Objective: To evaluate the efficacy and safety of the foscarnet–ganciclovir combination in induction therapy (IT) and maintenance therapy (MT) for cytomegalovirus (CMV) central neurological disorders in HIV-infected patients.
Design: An open pilot non-comparative multicentre study.
Methods: Thirty-one patients with acute CMV encephalitis (CMVe) (n = 17) or CMV myelitis (CMVm) (n = 14) during the era before highly active antiretroviral therapy (HAART) received intravenous IT with foscarnet 90 mg/kg plus ganciclovir 5 mg/kg twice a day followed by MT. The primary endpoint was clinical efficacy, assessed at the end of the induction phase.
Results: The foscarnet–ganciclovir combination in IT resulted in a 74% (23 out of 31 patients) clinical improvement or stabilization. Eight patients did not respond clinically. Side-effects leading to drug discontinuation occurred in 10 patients during IT. Among the 23 patients who qualified for the maintenance phase, CMV disease progressed in 10, with a median time to the first relapse of 126 days (range 64–264 days). Overall, the median survival time was 3 months [95% confidence interval (CI), 2–4 months].
Conclusion: The combination of foscarnet and ganciclovir can safely be used for CMV central nervous system (CNS) infection, with an improvement or stabilization in 74% of patients. Life-long MT with this combination is recommended as long as the immune system is profoundly impaired.
From the Departments of aMaladies Infectieuses et Tropicales, bVirologie, Hôpital Pitié-Salpétrière, Paris, France; cVirologie, dINSERM SC4, Hôpital Saint-Antoine, Paris, France; eMédecine Interne, Hôpital Bicêtre, Kremlin-Bicêtre, France; fMédecine Interne, Hôpital Béclère, Clamart, France; gMaladies Infectieuses, Hôpital Bichat, Paris, France; and hMédecine Interne, Hôpital Cochin, Paris, France.
Sponsorship: This work was supported by the Agence Nationale de Recherche sur le SIDA (ANRS 037).
Correspondence and requests for reprints to: Professor C. Katlama, Maladies Infectieuses, Hôpital Pitié-Salpétrière, 45–83 boulevard de l'Hôpital, Paris, France F75013.
This study was presented in part at the 6th European Conference on Clinical Aspects and Treatment of HIV Infection. Hamburg, 11–15 October 1997 [Abstract 400/B6] and the 5th Conference on Retroviruses and Opportunistic Infections. Chicago, 1–5 February 1998 [Abstract 263].
Received: 15 December 1999; accepted: 22 December 1999.