Important note: Information in this article was accurate in October 2002. The state of the art may have changed since the publication date.AIDSWEEKLY Plus; October 28, 2002
Michael Greer, Senior Medical Writer
"1263W94 [maribavir; 5,6-dichloro-2-(isopropylamino)-1,beta-L-ribofuranosyl-1-H-benzimidazole] is a novel benzimidazole compound for treatment of human cytomegalovirus (HCMV) infection and disease, with potent in vitro activity against HCMV and good oral bioavailability," explained Jacob P. Lalezari and colleagues working with Quest Clinical Research, Mount Zion Medical Center, and San Francisco General Hospital in San Francisco, and with GlaxoSmithKline in Research Triangle Park, North Carolina, and Stevenage, United Kingdom.
1263W94 can prevent HCMV shedding in male HIV patients without significant toxicity, Lalezari and coauthors reported in the September 2002 edition of Antimicrobial Agents and Chemotherapy.
The researchers examined the safety, efficacy, and pharmacokinetics of 1263W94 in a phase I clinical trial. Adult male HIV patients were treated with daily doses of 300-2,400 mg of 1263W94 or placebo for 28 days, according to the report.
Semen HCMV titers fell by an average of 2.9 to 3.7 log plaque forming units (PFU)/mL, depending on the dosage level, study data showed. The agent was well tolerated in this cohort although several participants reported taste disturbances during treatment.
1263W94 was absorbed quickly after oral administration, with linear pharmacokinetics predictable after a single dose (Phase I dose escalation trial evaluating the pharmacokinetics, anti-human cytomegalovirus (HCMV) activity, and safety of 1263W94 in human immunodeficiency virus-infected men with asymptomatic HCMV shedding. Antimicrob Agents Chemother 2002 Sep;46(9):2969-76.
"1263W94 demonstrated in vivo anti-HCMV activity in semen at all of the dosage regimens tested," Lalezari and colleagues concluded.
The corresponding author for this report is Mary Beth Wire, Clinical Pharmacology and Experimental Medicine, GlaxoSmithKline, 5 Moore Dr., 17.2214.2b, Research Triangle Park, NC 27709 USA. E-mail: mbm27778@gsk.com.
Key points reported in this study include:
1263W94, a novel anti-human cytomegalovirus (HCMV) agent, has shown promise in early clinical trials
This benzimidazole compound reduced HCMV shedding in semen by almost 4 log units at the highest doses tested
1263W94 was well tolerated although taste disturbances were reported by several study participants
This article was prepared by AIDS Weekly editors from staff and other reports.
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