1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP
October 25 - 29, 2003 Warsaw, Poland
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9TH EUROPEAN AIDS CONFERENCE (EACS) 1st EACS RESISTANCE & PHARMACOLOGY WORKSHOP October 25 - 29, 2003 Warsaw, Poland |
| 7.3 Phase III/IV Trials F1/4 - INDUCTION THERAPY WITH TRIZIVIR (ZIDOVUDINE/LAMIVUDINE/ABACAVIR) [TZV] PLUS EFAVIRENZ [EFV]: TIME STUDY (AZL30004) RESULTS AT 24 WEEKS |
| (1) Royal Free Ctr for HIV Med, UCL Med Sch, London, UK,2 CHU St-Pierre, Brussels, Belgium,3 Chelsea and Westminster Hosp, London, UK,4 Hos Lariboisiere, Paris, France,5 CHU Gui de Chauliac, Montpellier, France,6 Hosp Clinico San Carlos, Madrid, Spain,7 Infectious Diseases, HSR Hosp, Milano, Italy,8 Univ Hosp Bonn, Germany |
Objectives: To assess the safety and efficacy of TZV/EFV as a quadruple therapy induction-maintenance regimen.
Methods: Subjects received TZV/EFV during a 24 week induction phase before randomization to one of three arms: TZV+EFV for 48 weeks, TZV+EFV for 24 weeks followed by TZV for a further 24 weeks, or TZV for 48 weeks. This interim analysis reports the safety and efficacy of TZV/EFV during the 24-week induction phase.
Results: 377 naïve HIV-1 infected subjects, baseline median vRNA 4.92 (2.75-5.88) log10 c/mL (49% ³100,000c/ml) and CD4 cell count 230 (19-940) cells/mm3 (41% <200 cells) enrolled. Week 24 proportions with vRNA <50c/mL were 242/377(64%, ITT: M=F) and 245/276(89%, ITT:Observed). Proportions with vRNA<50c/mL (ITT:Observed) by entry vRNA(EvRNA) were: 128/134(96%), 89/103(86%) and 28/39(72%) for EvRNA £100,000, 100,000-750,000 and >750,000 respectively; median time to vRNA <50c/mL was 8.7 and 16 weeks in the <100,000 and >100,000 strata respectively. Median CD4 cell count increase was 104 cells/mm3. 131 patients discontinued any drug prematurely: 90(24%) for adverse events (including 10% CNS, 9% HSR, 5% gastrointestinal), 10 (3%) for virological failure and 31 (8%) for other reasons. HSR events occurred in the first two weeks while treatment limiting CNS events emerged throughout 24 weeks.
Conclusions: TZV+EFV is a compact and potent QUAD regimen but this particular regimen was associated with a high incidence of adverse events leading to drug discontinuations. Patients remaining in the study benefited from an effective reduction in vRNA (including those with very high viral load at baseline), and an improvement in CD4 cell counts.
Presenting Author: Dr. Margaret Johnson, Royal Free Hospital, 10th Floor, Royal Free Hospital, Pond Street, NW3 2QG, London, United Kingdom, Phone: 0044 (0) 20 7830 2775
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