October 27, 1997
Volume 50, No. 10
Simultaneously giving AIDS patients the antiviral medication ganciclovir via pill and by a tiny pellet implanted in the eye delays or prevents complications of cytomegalovirus (CMV), one of the most common opportunistic infections associated with AIDS, reported Emory ophthalmologist Daniel Martin earlier this month at the Sixth European Conference on Clinical Aspects and Treatment of HIV Infection in Hamburg, Germany.
Martin and his colleagues from Roche Ganciclovir Study Group and elsewhere randomly assigned 377 AIDS patients diagnosed with CMV retinitis in one eye to receive one of three treatments: ganciclovir eye implant plus ganciclovir pill; eye implant plus placebo pill; or intravenous ganciclovir.
"Patients who received the combination therapy had by far the best outcomes," said Martin, principal investigator of the trial and an assistant professor at the School of Medicine. The combination treatment "delays the onset of new CMV disease and time to progression of CMV retinitis and reduces the incidence of Kaposi's sarcoma," he wrote in his study abstract.
In addition, subjects in the combined therapy group had fewer hospitalizations and spent less time in the hospital when they were admitted. The incidence of new AIDS-associated conditions was also reduced among those subjects receiving combined therapy.
Median survival time among the groups, though not statistically significant, was 568 days for the combination group, 388 for the implant-alone group and 426 for the intravenous group.
"Improvement in the quality of patients' lives with the combined therapy is substantial," Martin said. "We've shown that combining eye implants with capsules offers a positive alternative to the undesirable intravenous administration of ganciclovir that eventually requires hours-long, daily infusions and the insertion of a permanent catheter in the chest."
After six months of treatment, 22.4 percent of subjects on combined treatment developed CMV retinitis in the unaffected eye or developed new extraocular CMV complications, compared with 37.8 percent of subjects on implant-alone or 17.9 percent on intravenous therapy. The researchers calculated that adding the pill to the implant treatment reduced the overall risk of developing new systemic CMV complications by 40 percent.
Without treatment, CMV damages the light-catching retina on the back wall of the eye and can lead to blindness. Prior to the advent of highly active antiretroviral therapy to treat CMV, up to 45 percent of persons with AIDS were affected. The incidence is now reduced but still remains a significant problem.
Systemic administration of ganciclovir either by pill or intravenous catheter significantly reduced the development of Kaposi's sarcoma, a cancer common among AIDS patients that is not considered a complication of CMV. Only 1.5 percent of subjects receiving the antiviral drug intravenously and 2.7 percent receiving it by pill and implant developed the cancer, compared to 11.3 percent of patients who received the implant alone.
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