Both highly potent antiretroviral drug rescue therapy and treatment interruption have been suggested to be effective in patients with multiple treatment failure.
To assess both the benefits and risks of an 8-week treatment interruption associated with a six to nine-drug rescue regimen in patients with multiple treatment failures.
A randomized comparative controlled trial in 19 university hospitals in France.
Sixty-eight HIV-infected patients with multiple previous treatment failures and CD4 cell counts less than 200 × 106 cells/l and plasma HIV-1-RNA levels of 50 000 copies/ml or greater.
The primary efficacy outcome was the proportion of patients with at least a 1 log10 decrease (copies/ml) in the plasma HIV-1-RNA level after 12 weeks of therapy.
Treatment interruption followed by multidrug salvage therapy led to a greater proportion of patients achieving virological success (i.e. 1 log10 decrease) at 12 weeks compared with patients receiving multidrug therapy alone (62 versus 26%, intent-to-treat analysis; P = 0.007). The median decrease in the HIV-1-RNA level was −1.91 and −0.37 log10 copies/ml (P = 0.008), respectively. Treatment interruption led to an increase in the number of sensitive drugs of the multidrug regimen (71 versus 35% of regimen with at least two sensitive drugs; P = 0.004). Factors associated with virological success were treatment interruption, the reversion of at least one mutation to wild type, adequate plasma drug concentration, and the use of lopinavir.
Treatment interruption was beneficial for treatment-experienced HIV-infected patients with advanced HIV disease and multidrug-resistant virus.
From the aDépartement des Maladies Infectieuses et Tropicales/INSERM E 0214, and bLaboratoire de Virologie, Hôpital Pitié-Salpêtrière, 47–83 Boulevard de l'Hôpital, 75651 Paris Cedex 13, France; cService des Maladies Infectieuses, Hôpital Guy de Chauliac, 80 Avenue Augustin Fliche, 34295 Montpellier cedex 5, France; dService des Maladies Infectieuses, Hôpital Saint-Louis, 1 Avenue Claude Vellefaux, 75475 Paris cedex 10, France; and eLaboratoire de Pharmacologie, Hopital Bichat-Claude Bernard, 47 rue Henri Huchard, 75877 Paris Cedex 18, France.
Correspondence to: Christine Katlama, Departement des Maladies Infectieuses, Hôpital Pitié-Salpêtrière, 47 Boulevard de l'Hôpital, 75013 Paris, France.
Tel: +33 1 42 16 01 30/42; fax: +33 1 42 16 01 26; e-mail: firstname.lastname@example.org
Received: 19 February 2003; revised: 24 June 2003; accepted: 7 July 2003.