Efficacy and safety of abacavir plus lamivudine versus didanosine plus stavudine when combined with a protease inhibitor, a nonnucleoside reverse transcriptase inhibitor, or both in HIV-1 positive antiretroviral-naive persons.
OBJECTIVE
The combination of abacavir + lamivudine (ABC+3TC) versus didanosine + stavudine (ddI+d4T), each combined with other classes of antiretrovirals (ARVs) in ARV-naive patients, was compared for the combined endpoint of time to plasma HIV RNA >50 copies/mL (at or after the 8-month visit) or death (primary endpoint) in a nested substudy of an ongoing multicenter randomized trial.


METHODS
The substudy enrolled 182 patients; mean HIV RNA and CD4+ cell counts at baseline were 5.1 log10 copies/mL and 212 cells/mm3, respectively.


RESULTS
After a median follow-up of 28 months, rates of primary endpoint were 57.2 and 67.8 per 100 person-years for the ABC+3TC and ddI+d4T groups (hazard ratio [HR]=0.81, 95% confidence interval [CI] 0.58-1.14, p=.23).


CONCLUSIONS
There was a trend for treatments containing ABC+3TC to be better than treatments containing ddI+d4T with respect to HIV RNA decreases, CD4+ cell count increases, and tolerability.
MacArthur
R D
RD
Department of Medicine, Division of Infectious Diseases, Wayne State University, Detroit, Michigan 48201, USA. rmacarthur@med.wayne.edu
Chen
L
L
Peng
G
G
Novak
R M
RM
van den Berg-Wolf
M
M
Kozal
M
M
Besch
L
L
Yurik
T
T
Schmetter
B
B
Henley
C
C
Dehlinger
M
M
D019380:Anti-HIV Agents / Q000008:administration & dosage*; D018791:CD4 Lymphocyte Count; D016049:Didanosine / Q000008:administration & dosage; D015224:Dideoxynucleosides / Q000008:administration & dosage; D004359:Drug Therapy, Combination; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy*; D017320:HIV Protease Inhibitors / Q000008:administration & dosage; D015497:HIV-1; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage; D018119:Stavudine / Q000008:administration & dosage; D016896:Treatment Outcome; D000099227:Abacavir
D019380:Anti-HIV Agents; D016049:Didanosine; D015224:Dideoxynucleosides; D017320:HIV Protease Inhibitors; D019259:Lamivudine; D018894:Reverse Transcriptase Inhibitors; D018119:Stavudine; D000099227:Abacavir