Table 2. Clinical studies and trials reporting treatment outcomes of HIV/VL in East Africa (1998–2013).
Reference | Study Population and Design | Treatments | Patients | Initial Cure | Mortality | Initial Failurea | Tolerability | Comments |
Diro E, et al. [39] | Prospective study: initial treatment outcome of adult patients screened for PSP study (2011–2012) | SSG 20 mg/kg/d, 30 days | HIV+: 53 | 43.4% | 11.3% | 30.2% | 5.7% SSG discontinued for safety | Requiring SSG extension: 20 (37.7%). Final outcome: 77.4% cure |
Ritmeijer K, et al. [41] | Retrospective study: HIV+ adult VL patients in north Ethiopia (2010–2013), NGO program | AmBisome30 mg/kg total+MF 100 mg po/d −28 days | Total: 111 | 81.1% | 9.0% | 6.3%b | NA | |
VL relapse: 54 | 83.3% | 3.7% | 11.1%b | |||||
Hailu W, et al. [44] | Retrospective study. All patients treated with antimonials (2008–2009) at teaching public hospitals | Glucantime 20 mg/kg/d for 30 days (N- Ethiopia) | Total: 30 | 73.3% | 10% | 16.7% | 2 pancreatitis and 1 renal failure | |
- HIV+: 12 | 58.3% | NA | NA | NA | 2/3 (66.7%) relapse by 6 months among the HIV coinfected (only 25% seen by month 6 | |||
- HIV−: 14 | 92.9% | NA | NA | NA | ||||
Glucantime 20 mg/kg/d for 30 days (S-Ethiopia) | Total: 24 | 100% | 0 | 0 | NA | No relapse in HIV− | ||
Ritmeijer K, et al. [38] | Retrospective study. Severely sick or HIV+ adult VL patients (2007–2008), NGO program in N- Ethiopia | AmBisome 30 mg/kgc | HIV+: 195 | 59.5% | 6.7% | 32.3%b | NA | 21.5% on ART at VL diagnosis; 29/43 (67%) with CD4 less than 200 |
- PVL: 116 | 74.1% | 7.8% | 16.4% | |||||
- Relapse: 79 | 38.0% | 5.1% | 55.7% | |||||
HIV−: 94 | 92.6% | 6.4% | Noneb | NA | ||||
- PVL: 84 | 91.7% | 7.1% | 0 | |||||
- Relapse: 10 | 100% | 0 | 0 | |||||
SSG (30–40 d) 20 mg/kg/d as rescue therapy | HIV+ failing AmBisomed: 58 | 70.7% | 15.5% | 1.7% | 5/63 (7.9%) unable to tolerate SSG | |||
Hurissa Z, et al. [19] | Retrospective record analysis. All admitted adult VL patients (2006–2008). Two public hospitals in N- Ethiopia | SSG: 20 mg/kg/d for 30 days AmBisome: 3 mg/kg 6–10 days (only critically ill) | Adults: 241 | 84.6% | 10% | 5.4% | NA | Case fatality in HIV coinfected high SSG (24.5%) AmBisome (7.7%) |
- HIV+: 92 | 68.5% | 17.4% | 14.1% | |||||
- HIV−: 149 | 94.6% | 5.4% | 0 | |||||
Ritmeijer K, et al. [31] | Randomized controlled trial, nonblinded in N-Ethiopia. Male migrant workers. PVL (546); relapse (34) | MF 100 mg/d for 28 days | Total: 290 | 88.3% | 2.1% | 7.9% | Severe vomiting: 14/290 (4.8%) | At sixth month: Relapse: 10.3% |
- HIV+: 63 | 77.8% | 1.6% | 17.5% | - HIV+: 25.4% | ||||
- HIV−: 131 | 93.8% | 0.8% | 4.5% | - HIV−: 4.6% | ||||
- Unknown: 96 | 87.5% | 4.2% | 6.3% | |||||
SSG 20 mg/kg IM for 30 days | Total: 290 | 87.6% | 9.7% | 0.7% | Severe vomiting: 27/290 (9.7%); mainly HIV+ | Relapse: 2.4% | ||
- HIV+: 44 | 90.1% | 6.8% | 2.3% | - HIV+: 11.4% | ||||
- HIV−: 137 | 94.9% | 2.9% | 0.7% | - HIV−: 0.0% | ||||
-Unknown: 109 | 77.1% | 19.3% | 0.0% | |||||
Lyons S, et al. [65] | Retrospective study, NGO program in N-Ethiopia (1998–2000) | No info (SSG only available drug) | Total: 791 | 81.5% | 18.5% | NA | NA | |
- HIV+: 49 | 73.5% | 26.5% | ||||||
- HIV− : 164 | 93.3% | 6.7% | ||||||
Ritmeijer K, et al. [23] | Randomized controlled trial, nonblinded, 1998–1999. Only PVL adults included. NGO program; N-Ethiopia | SSG versus Pentostam | All primary VL. Total: 199 | 75.4% | 24.1% | NA | Vomiting Total: | Relapse: 3/114 (2.6%) |
- HIV+: 27 | 63% | 33.3% | 44.4% | 2/12 (16.7%) | ||||
- HIV−: 112 | 96.4% | 3.6% | 35.7% | 1/83 (1.2%) |
Abbreviations: PVL, primary visceral leishmaniasis; HIV−, HIV negative; HIV+, HIV positive; NA, not available; N-Ethiopia, north Ethiopia; S-Ethiopia, south Ethiopia; NGO, nongovernmental organization; PSP, pentamidine secondary prophylaxis; SSG, sodium stibogluconate, IM, intramuscular.
clinically defined unless otherwise stated;
parasitologically confirmed;
median dose used;
subgroup of the 195 HIV+ patients treated with liposomal amphotericin B (mentioned above).