World Health Organization, Geneva, Switzerland.
Int J Tuberc Lung Dis. 2012 Jan;16(1):6-15. doi: 10.5588/ijtld.10.0626. Epub 2011 Aug 3.
To assess how to best manage co-administration of rifabutin (RFB) and human immunodeficiency virus 1 (HIV-1) protease inhibitor (PI) containing antiretroviral treatment (ART). Recommended for initial anti-tuberculosis treatment, rifampicin (RMP) lowers PI concentrations below therapeutic levels, posing significant challenges for ART. As RFB has little effect on PI concentrations, it could be an alternative to RMP.
A review of the scientific literature on the safety and efficacy of RFB for adult tuberculosis (TB) treatment was conducted, focusing on ART-TB co-therapy. A cost comparison was performed between treatment regimens, and estimates of the burden of TB disease in patients on ART were used to model RFB demand in low- and middle-income countries (LMICs).
Eleven clinical studies were identified, comprising 1543 TB patients treated with RFB; 980 (64%) were living with HIV. RFB was as safe and effective as RMP, including in 313 patients receiving co-administered ART (unboosted PIs included indinavir, nelfinavir or saquinavir; a minority received ritonavir [RTV] boosted amprenavir or saquinavir). The total cost for 6 months of all HIV and TB treatment containing RTV-boosted lopinavir (LPV) and RFB is US$410, compared to US$455 if RMP is used with LPV super-boosted with RTV. Our model suggests that demand for RFB in LMICs could be between 10,000 and 18,000 courses by 2012.
RFB is effective and safe in combination with the PIs studied, cost-saving for co-therapy with currently recommended boosted PIs, and may have a pivotal role in the roll-out of ART. Further research into a daily dose of RFB to simplify dosing regimens and developing fixed-dose combinations can enhance the public sector roll-out of ART.
评估如何最好地管理利福布丁（RFB）和含人类免疫缺陷病毒 1（HIV-1）蛋白酶抑制剂（PI）的抗逆转录病毒治疗（ART）联合应用。利福平（RMP）被推荐用于初始抗结核治疗，但它会降低 PI 的浓度至治疗水平以下，这对 ART 构成了重大挑战。由于 RFB 对 PI 浓度的影响较小，因此它可能是 RMP 的替代品。
对 RFB 用于成人结核病（TB）治疗的安全性和疗效的科学文献进行了综述，重点关注 ART-TB 联合治疗。对不同治疗方案进行了成本比较，并使用接受 ART 治疗的患者中结核病疾病负担的估计值来对低收入和中等收入国家（LMICs）中 RFB 的需求进行建模。
确定了 11 项临床研究，共纳入 1543 例接受 RFB 治疗的 TB 患者；其中 980 例（64%）合并 HIV 感染。RFB 与 RMP 一样安全有效，包括在 313 例接受联合 ART 治疗的患者中（联合应用的 PI 包括茚地那韦、奈非那韦或沙奎那韦；少数患者接受利托那韦[RTV]增效的安普那韦或沙奎那韦）。包含 RTV 增效洛匹那韦（LPV）和 RFB 的 6 个月所有 HIV 和 TB 治疗总成本为 410 美元，如果将 LPV 与 RTV 超级增效的利福平联合使用，则为 455 美元。我们的模型表明，到 2012 年，在 LMICs 中对 RFB 的需求可能在 10000 至 18000 个疗程之间。
RFB 与研究中的 PI 联合应用时具有有效性和安全性，与目前推荐的增效 PI 联合治疗相比可节省成本，并且可能在 ART 的推广中发挥关键作用。进一步研究 RFB 的每日剂量以简化给药方案和开发固定剂量组合可以促进 ART 在公共部门的推广。
