Discontinuation of maintenance therapy for cytomegalovirus retinitis in HIV-infected patients receiving highly active antiretroviral therapy

Objective: To study the safety of discontinuing cytomegalovirus (CMV) maint enance therapy among patients with cured CMV retinitis receiving highly act ive antiretroviral therapy (HAART). Methods: Patients with a history of CMV retinitis who were receiving anti-C MV maintenance therapy and who had a CD4 cell count > 75 x 10(6) cells/l an d a plasma HIV RNA level < 30 000 copies/ml while on HAART were included in a multicentre prospective study. Maintenance therapy for CMV retinitis was discontinued at enrolment and all the patients were monitored for 48 weeks by ophthalmological examinations and by determination of CMV markers, CD4 cell counts and plasma HIV RNA levels. T helper-1 anti-CMV responses were a ssessed in a subgroup of patients. The primary study endpoint was recurrenc e of CMV disease. Results: At entry, the 48 assessable patients had been taking HAART for a m edian of 18 months. The median CD4 cell count was 239 x 10(6) cells/l and t he median HIV RNA load was 213 copies/ml. Over the 48 weeks, 2 of the 48 pa tients had a recurrence of CMV disease. The cumulative probability of CMV r etinitis relapse was 2.2% at week 48 (95% confidence interval, 0.4-11.3) an d that of all forms of CMV disease 4.2%. CMV blood markers remained negativ e throughout follow-up. The proportion of patients with CMV-specific CD4 T cell reactivity was 46% at baseline and 64% at week 48. Conclusions: CMV retinitis maintenance therapy may be safely discontinued i n patients with CD4 cell counts above 75 x 10(6) cells/l who have been taki ng HAART for at least 18 months. (C) 2001 Lippincott Williams & Wilkins.