Being Alive; March, 1995
R. Scott Hitt, M.D.

Treatments to stave off infection and prolong life exist for most of the common opportunistic infections currently known to threaten people with AIDS. Cytomegalovirus (CMV), a member of the herpes family, has been one of the last hold-outs. In December, however, the Food and Drug Administration (FDA) approved the use of an oral form of ganciclovir (DHPG) as a treatment for stable CMV retinitis, a serious eye infection.

CMV is a common virus. Approximately 80% of the adult population has been infected with it. When first infected with CMV, people usually experience flu-like symptoms. Then the virus, like its other cousins in the herpes family, lies dormant in the body for a long time without producing symptoms. When conditions are right, usually only when the infected person's immune system is severely compromised, CMV can begin to grow again in certain organs, causing damage. Normally this happens only when T-cell counts fall below 50.

Officially, oral ganciclovir is approved for patients whose CMV retinitis has been stabilized with the intravenous form of ganciclovir. Promising reports from recent studies, however, show that oral ganciclovir can slow or even prevent the development of CMV disease in patients with very low T-cell counts.

Drug Will Improve Qualify of Life

CMV can manifest itself in many different ways. If the virus grows in the back of the eye, it produces an extremely dangerous condition called retinitis, which affects about 25% of people with AIDS. The first symptoms of CMV retinitis are usually visual changes or loss of a part of a field of vision. If not caught and treated early, CMV retinitis can lead to blindness.

CMV can also grow in the gastrointestinal tract causing diarrhea and abdominal pain. More rarely, it can invade the lungs, causing pneumonia, or the peripheral nerves, causing nerve damage.

Until the FDA's recent action, patients with CMV disease required intravenous treatment with ganciclovir or foscarnet. CMV in the lungs or gastrointestinal tract requires several weeks of treatment, and because of the high rate of recurrence, CMV retinitis requires life-long treatment. Long-term IV therapy has enormous impact on quality of life, so the development of an oral alternative constitutes tremendous advancement for people with CMV disease and hope for patients with T-cell counts lower than 100 who want to prevent CMV disease.

Study Findings

The FDA approved oral ganciclovir based on recent studies conducted by Syntex, the drug manufacturer of oral ganciclovir. The study results indicate that oral and intravenous ganciclovir, administered three times daily in doses of 1000 mg, were equally effective in delaying recurrence of already diagnosed CMV retinitis. Oral Ganciclovir, administered in doses of 500 mg six times a day, was not as effective. (See Table 1)

If the CMV retinitis recurs, the IV ganciclovir is doubled in dosage for two weeks to regain control. Since recurrence of the growth of CMV retinitis occurs with either form of ganciclovir in an average of 53 days, I have recommended that my patients use a double dose of IV ganciclovir for two weeks every three months in order to try and prevent any recurrences. In preliminary results from another study, Syntex reports that individuals receiving oral ganciclovir experienced about half the occurrence of CMV retinitis when compared with study participants who received a placebo. The incidence of other types of CMV infection was even lower. (See Table 2) Participants in the Syntex study had T-cell counts of less than 50 or T-cell counts of less than 100 with a previous history of opportunistic infection. Since oral ganciclovir decreases the incidence of CMV by only 50 percent, studies are underway to see if higher doses produce even better results.

Who Should Take Oral Ganciclovir

A simple blood test called the CMV antibody titer test indicates whether a person has been exposed to CMV. Persons who have been exposed could possibly develop CMV disease if their T-cell counts fall below 100. Preventive treatment should, therefore, be considered by individuals with positive CMV antibody titer results whose T-cell counts are less than 100. People on oral ganciclovir need not take acyclovir (Zovirax) for other types of herpes infections.

The recommended dosage is four capsules three times a day. The high dosage is necessary because the body's rate of absorption is less than 10%. Since it is slightly better absorbed with food, it should be taken with meals. The only known side effect of oral ganciclovir is possible lowering of the white blood cell count. This, however, can be managed by stopping the medication for a while or by taking an injection of a drug called Neupogen to increase the body's own production of white blood cells. The cost of the drug will be around $3.50 a capsule or about $40 per day. This cost is substantially lower than the administration of IV ganciclovir. We are hopeful that this drug will be covered by insurance companies and by the state AIDS drug assistance program.

Since 1987, the number of people developing AIDS has climbed each year, but the number of people dying of AIDS in the United States has stabilized. Most AIDS specialists attribute this to the use of antivirals and medications designed to prevent opportunistic infections. As we have delayed the development of pneumocystis pneumonia, toxoplasmosis and most recently MAC through low doses of preventive medications, we have seen an increase in the incidence of CMV disease. We are hopeful that oral ganciclovir will help patients like Skip stay ahead of the curve until there is a cure.

(R. Scott Hitt, M.D. is a member of the Pacific Oaks Medical Group, 310.652.2562.)

Table 1

Median number of days to relapse IV Ganciclovir

54 Oral GCV 1000 mg x 3

53 Oral GCV 500 mg x 6 32

950301
BA950304

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