504 
Didanosine, Lamivudine, and Efavirenz vs Zidovudine, Lamivudine, and Efavirenz, for Initial Treatment of HIV Infection: Planned 24-Week Analysis of a Prospective Randomized Non-inferiority Clinical Trial, GESIDA 39/03
Juan Berenguer*1, E Ribera2, P Domingo3, R Palacios4, P Miralles1, M Ribas5, J González6, V Asensi7, J Gimeno8, A Terrón9, and GESIDA 3903 Team
1Hosp Gregorio Maranon, Madrid, Spain; 2Hosp Vall d'Hebron, Barcelona, Spain; 3Hosp Sant Pau, Barcelona, Spain; 4Hosp Virgen de la Victoria, Malaga, Spain; 5Hosp Son Dureta, Palma de Mallorca, Spain; 6Hosp La Paz, Madrid, Spain; 7Hosp Central Asturias, Oviedo, Spain; 8Hosp del Mar, Barcelona, Spain; and 9Hosp de Jerez, Spain
Background: The regimen of didanosine, lamivudine, and efavirenz
(ddI+3TC+EFV) for initial
treatment of HIV infection has been
insufficiently analyzed in well-designed clinical trials.
Methods: This was an open-label, randomized study to
compare the non-inferiority of ddI+3TC+EFV vs the lamivudine/zidovudine combination tablet and EFV (COM-EFV). Both regimens were administered with food to improve
tolerability and patient convenience. Patients were stratified according to baseline
HIV RNA < or ≥100,000 copies/mL. The primary
endpoint was the proportion of patients achieving HIV-1 RNA <50 copies/mL at week 48. The intent-to-treat analysis (M/S any drug = F) included all patients randomized exposed to at
least 1 dose of study medication. This study is registered with ClinicalTrials.gov, Identifier: NCT00256828. The last
patient last visit (48 weeks) is expected in December 2006.
Results: Baseline characteristics and study outcomes at
week 24 for the intent-to-treat population are shown in the following table
Conclusions: At week
24, ddI+3TC+EFV
administered once daily with food provided similar antiviral efficacy to that
of COM-EFV. A
significantly
higher proportion of patients in the COM-EFV arm than in the ddI+3TC+EFV
arm discontinued the study drugs due to adverse events. The CD4 cell
increase was significantly higher in the ddI+3TC+EFV arm.
|
|
COM-EFV
|
ddI/3TC/EFV
|
|
|
Baseline Characteristics
|
n=183
|
n=186
|
p
|
|
Median age (range)
|
40.2 (57.07)
|
38.88 (55.5)
|
0.50
|
|
Female sex n (%)
|
43 (23.5%)
|
42 (22.6%)
|
0.47
|
|
Median HIV RNA log10
copies/mL (IQR)
|
5.0 (1.00)
|
5.0 (0.91)
|
0.82
|
|
Median CD4 cells/μL
(IQR)
|
216 (160.0)
|
205 (190.75)
|
0.92
|
|
CDC stage C; n (%)
|
43 (23.5%)
|
28 (15.1%)
|
0.12
|
|
Outcomes at week 24
|
|
|
|
|
Study discontinuations n (%)
|
39 (21.3%)
|
25 (13.4%)
|
0.03
|
|
Lost to follow-up n (%)
|
7 (3.8%)
|
5 (2.7%)
|
0.37
|
|
Adverse events n (%)
|
22 (12.0%)
|
11 (5.9%)
|
0.03
|
|
HIV-1 RNA < 400
copies/mL n
(%)
|
128/176* (72.7%)
|
137/176* (77.8%)
|
0.16
|
|
HIV-1 RNA < 50 copies/mL n (%)
|
116/176* (65.9%)
|
125/176* (71.0%)
|
0.18
|
|
Median CD4 cell increase/µL (IQR)
|
110 (151.5)
|
128 (148.0)
|
0.03
|
* When
this analysis was performed, HIV-1 RNA viral load
results for 7 patients in the COM-EFV arm and 10 patients in the ddI/3TC/EFV arm were pending.
|
