MRC Clinical Trials Unit at University College London, London, UK.
University of Cape Town Lung Institute, Cape Town, South Africa.
BMC Pulm Med. 2019 Aug 14;19(1):152. doi: 10.1186/s12890-019-0907-6.
The phase III REMoxTB study prospectively enrolled HIV-positive (with CD4+ count > 250 cells, not on anti-retroviral therapy) and HIV-negative patients. We investigated the incidence of adverse events and cure rates according to HIV status for patients receiving standard TB therapy in the trial.
Forty-two HIV-positive cases were matched to 220 HIV-negative controls by age, gender, ethnicity, and trial site using coarsened exact matching. Grade 3 and 4 adverse events (AEs) were summarised by MedDRA System Organ Class. Kaplan-Meier curves for time to first grade 3 or 4 AE were constructed according to HIV status with hazard ratios calculated. Patients were considered cured if they were culture negative 18 months after commencing therapy with ≥2 consecutive negative culture results.
Twenty of 42 (47.6%) HIV-positive and 34 of 220 (15.5%) HIV-negative patients experienced ≥1 grade 3 or 4 AE, respectively. The majority of these were hepatobiliary disorders that accounted for 12 of 40 (30.0%) events occurring in 6 of 42 (14.3%) HIV-positive patients and for 15 of 60 (25.0%) events occurring in 9 of 220 (4.1%) HIV-negative patients. The median time to first grade 3 or 4 AE was 54 days (IQR 15.5-59.0) for HIV-positive and 29.5 days (IQR 9.0-119.0) for HIV-negative patients, respectively. The hazard ratio for experiencing a grade 3 or 4 AE among HIV-positive patients was 3.25 (95% CI 1.87-5.66, p < 0.01). Cure rates were similar, with 38 of 42 (90.5%) HIV-positive and 195 of 220 (88.6%) HIV-negative patients (p = 0.73) cured at 18 months.
HIV-positive patients receiving standard TB therapy in the REMoxTB study were at greater risk of adverse events during treatment but cure rates were similar when compared to a matched sample of HIV-negative patients.
III 期 REMoxTB 研究前瞻性纳入了 HIV 阳性（CD4+计数>250 细胞，未接受抗逆转录病毒治疗）和 HIV 阴性患者。我们根据试验中接受标准结核病治疗的患者的 HIV 状态，调查了不良事件的发生率和治愈率。
通过粗化精确匹配，将 42 例 HIV 阳性病例与 220 例 HIV 阴性对照按年龄、性别、种族和试验地点进行匹配。根据 MedDRA 系统器官类别总结 3 级和 4 级不良事件（AE）。根据 HIV 状态构建首次发生 3 级或 4 级 AE 的时间的 Kaplan-Meier 曲线，并计算风险比。如果患者在开始治疗后 18 个月培养结果阴性，且连续两次培养结果均为阴性，则认为治愈。
42 例 HIV 阳性患者中有 20 例（47.6%）和 220 例 HIV 阴性患者中有 34 例（15.5%）经历了≥1 次 3 级或 4 级 AE。大多数为肝胆疾病，其中 6 例（14.3%）HIV 阳性患者中发生 12 例（30.0%），9 例（4.1%）HIV 阴性患者中发生 15 例（25.0%）。HIV 阳性患者首次发生 3 级或 4 级 AE 的中位时间为 54 天（IQR 15.5-59.0），HIV 阴性患者为 29.5 天（IQR 9.0-119.0）。HIV 阳性患者发生 3 级或 4 级 AE 的风险比为 3.25（95%CI 1.87-5.66，p<0.01）。18 个月时，HIV 阳性患者的治愈率为 38/42（90.5%），HIV 阴性患者的治愈率为 195/220（88.6%）（p=0.73），治愈率相似。
在 REMoxTB 研究中接受标准结核病治疗的 HIV 阳性患者在治疗期间发生不良事件的风险更高，但与匹配的 HIV 阴性患者相比，治愈率相似。
