The Pharmaceutical Journal
Vol 268 No 7196 p597-604
4 May 2002

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New England Journal of Medicine (www.nejm.org)

Oral ganciclovir prodrug effective in treatment of cytomegalovirus retinitis

An oral prodrug of ganciclovir, valganciclovir (Valcyte), appears to be as effective as intravenous ganciclovir for initial treatment of cytomegalovirus retinitis in patients with AIDS, a new study shows. The prodrug, which is rapidly hydrolysed to ganciclovir when administered orally, is also effective for long-term management in these patients.

Dr Daniel Martin, department of ophthalmology, Emory University School of Medicine, Atlanta, and colleagues randomly assigned 160 patients to receive one of two regimens: valganciclovir, 900mg twice daily for three weeks followed by 900mg once daily for one week; or ganciclovir, 5mg/kg twice daily for three weeks followed by 5mg/kg once daily for a week. After four weeks of treatment, both groups were assigned to receive maintenance treatment with 900mg of valganciclovir daily.

The researchers say that a twice-daily dose of oral valganciclovir 900mg for induction therapy has an efficacy and safety profile similar to that for intravenous ganciclovir. Of those who could be evaluated, progression of cytomegalovirus retinitis during the first four weeks of treatment was seen in seven out of 71 patients taking valganciclovir and seven out of the 70 patients assigned ganciclovir. The main difference in the safety profile between the two treatment groups related to the mode of administration.

The median times to progression of retinitis were 125 days in the ganciclovir group and 160 days in the group treated with valganciclovir. However, the researchers comment that time to progression may vary from patient to patient and careful surveillance throughout treatment is recommended.

Commenting on valganciclovir's use for maintenance therapy, the researchers say: "Once-daily dosing with oral valganciclovir for maintenance treatment may increase adherence and therefore improve outcomes." (New England Journal of Medicine 2002;346:1119)

Roche expects to launch valganciclovoir in the United Kingdom later this month.