Safety and effectiveness of sodium stibogluconate and paromomycin combination for the treatment of visceral leishmaniasis in eastern Africa: Results from a pharmacovigilance programme

by Kimutai R, Musa AM, Njoroge S, Omollo R, Alves F, Hailu A, Khalil EAG, Diro E, Soipei P, Musa B, Salman K, Ritmeijer K, Chappuis F, Rashid J, Mohammed R, Jameneh A, Makonnen E, Olobo J, Okello L, Sagaki P, Strub N, Ellis S, Alvar J, Balasegaram M, Alirol E, Wasunna MClinical Drug Investigation 2017, doi:10.1007/s40261-016-0481-0.

Summary: In 2010, WHO recommended a new first-line treatment for visceral leishmaniasis (VL) in Eastern Africa, a combination of intravenous (IV) or intramuscular (IM) sodium stibogluconate (SSG) and IM paromomycin (PM). A pharmacovigilance (PV) programme was developed to monitor the new treatment’s safety and effectiveness in routine clinical practice. This first regional PV programme in VL supports SSG-PM combination as first-line treatment for primary VL in Eastern Africa. SSG-PM was effective and safe except in HIV/VL co-infected or older patients. Active PV surveillance of targeted safety, effectiveness and key VL outcomes such us VL relapse, PKDL and HIV/VL co-infection should continue and PV data integrated to national and WHO PV databases.

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