Table 1. Demographic and clinical characteristics of visceral leishmaniasis and HIV co-infected patients treated with a combination of liposomal amphotericin B (AmBisome) and miltefosine by MSF in Ethiopia from January 2011 to August 2014, by visceral leishmaniasis treatment history.
| Characteristic | Total (N = 173) | Primary VL (N = 83) | Relapse VL (N = 90) | P |
|---|---|---|---|---|
| Sex, n (%) | ||||
| - Male | 170 (98.3%) | 80 (96.4%) | 90 (100.0%) | 0.11a |
| - Female | 3 (1.7%) | 3 (3.6%) | 0 (0.0%) | |
| Age (years), median (IQR) | 32.0 (28.0–39.0) | 32.0 (27.0–37.0) | 34.0 (28.0–40.0) | 0.07b |
| Age (years), n (%) | ||||
| - 18–40 | 141 (81.5%) | 73 (88.0%) | 68 (75.6%) | 0.04c |
| - >40 | 32 (18.5%) | 10 (12.1%) | 22 (24.4%) | |
| Residential status, n (%); n = 171 | ||||
| - Migrant worker | 70 (41.0%) | 34 (41.5%) | 36 (40.5%) | 0.89c |
| - Resident | 101 (59.1%) | 48 (58.5%) | 53 (59.6%) | |
| Spleen size (cm), median (IQR); n = 170 | 6.0 (4.0–10.0) | 6.0 (3.0–10.0) | 6.0 (4.0–10.0) | 0.62b |
| Spleen size ≥11 cm, n (%) | ||||
| - Yes | 28 (16.5%) | 13 (15.7%) | 15 (17.2%) | 0.78c |
| - No | 142 (83.5%) | 70 (84.3%) | 72 (82.8%) | |
| Hemoglobin level (g/dL), median (IQR); n = 168 | 8.2 (6.7–9.2) | 8.1 (6.5–9.1) | 8.3 (7.1–9.8) | 0.11b |
| Hemoglobin level ≤6.5 g/dL, n (%) | ||||
| - Yes | 40 (23.8%) | 21 (25.6%) | 19 (22.1%) | 0.59c |
| - No | 128 (76.2%) | 61 (74.4%) | 67 (77.9%) | |
| Body mass index (kg/m2), median (IQR); n = 164 | 16 (15–18) | 16 (15–18) | 17 (15–18) | 0.39b |
| Body mass index <16 Kg/m2, n (%) | ||||
| - Yes | 68 (41.5%) | 36 (46.8%) | 32 (36.8%) | 0.20c |
| - No | 96 (58.5%) | 41 (53.3%) | 55 (63.2%) | |
| Tuberculosis, n (%); n = 170 | ||||
| - Yes | 39 (22.9%) | 16 (19.8%) | 23 (25.8%) | 0.35c |
| - No | 131 (77.1%) | 65 (80.3%) | 66 (74.2%) | |
| Jaundice, n (%); n = 169 | ||||
| - Yes | 5 (3.0%) | 3 (3.7%) | 2 (2.3%) | 0.67a |
| - No | 164 (97.0%) | 78 (96.3%) | 86 (97.7%) | |
| Duration of illness (months), median (IQR); n = 164 | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 1.0 (1.0–2.0) | 0.06b |
| Duration of illness ≥2 months, n (%) | ||||
| - Yes | 60 (36.6%) | 36 (46.2%) | 24 (27.9%) | 0.02c |
| - No | 104 (63.4%) | 42 (53.9%) | 62 (72.1%) | |
| Bleeding, n (%); n = 167 | ||||
| - Yes | 5 (3.0%) | 2 (2.5%) | 3 (3.5%) | 1.00a |
| - No | 162 (97.0%) | 79 (97.5%) | 83 (96.5%) | |
| Weakness, n (%)d; n = 170 | ||||
| - Collapse | 1 (0.6%) | 0 (0.0%) | 1 (1.1%) | 0.29a |
| - Severe | 26 (15.3%) | 15 (18.5%) | 11 (12.4%) | |
| - Other | 143 (84.1%) | 66 (81.5%) | 77 (86.5%) | |
| Edema and/or ascites, n (%); n = 168 | ||||
| - Yes | 13 (7.7%) | 9 (11.1%) | 4 (4.6%) | 0.11c |
| - No | 155 (92.3%) | 72 (88.9%) | 83 (95.4%) | |
| CD4 count (cells/μl)e, median (IQR); n = 89 | 102 (49–182) | 115 (59–209) | 86 (44–136) | 0.05b |
| CD4 count (cells/μl), n (%) | ||||
| - ≤100 | 44 (49.4%) | 19 (44.2%) | 25 (54.4%) | 0.23a |
| - 101–199 | 27 (30.3%) | 12 (27.9%) | 15 (32.6%) | |
| - 200–349 | 15 (16.9%) | 9 (20.9%) | 6 (13.0%) | |
| - ≥350 | 3 (3.4%) | 3 (7.0%) | 0 (0.0%) | |
| WHO stage, n (%); n = 138 | ||||
| - I/II/III | 32 (23.2%) | 13 (22.4%) | 19 (23.8%) | 0.85c |
| - IV | 106 (76.8%) | 45 (77.6%) | 61 (76.3%) | |
| Advanced HIVf; n = 151 | ||||
| - Yes | 111 (73.5%) | 48 (69.6%) | 63 (76.8%) | 0.31c |
| - No | 40 (26.5%) | 21 (30.4%) | 19 (23.2%) | |
| ART regimeng, n (%); n = 152 | ||||
| - Tenofovir based regimen | 90 (59.2%) | 48 (71.6%) | 42 (49.4%) | <0.001c |
| - Non-tenofovir based regimen | 45 (29.6%) | 7 (10.5%) | 38 (44.7%) | |
| - None | 17 (11.2%) | 12 (17.9%) | 5 (5.9%) | |
| ART initiated before VL episode, n (%); n = 165 | ||||
| - Yesh | 106 (64.2%) | 33 (42.3%) | 73 (83.9%) | <0.001c |
| - No | 59 (35.8%) | 45 (57.7%) | 14 (16.1%) | |
| Parasite grade, median (IQR); n = 137 | 5 (3–6) | 4 (1–6) | 5 (4–6) | 0.003b |
| Parasite grade, n (%)i; n = 170 | ||||
| - <6+ | 82 (48.2%) | 36 (43.9%) | 46 (52.3%) | <0.001c |
| - 6+ | 55 (32.4%) | 15 (18.3%) | 40 (45.5%) | |
| - Not done: serological/clinical diagnosis | 33 (19.4%) | 31 (37.8%) | 2 (2.3%) | |
| Cured after initial treatment, n (%); n = 145 | ||||
| - Parasitological cure | 80 (55.2%) | 28 (43.1%) | 52 (65.0%) | 0.008c |
| - Clinical cure | 65 (44.8%) | 37 (56.9%) | 28 (35.0%) |
Abbreviations: ART, antiretroviral therapy; IQR, interquartile range; VL, visceral leishmaniasis.
a Fisher’s exact test.
b Two-sample Wilcoxon rank-sum (Mann-Whitney) test.
c Chi-squared test.
d Defined according to MSF guidelines as follows: [State of collapse (unable to sit up unaided and cannot drink unaided); severely weak (cannot walk 5 meters without assistance); other types of weakness were classified as “other”].
e CD4 count result is <6 months from VL treatment initiation.
f WHO stage IV or CD4 <50 cells/μL.
g Stavudine, lamivudine and nevirapine; zidovudine, lamivudine and efavirenz; tenofovir, lamivudine and efavirenz; zidovudine, lamivudine and nevirapine; stavudine, lamivudine and efavirenz.
h Of the 106 patients that started ART before the VL episode: 51 started tenofovir based regimen, 45 started non-tenofovir based regimen, and in 10 patients the ART regimen was missing. The overall results of “ART initiated before VL episode (in ART categories)” by “VL treatment history” are similar to those presented.
i132 (76.3%) spleen aspirates, 4 (2.3%) bone marrow aspirates, 1 lymph node aspirate (0.6%), 33 (19.1%) no parasitological test done (31 were primary VL), and 3 (1.7%) data missing. Overall– 90 (52.0%) parasitological diagnosis, 74 (42.8%) serological diagnosis, 6 (3.5%) clinical diagnosis (all were relapse VL) and 3 (1.7%) data missing.