Characteristics associated with virologic failure in high-risk HIV-positive participants with prior failure: a post hoc analysis of ACTG 5251

Figures & data

Table 1 Baseline characteristics of the study participants

Number of participants		59
Age (years)	Median (IQR)	47 (37, 53)
	Range	22–66
Gender	Male	36 (61%)
	Female	23 (39%)
Race/Ethnicity	Black, Non-Hispanic	43 (73%)
	White, Non-Hispanic	9 (15%)
	Hispanic (Regardless of Race)	7 (12%)
Education	<High school (HS)	17 (29%)
	HS or GED	15 (25%)
	Some college/Tech. school	23 (39%)
	College graduate (BA or BS)	4 (7%)
Yearly income	<$5,000	15 (25%)
	$5,000–$19,999	18 (31%)
	$20,000–$49,999	16 (27%)
	≥$50,000	3 (5%)
	Missing	7 (12%)
Recruitment source	ACTG clinic patient	45 (76%)
	ACTG co-enrolling trial	14 (24%)
Baseline CD4 + cells/mm^3	Median (IQR)	180 (57, 333)
	Range	7 - 852
Nadir CD4 + cells/mm^3	Median (IQR)	68 (11, 207)
	10%, 90%	5, 275
Baseline log10 HIV-1 RNA c/mL	Median (IQR)	4.0 (3.2, 4.9)
	Range	1.8 - 5.9
Continuing regimen at entry	Yes	28 (47%)
	No	31 (53%)
No. prior ART regimen changes	0	8 (14%)
	1	11 (19%)
	2	9 (15%)
	3	8 (14%)
	4	10 (17%)
	≥5	13 (22%)
Reverse transcriptase resistance	One or more mutation	38 (64%)
mutations	Missing data	1 (2%)
Protease inhibitor resistance mutations	One or more mutation	35 (59%)
	Missing data	1 (2%)
Integrase resistance mutations	One or more mutation	2 (3%)
	Missing data	1 (2%)
HIV co-receptor tropism	CCR5	7 (12%)
	CXCR4 or Dual/Mixed	5 (8%)
	Insufficient to measure	2 (3%)
	Missing data (no sample)	45 (76%)
Ever treated for or diagnosed	Yes	28 (47%)
with depression	No	31 (53%)
Ever treated for or diagnosed	Yes	10 (17%)
with anxiety	No	49 (83%)
Ever treated for or diagnosed	Yes	18 (31%)
with substance abuse disorder?	No	41 (69%)
History cigarette smoking	Yes	40 (68%)
	No	19 (32%)
Currently smoking cigarettes	Yes	32 (54%)
	No	27 (46%)
Depression (CES-D10)	Mean (S.D.)	8.9 (6.2)
	Median (IQR)	8 (4, 13)
Illness perceptions	Mean (S.D.)	37.6 (11.7)
	Median (IQR)	38 (30, 48)
Visual analog scale (VAS) adherence	Median (IQR)	76% (50, 90)
Non-perfect adherence (VAS)	Yes	43 (73%)
	No	5 (8%)
	Missing or not on cART	11 (19%)

Figure 1 Enrollment and follow-up of study participants.

Note: 1 additional death occurred after week 24.

Table 2 Variables associated with week 24 detectable HIV virus and non-perfect adherence by visual analog scale (exact logistic regression)

	Week 24 HIV RNA ≥200c/mL				Week 24 Adherence <100% by visual analog scale
Covariable	Univariable		Multivariable analysis (all with univariable p-value <0.2)		Univariable		Multivariable analysis (all with univariable p-value <0.2, except week 12 adherence measures [due to co-linearity])
	Exact OR (95% CI)	p-value	Exact OR (95% CI)	p-value	Exact OR (95% CI)	p-value	Exact OR (95% CI)	p-value
Age (per year)	0.97 (0.91, 1.04)	0.41	–	–	0.98 (0.92, 1.04)	0.58	–	–
Sex (female vs. male)	1.30 (0.31, 5.84)	0.93	–	–	0.85 (0.19, 3.92)	>0.99	–	–
Black or African-American (yes vs. no)	1.52 (0.24, 10.00)	0.87	–	–	0.62 (0.05, 4.55)	0.94	–	–
Continuing regimen at entry (yes vs. no)	1.32 (0.32, 5.56)	0.90	–	–	1.23 (0.29, 5.56)	>0.99	–	–
On cART at entry (yes vs. no)	0.44 (0.06, 2.33)	0.45	–	–	0.93 (0.16, 4.76)	>0.99	–	–
Number of prior cART regimen changes (per change)	0.98 (0.77, 1.25)	0.88	–	–	1.05 (0.79, 1.43)	0.80	–	–
CES-D10 depression score*	1.07 (0.96, 1.21)	0.21	–	–	1.31 (1.11, 1.62)	<0.001	1.24 (1.03, 1.54)	0.022
Any cigarette smoking history (yes vs. no)	0.79 (0.16, 3.57)	0.99	–	–	0.74 (0.13, 3.57)	0.94	–	–
Substance use in the last year (yes vs. no)	1.52 (0.07, 100.00)	>0.99	–	–	1.54 (0.12, I^#)	0.75	–	–
IPQ-B illness perceptions score*	1.09 (1.02, 1.17)	0.008	1.06 (0.96, 1.18)	0.29	1.15 (1.06, 1.28)	<0.001	1.11 (1.02, 1.24)	0.013
Self-efficacy score*	0.96 (0.62, 1.48)	0.93	–	–	0.97 (0.62, 1.49)	0.96	–	–
Week 12 non-perfect VAS adherence (yes vs. no)	7.44 (1.32, 57.63)	0.018	11.53 (0.46, 1485)	0.23	25.53 (3.46, I^#)	<0.001	–	–
Week 12 non-perfect 4-day adherence (yes vs. no)	6.02 (0.56, 321.99)	0.20	–	–	4.89 (0.61, I^#)	0.15	–	–
Week 12 HIV-1 RNA ≥200 c/ml (yes vs. no)	25.74 (3.44, 357.7)	<0.001	24.80 (2.29, 1493)	0.003	1.72 (0.31, 10.76)	0.73	–	–

Note: “yes vs. no” = “yes” the effect and “no” the reference category. OR=odds ratio.

* ORs reflect per unit higher for each of the specified score.

# unable to calculate upper CI.