Evaluation of Adverse Drug Events in Patients on Anti-Retroviral Therapy Regimen at Omdurman Voluntary Counselling and Testing and Anti-Retroviral Therapy Center in Sudan – A Cross-Sectional Study

Figures & data

Table 1 Socio-Demographics of the Studied Patients (n=357)

Variable	Categories of the variable	Number (Frequency %)
Age (years)	18–24	9 (2.5)
	25–34	85 (23.8)
	35–44	129 (36.1)
	45–54	97 (27.2)
	55–65	28 (7.8)
	> 65	9 (2.5)
Gender	Male	186 (52.1)
	Female	171 (47.9)
Address	Khartoum State	321 (89.9)
	Outside Khartoum State	36 (10.1)
Marital Status	Single	63 (17.6)
	Married	210 (58.8)
	Widowed	28 (7.8)
	Divorced/separated	56 (15.7)
Education	Literate	299 (83.8)
	Illiterate	58 (16.2)
Employment	Employed	225 (63)
	Unemployed	132 (37)

Table 2 Clinical Characteristics, Used Antiretroviral Therapy (ART) Regimens, Opportunistic Infections, and Other Related Problems Among the Studied Patients (n=357)

Variable	Number (Frequency %)
Clinical stage:
Stage I	75 (21)
Stage II	29 (8.1)
Stage III	221 (61.9)
Stage IV	32 (9)
Tuberculosis
Yes	11 (3.1)
No	346 (96.9)
Comorbid disease
Yes	67 (18.8)
No	290 (81.2)
Duration in month since first starting antiretroviral therapy (ART):
0–36 months	124 (34.7)
37–72 months	96 (26.9)
73–96 months	37 (10.4)
97–144 months	66 (18.5)
> 144 months	34 (9.5)
Type of antiretroviral therapy (ART) regimen:
1c	19 (5.3)
1d	43 (12)
1e	279 (78.2)
Second-line regimen	14 (3.9)
Tenofovir + Nevirapine	2 (0.6)
The opportunistic infections and other related problems during current regimen:
None	267 (74.8)
Zoster	9 (2.5)
Pneumonia	5 (1.4)
Dementia/ Encephalopathy	2 (0.6)
Oral/vaginal thrush	15 (4.2)
Ulcers (mouth, genital, etc.)	1 (0.3)
Fever	18 (5)
Difficult breathing	4 (1.1)
Weight loss	16 (4.5)
Urethral discharge	6 (1.7)
Cough	18 (5)
Pelvic inflammatory disease	2 (0.6)

Abbreviations: 1c, Zidovudine + Lamivudine + Nevirapine; 1d, Zidovudine + Lamivudine + Efavirenz; 1e, Tenofovir + Lamivudine + Efavirenz; Second-line, Zidovudine + Lamivudine + Lopinavir/low dose Ritonavir.

Table 3 Distribution of Adverse Drug Events (ADEs) Among the Studied Patients Experienced ADEs (n=198)

Adverse Drug Event	Number (Frequency %)
Nausea	53 (26.8)
Diarrhea	14 (7.1)
Fatigue	63 (31.8)
Headache	23 (11.6)
Rash	15 (7.6)
Peripheral neuropathy	39 (19.7)
Anemia	4 (2)
Jaundice	3 (1.5)
Abdominal pain	12 (6.1)
Fat changes	3 (1.5)
CNS manifestations:	111 (56.1)
Dizziness	97 (49)
Anxiety	14 (7.1)
Nightmares	23 (11.6)
Depression	6 (3)

Table 4 Distribution of Outcome, Severity, Seriousness and Intervention to Adverse Drug Events (ADEs) Experienced by the Studied Patients (n=198)

Adverse Drug Event	Number (Frequency %)
	Outcome				Severity			Seriousness		Intervention
	Recovered	Recovering	Not Recovered	Recovered with sequelae	Mild	Moderate	Severe	Serious	Non-Serious	No	Switch Therapy	Pharmacologic Treatment	Pre-treat Counselling	Post-Treatment Counselling
Nausea (N=53)	38 (71.7)	4 (7.6)	11 (20.8)	0 (0)	22 (41.5)	11 (20.8)	20 (37.7)	0 (0)	53 (100)	18 (34)	1 (1.9)	3 (5.7)	30 (56.6)	1 (1.9)
Diarrhea (N=14)	10 (71.4)	3 (21.4)	1 (7.1)	0 (0)	5 (35.7)	3 (21.4)	6 (42.9)	0 (0)	14 (100)	7 (50)	1 (7.1)	2 (14.3)	4 (28.6)	0 (0)
Fatigue (N= 63)	29 (46)	10 (15.9)	24 (38.1)	0 (0)	13 (20.6)	31 (49.2)	19 (30.2)	0 (0)	63 (100)	23 (36.5)	0 (0)	1 (1.6)	39 (61.9)	0 (0)
Headache (N= 23)	14 (60.9)	5 (21.7)	4 (17.4)	0 (0)	6 (26.1)	8 (34.8)	9 (39.1)	0 (0)	23 (100)	11 (47.8)	0 (0)	3.0 (13)	8 (34.8)	1 (4.4)
Rash (N= 15)	10 (66.7)	4 (26.7)	1 (6.7)	0 (0)	6 (40)	3 (20)	6 (40)	0 (0)	15 (100)	4 (26.7)	0 (0)	6 (40)	4 (26.7)	1 (6.7)
Peripheral Neuropathy (N= 39)	9 (23.1)	14 (35.9)	15 (38.5)	1 (2.6)	9 (23.1)	10 (25.6)	20 (51.3)	0 (0)	39 (100)	10 (25.6)	0 (0)	7 (18)	21 (53.9)	1 (2.6)
Anemia (N= 4)	1 (25)	1 (25)	2 (50)	0 (0)	0 (0)	1 (25)	3 (75)	0 (0)	4 (100)	4 (100)	0 (0)	0 (0)	0 (0)	0 (0)
Jaundice (N= 3)	3 (100)	0 (0)	0 (0)	0 (0)	1 (33.3)	0 (0)	2 (66.7)	0 (0)	3 (100)	1 (33.3)	0 (0)	0 (0)	0 (0)	2 (66.7)
Abdominal pain (N= 12)	7 (58.3)	2 (16.7)	3 (25)	0 (0)	5 (41.7)	4 (33.3)	3 (25)	0 (0)	12 (100)	4 (33.3)	0 (0)	1 (8.3)	6 (50)	1 (8.3)
Fat changes (N=3)	2 (66.7)	0 (0)	1 (33.3)	0 (0)	0 (0)	1 (33.3)	2 (66.7)	0 (0)	3 (100)	2 (66.7)	0 (0)	0 (0)	1 (33.3)	0 (0)
Dizziness (N=97)	64 (66)	15 (15.5)	18 (18.6)	0 (0)	33 (34)	27 (27.8)	37 (38.1)	0 (0)	97 (100)	27 (27.8)	1 (1%)	1 (1%)	62 (63.9)	6 (6.2)
Anxiety (N=14)	9 (64.3)	1 (7.1)	4 (28.6)	0 (0)	5 (35.7)	6 (42.9)	3 (21.4)	0 (0)	14 (100)	6 (42.9)	0 (0)	0 (0)	8 (57.1)	0 (0)
Nightmares (N= 23)	12 (52.2)	5 (21.7)	6 (26.1)	0 (0)	10 (43.5)	8 (34.8)	5 (21.7)	0 (0)	23 (100)	14 (60.9)	0 (0)	0 (0)	9 (39.1)	0 (0)
Depression (N= 6)	5 (83.3)	1 (16.7)	0 (0)	0 (0)	1 (16.7)	3 (50.0)	2 (33.3)	0 (0)	6 (100)	4 (66.7)	0 (0)	0 (0)	2 (33.3)	0 (0)

Table 5 Causality Assessment of Each Adverse Drug Event (ADE) Using Naranjo Scale Among the Studied Patients Experienced ADEs (N=369)

Adverse Drug Event	Causality of Adverse Drug Event (ADE), Number (Frequency %)
	Definite	Probable	Possible	Doubtful
Nausea (N=53)	0 (0)	47 (88.7)	5 (9.4)	1 (1.9)
Diarrhea (N=14)	0 (0)	7 (50)	7 (50)	0 (0)
Fatigue (N= 63)	0 (0)	60 (95.2)	3 (4.8)	0 (0)
Headache (N= 23)	0 (0)	19 (82.6)	4 (17.4)	0 (0)
Rash (N= 15)	0 (0)	11 (73.3)	3 (20)	1 (6.7)
Peripheral neuropathy (N= 39)	0 (0)	33 (84.6)	4 (10.3)	2 (5.1)
Anemia (N= 4)	0 (0)	0 (0)	4 (100)	0 (0)
Jaundice (N= 3)	0 (0)	0 (0)	2 (66.7)	1 (33.3)
Abdominal pain (N= 12)	0 (0)	7 (58.3)	5.0 (41.7)	0 (0)
Fat changes (N=3)	0 (0)	3 (100)	0 (0)	0 (0)
Dizziness (N=97)	0 (0)	91 (93.8)	6 (6.2)	0 (0)
Anxiety (N=14)	0 (0)	8 (57.1)	6 (42.9)	0 (0)
Nightmares (N= 23)	0 (0)	19 (82.6)	4 (17.4)	0 (0)
Depression (N= 6)	0 (0)	3 (50)	3 (50)	0 (0)

Table 6 Association Between Socio-Demographic Characteristics and the Occurrence of Adverse Drug Events (ADEs) Among the Studied Patients (n=357)

Socio-demographic Characteristic		Occurrence of ADEs Number (Frequency %)		P value
		No	Yes
Age (years)	18–24	6 (66.7)	3 (33.3)	0.2
	25–34	33 (38.8)	52 (61.2)
	35–44	54 (41.9)	75 (58.1)
	45–54	50 (51.5)	47 (48.5)
	55–65	14 (50)	14 (50)
	> 65	2 (22.2)	7 (77.8)
Gender	Male	88 (47.3)	98 (52.7)	0.3
	Female	71 (41.5)	100 (58.5)
Address	Khartoum State	142 (44.2)	179 (55.8)	0.7
	Other state	17 (47.2)	19 (52.8)
Education	Educated	126 (42.1)	173 (57.9)	0.039*
	Uneducated	33 (56.9)	25 (43.1)
Employment	Employed	107 (47.6)	118 (52.4)	0.1
	Unemployed	52 (39.4)	80 (60.6)
Marital status	Single	31 (49.2)	32 (50.8)	0.2
	Married	97 (46.2)	113 (53.8)

Notes: The symbol (*) represents a statistically significant P value (less than 0.05).

Table 7 Association Between Antiretroviral Therapy (ART) Regimens and Adverse Drug Events (ADEs) Among the Studied Patients (N=369)

Adverse Drug Event	Number (Frequency %)										P value
	1c		1d		1e		Second line		Tenofovir + nevirapine
	Absent	Present	Absent	Present	Absent	Present	Absent	Present	Absent	Present
Nausea	18 (94.7)	1 (5.3)	32 (74.4)	11 (25.6)	241 (86.4)	3 (13.6)	11 (78.6)	3 (21.4)	2 (100)	0 (0)	0.2
Diarrhea	19 (100)	0 (0)	40 (93)	2 (7)	268 (96.4)	11 (3.6)	13 (92.9)	1 (7.1)	2 (100)	0 (0)	0.7
Fatigue	16 (84.2)	3 (15.8)	37 (86)	6 (14)	226 (81)	53 (19)	13 (92.9)	1 (7.1)	2 (100)	0 (0)	0.7
Headache	18 (94.7)	1 (5.3)	38 (88.4)	5 (11.6)	264 (94.6)	15 (5.4)	12 (85.7)	2 (14.3)	2 (100)	0 (0)	0.4
Rash	18 (94.7)	1 (5.3)	43 (100)	0 (0)	265 (94.6)	14 (5)	12 (85.7)	2 (14.3)	2 (100)	0 (0)	0.9
Peripheral Neuropathy	17 (89.5)	2 (11)	36 (81.4)	7 (18.6)	250 (89.2)	29 (10.4)	13 (92.9)	1 (7.1)	2 (100)	0 (0)	0.9
Anemia	19 (100)	0 (0)	43 (100)	0 (0)	276 (98.6)	3 (1.1)	13 (92.9)	1 (7.1)	2 (100)	0 (0)	0.7
Jaundice	19 (100)	0 (0)	43 (100)	0 (0)	277 (99.3)	2 (0.7)	14 (100)	0 (0)	1 (50)	1 (50)	0.001*
Abdominal pain	19 (100)	0 (0)	40 (93)	3 (7)	271 (97.1)	8 (2.9)	14 (100)	0 (0)	1 (50)	1 (50)	0.02*
Fat changes	19 (100)	0 (0)	42 (97.7)	1 (2.3)	276 (99.3)	2 (0.7)	14 (100)	0 (0)	2 (100)	0 (0)	0.99
CNS manifestations	16 (84.3)	3 (15.7)	31 (72.1)	12 (27.9)	186 (66.7)	93 (33.3)	11 (78.6)	3 (21.4)	2 (100)	0 (0)	0.3

Notes: The symbol (*) represents a statistically significant P value (less than 0.05).

Abbreviations: ART, antiretroviral therapy; 1c, Zidovudine + Lamivudine + Nevirapine; 1d, Zidovudine + Lamivudine + Efavirenz; 1e, Tenofovir + Lamivudine + Efavirenz; Second-line, Zidovudine + Lamivudine + Lopinavir/low dose Ritonavir; CNS, central nervous system.