Division of Gastroenterology and Hepatology, Stanford University Medical Center, Palo Alto, California.
Hepatobiliary Section, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan; Hepatitis Research Center, College of Medicine and Cohort Research Center, Kaohsiung Medical University, Kaohsiung, Taiwan.
Clin Gastroenterol Hepatol. 2024 Mar;22(3):572-580.e5. doi: 10.1016/j.cgh.2023.09.002. Epub 2023 Sep 19.
BACKGROUND & AIMS: It is unclear if there may be sex differences in response to nucleos(t)ide analogs including virologic response (VR), biochemical response (BR), complete response (CR), and hepatocellular carcinoma (HCC) incidence among hepatitis B patients. We compared nucleos(t)ide analog treatment outcomes by sex.
We performed a retrospective cohort study of 3388 treatment-naïve adult hepatitis B patients (1250 female, 2138 male) from the Real-World Evidence from the Global Alliance for the Study of Hepatitis B Virus consortium who initiated therapy with either entecavir or tenofovir from 22 sites (Argentina, Korea, Japan, Taiwan, and the United States). We used propensity-score matching to balance background characteristics of the male and female groups and competing-risks analysis to estimate the incidence and subdistribution hazard ratios (SHRs) of VR, BR, CR, and HCC.
Females (vs males) were older (52.0 vs 48.6 y); less likely to be overweight/obese (49.3% vs 65.7%), diabetic (9.9% vs 13.1%), or cirrhotic (27.9% vs 33.0%); and had a lower HBV DNA level (5.9 vs 6.0 log10 IU/mL) and alanine aminotransferase level (91 vs 102 IU/L) (all P < .01). However, after propensity-score matching, relevant background characteristics were balanced between the 2 groups. Females (vs males) had similar 5-year cumulative VR (91.3% vs 90.3%; P = .40) and HCC incidence rates (5.1% vs 4.4%; P = .64), but lower BR (84.0% vs 90.9%; P < .001) and CR (78.8% vs 83.4%; P = .016). Males were more likely to achieve BR (SHR, 1.31; 95% CI, 1.17-1.46; P < .001) and CR (SHR, 1.16; 95% CI, 1.03-1.31; P = .016), but VR and HCC risks were similar.
Sex differences exist for treatment outcomes among hepatitis B patients. Male sex was associated with a 16% higher likelihood of clinical remission and a 31% higher likelihood of biochemical response than females, while virologic response and HCC incidence were similar between the 2 groups.
目前尚不清楚在核苷(酸)类似物治疗中,包括病毒学应答(VR)、生化学应答(BR)、完全应答(CR)和肝细胞癌(HCC)发生率,是否存在性别差异。我们比较了不同性别乙型肝炎患者对核苷(酸)类似物治疗的反应。
我们对全球乙型肝炎病毒研究联盟真实世界证据中的 3388 例初治成年乙型肝炎患者(1250 例女性,2138 例男性)进行了回顾性队列研究,这些患者来自 22 个研究地点(阿根廷、韩国、日本、中国台湾和美国),在开始治疗时分别接受恩替卡韦或替诺福韦治疗。我们使用倾向评分匹配来平衡男性和女性组的背景特征,并使用竞争风险分析来估计 VR、BR、CR 和 HCC 的发生率和亚分布危险比(SHR)。
女性(vs 男性)年龄更大(52.0 岁 vs 48.6 岁);不太可能超重/肥胖(49.3% vs 65.7%)、糖尿病(9.9% vs 13.1%)或肝硬化(27.9% vs 33.0%);HBV DNA 水平(5.9 对数 10 IU/ml vs 6.0 对数 10 IU/ml)和丙氨酸氨基转移酶水平(91 IU/L vs 102 IU/L)较低(均 P <.01)。然而,经过倾向评分匹配后,两组之间的相关背景特征得到了平衡。女性(vs 男性)5 年累积 VR 相似(91.3% vs 90.3%;P =.40),HCC 发生率也相似(5.1% vs 4.4%;P =.64),但 BR(84.0% vs 90.9%;P <.001)和 CR(78.8% vs 83.4%;P =.016)较低。男性更有可能达到 BR(SHR,1.31;95%CI,1.17-1.46;P <.001)和 CR(SHR,1.16;95%CI,1.03-1.31;P =.016),但 VR 和 HCC 风险相似。
乙型肝炎患者的治疗结果存在性别差异。与女性相比,男性的临床缓解率高 16%,生化学缓解率高 31%,而病毒学应答和 HCC 发生率在两组间相似。