Pujari Sanjay, Dravid Ameet, Gupte Nikhil, Joshi Kedar, Bele Vivek
Institute of Infectious Diseases, Kumar Business Court, Pune, India.
Medscape J Med. 2008;10(8):196. Epub 2008 Aug 20.
To assess effectiveness and safety of a generic fixed-dose combination of tenofovir (TDF)/emtricitabine (FTC)/efavirenz (EFV) among HIV-1-infected patients in Western India.
Antiretroviral (ARV)-naive and experienced (thymidine analog nucleoside reverse transcriptase inhibitor [tNRTI] replaced by TDF) patients were started on a regimen of 1 TDF/FTC/EFV pill once a day. They were followed clinically on a periodic basis, and viral loads and CD4 counts were measured at 6 and 12 months. Creatinine clearance was calculated at baseline and at 6 months and/or as clinically indicated. Effectiveness was defined as not having to discontinue the regimen due to failure or toxicity.
One hundred forty-one patients who started TDF/FTC/EFV before 1 June 2007 were eligible. Of these, 130 (92.2%) and 44 (31.2%) had 6- and 12-months follow-up, respectively. Thirty-five percent of the patients were ARV-naive. Eleven patients discontinued treatment (4 for virologic failure, 1 for grade 3-4 central nervous system disturbances, 4 for grade 3-4 renal toxicity, and 2 for cost). Ninety-six percent of patients were virologically suppressed at 6 months. Frequency of TDF-associated grade 3-4 renal toxicity was 2.8%; however, 3 of these patients had comorbid conditions associated with renal dysfunction.
A fixed-dose combination of generic TDF/FTC/EFV is effective in ARV-naive and experienced patients. Although frequency of severe renal toxicity was higher than has been reported in the literature, it was safe in patients with no comorbid renal conditions.
评估替诺福韦（TDF）/恩曲他滨（FTC）/依非韦伦（EFV）的仿制固定剂量组合在印度西部HIV-1感染患者中的有效性和安全性。
未接受过抗逆转录病毒（ARV）治疗的患者以及有治疗经验（用TDF替代胸苷类似物核苷逆转录酶抑制剂[tNRTI]）的患者开始每日服用1片TDF/FTC/EFV。对他们进行定期临床随访，并在6个月和12个月时测量病毒载量和CD4细胞计数。在基线、6个月时和/或根据临床指征计算肌酐清除率。有效性定义为不因治疗失败或毒性而不得不停用该治疗方案。
2007年6月1日前开始服用TDF/FTC/EFV的141例患者符合条件。其中，分别有130例（92.2%）和44例（31.2%）进行了6个月和12个月的随访。35%的患者未接受过ARV治疗。11例患者停止治疗（4例因病毒学失败，1例因3 - 4级中枢神经系统紊乱，4例因3 - 4级肾毒性，2例因费用问题）。96%的患者在6个月时病毒得到抑制。TDF相关的3 - 4级肾毒性发生率为2.8%；然而，这些患者中有3例伴有与肾功能不全相关的合并症。
仿制的TDF/FTC/EFV固定剂量组合在未接受过ARV治疗和有治疗经验的患者中有效。尽管严重肾毒性的发生率高于文献报道，但在无合并肾脏疾病的患者中是安全的。
