(ATDN) Oral Ganciclovir for Maintenance


(ATDN) Oral Ganciclovir for Maintenance

Treatment Review #16; January 1995

Ganciclovir is a drug used to treat cytomagalovirus (CMV) infection. The drug is given through a permanently placed catheter. The catheter is a tube that goes into a large vein in the chest. The first part of ganciclovir treatment is called induction therapy. After the infection is under control, you have to go on maintenance therapy, which means daily infusions of ganciclovir at a lower dose.

A pill form of the drug has been developed. Oral ganciclovir has been in clinical trials as a maintenance treatment after induction therapy with IV ganciclovir. Syntex, the company that makes oral ganciclovir, has applied to the FDA for approval of the drug as an alternative to IV ganciclovir for maintenance therapy.

Oral ganciclovir is not yet on the market in any country.

The FDA voted to recommend that the company's New Drug Application for oral ganciclovir be approved. One newsletter reports that the committee in charge of making the recommendations was hesitant to recommend oral ganciclovir for prevention of CMV because there is the threat of creating resistance to the drug and because of its high cost. The drug company will not discuss the cost of the drug until it is approved for marketing.

Resistance may develop to IV ganciclovir as well. But most people would prefer taking the pills to daily infusions, even though you may have to take as many as 12 pills a day. The oral form would also lessen the risk of infections at the catheter site. Syntex has a compassionate use program to make oral ganciclovir available to those who cannot take the drug intravenously. Doctors can call (800) 569-4630 for more information. A trial studying oral ganciclovir for the treatment of CMV in children is also open.


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This information is designed to support, not replace, the relationship that exists between you and your doctor.
©1995. AEGIS.