Patients sickened by visceral leishmaniasis (VL) endure fever, weight loss/decreased appetite, enlargement of the spleen, and anemia. Left untreated, VL is almost always fatal. Photo: ©Jonathan Torgovnik.
Neglected disease of poverty
Visceral leishmaniasis (VL), also known as kala-azar or black fever, kills up to 30,000 people every year, mostly in low-resource settings in countries of the Indian subcontinent and East Africa. The disease is transmitted through the bite of a sand fly. Smaller than mosquitoes, these tiny insects can pass through most netting and inflict a bite a victim rarely even feels. The disease affects the visceral organs, causing chronic fever, weight loss, and anemia; left untreated, it is most often fatal.
Paromomycin, an off-patent aminoglycoside antibiotic, is an established drug with an extensive history of use and a well-characterized safety profile. In partnership with others, PATH developed paromomycin intramuscular injection (PMIM) as a new, safe, effective, and affordable treatment option for VL and worked with leading clinical researchers and an Indian pharmaceutical company to manufacture the drug and register it with India’s national drug regulatory agency in 2006.
Shifting focus to Bangladesh
Following regulatory approval and a large-scale phase 4 clinical study of PMIM in India, PATH sponsored a phase 3(b) study in Bangladesh, in partnership with the Bangladeshi Ministry of Health and the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b). This study was initiated in 2011 at two government health clinics in Mymensingh District and enrolled 120 patients between the ages of 5 and 55.
Vials of paromomycin intramuscular injection (PMIM). Photo: ©Jonathan Torgovnik.
The study contributed to the safety and efficacy profile of PMIM, as well as to the national VL elimination strategy. Considerable efforts were also made to build capacity for local staff to conduct clinical research according to international quality standards.
The work was recently highlighted in the article “Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh,” published in PLOS Neglected Tropical Diseases. Excerpt from the Author Summary:
Although sodium stibogluconate, miltefosine, and paromomycin are included in the National Essential Drug List for VL, only miltefosine is currently registered in Bangladesh. Paromomycin is a low-cost drug that was demonstrated to be an efficacious and safe treatment for VL in endemic areas of India, which led to approval of paromomycin IM injection (PMIM) for the treatment of VL in India in 2006 and inclusion of PMIM in the WHO Essential Medicines List in 2007. A subsequent Phase IV trial in India revealed a similarly high efficacy and safety profile coupled with high treatment compliance in a rural outpatient setting. We confirmed the effectiveness, safety, and high compliance of PMIM when used in an outpatient setting in Bangladesh. This study supports the registration of PMIM as a low-cost treatment option for VL in Bangladesh.
Read the full article.