Patel Dishank, Desai Mira, Shah A N, Dikshit R K
Department of Pharmacology, B. J. Medical College and Civil Hospital, Ahmedabad, Gujarat, India.
Perspect Clin Res. 2013 Oct;4(4):215-20. doi: 10.4103/2229-3485.120170.
Multi-drug resistance in treatment-experienced human immune deficiency virus (HIV) patients has been a major cause to first line antiretroviral therapy (ART) failure, necessitating a switch to second line therapy. In India, the second line treatment program is still relatively new with little experience and unclear outcomes. It is therefore, critical to assess the clinical, virological and immunological effectiveness and treatment outcome over the 1(st) year of follow-up in the patients' switched to the second line ART at public sector tertiary care center.
A prospective, observational study was carried out on HIV positive patients switched on second line ART from January 2010 to December 2010 at ART Centre, Civil Hospital, Ahmedabad. Demographic details, symptoms, adverse drug reactions (ADRs), second line ART regimens, CD4 count, and plasma viral load (PVL) were recorded in a case record form. Patients were followed-up monthly for 12 months. The data was analyzed by t-test, z-test, and Fisher-exact test.
Out of 126 patients, 82 received regimen V [zidovudine (ZDV) + lamivudine (3TC) + tenofovir (TDF) + boosted lopinavir (LPV/r)] and 44 received regimen Va [3TC + TDF + LPV/r]. A significant (P < 0.0001) increase in mean body weight and marked reduction in number of patients (7) categorized as WHO stage III/IV was observed at 12 months of second line ART. Moreover, a significant immune reconstitution with increase in mean CD4 count and viral suppression (PVL < 400 copies/ml) in 103 (82%) patients (P < 0.0001) was also observed. A total of 83 ADRs were observed in 69 (55%) patients, the most common being dyslipidemia (57) followed by anemia (9).
Early treatment outcome with second line ART was good with 82% success rate in treatment experienced HIV patients. Dyslipidemia and anemia were the common ADRs observed.
接受过治疗的人类免疫缺陷病毒(HIV)患者的多药耐药性一直是一线抗逆转录病毒疗法(ART)失败的主要原因,因此需要转而采用二线疗法。在印度,二线治疗方案仍然相对较新,经验较少且结果尚不明朗。因此,评估在公共部门三级医疗中心转而接受二线ART治疗的患者在随访第1年的临床、病毒学和免疫学疗效及治疗结果至关重要。
对2010年1月至2010年12月在艾哈迈达巴德市民医院ART中心转而接受二线ART治疗的HIV阳性患者进行了一项前瞻性观察研究。人口统计学细节、症状、药物不良反应(ADR)、二线ART方案、CD4细胞计数和血浆病毒载量(PVL)被记录在病例记录表中。患者每月随访12个月。数据采用t检验、z检验和Fisher精确检验进行分析。
126例患者中,82例接受方案V[齐多夫定(ZDV)+拉米夫定(3TC)+替诺福韦(TDF)+洛匹那韦利托那韦(LPV/r)],44例接受方案Va[3TC+TDF+LPV/r]。二线ART治疗12个月时,观察到平均体重显著增加(P<0.0001),且归类为世界卫生组织III/IV期的患者数量显著减少(7例)。此外,还观察到103例(82%)患者平均CD4细胞计数增加且病毒得到抑制(PVL<400拷贝/ml),免疫显著重建(P<0.0001)。69例(55%)患者共观察到83例ADR,最常见的是血脂异常(57例),其次是贫血(9例)。
二线ART的早期治疗结果良好,在接受过治疗的HIV患者中的成功率为82%。血脂异常和贫血是观察到的常见ADR。