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Combination Drug Therapy for AIDS Found to Control Blinding Eye Infection

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Researchers at the National Institutes of Health have discoveredthat a combination of protease inhibitors and other anti-HIV drugsused to treat people with AIDS can prevent or delay the progression ofcytomegalovirus (CMV) retinitis, a potentially blinding eyecomplication of AIDS. A letter detailing these findings is publishedin the May 21, 1997 issue of the Journal of the American MedicalAssociation(JAMA).

“This discovery is significant because it suggests that, undercertain circumstances, people with CMV retinitis can stop takingstandard anti-CMV medications and the disease would not progress,”said Dr. Carl Kupfer, director of the National Eye Institute, one ofthe Federal government’s National Institutes of Health (NIH). “Thestandard anti-CMV medications can be toxic and some require dailyintravenous administration. This new drug therapy may lead to asignificant improvement in the quality of life for people with AIDSwho have CMV retinitis.”

NEI researchers discovered that certain CMV retinitis patients wereable to stop standard CMV treatment, which can cause kidney toxicityand low blood cell counts, without progression of the disease. Thesepatients were placed on both protease inhibitors and other anti-HIVmedications, and subsequently experienced an elevation of CD4 cellcounts, which are blood cells that fight infection. These combinationsof protease inhibitors and other anti-HIV medications, called highlyactive antiretroviral therapy (HAART), also decreased the amount ofHIV in the patients’ blood.

CMV retinitis is a common complication of AIDS and mostly occurs inthe disease’s later stages, when the patient’s immune system isseverely affected. CMV retinitis had been

increasing in frequency as people with AIDS live longer, with up to40% of all adults with AIDS eventually developing the disease.Standard treatment for CMV retinitis, which can cause blindness ifleft untreated, requires life-long medication with a variety ofanti-CMV drugs that can be cumbersome, costly, and toxic. It isestimated that current yearly treatment cost for CMV retinitis rangesbetween $50-100,000 per patient.

“Our findings suggest that the combination of proteaseinhibitors and other anti-HIV medications can restore the immunesystem to a point where it can fight the CMV retinitis infection onits own,” said Dr. Scott Whitcup, clinical director of NEI andfirst author of the JAMA letter. “In fact, we have recentlynoticed a significant decrease in the number of new cases of CMVretinitis in our patients with AIDS.” Protease inhibitors are aclass of promising drugs recently introduced that, when taken withother HIV-fighting medications, have shown success in prolonging thelives of people with AIDS.

“The use of anti-HIV drug combinations, when accompanied by anincrease in CD4 cell counts, may allow us to change standard treatmentfor CMV retinitis,” Dr. Whitcup said. “We are encouragedthat some patients having favorable immune responses to this new drugtherapy may be able to stop standard anti-CMV retinitis medication fora period of time. Even a brief period off the costly and inconvenientanti-CMV medications may be beneficial to patients.”

“This initial observation is based on only four patients,”said Dr. Whitcup. “We will need more information beforerecommending that all people with CMV retinitis and elevated CD4counts stop their anti-CMV retinitis medication.” The NationalEye Institute is seeking to recruit AIDS patients for a largerclinical study at the NIH clinical center in Bethesda, Maryland. Thesepatients must have CMV retinitis that does not immediately threatensight, a CD4 count above 150, and must be taking anti-CMV medication.”There’s still a chance that some patients, despite increased CD4counts, may not have the appropriate immune cells to fight the CMVretinitis,” Dr. Whitcup said. “The National Eye Institute’slarger clinical trial will examine this more closely.”

People with AIDS and their doctors who are interested inparticipating in the NEI study can Contact Cheryl Perry, R.N. at301-435-4559 or by e-mail at cperry@box-c.nih.gov.

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  • Whitcup SM, Fortin E, Nussenblatt RB, Polis MA, Muccioli C, Belfort R Jr. Therapeutic Effect of Combination Antiretroviral Therapy on Cytomegalovirus Retinitis. JAMA. 1997 May 21. PubMed

June 2001