Sivadasan Ajith, Abraham O C, Rupali Priscilla, Pulimood Susanne A, Rajan Joyce, Rajkumar S, Zachariah Anand, Kannangai Rajesh, Kandathil Abraham Joseph, Sridharan G, Mathai Dilip
Department of Medicine, Christian Medical College, Vellore.
J Assoc Physicians India. 2009 May;57:384-8.
To determine the rates, reasons and predictors of treatment change of the initial antiretroviral treatment (ART) regimen in HIV-infected south Indian adults.
In this prospective cohort study, ART-naive adults initiated on generic, fixed dose combination ART as per the National AIDS Control Organization guidelines were followed up at an academic medical center. Treatment change was defined as any event which necessitated a change in or discontinuation of the initial ART regimen.
Two hundred and thirty persons with HIV infection (males 74.8% and median age 37 years) were followed up for median duration of 48 weeks. The majority (98.7%) had acquired HIV infection through the heterosexual route. Most (70.4%) had advanced IV infection (WHO clinical stage 3 or 4) and 78% had CD4+ T-lymphocyte counts below 200 cells/microL. The initial ART regimens used were: Lamivudine (3TC) with Stavudine (d4T) (in 76%) or Azidothymidine (AZT) and Nevirapine (NVP) (in 86%) or Efavirenz (EFV). The cumulative incidence of treatment change was 39.6% (91 patients). Drug toxicity (WHO grade 3 or 4) was the reason for treatment change among 62 (27%) (incidence rate 35.9/100 person-years). The most common toxicities were attributable to the thymidine analogue nucleoside reverse transcriptase inhibitors (NRTIs), d4T and AZT [lactic acidosis (8.7%), anemia (7%) and peripheral neuropathy (5.2%)]. The other toxicities were rash (3.9%) and hepatitis (1.3%) due to NVP. The mortality (4.6/100 person-years) and disease progression rates (4.1/100 person-years) were low.
The ART regimens used in this study were effective in decreasing disease progression and death. However, they were associated with high rates of drug toxicities, particularly those attributable to thymidine analogue NRTI. As efforts are made to improve access to ART, treatment regimens chosen should not only be potent, but also safe.
确定印度南部感染HIV的成年人初始抗逆转录病毒治疗（ART）方案的治疗变更率、原因及预测因素。
在这项前瞻性队列研究中，于一家学术医疗中心对按照国家艾滋病控制组织指南开始接受通用型固定剂量联合ART治疗的初治成年人进行随访。治疗变更定义为任何需要改变或停用初始ART方案的事件。
230例HIV感染者（男性占74.8%，中位年龄37岁）接受了中位时长为48周的随访。大多数（98.7%）通过异性传播途径感染HIV。多数（70.4%）患有晚期IV期感染（世界卫生组织临床分期3或4期），78%的患者CD4+T淋巴细胞计数低于200个/微升。使用的初始ART方案为：拉米夫定（3TC）与司他夫定（d4T）（76%）或齐多夫定（AZT）及奈韦拉平（NVP）（86%）或依非韦伦（EFV）。治疗变更的累积发生率为39.6%（共91例患者）。药物毒性（世界卫生组织3或4级）是62例（27%）治疗变更的原因（发生率为35.9/100人年）。最常见的毒性反应归因于胸苷类似物核苷类逆转录酶抑制剂（NRTIs），即d4T和AZT[乳酸性酸中毒（8.7%）、贫血（7%）及周围神经病变（5.2%）]。其他毒性反应包括因NVP引起的皮疹（3.9%）和肝炎（1.3%）。死亡率（4.6/100人年）和疾病进展率（4.1/100人年）较低。
本研究中使用的ART方案在降低疾病进展和死亡方面有效。然而，它们与较高的药物毒性发生率相关，尤其是归因于胸苷类似物NRTI的毒性反应。在努力改善ART可及性的过程中，所选择的治疗方案不仅应强效，还应安全。
