马拉维一个农村地区扩大高效抗逆转录病毒治疗的效果评估

Scaling up of highly active antiretroviral therapy in a rural district of Malawi: an effectiveness assessment.

作者信息

Ferradini Laurent, Jeannin Arnaud, Pinoges Loretxu, Izopet Jacques, Odhiambo Didakus, Mankhambo Limangeni, Karungi Gloria, Szumilin Elisabeth, Balandine Serge, Fedida Gaëlle, Carrieri M Patrizia, Spire Bruno, Ford Nathan, Tassie Jean-Michel, Guerin Philippe J, Brasher Chris

机构信息

Epicentre, Paris, France.

出版信息

Lancet. 2006 Apr 22;367(9519):1335-42. doi: 10.1016/S0140-6736(06)68580-2.

DOI:10.1016/S0140-6736(06)68580-2

PMID:16631912

Abstract

BACKGROUND

The recording of outcomes from large-scale, simplified HAART (highly active antiretroviral therapy) programmes in sub-Saharan Africa is critical. We aimed to assess the effectiveness of such a programme held by Médecins Sans Frontières (MSF) in the Chiradzulu district, Malawi.

METHODS

We scaled up and simplified HAART in this programme since August, 2002. We analysed survival indicators, CD4 count evolution, virological response, and adherence to treatment. We included adults who all started HAART 6 months or more before the analysis. HIV-1 RNA plasma viral load and self-reported adherence were assessed on a subsample of patients, and antiretroviral resistance mutations were analysed in plasma with viral loads greater than 1000 copies per mL. Analysis was by intention to treat.

FINDINGS

Of the 1308 patients who were eligible, 827 (64%) were female, the median age was 34.9 years (IQR 29.9-41.0), and 1023 (78%) received d4T/3TC/NVP (stavudine, lamivudine, and nevirapine) as a fixed-dose combination. At baseline, 1266 individuals (97%) were HAART-naive, 357 (27%) were at WHO stage IV, 311 (33%) had a body-mass index of less than 18.5 kg/m2, and 208 (21%) had a CD4 count lower than 50 cells per muL. At follow-up (median 8.3 months, IQR 5.5-13.1), 967 (74%) were still on HAART, 243 (19%) had died, 91 (7%) were lost to follow-up, and seven (0.5%) discontinued treatment. Low body-mass index, WHO stage IV, male sex, and baseline CD4 count lower than 50 cells per muL were independent determinants of death in the first 6 months. At 12 months, the probability of individuals still in care was 0.76 (95% CI 0.73-0.78) and the median CD4 gain was 165 (IQR 67-259) cells per muL. In the cross-sectional survey (n=398), 334 (84%) had a viral load of less than 400 copies per mL. Of several indicators measuring adherence, self-reported poor adherence (<80%) in the past 4 days was the best predictor of detectable viral load (odds ratio 5.4, 95% CI 1.9-15.6).

INTERPRETATION

These data show that large numbers of people can rapidly benefit from antiretroviral therapy in rural resource-poor settings and strongly supports the implementation of such large-scale simplified programmes in Africa.

摘要

背景

记录撒哈拉以南非洲大规模简化高效抗逆转录病毒治疗（HAART）项目的成果至关重要。我们旨在评估无国界医生组织（MSF）在马拉维奇拉祖鲁区开展的此类项目的效果。

方法

自2002年8月起，我们在该项目中扩大并简化了HAART。我们分析了生存指标、CD4细胞计数变化、病毒学反应以及治疗依从性。纳入的成年人在分析前均已开始HAART治疗6个月或更长时间。对部分患者样本评估了HIV-1 RNA血浆病毒载量和自我报告的依从性，并对病毒载量大于每毫升1000拷贝的血浆中的抗逆转录病毒耐药突变进行了分析。分析采用意向性治疗。

结果

在1308名符合条件的患者中，827名（64%）为女性，中位年龄为34.9岁（四分位间距29.9 - 41.0），1023名（78%）接受了司他夫定/拉米夫定/奈韦拉平（d4T/3TC/NVP）的固定剂量组合治疗。基线时，1266人（97%）此前未接受过HAART治疗，357人（27%）处于世界卫生组织IV期，311人（33%）体重指数低于18.5 kg/m²，208人（21%）CD4细胞计数低于每微升50个细胞。随访时（中位8.3个月，四分位间距5.5 - 13.1），967人（74%）仍在接受HAART治疗，243人（19%）死亡，91人（7%）失访，7人（0.5%）停止治疗。低体重指数、世界卫生组织IV期、男性以及基线CD4细胞计数低于每微升50个细胞是前6个月死亡的独立决定因素。12个月时，仍在接受治疗的个体概率为0.76（95%置信区间0.73 - 0.78），CD4细胞计数的中位增加值为每微升165个（四分位间距67 - 259）。在横断面调查（n = 398）中，334人（84%）病毒载量低于每毫升400拷贝。在多个衡量依从性的指标中，过去4天自我报告依从性差（<80%）是可检测病毒载量的最佳预测指标（比值比5.4，95%置信区间1.9 - 15.6）。