10 GAY PEOPLE'S CHRONICLE JANUARY 13, 1995

HEALTH WATCH

Existing and new treatments for cytomegalovirus

by John Carey, M.D. Cytomegalovirus is a virus that causes complications in about 20 percent of people with AIDS, especially those with fewer than 100 CD-4 cells. The complications can take a number of forms, including ulcers in the esophagus or the colon. Infection of the the retina, which can cause blindness, is regarded as one of the most serious complications of CMV infection. Currently if someone is diagnosed with retinitis, the treatment consists of long-term i.v. therapy with one of two available drugs, either Foscarnet or ganciclovir. Despite current treatments, most people have slowly progressive disease with

some permanent loss of vision.

This situation has prompted a number of investigators to try to improve treatment for CMV retinitis. One approach would be to try to prevent CMV disease from occurring altogether. This approach is called primary prophylaxis, and there are two drugs that are currently in clinical trials looking at their ability to prevent serious CMV disease.

The first drug is an oral form of the drug ganciclovir. Oral ganciclovir at a dose of 3 grams per day was compared to an inactive substance in people with low T4, cells but no evidence of CMV disease when the trial began. The follow-up showed that the people who were receiving oral ganciclovir had half

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as many occurrences of CMV as those who were receiving an inactive compound, 15 percent versus 30 percent.

The reason that more people did not benefit from oral ganciclovir may be that the drug is absorbed poorly from the intestines. The manufacturer of Syntex, an oral ganciclovir, has applied to the FDA to release the drug on the basis of this study. A decision from the FDA is expected this spring. A second compound called valaciclovir is also in the middle of a large clinical trial.

There has also been research in improving treatment for people with established CMV infection. There is currently a lot of interest in implants. These are tiny devices that are surgically placed inside the eye of someone with CMV infection. The implant releases a steady supply of the drug over months. The data to support the usefulness of the devices comes from a small trial where patients with non-sight-threatening retinitis were assigned to either immediate treatment with an implant, or delayed treatment. In delayed treatment, an implant was placed when the opthamologist saw evidence that the eye disease was progressing.

The average time to progression of CMV in the group with delayed treatment was 15 days, as compared to 229 days in the immediate group. This difference is considered highly significant. Problems with this treatment is that the implants only deliver drug to one eye so CMV can occur in the opposite eye or other parts of the body. This would then require systematic therapy in addition to the implant.

Another concern is that some people in the implant study experienced a retinal detachment. This is when the retina becomes separated from the rest of the eye. This condition may result in significant loss of vision but may be treated by putting silicon oil in the eye. This condition also occurs as a result of

CMV infection so we can not be sure if the detachments seen in this trial are a result of the implants. Chiron, which makes the implants, plans several additional studies and hopes to get FDA approval for the implants some time in 1995.

Another approach to the treatment of CMV disease is to try to improve the body's specific immune response to the virus. People who undergo bone marrow and other organ transplants also have problems with CMV infection. There is data to suggest that the occurrence of CMV pneumonia in these patients is decreased if they get treatment with anti-CMV antibodies.

The AIDS Clinical Trials Unit at Case Western Reserve University in Cleveland is working with a new compound called MSL 109. This is a preparation of monoclonal antibodies against CMV. The data to date suggest that it has no side effects, although other monoclonal antibodies have caused fever, rash and shortness of breath. The trial which will begin early in 1995 will look at the safety and usefulness of MSL 109 in people who have just been diagnosed with CMV retinitis. People will receive either ganciclovir or foscarnet, whichever their doctor thinks is best, and either one of two doses of MSL 109 or an inactive substance. People will be followed for at least 11 months looking at the rate of progression of the CMV infection.

Whatever the outcome of these studies, 1995 promises to be a year where people with HIV can expect to see some major advances in the treatment and prevention of CMV infection.

John Carey has cared for people with AIDS since 1983. He is the medical director of the Special Immunology Unit at University Hospitals of Cleveland, an outpatient unit for people with HIV/AIDS.

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