. 2013 Jun;29(6):859–870. doi: 10.1089/aid.2012.0292

Table 4.

Sparse Pharmacokinetic Parameters as a Predictor for Antiretroviral Responses at Week 48

	n^a	N^a	Odds ratio (95% CI)^b	p-value^b
HIV RNA<400 at week 48^c
GM all (nM)	152	185	1.246 (0.510, 3.040)	0.630
GM C_12h (nM)	98	115	2.578 (0.740, 8.978)	0.137
C_min (nM)	152	185	0.691 (0.321, 1.489)	0.345
HIV RNA<50 at week 48
GM all (nM)	137	184	1.332 (0.615, 2.882)	0.467
GM C_12h (nM)	88	114	2.379 (0.841, 6.725)	0.102
C_min (nM)	137	184	0.988 (0.517, 1.888)	0.971
Virologic failure^d
GM all (nM)	42	185	0.428 (0.187, 0.977)	0.044
GM C_12h (nM)	22	115	0.393 (0.132, 1.166)	0.092
C_min (nM)	42	185	0.684 (0.349, 1.340)	0.269

^{^a}

N, number of patients with both PK and efficacy data. n, number of patients (out of N) with events.

^{^b}

Logistic regression with the following covariates: baseline HIV RNA (log₁₀ copies/ml) and PK parameters (in log₁₀ scale).

^{^c}

For HIV RNA <400 at week 48, a reliable estimate of odds ratio with corresponding p-value cannot be obtained due to the low number of subjects who failed this criterion.

^{^d}

Virologic failure was defined as (1) nonresponders who had a confirmed <1.0 log₁₀ decrease from baseline plasma HIV RNA and HIV RNA >50 copies/ml starting at week 24 or beyond, or (2) viral rebound starting at week 24 or beyond, which was defined as (a) HIV RNA >50 copies/ml (on two consecutive measurements at least 1 week apart) after initial response with HIV RNA <50 copies/ml, or (b) >1.0 log₁₀ increase in HIV RNA above nadir level (on two consecutive measurements at least 1 week apart).

Note: (1) Patients who prematurely discontinued assigned treatment due to lack of efficacy were considered as failures (OF). (2) Raltegravir (400 mg b.i.d.) was administered with an optimized background therapy.