Oral drug equals IV for CMV retinitis
Oral drug equals IV for CMV retinitis
A phase III study comparing an oral treatment to an intravenous therapy for newly diagnosed patients with cytomegalovirus (CMV) retinitis, which infects more than 90% of patients living with HIV and AIDS, found that in each treatment group, only seven of 73 patients experienced progression of CMV retinitis during the four-week randomized trial.
In the study, 160 patients were randomized to receive either valganciclovir 900 mg taken orally twice daily for three weeks followed by 900 mg once daily for one week, or Cytovene-IV 5 mg/kg twice daily for three weeks followed by 5 mg/kg once daily for one week. The two groups were balanced with regard to CD4 counts and use of protease inhibitors. Findings include:
• The majority of patients in both groups cleared measurable virus from their systems.
• During an open-label extension of the trial, patients originally assigned to either group also had similar outcomes with regard to retinitis progression, side effects, and survival.
"As an oral medication that provides similar blood levels to ganciclovir, valganciclovir offers significant advantages to patients in terms of convenience and also avoids catheter-related complications," notes Daniel F. Martin, MD, associate professor with the Emory School of Medicine in Atlanta and one of the study’s lead investigators.
Both drugs are manufactured by Hoffmann-LaRoche of Nutley, NJ. For more information, visit www.rocheusa.com.
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