Deploying prefabricated factory systems to strengthen the fight against visceral leishmaniasis

Kala azar, black fever, or visceral leishmaniasis. VL for short.

The most serious of three main forms of leishmaniasis, VL is a neglected tropical disease (NTD) that is almost always fatal if left untreated. Like the other kinds of leishmaniasis, it is caused by protozoan parasites, transmitted by the bite of infected female phlebotomine sandflies. Even though only a small proportion of people infected by leishmaniasis-causing parasites will contract the disease, every year, about 700,000 to 1 million new cases of all kinds of leishmaniasis are witnessed globally.

Visceral leishmaniasis, specifically, is characterised by fever, weight loss, anaemia, and spleen and liver enlargement. The WHO estimates that globally, 50,000 to 90,000 new cases of VL occur annually, even though only roughly 25 to 45% are reported to the global health agency. VL is endemic in 80 countries including Iraq, Sudan, Somalia and Yemen, but Brazil, east Africa, and India are home to the majority of cases. Most concerning is the fact that VL has great outbreak and mortality potential, meaning that rapidly controlling disease spread is critical to saving lives.

Visceral leishmaniasis in east Africa

All forms of leishmaniasis are endemic in the eastern part of Africa, with visceral leishmaniasis outbreaks being fairly frequent. In 2022, at 73%, eastern Africa claimed the lion’s share of global VL cases. Dishearteningly, half of these cases were reported in children under the age of 15 years.

On the bright side, leishmaniasis is treatable and curable. Though complex, preventing and controlling the disease is also possible. This requires implementing a range of tools including early diagnosis and treatment to reduce mortality and transmission; it also encompasses vector control, disease surveillance, control of animal reservoir hosts, education, and strong partnerships.

Promisingly, in October 2023, Bangladesh became the first country in the world to be validated for having eliminated VL as a public health problem. The journey towards this achievement began in 2005, with the launch of a regional strategic framework targeting VL in Asia. In east Africa, too, the hope is that such progress can be made.

The evidence exists: kala azar is a serious threat to public health, but it can be eliminated. There is hope.

In alignment with the WHO roadmap for neglected tropical diseases 2021-2030, in June 2024, the WHO launched a comprehensive framework to eliminate the scourge of visceral leishmaniasis in eastern Africa. Designed to guide policymakers, health authorities, and other stakeholders involved in improving public health in Chad, Djibouti, Eritrea, Ethiopia, Kenya, Somalia, South Sudan, Sudan, and Uganda, the elimination framework is built on five central strategies.

Early diagnosis and treatment; integrated vector management; effective surveillance; advocacy, social mobilisation and partnership building; and implementation and operational research. These are to be the pillars supporting the fight against VL in eastern Africa.

The targets to aim for in this fight? For starters, a 90% reduction in VL cases in the region, bringing the number down to fewer than 1,500 cases annually by 2030. By the same year, the WHO’s elimination framework also hopes to achieve detection and treatment of 90% of cases within 30 days of onset of symptoms, a 100% decline in VL deaths in children, 100% of patients with VL-HIV co-infections to be started on antiretroviral therapy, and last but not the least, the detection, reporting and management of all post-kala-azar dermal leishmaniasis (PKDL) cases.

Building capacity to eliminate VL in eastern Africa

The WHO’s VL elimination framework also outlines some mid-term targets, to be achieved by 2027. These include a 60% reduction in new VL cases, 100% HIV screening for all VL cases that are detected with 100% of results reported, and 75% of VL cases detected and started on treatment within a month of symptom onset.

To achieve these midterm targets and eventually the final targets of this elimination strategy, stakeholders in eastern Africa have a lot to do, from planning to implementation to consolidation to maintenance.

In the initial planning phase of 1 to 2 years, countries in the region must develop policies and strategies that address questions related to systems, partnerships, financing, data and more. They must also assess their country’s burden of VL, establish the terms that will underlie the implementation of the framework (including forecasting and ensuring a secure supply of drugs and diagnostics), identify research priorities for vector control and the development of better diagnostics, treatments, and vaccines, and develop a timeline.

While the implementation or attack phase is proposed to last for 4 to 5 years, the consolidation phase will persist another 2 to 3 years after, while the maintenance phase will cap the programme, setting eastern African countries on a VL-free path.

Procuring essential supplies for VL control and management

The WHO’s strategic framework for 2023-2030 notes that the availability of top-quality diagnostic tests, medicines, and integrated vector management supplies plays a fundamental role in the control and elimination of this dangerous disease.

While all the anti-leishmaniasis medicines and two serological tests are mentioned in the WHO Essential Medicines List and the WHO’s in vitro diagnostic test list, respectively, challenges persist. These challenges range from financing and forecasting to pricing, procurement and logistics.

For instance, VL treatment regimens are eco-epidemiology specific – this means that they are highly specific to regional disease burdens, making the market for specific treatments fairly niche. Further, most of the diagnostics and drugs for VL are supplied through single manufacturers. Warehousing, pricing, cold chain requirements, and small order quantities at national levels pose additional challenges.

Making VL diagnostics and drugs in Africa?

As public health authorities, regional entrepreneurs, and development organisations coordinate in the fight against VL, they cannot ignore the need for Africa to make its own diagnostics and treatments against this fatal disease.

To achieve the targets set for 2030, these stakeholders need to kick into action promptly. As they set the ball rolling with the planning stage, they must consider developing capacity for local manufacturing of essential supplies for VL management. This is where portable biopharma factory solutions like PodTech™’s podules™ can help.

Establishing PodTech™’s plug-and-play factory systems takes about half as much time as project schedules for traditional factories. Moreover, their flexibility, scalability and relocatability make podules ideal for addressing the highly local epidemiologies of eastern African countries.

From manufacturing simple chemicals and small molecules to inoculation suites, R&D, diagnosis, labs and testing, PodTech™ offers solutions to a range of problems that plague the fight against visceral leishmaniasis. To ensure that such agile and efficient solutions – which come equipped with everything manufacturers need to get started, from air handling to fire protection and utilities – deliver maximum impact, decision-makers should incorporate them into their VL-fighting plans right from the start.

The fight against VL may be a tough one, but with PodTech™, it is possible.