Kwakwa Helena, Bran Jacqueline, Ruff Julia, Sharaf Salma, Seung Hyunuk, Choe Sunny, Chua Joel V
Newlands Health, Philadelphia, PA 19114, USA.
Institute of Human Virology, University of Maryland School of Medicine, Baltimore, MD 21201, USA.
Viruses. 2025 Mar 31;17(4):510. doi: 10.3390/v17040510.
HIV and hepatitis B virus (HBV) coinfection has been associated with a higher risk of morbidity and mortality. HBV-active antiretroviral regimens have significantly improved the outcomes for coinfected people. Although bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) is safe and efficacious for the treatment of HIV, there are few randomized studies on the treatment of HIV/HBV coinfection.
This open-label switch study enrolled adults with HIV/HBV coinfection from two clinical centers. The participants were switched from their current antiretroviral regimen (regardless of viral suppression) to BIC/FTC/TAF, taken once daily for 48 weeks. The primary endpoints were the proportion of participants with HIV RNA < 50 copies/mL and HBV DNA < 29 IU/mL at Week 24.
Twenty-eight participants were enrolled, with a median age of 51 years; the majority were Black (89%) and male (86%). At baseline, 71% (20/28) and 79% (22/28) were HIV- and HBV-suppressed, respectively, and 64% (18/28) exhibited suppression for both. At week 24, 89% (25/28) and 86% (24/28) were HIV- and HBV-suppressed, respectively, and 82% (23/28) exhibited suppression for both. The most common treatment-related adverse event was nausea (2/28). None of the participants discontinued the treatment due to an adverse event. No serious adverse events or hepatitis flares were observed.
BIC/FTC/TAF is a safe and suitable option for the treatment of HIV/HBV-coinfected patients.
HIV与乙型肝炎病毒（HBV）合并感染与更高的发病和死亡风险相关。具有HBV活性的抗逆转录病毒治疗方案显著改善了合并感染者的治疗结局。尽管比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺（BIC/FTC/TAF）在治疗HIV方面安全有效，但针对HIV/HBV合并感染治疗的随机研究较少。
这项开放标签转换研究纳入了来自两个临床中心的HIV/HBV合并感染的成年人。参与者从他们当前的抗逆转录病毒治疗方案（无论病毒是否得到抑制）转换为BIC/FTC/TAF，每日服用一次，持续48周。主要终点是在第24周时HIV RNA<50拷贝/mL且HBV DNA<29 IU/mL的参与者比例。
共纳入28名参与者，中位年龄为51岁；大多数为黑人（89%）且为男性（86%）。基线时，分别有71%（20/28）和79%（22/28）的HIV和HBV得到抑制，64%（18/28）两者均得到抑制。在第24周时，分别有89%（25/28）和86%（24/28）的HIV和HBV得到抑制，82%（23/28）两者均得到抑制。最常见的治疗相关不良事件是恶心（2/28）。没有参与者因不良事件而停止治疗。未观察到严重不良事件或肝炎发作。
BIC/FTC/TAF是治疗HIV/HBV合并感染患者的一种安全且合适的选择。
