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Background:
ARV regimens have demonstrated potent virologic and CD4 cell responses,
but longer-term data are needed to evaluate durability of response.
Methods:
100 ARV-naive patients (pts) received one of 3 doses of LPV/r with
d4T/3TC BID.After 48 wks, all pts received LPV/r 400/100 mg BID with
d4T/3TC.
Results:
Median baseline HIV RNA and CD4+ T cell count were 4.9 log 10
c/mL and 338 cell/mm3. Prior to wk 300, 37 pts discontinued LPV/r
(adverse events [AE] 16%, loss to followup9%, nonadherence 4%, other
8%). At wk 300, 63/63 (observed data, OD, 100%) and 63/100
(intent-to-treat, ITT, 63%) had HIV RNA, <400 c/mL. 61/63 (OD, 97%) and
61/100 (ITT, 61%)had HIV RNA <50 c/mL. All pts with HIV RNA >500
copies/mL at any time after wk 24 had samples submitted for resistance
testing. In pts with available genotype, 0/17 demonstrated LPV or d4T
resistance, and 3/17 had 3TC resistance. Absence of detectable LPV
resistance was confirmed by phenotypic analysis (max. fold change in LPV
susceptibility <1.5-fold). Mean (median) CD4+ T cell increase from
baseline to wk 300 was 595 (540) cell/mm3; 53/63 pts had CD4+ T cell
counts >500/mm3 at wk 300. The
most common drug-related moderate/severe AEs through wk 300 were
diarrhea (28%), nausea (16%), and abnormal fat distribution (13%). At wk
300, 70% and 62% had Grade 0/1 total cholesterol (TC), <240 mg/dL or
triglycerides (TG), <400 mg/dL; while 6% and 8% demonstrated Grade 3/4
values (TC >300 mg/dL or TG >750 mg/dL).
Conclusions:
LPV/r-based therapy demonstrated sustained ARV activity and was
generally well tolerated in ARV-naive pts through 300 wks of therapy.
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