J. Reynes et al., ONCE-DAILY ADMINISTRATION OF DIDANOSINE I N COMBINATION WITH ZIDOVUDINE IN NAIVE HIV-INFECTED ADULTS, Pathologie et biologie, 45(5), 1997, pp. 441-444
25 HIV-infected antiretroviral-naive adults were included in a 24-week
study to evaluate the efficacy and the tolerability of a zidovudine/d
idanosine combination therapy in which didanosine was administered onc
e daily (200 mg if weight < 60 kg, 300 mg if weight > 60 kg) and zidov
udine twice daily (500 mg/day if weight < 90 kg, 600 mg/day if weight
> 90 kg). 5 patients discontinued their treatment early: 3 had poor co
mpliance and 2 presented adverse events, Evaluation of treatment effic
acy was based on CD4+ T cell enumeration and HIV RNA level quantitatio
n in plasma (NASBA). Baseline values were 278 CD4+/mm(3) and 5.42 log
RNA copies/ml. Mean changes from baseline were +102 CD4+/mm(3) and -2.
14 log RNA copies/ml at week 8 and +156 CD4+/mm(3) and -2.07 log RNA c
opies/ml at week 24, HIV RNA in plasma was lower than the detection li
mit (2.60 log RNA copies/ml) in 55% of patients at week 8 and in 30% a
t week 24. No major adverse events such as neuropathy or pancreatitis
were observed. Once-daily administration of didanosine in combination
with twice-daily administration of zidovudine is a well tolerated regi
men that appears to be as effective ad the conventional zidovudine/did
anosine combination regimen.