Home Search Abstracts Browse Sessions Program Committee View Session E-mail Abstract Author

 

 

Session 143 Poster Abstracts
NRTI Toxicities
Wednesday, 1:30 - 3:30 pm
Hall B


830    
Hematologic Benefit of Switching from Regimens Combining Protease Inhibitors and Zidovudine plus Lamivudine to Once-daily Emtricitabine, Didanosine, and Efavirenz. A Sub-study of the ANRS 099 ALIZE Trial
JM Molina*1, M Bentata2, M Garré3, F Colin4, J Hinkle5, C Leport6, Y Levy7, C Goujard8, N Adda5, J Quin5, C Rancinan4, F Rousseau5, and ALIZE study group
1Hosp St-Louis, Paris, France; 2Avicenne, France; 3Brest, France; 4INSERM U593, Bordeaux, France; 5Gilead Sci, NC, USA; 6Hosp Bichat-Claude Bernard, Paris, France; 7Henri Mondor Hosp, Créteil, France; and 8Kremlin-Bicetre Hosp, France

Background:  Previous studies have demonstrated that low hemoglobin level is an independent risk factor for progression to AIDS and death. Various risk factors for HIV-related anemia have been identified, including clinical AIDS, CD4+ cell counts < 200 cell/mm3, high plasma viral load, female gender, African ethnicity, and zidovudine (ZDV) use. 

Methods:  ANRS-099 was a randomized, open-label, 48-week switch study in patients on a stable protease inhibitor (PI)-containing HAART regimen with plasma HIV RNA levels < 400 copies/mL in the previous 6 months. Patients were randomized to continue the PI regimen or switch to the entirely once-daily regimen of emtricitabine (FTC) plus didanosine (ddI) plus efavirenz (EFV). Change from baseline in hemoglobin (g/dL) and neutrophils (%) were compared between randomized treatment arms at week 48 in the subset of patients receiving ZDV+3TC+PI at entry and compared using a 2 sample t-test.

Results:  We enrolled 355 patients, of whom 150 were taking ZDV plus lamivudine (3TC) as a component of their stable PI HAART regimen at entry. Median duration of HAART was 35 months. Mean baseline and change from baseline results for hemoglobin, neutrophils, and CD4+ T-lymphocytes are shown in the table.

 

Lab Parameter

Analysis Variable

ZDV+3TC+PI
(N=76)

FTC+ddI+EFV
(N=74)

difference

P value

Hemoglobin (g/dL)

Baseline Mean ± SD

14.0 ± 1.4 

13.8 ± 1.3 

0.2  

0.45

Week 48 change from baseline

–0.4

+0.7

1.1

<0.01

Neutrophils(x109/l)

Baseline mean ± SD

3083 ± 1253 

2825 ± 1355 

258 

0.23

Week 48 % change from baseline

+6%

+32%

26%

<0.01

CD4+ (cells/mm3)

Baseline Mean± SD

483 ± 322

463 ± 309

20  

0.69

Week 48 change from baseline

+9

+34

25

0.27

Plasma HIV-1 RNA

Week 48 < 400 copies/mL (%)

90%

95%

 5%

0.26

Conclusions:  A significant improvement in hemoglobin and neutrophil count was observed in patients switching to the entirely once-daily regimen of FTC+ddI+EFV while maintaining virologic control and immunologic response.

Keywords: anemia; neutropenia; zidovudine