Infectious Diseases Unit, Department of Medicine, Helen Joseph Hospital, University of the Witwatersrand, Johannesburg, South Africa.
BMC Infect Dis. 2011 Sep 17;11:244. doi: 10.1186/1471-2334-11-244.
There has been major improvement in the survival of HIV-1 infected individuals since the South African Government introduced highly active anti-retroviral therapy (HAART) in the public sector in 2004. This has brought new challenges which include the effects of stavudine-related toxicities.
Prospective analysis of a cohort of 9040 HIV-infected adults who were initiated on HAART at the Themba Lethu Clinic (TLC) in Johannesburg between April 1, 2004 to December 31, 2007, and followed up until June 30, 2008.
Amongst the 9040 study subjects, 8497(94%) were on stavudine based therapy and 5962 (66%) were women. The median baseline CD4 count was 81 cells/mm3 (IQR 29-149). Median follow up on HAART was 19 months (IQR: 9.1-31.6). The proportion of HAART-related side effects for stavudine compared to non-stavudine containing regimens were, respectively: peripheral neuropathy,17.1% vs. 11.2% (p < 0.001); symptomatic hyperlactataemia, 5.7% vs. 2.2% (p < 0.0005); lactic acidosis, 2.5 vs. 1.3% (p = 0.072); lipoatrophy, 7.3% vs. 4.6% (p < 0.05). Among those on stavudine-based regimens, incidence rates for peripheral neuropathy were 12.1 cases/100 person-years (95%CI 7.0-19.5), symptomatic hyperlactataemia 3.6 cases/100 person-years (95%CI 1.2-7.5), lactic acidosis 1.6 cases/100 person-years (95%CI 0.4-5.2) and lipoatrophy 4.6 cases/100 person-years (95%CI 2.1-9.6). Females experienced more toxicity when compared to males in terms of symptomatic hyperlactataemia (p < 0.0001), lactic acidosis (p < 0.0001), lipoatrophy (p < 0.0001) and hypertension (p < 0.05).
We demonstrate significant morbidity associated with stavudine. These data support the latest WHO guidelines, and provide additional evidence for other resource limited HAART rollout programs considering the implementation of non-stavudine based regimens as first line therapy.
自南非政府于 2004 年在公共部门推出高效抗逆转录病毒治疗（HAART）以来，HIV-1 感染者的生存率得到了极大提高。这带来了新的挑战，包括司他夫定相关毒性的影响。
对 2004 年 4 月 1 日至 2007 年 12 月 31 日期间在约翰内斯堡 Themba Lethu 诊所（TLC）开始接受 HAART 的 9040 名 HIV 感染成年患者进行前瞻性分析，并随访至 2008 年 6 月 30 日。
在 9040 名研究对象中，8497 名（94%）接受了基于司他夫定的治疗，5962 名（66%）为女性。基线 CD4 计数中位数为 81 个细胞/mm3（IQR 29-149）。HAART 的中位随访时间为 19 个月（IQR：9.1-31.6）。与非司他夫定含药方案相比，HAART 相关副作用在司他夫定组中的比例分别为：周围神经病变，17.1%比 11.2%（p < 0.001）；症状性高乳酸血症，5.7%比 2.2%（p < 0.0005）；乳酸酸中毒，2.5%比 1.3%（p = 0.072）；脂肪萎缩，7.3%比 4.6%（p < 0.05）。在接受司他夫定治疗的患者中，周围神经病的发生率为 12.1 例/100 人年（95%CI 7.0-19.5），症状性高乳酸血症为 3.6 例/100 人年（95%CI 1.2-7.5），乳酸酸中毒为 1.6 例/100 人年（95%CI 0.4-5.2），脂肪萎缩为 4.6 例/100 人年（95%CI 2.1-9.6）。与男性相比，女性在症状性高乳酸血症（p < 0.0001）、乳酸酸中毒（p < 0.0001）、脂肪萎缩（p < 0.0001）和高血压（p < 0.05）方面经历了更多的毒性。
我们证明了司他夫定相关的显著发病率。这些数据支持最新的世卫组织指南，并为其他资源有限的 HAART 推出计划提供了额外的证据，这些计划考虑实施非司他夫定为基础的方案作为一线治疗。
