3rd International AIDS Society Conference on HIV Pathogenesis and Treatment Rio de Janeiro - July 24 - 27, 2005

E-184V STUDY. LAMIVUDINE MONOTHERAPY VS TREATMENT INTERRUPTION IN FAILING HIV-1 INFECTED SUBJECTS, HARBOURING THE M184V MUTATION: 48-WEEK FINAL RESULTS

IAS Conf HIV Pathog Treat 2005 Jul 24-27;3rd: Abstract No. WeFo0204

Castagna A.¹, Danise A.¹, Menzo S.², Galli L.¹, Boeri E.¹, Gianotti N.¹, Carini E.¹, Tiberi S.¹, Cernuschi M.¹, Hasson H.¹, Mammarella M.², Guffanti M.¹, Seminari E.¹, Clementi M.¹, Lazzarin A.^1
1Vita-Salute San Raffaele University, Milan, Italy ²University of Marche, Ancona, Italy

INTRODUCTION: In pts with treatment failure, maintaining a virus with M184V mutation may allow a decline in CD4 cells slower than therapy interruption. Aim of the study was to assess the frequency of immunological failure (CD4 <350 cells/µL) (IF)/clinical failure (occurrence of first B or C CDC event) (CF) in failing pts who stop treatment or receive 3TC monotherapy.

METHODS: This prospective, open-label, 48-week pilot study randomised 50 pts failing 3TC containing HAART, requesting therapy interruption (TI), with CD4 >500 cells/µL, HIV-RNA >1000 cp/mL and with M184V mutation to stop treatment (TI-group) or to receive lamivudine 300 mg QD monotherapy (3TC-group). Replicative capacity was tested using a recombinant phenotypic method. Primary analysis was ITT/r.

RESULTS: At screening, TI-group and 3TC-group median (IQR) CD4 number, CD4 percentage, HIV-RNA log₁₀, nadir CD4 number were 629 (563 – 768), 27.6 (25.2 – 32), 3.78 (3.33 – 4.30), 260 (155 – 350), and 620 (583 – 708), 24.7 (19.328.8), 3.91 (3.41 – 4.11), 283 (250 – 341), respectively. 17/25 pts (68%, 95%Cl: 48 – 83) in TI-group and 11/25 pts (44%, 95%CI: 24 – 65) in 3TC-group discontinued the study because of IF/CF in all but one pt in each group. CF occurred in 2/25 (8%) pts in TI-group only (one oesophageal candidiasis and one PID). At week 48 mean (95%C1) CD4 number, CD4 percentage, HIV-RNA log₁₀ changes from BL were -189 (-236,-141), -7.8 (-9.5,-6.1), 1.23 (0.96,1.5) in TI-group and -143 (-202,-83), -4.3 (-6.4,-2.3) (p=0.003), 0.67 (0.48,0.86) (p=0.001) in 3TC-group. Median (IQR) BL and 48 week (or discontinuation) number of NRTI, NNRTI and PI resistance mutations were 4 (2 – 6), 1 (0 – 1), 2 (17) and 0 (0 – 1), 0 (0 – 0), 1 (0 – 2) in TI-group; 5 (4 – 5), 1 (0 – 1), 3 (0 – 6) and 3 (2 – 4), 0 (0 – 1), 2 (0 – 4) in 3TC-group. Increase in number of resistance mutations was never observed. Median (IQR) fold replicative capacity recovery (48-week/BL p24Ag ratio) was 9.75 (3.15 – 26.12) in TI-group and 2.36 (1.02 – 6.48) in 3TC-group.

CONCLUSIONS: 3TC monotherapy induces less immunological and clinical failure than TI. This strategy is associated with maintenance of reduced viral fitness, low viral rebound and reduction of resistance mutations.

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Clinical | WeFo0204 | A. Castagna
Salvage therapy in different clinical settings

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