Research Article: Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh

Date Published: October 23, 2015

Publisher: Public Library of Science

Author(s): Kazi M. Jamil, Rashidul Haque, Ridwanur Rahman, M. Abul Faiz, Abu Toha Md. Rezwanul Haque Bhuiyan, Amresh Kumar, Syed Misbah Hassan, Heather Kelly, Pritu Dhalaria, Sonali Kochhar, Philippe Desjeux, Mohammad A. A. Bhuiyan, Mohammed M. Khan, Raj Shankar Ghosh, Diana N. J. Lockwood. http://doi.org/10.1371/journal.pntd.0004118

Abstract: BackgroundThis study was conducted in Bangladeshi patients in an outpatient setting to support registration of Paromomycin Intramuscular Injection (PMIM) as a low-cost treatment option in Bangladesh.MethodologyThis Phase IIIb, open-label, multi-center, single-arm trial assessed the efficacy and safety of PMIM administered at 11 mg/kg (paromomycin base) intramuscularly once daily for 21 consecutive days to children and adults with VL in a rural outpatient setting in Bangladesh. Patients ≥5 and ≤55 years were eligible if they had signs and symptoms of VL (intermittent fever, weight loss/decreased appetite, and enlarged spleen), positive rK39 test, and were living in VL-endemic areas. Compliance was the percentage of enrolled patients who received 21 daily injections over no more than 22 days. Efficacy was evaluated by initial clinical response, defined as resolution of fever and reduction of splenomegaly at end of treatment, and final clinical response, defined as the absence of new clinical signs and symptoms of VL 6 months after end of treatment. Safety was assessed by evaluation of adverse events.Principal FindingsA total of 120 subjects (49% pediatric) were enrolled. Treatment compliance was 98.3%. Initial clinical response in the Intent-to-Treat population was 98.3%, and final clinical response 6 months after end of treatment was 94.2%. Of the 119 subjects who received ≥1 dose of PMIM, 28.6% reported at least one adverse event. Injection site pain was the most commonly reported adverse event. Reversible renal impairment and/or hearing loss were reported in 2 subjects.Conclusions/SignificancePMIM was an effective and safe treatment for VL in Bangladesh. The short treatment duration and lower cost of PMIM compared with other treatment options may make this drug a preferred treatment to be investigated as part of a combination therapy regimen. This study supports the registration of PMIM for use in government health facilities in Bangladesh.Trial RegistrationClinicalTrials.gov identifier: NCT01328457

Partial Text: Visceral leishmaniasis (VL), also known as kala-azar, remains one of the most neglected diseases in Bangladesh with an estimated 65 million people at risk of the disease [1]. Widely available, safe, and affordable therapies for visceral leishmaniasis are needed. Although VL was nearly eliminated in Bangladesh during the Malaria Eradication Programme of 1961–1970 [2], the country experienced an epidemic in the mid-2000s (9,379 cases reported in 2006 by the Ministry of Health and Family Welfare [MoHFW]) [3]. More recently, the number of VL cases reported by MoHFW has declined annually from 4,932 cases in 2007 to 3,300 cases in 2011 [3, MoHFW personal communication]. Although the decline in reported VL cases is promising, sustained efforts are needed to meet the Kala-Azar Elimination Program target of <1 case annually per 10,000 population at the upazila level by 2015. In a Phase III randomized, controlled, open-label clinical trial in 667 children and adults in India, PMIM (11 mg/kg/day [base] administered intramuscularly for 21 days) was determined to be a safe and effective for treatment of VL [4]. PMIM was subsequently registered for the treatment of VL in India in 2006 and was included in the WHO Essential Medicines List in 2007. Source: http://doi.org/10.1371/journal.pntd.0004118

 

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