New WHO guideline for kala-azar-HIV patients reduces treatment duration from 38 to 14 days
The development comes as a boon for patients, especially in Bihar, which has 84% of the country’s nearly 95 cases of visceral leishmaniasis with HIV, as per government data till 2021.
The World Health Organisation (WHO) on Wednesday released new guidelines for treatment of patients with visceral leishmaniasis (VL) or kala-azar co-infected with human immunodeficiency virus (HIV), reducing the duration of treatment from 38 to 14 days in India, said Dr Kavita Singh, director, Drugs for Neglected Diseases initiative (DNDi), South Asia, which partnered in the research.
This comes as a boon for such patients, especially in Bihar, which has 84% of the country’s nearly 95 cases of visceral leishmaniasis with HIV, as per government data till 2021.
“The previous recommended treatment for HIV-VL co-infection consists of intermittent injections of liposomal amphotericin B (AmBisome) over a period of 38 days. The new treatment uses a combination of AmBisome and oral miltefosine over 14 days and has resulted in a significantly better efficacy rates,” said Dr Singh.
The new guidelines to recommend better treatments are based on results of two studies conducted in India by Médecins Sans Frontières (MSF), and in Ethiopia by the DNDi.
The Indian study on 150 patients was conducted between 2017 and 2020 at Patna’s Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), which is a centre for clinical trials of the Indian Council of Medical Research (ICMR). Its findings were published in the Clinical Infectious Diseases scientific journal on February 11, 2022. Soon thereafter, the research partners moved the WHO for approval.
“The new treatment regimen is good, as it reduces the use of injectable drugs and significantly increases the chances for patients to be cured. We are proud of this achievement,” said Dr Krishna Pandey, director, Rajendra Memorial Research Institute and the principal investigator in the study.
In the Indian study, the new recommended treatment regimen demonstrated 96% efficacy at six months compared to 88% in the previous treatment, said Dr Singh.
Bihar and Jharkhand are the two most kala-azar endemic states in India. Goriakothi block in Bihar’s Siwan district and Isuapur in Saran district; besides Hiranpur, Amrapara, Littipara and Jama blocks in Jharkhand’s Pakur district and Kathikund and Dumka sadar in Dumka district have kala-azar endemicity of over 1 per 10,000 population.
Bihar reported 163 of India’s total 215 cases of kala azar and four of the five deaths in the last financial year. Jharkhand had 44 cases and one death, Uttar Pradesh six cases and West Bengal two during the same period, as per provisional data on the website of the National Center for Vector Borne Diseases Control, New Delhi.
The new WHO guidelines will significantly improve the lives of patients affected by both diseases who suffer from stigma, ostracization, loss of income and repeated relapses, said Dr Fabiana Alves, Director of neglected tropical diseases Leishmaniasis and Mycetoma at DNDi.
“For the first time, patients with VL-HIV co-infection in India will be treated with an evidence-based treatment. This is an important step towards recognising these patients as highly vulnerable both from a clinical and social perspective. Improving their management will benefit both patients and the VL elimination programme. However, there remains a lot to be done, as these patients present with multiple complex medical issues that need to be addressed holistically, including a very high prevalence of tuberculosis,” said a DNDi communique quoting Dr Sakib Burza, medical advisor and study coordinator at MSF.
Visceral leishmaniasis, also known as kala-azar, is a neglected tropical parasitic disease transmitted by female sand fly, causing fever, weight loss and is fatal if left untreated. People living with HIV in VL endemic areas are 100 to 2,300 times more likely to develop visceral leishmaniasis than those without HIV, the DNDi communique added.