiting its success. There is a need for an effective and safe first-line regimen, to cope with the ever-increasing incidence of non-adherence and primary resistance. A more recent first-line treatment regimen consists of Tenofovir (TDF, 300 mg) + Emtricitabine (FTC, 200 mg) + Efavirenz (EFV, 600 mg).
To evaluate the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV.
We searched the Cochrane Central Register of Controlled Trials, EMBASE, GATEWAY, LILACS, PubMed, AEGIS, and the WHO prospective clinical trials registry in November 2011.
Randomized controlled trials evaluating the effects of TDF + FTC + EFV compared with other HAART regimens.
Two reviewers independently assessed trial eligibility and risk of bias, and extracted data from the included study.
Only one study involving 517 antiretroviral-naive HIV infected adults was included in this review. Participants were randomly assigned to receive either a regimen of TDF (300 mg), FTC (200mg), and EFV (600mg ) once daily; or a regimen of fixed-dose zidovudine (AZT) (300 mg) and lamivudine (3TC) (150 mg) twice daily plus EFV (600mg) once daily. Significantly more patients in the TDF-FTC group reached and maintained HIV RNA levels of less than 50 copies per milliliter compared to the AZT- 3TC group (RR 1.13; 95% CI 1.02 to 1.25). Also, more participants in the TDF-FTC group had greater increase from baseline CD4 cell counts compared to the AZT-3TC group (190 vs. 158 cells per mm(3)). More patients in the AZT-3TC group than in the TDF-FTC group had adverse events resulting in discontinuation of the study drugs (9% vs. 4%, respectively; P = 0.02). There was no statistically significant difference in all cause mortality (RR 0.50; 95% CI 0.05 to 5.46).
AUTHORS' CONCLUSIONS: Only one trial has shown beneficial effects and safety of TDF+ FTC + EFV as first-line treatment for patients with HIV. The effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV cannot be assessed on the basis of only one trial. Further studies evaluating the effects and safety of TDF + FTC + EFV as first-line treatment for patients with HIV are needed.
目前推荐的抗逆转录病毒治疗是高效抗逆转录病毒疗法（HAART）。尽管HAART与治疗的临床反应改善相关，但依从性和病毒耐药性问题是限制其成功的主要挑战。需要一种有效且安全的一线治疗方案，以应对依从性不佳和原发耐药发生率不断上升的情况。一种较新的一线治疗方案由替诺福韦（TDF，300毫克）+恩曲他滨（FTC，200毫克）+依非韦伦（EFV，600毫克）组成。
评估TDF+FTC+EFV作为HIV患者一线治疗的疗效和安全性。
我们于2011年11月检索了Cochrane对照试验中央注册库、EMBASE、GATEWAY、LILACS、PubMed、AEGIS以及世界卫生组织前瞻性临床试验注册库。
评估TDF+FTC+EFV与其他HAART方案相比疗效的随机对照试验。
两名评价员独立评估试验的纳入资格和偏倚风险，并从纳入研究中提取数据。
本综述仅纳入了一项涉及517名未接受过抗逆转录病毒治疗的HIV感染成人的研究。参与者被随机分配接受以下方案之一：每日一次服用TDF（300毫克）、FTC（200毫克）和EFV（600毫克）；或每日两次服用固定剂量的齐多夫定（AZT）（300毫克）和拉米夫定（3TC）（150毫克）加每日一次服用EFV（600毫克）。与AZT-3TC组相比，TDF-FTC组中达到并维持HIV RNA水平低于每毫升50拷贝的患者显著更多（RR 1.13；95%CI 1.02至1.25）。此外，与AZT-3TC组相比，TDF-FTC组中更多参与者的CD4细胞计数较基线有更大增加（每立方毫米190个细胞对158个细胞）。AZT-3TC组中因不良事件导致停用研究药物的患者比TDF-FTC组更多（分别为9%对4%；P=0.02）。全因死亡率无统计学显著差异（RR 0.50；95%CI 0.05至5.46）。
仅有一项试验显示TDF+FTC+EFV作为HIV患者一线治疗具有有益效果和安全性。仅根据一项试验无法评估TDF+FTC+EFV作为HIV患者一线治疗的疗效和安全性。需要进一步研究评估TDF+FTC+EFV作为HIV患者一线治疗的疗效和安全性。
