Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes after Hepatitis C Eradication (CHROME)

在艾滋病毒携带者(PLWH)中，与普通人群相比，急性心肌感染的风险增加了50%。尽管高效抗逆转录病毒疗法(HAART)的出现对PLWH有几个好处，包括延长预期寿命，但较长的寿命也使这一人群容易患上年龄匹配的未感染艾滋病毒的人的共病，包括心血管疾病。此外，HAART本身是心血管疾病(CVD)的危险因素，由HIV和ART引起的持续性炎症和慢性免疫激活会导致促炎状态，这种状态也 会增加患心血管疾病的风险。 丙型肝炎是另一种发病率和死亡率都很高的慢性病毒感染。直接作用抗病毒药物(DAAs)的发展极大地提高了丙型肝炎病毒的治愈率。然而，除了对肝脏的影响外，慢性感染丙型肝炎病毒还会导致许多与发病率和死亡率相关的肝外表现，包括心血管疾病。因此，与普通人群相比，合并感染丙型肝炎病毒和艾滋病病毒的患者心血管风险更大。如果丙型肝炎病毒的治疗可以降低HIV和丙型肝炎病毒混合感染患者的心血管疾病风险，那么这将为这一人群的早期丙型肝炎治疗提供一个指征。 因此，我们启动了一项试验性、干预性、非随机化、对照前瞻性研究，以治疗单一感染和HIV合并感染的患者，并将心血管风险结果与单一感染HIV的对照进行比较。这项初步研究将证明，丙型肝炎病毒的功能性治疗是否可以减少心肌损伤和心血管疾病的风险。 该提案由NIH的长凳到床边项目以及IHV ID部门和默克公司提供资金。核磁共振将在美国国立卫生研究院进行。记录在案的IRB将是马里兰大学巴尔的摩大学。 该方案已经纳入了33名患者，应该会在2020年完成登记。

Among people living with HIV (PLWH), there is a 50% increased risk of acute myocardial infection compared to the general population. Although the advent of highly active antiretroviral therapy (HAART) has had several benefits for PLWH,including increased life expectancy, the longer life span has also made this population apt to develop comorbidities seen in age-matched individuals without HIV, including cardiovascular disease. In addition, HAART itself is a risk factor for cardiovascular disease (CVD), and persistent inflammation and chronic immune activation caused by HIV and ART results in a proinflammatory state that also increases the risk for cardiovascular disease. Hepatitis C (HCV) is another chronic viral infection with significant morbidity and mortality. The development of directly acting antivirals (DAAs) has dramatically improved the cure rate of HCV treatment. However, besides the effects on the liver, chronic infection with HCV leads to numerous extrahepatic manifestations that are associated with morbidity and mortality, including cardiovascular disease. Therefore, patients co-infected with HCV and HIV have a magnified cardiovascular risk than that of the general population. If treatment of HCV can lower the risk of CVD among HIV and HCV co-infected patients, then this would provide an indication for early HCV treatment in this population. As such, we have initiated a pilot, intervention, non-randomized, controlled prospective study to treat HCV in mono-infected and HIV co-infected individuals and compare cardiovascular risk outcomes to HIV mono-infected controls. This pilot study will demonstrate whether functional cure of HCV reduces myocardial injury and risk of cardiovascular disease. The proposal was funded by the Bench-to-Bedside program at NIH and the IHV ID Department and Merck. The MRIs will be done at the NIH. The IRB of Record will be the University of Maryland Baltimore. The protocol has enrolled 33 patients and should complete enrollment in 2020.