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Randomized prospective trial of ganciclovir maintenance therapy for cytomegalovirus retinitis
M A Jacobson1, J J O'Donnell, H R Brodie
1Department of Medicine, University of California San Francisco.
Insights
Long-term ganciclovir maintenance therapy for cytomegalovirus (CMV) retinitis in AIDS patients delays disease progression and suppresses CMV shedding. However, it does not halt retinitis progression or eradicate CMV.
Area of Science:
- Ophthalmology
- Infectious Diseases
- Virology
Background:
- Cytomegalovirus (CMV) retinitis is a significant opportunistic infection in patients with acquired immunodeficiency syndrome (AIDS).
- Long-term management strategies are crucial for controlling CMV retinitis and preventing vision loss in immunocompromised individuals.
Purpose of the Study:
- To evaluate the efficacy of long-term maintenance therapy with ganciclovir for cytomegalovirus retinitis in patients with AIDS.
- To compare the outcomes of immediate versus deferred ganciclovir maintenance therapy.
Main Methods:
- A randomized prospective comparative study involving 11 AIDS patients with CMV retinitis.
- Patients received induction therapy followed by randomization to immediate or deferred daily ganciclovir maintenance therapy.
- Evaluated time to retinitis progression and CMV shedding rates via viral cultures.
Main Results:
- Median time to retinitis progression was significantly longer in patients receiving immediate maintenance therapy (42 days) compared to deferred therapy (16 days) (P=0.07).
- After crossover, deferred maintenance patients showed a median progression time of 58 days compared to 16 days off maintenance (P=0.13).
- CMV was detected in 9% of cultures during maintenance therapy versus 40% off maintenance (P<0.001), indicating suppressed viral shedding.
Conclusions:
- Ganciclovir maintenance therapy delays, but does not halt, the progression of CMV retinitis in AIDS patients.
- Maintenance therapy suppresses CMV shedding but does not eradicate the virus.
- These findings support the use of ganciclovir maintenance therapy for managing CMV retinitis in this population.
Abstract:
We report the first randomized prospective comparative study of long-term maintenance ganciclovir (9-[2-hydroxy-1-(hydroxymethyl)ethoxymethyl]guanine, BW759U, DHPG) therapy for cytomegalovirus retinitis in patients with the acquired immunodeficiency syndrome (AIDS). Eleven retinitis patients who received a 10-day course of ganciclovir induction therapy and then were randomized to receive either immediate daily ganciclovir maintenance therapy or deferred maintenance (eight deferred maintenance, three immediate maintenance) were evaluated for drug efficacy. Median time to retinitis progression was 42 days for the immediate maintenance group compared with 16 days for the deferred maintenance group, (P = 0.07). After crossing over to maintenance therapy, patients in the deferred group had a median time to retinitis progression of 58 days compared to 16 days while not on maintenance therapy (P = 0.13). Only 9% of cultures obtained while patients received maintenance therapy were positive for cytomegalovirus, vs 40% of those obtained off maintenance (P less than 0.001). We can state then that maintenance therapy with ganciclovir delays, but does not halt, progression of cytomegalovirus retinitis and suppresses, but does not eradicate, cytomegalovirus shedding in patients with AIDS.