Valganciclovir for suppression of human herpesvirus-8 replication: a randomized, double-blind, placebo-controlled, crossover trial.

摘要: BACKGROUND: Human herpesvirus-8 (HHV-8) replication is critical in the induction and maintenance of Kaposi sarcoma, primary effusion lymphoma, some cases Castleman disease. In vitro observational studies suggest that ganciclovir inhibits HHV-8 replication, but no randomized clinical trials have been conducted. METHODS: A total 26 men infected with were to receive 8 weeks valganciclovir administered orally (900 mg once per day) or placebo orally. After a 2-week washout period, participants each group received study drug they had not yet taken (either placebo), for additional weeks. Oral swab samples collected daily during study, CMV DNA quantified by real-time PCR. RESULTS: 16 human immunodeficiency virus (HIV)-positive 10 HIV-negative enrolled completed study. Of 3,439 expected provide, 3029 (88%) available analysis. was detected on 44% swabs from who receiving placebo, compared 23% (relative risk [RR], 0.54 [95% confidence interval {CI}, 0.33-0.90]; P = .02). Valganciclovir reduced oropharyngeal shedding cytomegalovirus 80% (RR, 0.20 CI, 0.08-0.48]; < .001). Shedding independent. Hematologic, renal, hepatic toxicities more common among active drug, those though reported days diarrhea. CONCLUSIONS: day well tolerated significantly reduces frequency quantity replication.