By Sharon Atieno
The results of clinical trials conducted in Ethiopia have paved way for more effective and safer treatments for people with both human immunodeficiency virus (HIV) and visceral leishmaniasis (VL). Previously, the monotherapy treatment had led to poor treatment outcomes.
VL, also known as kalaazar with almost 90,000 cases in Asia, Africa and South America is the second largest parasitic killer after malaria with 20,000- 30, 000 deaths annually. It is caused by a sand fly bite and immunity is generated after treatment.
HIV alters the severity of kalaazar, worsens treatment outcomes, relapse rates and increases the risk of death. Co-infection remains prevalent in several parts globally with North-West Ethiopia having the highest global burden of VL in people living with HIV at 20 percent to 40 percent.
Another key aspect is preventing recurrence of disease as relapse cases are more difficult to cure therefore, becoming reservoirs of the parasite and playing a role in transmission.
Dr. Jorge Alvar, senior advisor on leishmaniasis at Drugs for Neglected Diseases (DNDi) in a press release points out that young workers in Ethiopia who have migrated to the lowlands for seasonal work and are at risk of contracting HIV are also exposed to sand fly bites that cause kalaazar as they sleep in improvised shelters. “There is an urgent need for better treatment and outcomes for this seriously ill and neglected population,” he notes.
The World Health Organization (WHO) guidelines recommend liposomal amphotericin B, AmBisome as the first line of treatment for HIV/VL co-infection. WHO’s regimen was arrived at after a single clinical trial in Spain hence, it lacks proper evaluation in endemic areas.
Medecin Sans Frontieres, an international medical humanitarian organization, between 2011 and 2014 began using a compassionate use regimen, involving the combination of AmBisome with the oral drug miltefosine in Abdurafi Health Centre in North-West Ethiopia.
In a bid to confirm the results of the effectiveness of the treatment in controlled clinical studies, DNDi ran a Phase III study in 2014 testing both AmBisome monotherapy (40mg/kg) as per WHO recommendations and a combination of AmBisome infusion (30mg/kg) and miltefosine orally for 28 days (100mg/day) in 58 HIV/VL patients in two sites in Ethiopia.
The results of the study- which has been published in PLOS Neglected Tropical Diseases journal- proved the high efficacy of the combination therapy with 67 percent cure rate when treatment lasted 28 days, and increased to 88 percent cure rate when patients who were not cured received a second round of treatment to clear leishmania parasite with a fuel treatment lasting 58 days.
“Considering the individual and public health benefits, there is a strong case for the prompt adoption of this treatment in international and national guidelines,” said Dr. Alvar. “The results also suggest a new case for management strategy is needed, whereby using one or two rounds of treatment depends on whether negative parasitology has been achieved.”
Although the combination regimen and treatment strategy suggested by the clinical trial proves to be effective for the HIV-VL co-infected patients, the medicines used remain very expensive, and quality of HIV care still remains a burden to ensuring long-term patient survival.
In order to reduce parasite circulation in the community, implementation of a regimen that enhances parasite clearance is important. Ensuring access and optimal care for the HIV-VL co-infected population could influence the efficacy of elimination programmes.