10th Conference on Retroviruses and Opportunistic Infections Boston, MA USA - February 10 -14, 2003

Conf Retroviruses Opportunistic Infect 2003 Feb 10-14;10th: abstract no. 64
J. Ananworanich^1,2 , P. Cardiello^1,3, P. Srasuebkul^1,2, T. Samor^1,2, E. Hassink³, A. Mahanontharit^1,2, T. Boonmangum^1,2, W. Apateerapong^1,2, A. Hill⁴, K. Ruxrungtham^1,2,5, D. Cooper^1,6, J. Lange^1,3, P. Phanuphak^1,2,5
1HIV Netherlands Australia Thailand Res Collaboration, Thai Red Cross AIDS Res Ctr, Bangkok; ²Thai Red Cross AIDS Res Ctr, Bangkok, Thailand; ³Intl Antiviral Therapy Eval Ctr, Amsterdam, The Netherlands; ⁴Roche, Welwyn, UK; ⁵Chulalongkorn Univ, Bangkok, Thailand; and ⁶Natl Ctr In HIV Epid and Clin Res (NCHECR), Univ of New South Wales, Sydney, Australia

BACKGROUND: To evaluate safety, ARV use, adverse events (AE), quality of life (QOL) of Structured Treatment Interruption (STI) in Thai patients (pts).

METHODS: A total 74 pts enrolled in the HIV-NAT 001 trial series (1 yr dual NRTI followed by 3 yrs PI-based HAART) were included and randomized when last CD4 > 350 c/mm³ and VL < 50 c/ml to 3 ARV arms; arm 1: continuous (cont), arm 2: CD4-guided, arm 3: wk on-wk off. At wk 0, pts in arm 2 and 3 stopped ARV. STI in arm 2 was based on CD4 of 350 or 30% drop/rise of CD4. Failure criteria in arm 1 and 3 were VL > 1000 or CD4 < 350 on ARV. All pts were on 2NRTI+SQV-SGC1600 mg/RTV100 mg qday. Primary endpoints were % of pts with AIDS/death or with CD4 > 350. Secondary endpoints were ARV use, AE, QOL, VL. Pts were followed for 48 wks. Intent-to-treat analysis was performed using last observed values. Differences between groups were analyzed using ANOVA and Kruskal Wallis tests.

RESULTS: Baseline characteristics were similar between groups for gender (38F/36M), mean age (34 yrs) and CD4 count (644). Both pre-ARV and pre-HAART VL logs were higher in arm 2 (4.8 and 3.2) and arm 3 (4.9 and 3.4) compared to arm 1 (4.3 and 2.6), p < 0.05. [table: see text] There were no AIDS/deaths and no differences in AE, serum lipids and QOL in the 3 arms. One arm 2 pt had acute retroviral syndrome at wk 4. All arm 3 failures had VL < 50 after cont ARV with same NRTI+BID SQV 1000/RTV100 (median FU of 22 wks).

CONCLUSIONS: CD4-guided and wk on-wk off strategies resulted in comparable clinical, AE and QOL outcomes to cont ARV. Proportion of pts with CD4 > 350 was similar in all arms although CD4-guided treatment had the largest CD4 count decrease. CD4-guided treatment was the best ARV cost saving strategy and had similar VL outcome to cont ARV. There were high rates of VL failures in the wk on-wk off arm; however, all had VL < 50 after continuing the same ARV regimen. Previous sub-optimal ARV prior to HAART may have contributed to STI failure.

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