ST LOUIS (MD Consult) - On August 31, 2009, Roche announced that the US Food and Drug Administration (FDA) has approved Valcyte (valganciclovir hydrochloride) for the prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant recipients (aged 4 months to 16 years), who are considered at high risk for CMV disease. In addition, the FDA approved a new pediatric oral solution formulation of Valcyte, which may ease administration of the drug to some pediatric patients.
According to Roche, cytomegalovirus infects approximately 80% of the US population. The virus usually lies dormant but can be reactivated at times when the immune system is compromised. In organ transplant recipients, CMV infection usually occurs during the first few months after transplantation, and resultant disease may cause complications in the lungs, kidneys, nervous system, liver, and gastrointestinal tract. Studies have shown that CMV infection has been correlated with an increased risk of death in transplant recipients.
The safety and efficacy of Valcyte have not been established in the prevention of CMV disease in pediatric solid organ transplant recipients younger than 4 months. Furthermore, the medication has not been approved for the treatment of congenital CMV.
The clinical toxicity of Valcyte, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia. In animal studies, ganciclovir was carcinogenic and teratogenic and caused aspermatogenesis.
Valcyte in tablet formulation has been previously approved for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome. The drug is also indicated for the prevention of CMV disease in high-risk kidney, heart, and kidney-pancreas transplant recipients.
圣路易斯(MD Consult)——罗氏公司在2009年8月31日宣布，美国食品药品管理局(FDA)已经批准Valcyte (商品名：万赛维；通用名：缬更昔洛韦盐酸盐)用于预防年龄在4个月到16岁小儿肾脏和心脏移植患者的巨细胞病毒(CMV)感染，此类患儿被认为是CMV感染的高危群体。此外，美国FDA还批准了一种新型的万赛维口服溶液制剂，以方便患儿的服用。
罗氏指出，大约80% 的美国人有CMV感染。该病毒通常处于休眠状态，但是，当免疫系统受到损害时会恢复活性。在器官移植患者中，CMV感染通常发生在移植后的最初几个月，可能导致肺、肾脏、肝脏、胃肠道以及神经系统的并发症。研究表明，CMV感染与移植患者的死亡风险增加相关。
对于年龄小于4个月的实体器官移植患儿，万赛维在预防其CMV感染的安全性及有效性方面尚未得以证实。此外，美国FDA尚未批准该药物用于治疗先天性巨细胞病毒感染。
万赛维的代谢产物为更昔洛韦，其临床毒性包括粒细胞减少、贫血及血小板减少。在动物实验中，更昔洛韦可致癌、致畸，并导致无精子生成。
此前，万赛维片剂已被批准用于治疗获得性免疫缺陷综合征患者的巨细胞病毒性视网膜炎。该药物还被用以预防肾脏、心脏、肾脏、胰腺移植术后高危患者的CMV感染。
