Objective: To study the safety of discontinuing cytomegalovirus (CMV) maintenance therapy among patients with cured CMV retinitis receiving highly active antiretroviral therapy (HAART).
Methods: Patients with a history of CMV retinitis who were receiving anti-CMV maintenance therapy and who had a CD4 cell count > 75 × 106 cells/l and 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 assessed in a subgroup of patients. The primary study endpoint was recurrence of CMV disease.
Results: At entry, the 48 assessable patients had been taking HAART for a median of 18 months. The median CD4 cell count was 239 × 106 cells/l and the median HIV RNA load was 213 copies/ml. Over the 48 weeks, 2 of the 48 patients had a recurrence of CMV disease. The cumulative probability of CMV retinitis relapse was 2.2% at week 48 (95% confidence interval, 0.4–11.3) and that of all forms of CMV disease 4.2%. CMV blood markers remained negative 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 in patients with CD4 cell counts above 75 × 106 cells/l who have been taking HAART for at least 18 months.
From the Departments of aInfectious Diseases, bImmunology, cOphthalmology and dVirology , Hôpital Pitié-Salpêtrière and the eHôpital Pasteur, Paris, fINSERM U330, Université Victor Segalen, Bordeaux 2, France and the gHôpital German Trias i Pujol Badalona, Spain. *See Appendix for the study members of RESTIMOP.
Received: 28 July 2000;
revised: 13 September 2000; accepted: 12 October 2000.
Sponsorship: Supported by a grant from the Agence Nationale de Recherches sur le SIDA (ANRS 078).
Requests for reprints to Dr C. Katlama, Department of Infectious Diseases, Hôpital Pitié-Salpêtrière, 47-83 Bld de l'Hôpital, 75013 Paris, France.
Note: The work in this paper has been presented in part at the Sixth Conference on Human Retroviruses and Related infections, Chicago, 1999 [abstract 456].