Tuberculosis Section, Division of Communicable Disease Control and Prevention, Alameda County Public Health Department, San Leandro, CA, USA.
Division of Gastroenterology and Hepatology, Veterans Affairs Palo Alto Healthcare System, 3801 Miranda Ave, Palo Alto, CA, 94063, USA.
J Immigr Minor Health. 2022 Dec;24(6):1594-1598. doi: 10.1007/s10903-022-01364-2. Epub 2022 Apr 16.
Latent tuberculosis infection (LTBI) prevalence among adults with chronic hepatitis B (CHB) is two times higher than LTBI prevalence in the general adult population. Although newer CHB treatments evaluated in clinical trials modulate the immune system and potentially increase LTBI reactivation risk, it is unknown whether CHB clinical trials are screening for LTBI. We describe LTBI screening practices in CHB clinical trials. We utilized the ClinicalTrials.gov website to identify clinical trials that evaluated CHB treatments. CHB treatments were categorized according to LTBI reactivation risk as unknown, low, moderate, and high-risk. Tuberculosis burden among countries in which CHB clinical trials were conducted were defined using World Health Organization definitions. Of 651 CHB clinical trials identified, 452 (69%) were included in the final cohort, among which 337 (75%), 108 (24%), and 7 (1%) evaluated CHB medications with a low, unknown, and moderate LTBI reactivation risk, respectively. A total of 330 (73.0%) CHB clinical trials reviewed were conducted in high TB burden countries. Three (0.6%) CHB trials reviewed screened for LTBI; one each among CHB treatments with low, moderate, and high LTBI reactivation risk. Although nearly 75% of all CHB clinical trials were conducted in high TB burden countries and 25% of trials evaluated CHB treatments with an unknown LTBI reactivation risk, less than 1% of trials screened for LTBI. Consideration should be given to screen for LTBI among CHB clinical trials given high prevalence of co-infection and potential for increased LTBI reactivation risk with CHB treatments evaluated.
慢性乙型肝炎（CHB）成人患者中的潜伏性结核感染（LTBI）患病率比普通成年人群中的 LTBI 患病率高两倍。虽然临床试验中评估的新型 CHB 治疗方法可调节免疫系统，并可能增加 LTBI 再激活风险，但尚不清楚 CHB 临床试验是否筛查 LTBI。我们描述了 CHB 临床试验中的 LTBI 筛查实践。我们利用 ClinicalTrials.gov 网站确定了评估 CHB 治疗方法的临床试验。根据 LTBI 再激活风险，将 CHB 治疗方法分为未知、低、中、高风险。根据世界卫生组织的定义，确定了开展 CHB 临床试验的国家的结核负担。在确定的 651 项 CHB 临床试验中，有 452 项（69%）被纳入最终队列，其中 337 项（75%）、108 项（24%）和 7 项（1%）分别评估了 LTBI 再激活风险低、未知和中风险的 CHB 药物。共有 330 项（73.0%）CHB 临床试验在高结核负担国家进行。有 3 项（0.6%）CHB 试验筛查了 LTBI；分别在 LTBI 再激活风险低、中、高的 CHB 治疗中各有 1 项。尽管近 75%的 CHB 临床试验在高结核负担国家进行，且 25%的试验评估了 LTBI 再激活风险未知的 CHB 治疗方法，但只有不到 1%的试验筛查了 LTBI。鉴于 CHB 感染者合并感染率高，且评估的 CHB 治疗方法可能增加 LTBI 再激活风险，因此应考虑在 CHB 临床试验中筛查 LTBI。
