Department of Medicine, Duke University Medical Center, Durham, North Carolina, United States of America.
PLoS One. 2011;6(7):e22276. doi: 10.1371/journal.pone.0022276. Epub 2011 Jul 18.
Rifapentine-based regimens for treating latent tuberculosis infection (LTBI) are being considered for future clinical trials, but even if they prove effective, high drug costs may limit their economic viability.
To inform clinical trial design by estimating the potential costs and effectiveness of rifapentine-based regimens for treatment of latent tuberculosis infection (LTBI).
We used a Markov model to estimate cost and societal benefits for three regimens for treating LTBI: Isoniazid/rifapentine daily for one month, isoniazid/rifapentine weekly for three months (self-administered and directly-observed), and isoniazid daily for nine months; a strategy of "no treatment" used for comparison. Costs, quality-adjusted life-years gained, and instances of active tuberculosis averted were calculated for all arms.
Both daily isoniazid/rifapentine for one month and weekly isoniazid/rifapentine for three months were less expensive and more effective than other strategies under a wide variety of clinically plausibly parameter estimates. Daily isoniazid/rifapentine for one month was the least expensive and most effective regimen.
Daily isoniazid/rifapentine for one month and weekly isoniazid/rifapentine for three months should be studied in a large-scale clinical trial for efficacy. Because both regimens performed well even if their efficacy is somewhat reduced, study designers should consider relaxing non-inferiority boundaries.
利福喷丁为基础的方案治疗潜伏性结核感染(LTBI)正在考虑未来的临床试验,但即使它们有效,高药物成本可能会限制其经济可行性。
通过估计利福喷丁为基础的方案治疗潜伏性结核感染(LTBI)的潜在成本和效果,为临床试验设计提供信息。
我们使用马尔可夫模型来估计三种 LTBI 治疗方案的成本和社会效益:异烟肼/利福喷丁每日 1 个月,异烟肼/利福喷丁每周 3 个月(自我管理和直接观察),异烟肼每日 9 个月;“不治疗”策略用于比较。计算所有方案的成本、质量调整生命年获益和避免活动性结核病的情况。
在广泛的临床合理参数估计下,异烟肼/利福喷丁每日 1 个月和每周 3 个月的方案都比其他方案更便宜、更有效。异烟肼/利福喷丁每日 1 个月是最便宜和最有效的方案。
应在大规模临床试验中研究异烟肼/利福喷丁每日 1 个月和每周 3 个月的方案的疗效。由于这两种方案即使疗效略有降低也表现良好,研究设计者应考虑放宽非劣效性边界。