Patient Reported Central Nervous System Adverse Events of Efavirenz-Based Antiretroviral Therapy in People Living with HIV in Northwest Ethiopia

Figures & data

Table 1 Sociodemographic Characteristics of Participants

Characteristics	Category	Frequency (%)
Sex	Male	206(59.7)
	Female	139 (40.3)
Age	<25	46(13.3)
	25–44	200(58.0)
	≥45	99(28.7)
Weight	≤50kg	133 (38.6)
	51–69kg	189 (54.8)
	≥70kg	23 (6.7)
Body mass index (BMI)	<18.50 (underweight)	61(17.7)
	18.50–24.99 (normal)	251(72.8)
	≥25.00 (overweight)	33(9.6)
Education status	No formal education	`81(23.5)
	Primacy school	105(30.4)
	Secondary school	115(33.3)
	Higher education	44(12.8)
Religion	Orthodox	281(81.4)
	Muslim	49(14.2)
	Others	15(4.3)
Economic status	Low	247(71.6)
	Moderate	77(22.3)
	Good	21(6.1)
Marital status	Married	125(36.2)
	Single	126(36.5)
	Divorced	49(14.2)
	Widowed	45(13.0)
Employment status	Employed by Government or private organization	105(30.4)
	Self-employed	119(34.5)
	Unemployed	121(35.1)
Alcohol use	Yes	138(40.0)
	No	207(60.0)
Smoking status	Yes	28(8.1)
	No	317(91.9)

Table 2 Clinical Characteristics of Participants

Characteristics	Category	Frequency (%)
CD4 count	<200 cells/mm^3	175 (50.7)
	≥200 cells/mm^3	170 (49.3)
Viral load	Undetectable	138 (40.0)
	≤1000 copies	97 (28.1%)
	>1000 copies	47 (13.6)
	Not reported	63 (18.3)
Disease stage	Stage 1	80(23.2)
	Stage 2	75(21.7)
	Stage 3	145(42.0)
	Stage 4	45(13.0)
Efavirenz-based regimen	TDF+3TC+EFV	272(78.8)
	AZT+3TC+EFV	73(21.2)
Duration since the start of efavirenz	<1years	60(17.4)
	1–3 years	119(34.5)
	4–6 years	85(24.6)
	7–10 years	36(10.4)
	>10 years	45(13.0)
Time of the day medication is taken	Morning	10(2.9)
	Night	252(73.0)
	Both	83(24.1)
Medication taking in relation to meal	Before meal	34(9.9)
	After meal	233(67.5)
	Both	78(22.6)
Any concomitant medical condition	Yes	43(12.5)
	No	302(87.5)
Concurrent use of other medication	Yes	90(26.1)
	No	255(73.9)

Abbreviations: TDF, tenofovir; 3TC, lamivudine; EFV, efavirenz; AZT, zidovudine.

Figure 1 CNS adverse events.

Table 3 Sociodemographic Factors Associated with Reported CNS Adverse Effects of Efavirenz

Variables	Category	CNS Adverse Event		COR (95% CI)	AOR (95% CI)	p-value
		No (%)	Yes (%)
Sex	Male	93 (45.1)	113 (54.9)	1.00	1.00
	Female	70 (50.4)	69 (49.6)	0.811 (0.527–1.248)	0.926 (0.572–1.498)	0.754
Age	<25 years	29 (63.0)	17 (37.0)	1.00	1.00
	25–44 years	94 (47.0)	106 (53.0)	1.924 (0.994–3.722)	1.955 (0.877–4.356)	0.101
	45 years and above	40 (40.4)	59 (59.6)	2.516 (1.224–5.174)	3.183 (1.302–7.782)	0.011*
Weight	50 kg or less	72 (54.1)	61 (45.9)	1.00	1.00
	51–69kg	80 (42.3)	109 (57.7)	1.608 (1.029–2.514)	1.615 (0.915–2.848)	0.098
	70 kg and above	11 (47.8)	12 (52.2)	1.288 (0.531–3.124)	1.281 (0.390–4.212)	0.683
BMI	<18.5 (underweight)	28 (45.9)	33 (54.1)	1.00	1.00
	18.5–24.99 (normal)	120 (47.8)	131 (52.2)	0.926 (0.528–1.624)	0.626 (0.310–1.264)	0.191
	≥25.0 (overweight)	15 (45.5)	18 (54.5)	1.018 (0.435–2.383)	0.538 (0.166–1.748)	0.302
Education	No formal education	43 (53.1)	38 (46.9)	1.00	1.00
	Primary school	48 (45.7)	57 (54.3)	1.344 (0.751–2.403)	1.267 (0.658–2.440)	0.479
	Secondary school	55 (47.8)	60 (52.2)	1.234 (0.698–2.182)	1.214 (0.647–2.277)	0.547
	Higher education	17 (38.6)	27 (61.4)	1.797 (0.851–3.795)	1.696 (0.724–3.969)	0.224
Religion	Orthodox Christian	130 (46.3)	151 (53.7)	1.00	1.00
	Muslim	24 (49.0)	25 (51.0)	0.897 (0.489–1.646)	0.995 (0.511–1.940)	0.989
	Others	9 (60.0)	6 (40.0)	0.574 (0.199–1.655)	0.465 (0.143–1.513)	0.203
Economic status	Low	99 (40.1)	148 (59.9)	1.00	1.00
	Moderate	50 (64.9)	27 (35.1)	0.361 (0.212–0.615)	0.303 (0.169–0.545)	<0.0001*
	Good	14 (66.7)	7 (33.3)	0.334 (0.130–0.858)	0.273 (0.098–0.760)	0.013*
Marital status	Married	54 (43.2)	71 (56.8)	1.00	1.00
	Single	63 (50.0)	63 (50.0)	0.761 (0.463–1.250)	0.802 (0.447–1.439)	0.459
	Divorced	23 (46.9)	26 (53.1)	0.860 (0.443–1.669)	0.779 (0.373–1.628)	0.506
	Widowed	23 (51.1)	22 (48.9)	0.727 (0.367–1.441)	0.746 (0.355–1.564)	0.437
Employment status	Employed by Government or private organization	47 (44.8)	58 (55.2)	1.00	1.00
	Self employed	56 (47.1)	63 (52.9)	0.912 (0.538–1.544)	0.996 (0.548–1.810)	0.990
	Unemployed	60 (49.6)	61 (50.4)	0.824 (0.488–1.392)	1.083 (0.583–2.013)	0.801
History of alcohol use	Yes	57 (41.3)	81 (58.7)	1.00	1.00
	No	106 (51.2)	101 (48.8)	0.671 (0.434–1.036)	0.611 (0.369–1.011)	0.055
Smoking history	Yes	11 (39.3)	17 (60.7)	1.00	1.00
	No	152 (47.9)	165 (52.1)	0.702 (0.319–1.547)	0.716 (0.292–1.755)	0.465

Note: *Significant association.

Abbreviations: CNS, central nervous system; COR, crude odds ratio; AOR, adjusted odds ratio; BMI, body mass index.

Table 4 Clinical Factors Associated with Reported CNS Adverse Effects of Efavirenz

Variables	Category	CNS Adverse Event		COR (95% CI)	AOR (95% CI)	p-value
		No (%)	Yes (%)
CD4 count	<200	47 (26.9)	128 (73.1)	1.00	1.00
	≥200	116 (68.2)	54 (31.8)	0.171 (0.107–0.272)	0.120 (0.038–0.383)	<0.0001*
Viral load	Undetectable	70 (50.7)	68 (49.3)	1.00	1.00
	≤1000	41 (42.3)	56 (57.7)	1.406 (0.833–2.372)	0.953 (0.302–3.012)	0.935
	>1000	21 (44.7)	26 (55.3)	1.275 (0.656–2.478)	1.618 (0.384–6.822)	0.513
Disease stage	Stage 1	77 (96.3)	3 (3.8)	1.00	1.00
	Stage 2	69 (92.0)	6 (8.0)	2.232 (0.538–9.266)	2.051 (3.81–11.041)	0.403
	Stage 3	8 (5.5)	137 (94.5)	439.54 (113.27–1705.61)	907.41 (136.41–6010.50)	<0.0001*
	Stage 4	9 (20.0)	36 (80.0)	102.67 (26.212–402.12)	157.283 (28.01–883.228)	<0.0001*
Drug regimen	TDF+3TC+EFV	109 (40.1)	163 (59.9)	1.00	1.00
	AZT+3TC+EFV	54 (74.0)	19 (26.0)	0.235 (0.132–0.419)	0.188 (0.027–1.285)	0.088
Duration of treatment	<1 year	32 (53.3)	28 (46.7)	1.00	1.00
	1–3 years	51 (42.9)	68 (57.1)	1.524 (0.817–2.843)	0.472 (0.093–2.397)	0.365
	4–6 years	43 (50.6)	42 (49.4)	1.116 (0.576–2.613)	1.025 (0.207–5.088)	0.976
	7–9 years	18 (50.0)	18 (50.0)	1.143 (0.500–2.613)	1.032 (0.150–7.119)	0.975
	≥10 years	19 (42.2)	26 (57.8)	1.564 (0.717–3.409)	0.404 (0.038–4.240)	0.450
Time of day the medication is taken	Morning	5 (50.0)	5 (50.0)	1.00	1.00
	Night	116 (46.0)	136 (54.0)	1.172 (0.331–4.150)	0.145 (0.008–2.704)	0.196
	Both	42 (50.6)	41 (49.4)	0.976 (0.263–3.626)	0.344 (0.012–9.940)	0.534
Medication taking in relation to meal	Before meal	17 (50.0)	17 (50.0)	1.00	1.00
	After meal	111 (47.6)	122 (52.4)	1.099 (0.535–2.257)	2.688 (0.521–13.871)	0.238
	Both	35 (44.9)	43 (55.1)	1.229 (0.548–2.753)	2.452 (0.376–15.996)	0.349
Concomitant medical condition	Yes	15 (34.9)	28 (65.1)	1.00	1.00
	No	148 (49.0)	154 (51.0)	0.557 (0.286–1.086)	0.107 (0.016–0.714)	0.021*
Concurrent use of other medication	Yes	42 (46.7)	48 (53.3)	1.00	1.00
	No	121 (47.5)	134 (52.5)	0.969 (0.599–1.568)	5.466 (1.545–19.336)	0.008*

Note: *Significant association.

Abbreviations: CNS, central nervous system; COR, crude odds ratio; AOR, adjusted odds ratio; TDF, tenofovir; 3TC, lamivudine; EFV, efavirenz; AZT, zidovudine.