[544] VIROLOGICAL AND IMMUNOLOGICAL IMPACT OF NNRTI WITHDRAWAL IN HIV-INFECTED PATIENTS WITH MULTIPLE TREATMENT FAILURES: A SUBSTUDY OF PUZZLE 2

2nd International AIDS Society Conference on HIV Pathogenesis and Treatment

Paris, France - July 13 - 16, 2003

[TITLE:] VIROLOGICAL AND IMMUNOLOGICAL IMPACT OF NNRTI WITHDRAWAL IN HIV-INFECTED PATIENTS WITH MULTIPLE TREATMENT FAILURES: A SUBSTUDY OF PUZZLE 2 – ANRS 107 TRIAL

[AUTHOR(S):] C Piketty¹, L Gérard², C Chazallon², V Calvez³, F Clavel⁴, AM Taburet⁵, PM Girard⁶, JP Aboulker² and the Puzzle 2 Study Group
¹Hop. Européen Georges Pompidou; ²Inserm SC10; ³Hop. Pitié-Salpêtrière; ⁴Hop. Bichat-Claude Bernard; ⁵Hop.Bicêtre; and ⁶Hop. Saint-Antoine, Paris, France

IAS Conf HIV Pathog Treat 2003 Jul 13-16;2nd: Abstract No. 544
Antiviral Therapy 2003; 8(Suppl. 1):S330

[ABSTRACT:] Objective: To assess the impact on viral load (VL) and CD4 cell count of NNRTI withdrawal from ongoing therapy of patients exhibiting incomplete viral suppression and multiple resistance mutations to PI, NRTI and NNRTI.

Methods: We assessed changes from Wk–4 to Wk0 in VL and CD4 in pts enrolled in a prospective trial prescribing that NNRTI be stopped at Wk–2 before pts be randomized at Wk0 to receive for the first 2 weeks either unchanged PI and NRTIs, or a combination of atazanavir (ATV) 300 mg once a day, ritonavir (RTV) 100 mg and unchanged NRTIs, and for the 24 following weeks a combination of ATV, RTV and recycled NRTIs. Trial eligibility included VL >4.0 log after failure of regimen lines containing at least two PIs and one NNRTI.

Results: 52 pts completed the study until Wk2. At baseline, median (range) CD4 was 206/mm³ (3, 595) and median HIV RNA was 5.0 log₁₀ (4.0, 6.2) copies/ml. Median number of previous PI, NRTI and NNRTI was 5, 4 and 1, respectively. NNRTI was stopped in the 20 recipient pts, whose NNRTI mutations number ranged from 1 to 3. Mean change in VL (log copies/ml ±sd) from Wk–4 to Wk0 was identical in patients receiving NNRTI at Wk–4 and those who did not [0.0 ±0.3 (95CI: –0.16, 0.14) and 0.0 ±0.3 (95CI: -0.09, 0.10), respectively]. Mean change in CD4 cell count (/mm³ ±sd) from Wk–4 to Wk0 was not significantly different in patients receiving NNRTI at Wk–4 and those who did not : –18 ±41 (95CI: –37, 1) and –1 ±50 (95CI: –19, 16).

Conclusions: No significant changes in VL or CD4 cell count were shown 2 weeks after NNRTI withdrawal. The data suggest that in the presence of specific resistance mutations, NNRTIs exert no antiretroviral activity and could be withdrawn without viral rebound.

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