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Oral Induction Therapy for CMV Retinitis, at Last

Valganciclovir, a prodrug of ganciclovir, provides an oral alternative to IV ganciclovir for induction therapy against CMV retinitis.

Cytomegalovirus (CMV) retinitis is one of the most devastating complications of AIDS. Treatment reduces disease progression and the risk for blindness. However, induction therapy requires intravenous (IV) treatment with ganciclovir, cidofovir, or foscarnet; maintenance therapy requires IV treatment, oral ganciclovir (up to 12 capsules daily), or ocular implants. Oral ganciclovir has insufficient bioavailability (6%) for induction therapy, but the oral prodrug valganciclovir is rapidly metabolized to ganciclovir and achieves serum levels comparable to those obtained with IV ganciclovir.

In this international, industry-sponsored trial, 160 AIDS patients with CMV retinitis were randomized between January 1997 and March 1999 to receive either IV ganciclovir or oral valganciclovir for induction therapy. Only 10% of subjects in each arm showed evidence of CMV disease progression at the end of 4 weeks. The median time to progression of retinitis was 125 days in the ganciclovir arm and 160 days in the valganciclovir arm. Adverse events differed between the 2 medications: Valganciclovir was more often associated with diarrhea, and ganciclovir with more catheter-related adverse events. However, overall frequency and severity of such events were the same in the 2 groups.

Comment: Oral therapy with valganciclovir is a welcome and much-anticipated option for AIDS patients requiring induction therapy for CMV retinitis. Considering the activity and pharmacokinetics of valganciclovir reported in this study, this agent should also be useful for maintenance therapy.

— Diane Havlir, MD

Published in Journal Watch Infectious Diseases May 24, 2002

Citation(s):

Martin DF et al. A controlled trial of valganciclovir as induction therapy for cytomegalovirus retinitis. N Engl J Med 2002 Apr 11; 346:1119-26.

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