A study conducted in Ethiopia demonstrated a 67 per cent cure rate after 28-day treatment, and 88 per cent cure rate when patients who were not cured the first time received a second round of treatment to clear visceral leishmaniasis parasites, with full treatment lasting 58 days.
Kala-azar is the second largest parasitic killer after malaria, with 20,000 to 30,000 deaths every year. Having HIV increases the severity of kala-azar, worsening treatment outcomes and increasing the risk of death.
In Kenya and Ethiopia, 20 to 40 per cent of cases of kala-azar are in people living with HIV. Current World Health Organisation guidelines recommend treating HIV/kala-azar co-infection with liposomal amphotericin B, but these recommendations have not been properly evaluated in most endemic areas.
On noticing high treatment failure rates among patients with HIV and kala-azar co-infection, MSF (Doctors without Borders) began dispensing a compassionate use combined regimen of AmBisome and milefosine at a health centre in north-west Ethiopia. Results from 150 patients on this treatment were very encouraging, but needed confirmation in controlled clinical studies.
The task was taken up by Drugs for Neglected Diseases (DNDi), which ran a Phase III study from 2014, testing AmBisome monotherapy (40 miligrammes per kilogramme of body weight) as per current WHO recommendations, and a combination of AmBisome infusion (30mg/kg) and oral miltefosine (100mg/day) for 28 days, in 58 patients in two study sites in Ethiopia. Findings demonstrated high efficacy of the combination therapy.
Neglected Tropical Diseases advisor for MSF Koert Ritmeijersaid that considering the individual and public health benefits, there is a strong case for the prompt adoption of this treatment in international and national guidelines.
He added that the findings also suggest that a new case management strategy is needed, such that using one or two rounds of treatment depends on whether negative parasitology has been achieved.
The findings published in PLOS Neglected Tropical Diseases, could lead to more effective and safer treatments for patients.