Recent Development of Visceral Leishmaniasis Treatments: Successes, Pitfalls, and Perspectives (original) (raw)
Related papers
2012
Background: Alternative treatments for visceral leishmaniasis (VL) are required in East Africa. Paromomycin sulphate (PM) has been shown to be efficacious for VL treatment in India. Methods: A multi-centre randomized-controlled trial (RCT) to compare efficacy and safety of PM (20 mg/kg/day for 21 days) and PM plus sodium stibogluconate (SSG) combination (PM, 15 mg/kg/day and SSG, 20 mg/kg/day for 17 days) with SSG (20 mg/kg/day for 30 days) for treatment of VL in East Africa. Patients aged 4–60 years with parasitologically confirmed VL were enrolled, excluding patients with contraindications. Primary and secondary efficacy outcomes were parasite clearance at 6-months follow-up and end of treatment, respectively. Safety was assessed mainly using adverse event (AE) data. Findings: The PM versus SSG comparison enrolled 205 patients per arm with primary efficacy data available for 198 and 200
Clinical Infectious Diseases, 2008
In Bihar, India, home to nearly one-half of the world's burden of visceral leishmaniasis, drug resistance has ended the usefulness of pentavalent antimony, which is the traditional first-line treatment. Although monotherapy with other agents is available, the use of 2 drugs with different modes of action might increase efficacy, shorten treatment duration, enhance compliance, and/or reduce the risk of parasite resistance. To test the feasibility of a new approach to combination therapy in visceral leishmaniasis (also known a kala-azar), we treated Indian patients with a single infusion of liposomal amphotericin B (L-AmB), followed 1 day later by short-course oral miltefosine.
2016
Background: Alternative treatments for visceral leishmaniasis (VL) are required in East Africa. Paromomycin sulphate (PM) has been shown to be efficacious for VL treatment in India. Methods: A multi-centre randomized-controlled trial (RCT) to compare efficacy and safety of PM (20 mg/kg/day for 21 days) and PM plus sodium stibogluconate (SSG) combination (PM, 15 mg/kg/day and SSG, 20 mg/kg/day for 17 days) with SSG (20 mg/kg/day for 30 days) for treatment of VL in East Africa. Patients aged 4–60 years with parasitologically confirmed VL were enrolled, excluding patients with contraindications. Primary and secondary efficacy outcomes were parasite clearance at 6-months follow-up and end of treatment, respectively. Safety was assessed mainly using adverse event (AE) data. Findings: The PM versus SSG comparison enrolled 205 patients per arm with primary efficacy data available for 198 and 200
Pharmacotherapeutic options for visceral leishmaniasis-current scenario
Clinical medicine. Pathology, 2009
Visceral leishmaniasis (VL) or Kala-azar is a protozoal disease, which was previously regarded as one of the most neglected tropical diseases. Management of this disease is quite difficult, because it is said to affect the poorest of the poor. Previously Sodium Stibogluconate (SSG) was regarded as the gold standard treatment for VL. But due to the increasing unresponsiveness, to this drug various other drugs were tried and are still being tried. Pentamidine is very toxic and has been discarded of late. Amphotericin B and its lipid formulations are very effective but require hospital admission and monitoring. Oral drugs like Miltefosine have already been launched. An amino glycoside Paromomycin and another oral drug Sitamaquine are in the pipe line. Interferon gamma has been used with discouraging results.
Journal of Parasitic Diseases, 2021
Liposomal amphotericin B (LAmB) is the drug of choice in Bangladesh to eliminate the burden of visceral leishmaniasis, also known as kala-azar, a fatal protozoan parasitic disease if left untreated. We aimed to assess efficacy and safety of a single-dose (10 mg/kg) LAmB in visceral leishmaniasis (VL) treatment among the visiting children and adults in a tertiary care setting. This prospective study includes 11 children and 19 adults with a confirmed diagnosis of kala-azar (total 30 cases). Intravenous infusion of LAmB (10 mg/kg body weight) was given to all of the patients. Clinical assessments were conducted during treatment, before hospital discharge, and on days 30 and 180 after treatment. Efficacy was estimated in terms of initial cure (at day 30) and the final cure (at 180 days). All information was recorded in a preformed case record form and analysis was performed in SPSS 22. The mean age was 27.13 ± 18.04 years (3–65) with male predominance (60%). Significant regression of spleen size was found following treatment with LAmB at 30 days and 180 days follow up visit (p < 0.05 for all). Overall, rate of initial cure was 90% (n = 27) (child 90.9% vs 89.47% adult) and final cure was 96.66% (n = 29) (child 100% vs 94.73% adult). Fourteen adverse events were recorded mostly including fever and/or shivering (85.71%). No case relapsed or were referred either due to management or Severe Adverse Event (SAE). In real-life experience, the LAmB treatment for visceral leishmaniasis is as safe and effective for treatment of kala-azar patients.Supplementary InformationThe online version contains supplementary material available at 10.1007/s12639-021-01379-w.
Clinical Infectious Diseases
Background This study aimed to determine whether paromomycin plus miltefosine (PM/MF) is noninferior to sodium stibogluconate plus paromomycin (SSG/PM) for treatment of primary visceral leishmaniasis in eastern Africa. Methods An open-label, phase 3, randomized, controlled trial was conducted in adult and pediatric patients at 7 sites in eastern Africa. Patients were randomly assigned to either 20 mg/kg paromomycin plus allometric dose of miltefosine (14 days), or 20 mg/kg sodium stibogluconate plus 15 mg/kg paromomycin (17 days). The primary endpoint was definitive cure after 6 months. Results Of 439 randomized patients, 424 completed the trial. Definitive cure at 6 months was 91.2% (155 of 170) and 91.8% (156 of 170) in the PM/MF and SSG/PM arms in primary efficacy modified intention-to-treat analysis (difference, 0.6%; 97.5% confidence interval [CI], −6.2 to 7.4), narrowly missing the noninferiority margin of 7%. In the per-protocol analysis, efficacy was 92% (149 of 162) and 91....