By Sharon Atieno
The World Health Organization (WHO) has released treatment guidelines for people co-infected with visceral leishmaniasis (VL), also known as kalaazar, and HIV in East Africa and South East Asia.
The new guidelines have been informed by evidence from studies carried out in Ethiopia and India by the Drugs for Neglected Diseases initiative (DNDi), Médecins Sans Frontières (MSF) and their partners which have shown the efficacy and safety of combination therapy (AmBisome plus miltefosine) to treat VL in HIV co-infected patients instead of monotherapy.
In Ethiopia, the study found 88% efficacy rate at the end of therapy (after 58 days) as opposed to the efficacy of 55% with the current standard treatment. In India, the new treatment regimen was efficacious for 96% of cases after 210 days, while 88% was observed for cases receiving standard treatment.
Besides advocating for the combination therapy and outlining its prescription, the new guidelines call for determine the HIV status of patients diagnosed with VL and doing routine screening for tuberculosis at VL diagnosis and follow-up.
Additionally, it advises extension of monotherapy in patients who do not show a good clinical response while advocating for monotherapy with AmBisome in cases where miltefosine is not available.
Also, the guidelines recommend providing comprehensive clinical management, including adequate HIV treatment and nutritional support, as well as ensuring access to contraception and pregnancy testing for women of child-bearing potential before administering miltefosine.
Further, secondary prophylaxis is recommended in particular for patients at high risk of relapse (e.g., patients not on anti-retroviral therapy (ART), with a low CD4 cell count (less than 200 cells/mm3), multiple previous VL episodes, failure to achieve clinical cure during the first episode of VL, no increase in CD4 cell count at follow-up), adding that patients should be evaluated on a case by case basis.
“The new WHO guidelines are a significant step that will greatly improve the lives of patients who are affected by both diseases and who are suffering from stigma, ostracization, loss of income, and repeated relapses,” said Dr Fabiana Alves, Director of NTDs (Neglected Tropical Diseases) Leishmaniasis and Mycetoma at DNDi in a statement.
Dr Rezika Mohammed, Assistant Professor of Internal Medicine, University of Gondar, who was the Principal Investigator of the study in Ethiopia in a statement noted that it is often hard to treat people living with these two diseases, because their weakened immune systems do not respond well to standard treatments.
“These patients have more frequent and more severe side effects from the treatment, higher risk of having another episode of visceral leishmaniasis in the future, and higher risk of death. The new treatment, now included in WHO guidelines, greatly increases their chance of being cured during a visceral leishmaniasis occurrence,” Mohammed said.
Since its identification in 1985, there have been rising cases of VL-HIV co-infection across the globe. To date about 45 countries have reported such cases, according to WHO.