Fosamprenavir or atazanavir once daily boosted with ritonavir 100 mg, plus tenofovir/emtricitabine, for the initial treatment of HIV infection: 48-week results of ALERT

Table 1 Demographic characteristics (ITT exposed population)^a and disposition

	FPV/r 1400/100 mg + TDF/FTC QD N = 53	ATV/r 300/100 mg + TDF/FTC N = 53	Total N = 106
Gender, n (%)
Male	42 (79%)	47 (89%)	89 (84%)
Female	11 (21%)	6 (11%)	17 (16%)
Age, y
Median (range)	40 (22–64)	40 (20–58)	40 (20–64)
Race, n (%) ^b
White	34 (64%)	26 (49%)	59 (56%)
Black	18 (34%)	24 (45%)	42 (40%)
Asian	0	1 (2%)	1 (<1%)
Other	1 (2%)	2 (4%)	2 (2%)
HIV-1 RNA, log ₁₀ copies/mL
Median (range)	4.924 (2.775–6.320)	4.890 (3.167–6.362)	4.907 (2.775–6.362)
HIV-1 RNA < 100,000 copies/mL	29 (55%)	29 (55%)	58 (55%)
HIV-1 RNA ≥ 100,000 copies/mL	24 (45%)	24 (45%)	48 (45%)
CD4+ cell count, cells/mm ³
Median (range)	161 (19–524)	188 (19–488)	171 (19–524)
CDC classification, n (%)
Class A (asymptomatic)	30 (57%)	34 (64%)	64 (60%)
Class B (symptomatic, non-AIDS)	14 (26%)	8 (15%)	22 (21%)
Class C (AIDS)	9 (17%)	11 (21%)	20 (19%)
Mean GFR (by MDRD), mL/min/1.73 m ²	87.7 (± 20.4)	90.6 (± 18.0)
Study Withdrawals
Completed	45 (85%)	49 (92%)	94 (89%)
Prematurely withdrawn	8 (15%)	4 (8%)	12 (11%)
Reason for premature withdrawal
Adverse event	1 (2%)	1 (2%)	2 (2%)
Lost to follow-up	2 (4%)	0	2 (2%)
Protocol violation	1 (2%)	0	1 (<1%)
Protocol-defined virologic failure	4 (8%)	3 (6%)	7 (7%)

^aComprised all patients exposed to ≥ 1 dose of randomized study medication.
^b12 patients in the FPV/r arm and 12 in the ATV/r arm were of Hispanic/Latino ethnicity.

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