NewOral anti-CMV treatment provides IV efficacy with oral convenience

Basel, Switzerland, 11 April 2002 — People with AIDS who are at risk of developing CMV, a viral infection that can potentially cause blindness have been shown to benefit from a new oral treatment, VALCYTE™, according to the results of a study published today in the New England Journal of Medicine. This will be welcome news for patients as previously the treatment options were inconvenient IV therapies requiring administration in a clinic setting.

The study reported a similar percentage of patients (90%) on oral VALCYTE and IV ganciclovir who remained free of CMV progression during the first 4 weeks of the study. The frequency and severity of adverse events were similar in both treatment arms.

"This study demonstrates that VALCYTE offers efficacy comparable to that of IV ganciclovir, among the most widely used agent in induction therapy for CMV retinitis, and does not require the use of a chronic indwelling intravenous catheter which can be problematic for some patients," said Dr. Daniel Martin, Associate Professor of Ophthalmology, Emory University School of Medicine, and lead investigator in the study. "I expect that VALCYTE will become a mainstay in the treatment of AIDS patients with CMV retinitis."

CMV is a member of the herpes family of viruses and is the leading cause of blindness in patients with AIDS. In individuals with healthy immune systems, CMV exists in the body in a dormant state. Among individuals with compromised immune systems, such as those with HIV/AIDS or patients taking post-transplant immunosuppressants, the virus can become active and manifest into a disease.

Study Design and Results
In this international, controlled study, investigators monitored treatment with oral VALCYTE vs. intravenous ganciclovir to prevent the progression of CMV during the first 4 weeks of therapy and subsequently when all patients were switched to receive VALCYTE. Photographs of the retina were used throughout the study to monitor any progression.

Of the 141 patients included in the final analysis published today, 70 were randomised to receive intravenous ganciclovir 5mg/kg twice daily for 3 weeks (induction) followed by 5 mg/kg once daily for 1 week (maintenance), and 71 to receive VALCYTE 900 mg (two 450 mg tablets) twice daily for 3 weeks (induction) followed by 900 mg once daily for 1 week (maintenance). Antiretroviral therapy did not change during the 4 weeks. After the initial 4 week induction phase, all patients received VALCYTE 900mg once daily. The median time to progression of retinitis for patients who received intravenous ganciclovir induction treatment was similar to those who received VALCYTE induction therapy (125 days vs. 160 days).

Availability of VALCYTE
Last month, VALCYTE received European regulatory acceptance as an oral therapy for the treatment of AIDS patients with CMV. National licenses from the 16 concerned member states are expected from this month.

VALCYTE has been available in the United States since 2001 following a priority review from the Food and Drug Administration (FDA). Priority reviews are given to treatments deemed to represent potentially major advances in healthcare.

About Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-oriented healthcare groups in the fields of pharmaceuticals, diagnostics and vitamins. Roche’s innovative products and services address needs for the prevention, diagnosis and treatment of disease, thus enhancing people’s well-being and quality of life.

Editors’ Note:
For patients with active CMV retinitis, the recommended induction dose with VALCYTE is 900mg (two 450mg tablets) twice a day for 21 days. Following induction treatment, or for patients who are CMV virus positive but with inactive disease requiring maintenance therapy, the recommended dose is 900mg (two 450 mg tablets) once daily.