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Lamivudine monotherapy in HIV-1-infected patients harbouring a lamivudine-resistant virus: a randomized pilot study (E-184V study)

Castagna, Antonellaa; Danise, Annaa; Menzo, Stefanoc; Galli, Lauraa; Gianotti, Nicolaa; Carini, Elisabettaa; Boeri, Enzob; Galli, Andreaa; Cernuschi, Massimoa; Hasson, Hamida; Clementi, Massimob; Lazzarin, Adrianoa

doi: 10.1097/01.aids.0000218542.08845.b2
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Objective: We compared the immunological and clinical outcomes of lamivudine monotherapy and complete therapy interruption in the treatment of HIV-1-infected patients harbouring lamivudine-resistant virus.

Methods: This 48-week, open-label pilot study randomly assigned HIV-infected patients receiving lamivudine-containing HAART and harbouring the M184V mutation to monotherapy with lamivudine 300 mg once daily (lamivudine group) or the discontinuation of all antiretroviral drugs (TI group). The primary endpoint was the occurrence of immunological or clinical failure; immunological failure was defined as the first report of a CD4 T-cell count less than 350 cells/μl, and clinical failure as the occurrence of a Centers for Disease Control and Prevention grade B or C event. The data were analysed on the basis of the intention-to-treat principle.

Results: By week 48, 20 of 29 patients in the TI group (69%; 95% CI 51–83%) and 12 of 29 in the lamivudine group (41%; 95% CI 26–59%) had discontinued the study because of immunological or clinical failure, which was significantly delayed in the lamivudine group (P = 0.018). Only patients in the TI group (6/29, 20.7%) experienced grade 3–4 clinical adverse events at least possibly related to HIV-1 (P = 0.02). The mean decline in CD4 cell percentage, viral rebound and recovery of HIV-1 replication capacity were significantly lower in the lamivudine group. The 24-week virological and immunological response after therapy resumption in patients who prematurely discontinued the study was similar in the two groups.

Conclusion: In HIV-1-infected patients harbouring a lamivudine-resistant virus, lamivudine monotherapy may lead to a better immunological and clinical outcome than complete therapy interruption.

From the aClinic of Infectious Diseases

bMicrobiology Laboratory, Vita-Salute San Raffaele University, Milan, Italy

cVirology Laboratory, Politecnica delle Marche University, Ancona, Italy.

Received 26 October, 2005

Revised 20 January, 2006

Accepted 6 February, 2006

Correspondence to Antonella Castagna, MD, Clinica di Malattie Infettive, Vita-Salute San Raffaele University, Via Stamira d'Ancona 20, 20127 Milan, Italy. Tel: +39 0226437938; fax: +39 0226437030; e-mail: castagna.antonella@hsr.it

This study was presented in part at the XVth International AIDS Conference, Bangkok, 9–14 July 2004, and at the 3rd IAS Conference, Rio de Janeiro, 23–27 July 2005.

© 2006 Lippincott Williams & Wilkins, Inc.