Patient characteristics and median 12...

Patient characteristics and median 12 and 18 h efavirenz and 8-OH-efavirenz concentrations are summarized in Table 1. When looking at NP performance, 21 participants scored less than −1 in two domains and 12 overall had composite NPZ scores below −1. Plasma concentrations of efavirenz did not correlate with NP performance (Table 1 and Figure 1). Conversely, higher 8-OH-efavirenz plasma concentrations at 12 and 18 h correlated with better learning (P = 0.002), language (P = 0.002) and total NPZ scores (P = 0.003) (Table 1 and Figure 1).

Table 1.

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Patient characteristics, median 12 and 18 h efavirenz and 8-OH-efavirenz concentrations and correlations between efavirenz and 8-OH-efavirenz concentrations and neuropsychological tests

Variable	Value		Range (IQR)
Median age	57		50–68
Median time on ART, years	11.25		1–22.8 (10.92)
Median CD4 cells/mm³	657		145–2062 (463)
Nadir CD4 cells/mm³	259		7–769 (342)
HIV RNA <20 copies/mL	30^a		—
Hepatitis C antibody	3^b		—
PK determination (median), ng/mL
12 h EFV	1967		IQR 1476–2394
18 h EFV	1676		IQR 1120–2062
12 h 8-OH-EFV	378		IQR 223–589
18 h 8-OH-EFV	384		IQR 216–621
	Efavirenz		8-OH-efavirenz
NP test	12 h post	18 h post	12 h post	18 h post	P value^c
Total z	0.04	0.09	0.38	0.52	0.003
Motor	0.13	0.15	0.20	0.37	0.044
Learning	0.1	0.11	0.52	0.61	0.002
Memory	0.05	0.13	0.27	0.2	0.24
Language	0.05	0.08	0.5	0.53	0.002
Executive	−0.03	−0.05	0.16	0.29	0.12
Speed	0.11	−0.02	0.31	0.42	0.02
Fluency	0.24	0.24	0.14	0.24	0.2

Variable	Value		Range (IQR)
Median age	57		50–68
Median time on ART, years	11.25		1–22.8 (10.92)
Median CD4 cells/mm³	657		145–2062 (463)
Nadir CD4 cells/mm³	259		7–769 (342)
HIV RNA <20 copies/mL	30^a		—
Hepatitis C antibody	3^b		—
PK determination (median), ng/mL
12 h EFV	1967		IQR 1476–2394
18 h EFV	1676		IQR 1120–2062
12 h 8-OH-EFV	378		IQR 223–589
18 h 8-OH-EFV	384		IQR 216–621
	Efavirenz		8-OH-efavirenz
NP test	12 h post	18 h post	12 h post	18 h post	P value^c
Total z	0.04	0.09	0.38	0.52	0.003
Motor	0.13	0.15	0.20	0.37	0.044
Learning	0.1	0.11	0.52	0.61	0.002
Memory	0.05	0.13	0.27	0.2	0.24
Language	0.05	0.08	0.5	0.53	0.002
Executive	−0.03	−0.05	0.16	0.29	0.12
Speed	0.11	−0.02	0.31	0.42	0.02
Fluency	0.24	0.24	0.14	0.24	0.2

P values considered significant if <0.01. PK, pharmacokinetics; EFV, efavirenz; 8-OH-EFV, 8-hydroxy efavirenz.

^aTwenty-six participants had HIV RNA <20 copies/mL and four had HIV RNA <100 copies/mL, but all four had HIV RNA <20 copies/mL on subsequent measurements.

^bThree participants had positive HCV antibodies, all had undetectable HCV viraemia at the time of study. Two participants had been previously treated for HCV and one had spontaneously cleared viraemia.

^cAdjusted with Bonferroni correction.

Table 1.

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Patient characteristics, median 12 and 18 h efavirenz and 8-OH-efavirenz concentrations and correlations between efavirenz and 8-OH-efavirenz concentrations and neuropsychological tests

Variable	Value		Range (IQR)
Median age	57		50–68
Median time on ART, years	11.25		1–22.8 (10.92)
Median CD4 cells/mm³	657		145–2062 (463)
Nadir CD4 cells/mm³	259		7–769 (342)
HIV RNA <20 copies/mL	30^a		—
Hepatitis C antibody	3^b		—
PK determination (median), ng/mL
12 h EFV	1967		IQR 1476–2394
18 h EFV	1676		IQR 1120–2062
12 h 8-OH-EFV	378		IQR 223–589
18 h 8-OH-EFV	384		IQR 216–621
	Efavirenz		8-OH-efavirenz
NP test	12 h post	18 h post	12 h post	18 h post	P value^c
Total z	0.04	0.09	0.38	0.52	0.003
Motor	0.13	0.15	0.20	0.37	0.044
Learning	0.1	0.11	0.52	0.61	0.002
Memory	0.05	0.13	0.27	0.2	0.24
Language	0.05	0.08	0.5	0.53	0.002
Executive	−0.03	−0.05	0.16	0.29	0.12
Speed	0.11	−0.02	0.31	0.42	0.02
Fluency	0.24	0.24	0.14	0.24	0.2

Variable	Value		Range (IQR)
Median age	57		50–68
Median time on ART, years	11.25		1–22.8 (10.92)
Median CD4 cells/mm³	657		145–2062 (463)
Nadir CD4 cells/mm³	259		7–769 (342)
HIV RNA <20 copies/mL	30^a		—
Hepatitis C antibody	3^b		—
PK determination (median), ng/mL
12 h EFV	1967		IQR 1476–2394
18 h EFV	1676		IQR 1120–2062
12 h 8-OH-EFV	378		IQR 223–589
18 h 8-OH-EFV	384		IQR 216–621
	Efavirenz		8-OH-efavirenz
NP test	12 h post	18 h post	12 h post	18 h post	P value^c
Total z	0.04	0.09	0.38	0.52	0.003
Motor	0.13	0.15	0.20	0.37	0.044
Learning	0.1	0.11	0.52	0.61	0.002
Memory	0.05	0.13	0.27	0.2	0.24
Language	0.05	0.08	0.5	0.53	0.002
Executive	−0.03	−0.05	0.16	0.29	0.12
Speed	0.11	−0.02	0.31	0.42	0.02
Fluency	0.24	0.24	0.14	0.24	0.2

P values considered significant if <0.01. PK, pharmacokinetics; EFV, efavirenz; 8-OH-EFV, 8-hydroxy efavirenz.

^aTwenty-six participants had HIV RNA <20 copies/mL and four had HIV RNA <100 copies/mL, but all four had HIV RNA <20 copies/mL on subsequent measurements.

^cAdjusted with Bonferroni correction.

Figure 1.

Correlation of efavirenz (EFV) and 8-OH-EFV concentrations and neuropsychological performance. Not all comparisons are included.

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