Len Oscar, Gavaldà Joan, Aguado José María, Borrell Núria, Cervera Carlos, Cisneros José Miguel, Cuervas-Mons Valentín, Gurguí Mercè, Martin-Dávila Pilar, Montejo Miguel, Muñoz Patricia, Bou Germán, Carratalà Jordi, Torre-Cisneros Julián, Pahissa Albert
Spanish Network for Research on Infection in Transplantation, Spain.
Clin Infect Dis. 2008 Jan 1;46(1):20-7. doi: 10.1086/523590.
Cytomegalovirus (CMV) infection causes morbidity in solid organ transplant (SOT) recipients, either by direct injury or in association with chronic allograft rejection or other opportunistic infections. Ganciclovir is the treatment of choice, but this agent requires intravenous administration, which affects its feasibility for long-term use. Valganciclovir, which has an oral bioavailability of 60%, has proven to be useful for prophylaxis of CMV infection in high-risk SOT recipients and for treating retinitis in persons with acquired immunodeficiency syndrome.
To compare the efficacy of valganciclovir (alone or as sequential therapy after a regimen of intravenous ganciclovir) with intravenous ganciclovir alone for preemptive therapy or treatment of CMV disease (viral syndrome or focal disease) in SOT recipients and to determine the incidence of adverse effects and relapses.
In this 2-year prospective, comparative cohort study, 376 episodes of preemptive therapy or treatment of CMV disease were recorded among 334 of 3467 SOT recipients included in the Spanish Network for Research on Infection in Transplantation (RESITRA) database. Intravenous ganciclovir was the first-line treatment in 170 episodes; valganciclovir followed by intravenous ganciclovir was administered in 82 episodes, and valganciclovir alone was administered in 112 episodes.
Valganciclovir was used as preemptive therapy or treatment for CMV disease in 84 and 28 episodes, respectively. Duration of treatment was longer in valganciclovir recipients than in ganciclovir recipients for both preemptive therapy (21 vs. 15 days; P < .001) or viral syndrome treatment (21 vs. 18 days; P < .01). In the valganciclovir arm, 94 (83.9%) of 112 episodes were treated successfully, with no statistical difference in the success rates versus the ganciclovir arm (85.8%) or ganciclovir-valganciclovir arm (95.1%). Eighteen episodes (16.1%) treated with valganciclovir were considered to have resulted in treatment failure (because of persistent antigenemia in 4 [3.6%], on the basis of clinical decision in 7 [6.2%], and because of recurrent disease in 7 [6.2%]). There were no incidents in which valganciclovir treatment was withdrawn because of toxicity.
Valganciclovir is safe and useful for preemptive therapy and treatment of CMV disease.
巨细胞病毒（CMV）感染可导致实体器官移植（SOT）受者发病，其途径既可以是直接损伤，也可以是与慢性移植排斥反应或其他机会性感染相关。更昔洛韦是首选治疗药物，但该药物需要静脉给药，这影响了其长期使用的可行性。缬更昔洛韦的口服生物利用度为60%，已被证明可用于预防高危SOT受者的CMV感染以及治疗获得性免疫缺陷综合征患者的视网膜炎。
比较缬更昔洛韦（单独使用或在静脉注射更昔洛韦治疗方案后序贯使用）与单独使用静脉注射更昔洛韦对SOT受者进行抢先治疗或治疗CMV疾病（病毒综合征或局灶性疾病）的疗效，并确定不良反应和复发的发生率。
在这项为期2年的前瞻性比较队列研究中，西班牙移植感染研究网络（RESITRA）数据库纳入的3467名SOT受者中的334名记录了376例CMV疾病的抢先治疗或治疗情况。170例采用静脉注射更昔洛韦作为一线治疗；8次采用缬更昔洛韦序贯静脉注射更昔洛韦治疗，112次单独使用缬更昔洛韦治疗。
缬更昔洛韦分别用于84例和28例CMV疾病的抢先治疗或治疗。对于抢先治疗（21天对15天；P < 0.001）或病毒综合征治疗（21天对18天；P < 0.01），缬更昔洛韦治疗组的治疗持续时间均长于更昔洛韦治疗组。在缬更昔洛韦治疗组中，112例中有94例（83.9%）治疗成功，与更昔洛韦治疗组（85.8%）或更昔洛韦-缬更昔洛韦治疗组（95.1%）的成功率相比无统计学差异。18例（16.1%）接受缬更昔洛韦治疗的病例被认为治疗失败（4例[3.6%]因持续抗原血症，7例[6.2%]基于临床决定，7例[6.2%]因疾病复发）。没有因毒性而停用缬更昔洛韦治疗的情况。
缬更昔洛韦对CMV疾病的抢先治疗和治疗是安全有效的。
