Seventh International Congress on Drug Therapy in HIV Infection


Glasgow, UK - 14-17 November 2004

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[PL2.4] Randomised comparison of maintenance therapy with trizivir [TZV] + efavirenz [EFV] vs TZV in naïve HIV-1 infected subjects: TIME study

Int Cong Drug Therapy HIV 2004 Nov 14-18;7:Abstract No. PL2.4

S. De Wit1, M. Johnson2, B. Gazzard3, J.F. Bergmann4, J. Reynes5, V. Estrada6, A. Castagna7, J. Rockstroh8
1CHU St Pierre, Brussels, Belgium; 2Royal Free Ctr; 3Chelsea & Westminster Hosp, London, UK; 4Hos Lariboisiere, Paris; 5CHU Gui de Chauliac, Montpellier, France; 6Hosp Clinico San Carlos, Madrid, Spain; 7HSR Hosp, Milano, Italy; 8Univ Hosp, Bonn, Germany

Safety and efficacy of TZV/EFV induction followed by simplification to TZV alone or continuation of TZV/EFV over 72 wks.

Subjects received TZV/EFV 24 wk induction therapy. Subjects with vRNA <50c/ml at wk 24 were randomised to TZV/EFV for 48 wks (Grp A) or TZV/EFV for 24 wks then TZV for 24 wks (Grp B) or TZV for 48 wks (Grp C).

Of the 377 subjects enrolled to the induction phase, 245 were randomised to Grps A (n=80), B (n=83) and C (n=82) in the maintenance phase. Proportions with vRNA <50c/ml at wk 72 (ITT switch/missing=failure) were 75%, 76% and 74% in the groups, respectively. Non inferiority of Grp B to A and C to A was established: point estimate -1%(-14,+12) and 1%(-13,+14), respectively. Median CD4 count changes were +167, +198 and +172 c/mm3 in the groups, respectively. Grade 2-4 drug related adverse events were reported in 11%, 10% and 4% of patients in Grps A, B and C, respectively: gastrointestinal and psychiatric events were most common. Median changes from baseline in fasting cholesterol were +0.82, +0.22 and +0.21 mmol/L in Grps A, B and C, respectively. Virologic failure occurred in 2,7 and 10 subjects in Grps A, B, C, respectively; only 3/7 patients (Grp B) and 3/10 (Grp C) had HIV-1 RNA >400 c/mL at failure.

Simplification to TZV maintenance after TZV/EFV induction therapy reduces drug-related events, reduces fasting cholesterol and maintains an immunological and virologic response compared to continuous TZV/EFV therapy.

SESSION 2: TREATMENT STRATEGIES AND ORAL PAPERS

2004-11-14
PL2.4

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