PMID- 34464401 OWN - NLM STAT- MEDLINE DCOM- 20211125 LR - 20231107 IS - 1935-2735 (Electronic) IS - 1935-2727 (Print) IS - 1935-2727 (Linking) VI - 15 IP - 8 DP - 2021 Aug TI - Efficacy and safety of a combined treatment of sodium stibogluconate at 20mg/kg/day with upper maximum daily dose limit of 850mg and Paromomycin 15mg/kg/day in HIV negative visceral leishmaniasis patients. A retrospective study, northwest Ethiopia. PG - e0009713 LID - 10.1371/journal.pntd.0009713 [doi] LID - e0009713 AB - BACKGROUND: Visceral leishmaniasis (VL) is one of the most neglected tropical infectious diseases. It is fatal if left untreated. The objective of this study was to assess the efficacy and safety of 17-day injections of combined regimen of sodium stibogluconate and paromomycin (SSG/PM) in HIV-negative VL patients. METHODS: A retrospective analysis of medical records of VL patients treated in the University of Gondar Hospital during period 2012-2019 was carried out. RESULTS: A total of 2836 patients were treated for VL from 2012 to 2019. Of these 1233 were treated with SSG-PM, and 1000 of them were included in the study. Initial cure was achieved in 922 (92.2%) patients. The frequency of treatment failure, treatment interruptions, default and deaths respectively were 30 (3%), 20 (2%), 13 (1.3%) and 15 (1.5%). Among 280 patients who completed 6-month follow up, the final cure was 93.9% (263/280), 4 (1.4%) relapsed and 13 (4.6%) developed post-kala-azar dermal leishmaniasis (PKDL). The most common adverse events (AEs) were raised liver transaminases (35.1%; 351 patients), injection site pain (29.1%, 291 patients) and raised serum alpha-amylase (29.1%, 291 patients). Factors associated with poor treatment outcomes were sepsis, pneumonia, and adverse events. CONCLUSION: A combination of SSG at 20mg/kg with upper daily maximum dose of 850mg and PM was effective for achieving initial cure at end of treatment and safe for treatment of HIV negative VL patients in northwestern Ethiopia. Our data are consistent with previous reports and confirms effectiveness of SSG/PM treatment regimen in the Eastern African countries. Efficacy at 6-months (93.9%) was estimated on data derived from patients who completed follow up and needs to be interrogated by future studies. FAU - Tamiru, Aschalew AU - Tamiru A AUID- ORCID: 0000-0003-4802-8363 AD - Leishmaniasis Research and Treatment Center, University of Gondar, College of Medicine and Health Science, Gondar, Ethiopia. FAU - Mohammed, Rezika AU - Mohammed R AUID- ORCID: 0000-0002-1410-0454 AD - Department of Internal Medicine, University of Gondar, College of Medicine and Health Sciences, Gondar, Ethiopia. FAU - Atnafu, Saba AU - Atnafu S AUID- ORCID: 0000-0001-9121-4183 AD - Leishmaniasis Research and Treatment Center, University of Gondar, College of Medicine and Health Science, Gondar, Ethiopia. FAU - Medhin, Girmay AU - Medhin G AD - Aklilu Lemma Institute of Pathobiology, Addis Ababa University, Addis Ababa, Ethiopia. FAU - Hailu, Asrat AU - Hailu A AD - Department of Microbiology, Immunology and Parasitology, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20210831 PL - United States TA - PLoS Negl Trop Dis JT - PLoS neglected tropical diseases JID - 101291488 RN - 0 (Antiprotozoal Agents) RN - 61JJC8N5ZK (Paromomycin) RN - V083S0159D (Antimony Sodium Gluconate) SB - IM MH - Adolescent MH - Adult MH - Antimony Sodium Gluconate/*administration & dosage/adverse effects/analysis MH - Antiprotozoal Agents/*administration & dosage/adverse effects/analysis MH - Child MH - Child, Preschool MH - Drug Dosage Calculations MH - Drug Therapy, Combination/adverse effects MH - Ethiopia MH - Female MH - Humans MH - Leishmaniasis, Visceral/*drug therapy MH - Male MH - Middle Aged MH - Paromomycin/*administration & dosage/adverse effects/analysis MH - Retrospective Studies MH - Treatment Outcome MH - Young Adult PMC - PMC8437273 COIS- The authors have declared that no competing interests exist. EDAT- 2021/09/01 06:00 MHDA- 2021/11/26 06:00 PMCR- 2021/08/31 CRDT- 2021/08/31 17:20 PHST- 2021/03/25 00:00 [received] PHST- 2021/08/06 00:00 [accepted] PHST- 2021/09/13 00:00 [revised] PHST- 2021/09/01 06:00 [pubmed] PHST- 2021/11/26 06:00 [medline] PHST- 2021/08/31 17:20 [entrez] PHST- 2021/08/31 00:00 [pmc-release] AID - PNTD-D-21-00425 [pii] AID - 10.1371/journal.pntd.0009713 [doi] PST - epublish SO - PLoS Negl Trop Dis. 2021 Aug 31;15(8):e0009713. doi: 10.1371/journal.pntd.0009713. eCollection 2021 Aug.