Abstract
Background. A phase 3 study demonstrated the safety and efficacy of paromomycin (paromomycin IM injection) for treatment of VL in an inpatient setting. Methods. This phase 4 study was conducted to assess the safety and efficacy of paromomycin in children and adults in an outpatient setting in Bihar, India. Results. This study enrolled 506 adult and pediatric patients. Of the 494 patients in the intent-to-treat (ITT) population, 98% received a full course of treatment. The overall study completion rate was 94% (462/494) for the ITT population and 96% (461/479) for the efficacy-evaluable (EE) population. Initial clinical cure was 99.6%, and final clinical cure 6 months after treatment was 94.2%. Grade 3 or 4 adverse events occurred in 5% of patients; events with a frequency of ≥1% were increases in alanine aminotransferase and aspartate aminotransferase. Conclusions. This study confirms the safety and efficacy of paromomycin to treat VL in an outpatient setting.
Highlights
Effective, affordable, and accessible treatments are urgently needed for underserved populations in developing nations who are afflicted with one of the most neglected diseases: visceral leishmaniasis (VL), or kala-azar in South Asia
The study was conducted in accordance with the current version of the Declaration of Helsinki, the Central Drugs Standard Control Organization’s (CDSCO) Good Clinical Practices (GCP) For Clinical Research In India (2005), the Indian Council of Medical Research’s (ICMR) Ethical Guidelines for Biomedical Research on Human Participants (2006), and Schedule Y of the Drug and Cosmetics Act and Rules
Paromomycin was shown to be efficacious when used in an outpatient setting
Summary
Effective, affordable, and accessible treatments are urgently needed for underserved populations in developing nations who are afflicted with one of the most neglected diseases: visceral leishmaniasis (VL), or kala-azar in South Asia. A recent study showed that AmBisome (liposomal amphotericin B) is highly effective after a single IV infusion, and a new price agreement for developing countries has made AmBisome a more affordable treatment option [8]. Journal of Tropical Medicine because of a continuing concern regarding development of drug resistance, there continues to be a need for new, safe, efficacious, and low-cost therapies for the treatment of VL. A phase 3 study demonstrated the safety and efficacy of paromomycin (paromomycin IM injection) for treatment of VL in an inpatient setting. This phase 4 study was conducted to assess the safety and efficacy of paromomycin in children and adults in an outpatient setting in Bihar, India. This study confirms the safety and efficacy of paromomycin to treat VL in an outpatient setting
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