一项评估北美 HBV-HIV 合并感染成年人组织学、临床和病毒学结局变化的前瞻性研究。
A Prospective Study Evaluating Changes in Histology, Clinical and Virologic Outcomes in HBV-HIV Co-infected Adults in North America.
机构信息
Virginia Commonwealth University, Richmond, VA.
University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA.
出版信息
Hepatology. 2021 Sep;74(3):1174-1189. doi: 10.1002/hep.31823. Epub 2021 Aug 25.
BACKGROUND AND AIMS
Histological and clinical outcomes in HBV-HIV coinfection in the era of combination antiretroviral therapy (cART) are poorly defined.
APPROACH AND RESULTS
Adult patients co-infected with HBV-HIV from eight North American sites were enrolled in this National Institutes of Health (NIH)-funded prospective observational study (n = 139). Demographic, clinical, serological, and virological data were collected at entry and every 24 weeks for ≤ 192 weeks. Paired liver biopsies were obtained at study entry and at ≥ 3 years of follow-up. Biopsies were assessed by a central pathology committee using the modified Ishak scoring system. Clinical outcome rate and changes in histology are reported. Among participants with follow-up data (n = 114), median age was 49 years, 91% were male, 51% were non-Hispanic Black, and 13% had at-risk alcohol use, with a median infection of 20 years. At entry, 95% were on anti-HBV cART. Median CD4 count was 562 cells/mm and 93% had HIV < 400 copies/mL. HBeAg was positive in 61%, and HBV DNA was below the limit of quantification (< 20 IU/mL) in 61% and < 1,000 IU/mL in 80%. Clinical events were uncommon across follow-up: one hepatic decompensation, two HCC, no liver transplants, and one HBV-related deaths, with a composite endpoint rate of 0.61/100 person-years. Incident cirrhosis (n = 1), alanine aminotransferase flare (n = 2), and HBeAg loss (n = 13) rates were 0.40, 0.65, and 6.86 per 100 person-years, respectively. No participants had HBsAg loss. Paired biopsy (n = 62; median 3.6 years apart) revealed minimal improvement in Histologic Activity Index (median [interquartile range]: 3 [2-4] to 3 [1-3]; P = 0.02) and no significant change in fibrosis score (1 [1-2] to 1 [0-3]; P = 0.58).
CONCLUSIONS
In a North American cohort of adults with HBV-HIV on cART with virological suppression, clinical outcomes and worsening histological disease were uncommon.
背景与目的
在联合抗逆转录病毒疗法（cART）时代，HBV-HIV 合并感染的组织学和临床结局定义尚不明确。
方法和结果
本研究纳入了来自 8 个北美地点的 139 名 HBV-HIV 合并感染的成年患者，这些患者均参加了由美国国立卫生研究院（NIH）资助的前瞻性观察性研究。在入组时和每 24 周（≤192 周）收集人口统计学、临床、血清学和病毒学数据。在研究入组时和随访≥3 年时获得配对肝活检。采用改良 Ishak 评分系统，由中心病理委员会对活检进行评估。报告临床结局发生率和组织学变化。在有随访数据的参与者（n=114）中，中位年龄为 49 岁，91%为男性，51%为非西班牙裔黑人，13%有酒精滥用风险，中位感染时间为 20 年。入组时，95%的患者正在接受抗 HBV cART。中位 CD4 计数为 562 个细胞/mm³，93%的 HIV 载量<400 拷贝/mL。HBeAg 阳性率为 61%，HBV DNA 低于检测下限（<20 IU/mL）的比例为 61%，<1000 IU/mL 的比例为 80%。在整个随访期间，临床事件并不常见：1 例肝功能失代偿，2 例 HCC，无肝移植，1 例 HBV 相关死亡，复合终点发生率为 0.61/100 人年。新发肝硬化（n=1）、丙氨酸氨基转移酶升高（n=2）和 HBeAg 丢失（n=13）的发生率分别为 0.40、0.65 和 6.86/100 人年。无患者出现 HBsAg 丢失。在 62 名接受配对肝活检的患者中（中位随访时间间隔 3.6 年），组织学活动指数（Histologic Activity Index，HAI）有轻微改善（中位数[四分位距]：3[2-4] 至 3[1-3]；P=0.02），纤维化评分无显著变化（1[1-2] 至 1[0-3]；P=0.58）。
结论
在接受 cART 治疗且病毒学抑制的 HBV-HIV 合并感染的北美成年患者队列中，临床结局和组织学疾病恶化并不常见。
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