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Study reduces risks of treatment against cutaneous leishmaniasis, says Fiocruz

Study developed at the Oswaldo Cruz Foundation (Fiocruz) opens a new perspective of treatment and cure for patients with cutaneous leishmaniasis, with high levels of scientific evidence. The disease, transmitted by the bite of an insect that feeds on blood, has old treatments that can be toxic to the heart, liver and pancreas.

“The biggest struggle we face in this work is that it doesn’t make sense for people to die as a result of treatment for a disease that doesn’t usually kill people. And what we have to treat are these very toxic medicines”, explained dermatologist Marcelo Rosandiski Lyra, researcher at the Laboratory of Clinical Research and Surveillance in Leishmaniasis at the National Institute of Infectious Diseases Evandro Chagas (INI), at Fiocruz.

The specialist highlights that even for patients who do not die, the complications of conventional treatment are very high. “Because the patient also undergoes the treatment, he has muscle pain, headache. He can have a series of complications related to the treatment.”

Coordinated in Rio de Janeiro by Lyra, the study proposes a change in the treatment for cutaneous leishmaniasis, replacing conventional treatment with intralesional treatment, that is, applying the medicine to the lesion itself. In Rio, two groups of people with cutaneous leishmaniasis were randomly selected and treated differently and monitored for two years. “During this period we monitor all the effects they had and the patient returns to the clinic several times. He is looked at very carefully.” According to Lyra, the work showed a very strong strength of evidence. “He managed to prove that it is a treatment in terms of 83% cure effectiveness, while conventional treatment has 68%. And in terms of safety and reduction of side effects, it was a winner.”

The study was supported by several institutions, such as the University of São Paulo (USP), the University of Brasília (UNB), the Faculty of Tropical Medicine of Manaus, the Federal University of Mato Grosso (UFMT) and the Federal University of Mato Grosso Grosso do Sul (UFMS), among others, which, for Marcelo Lyra, is important to give a national character to the results.

Tropical disease

Leishmaniasis is a disease caused by protozoa belonging to the genus Leishmania and transmitted by the bite of a blood-sucking insect. [que se alimenta de sangue] from the sandfly family, popularly known, among other names, as sand flies. Leishmaniasis is a disease that occurs in tropical regions, in developing countries, and can affect humans and other animals.

There are two types of leishmaniasis, cutaneous or integumentary, which causes wounds on the skin and mucous membranes, and visceral, which affects internal organs and has the dog as its main host. There is, however, no direct transmission between people and people and dogs. Visceral leishmaniasis is an extremely serious disease. “If the person is not treated, up to 90% of them die without treatment, because the internal organs are affected”, explained Lyra. Cutaneous leishmaniasis can affect, in addition to the skin, mucous membranes from the nose and mouth. “It is a serious disease because, sometimes, the patient causes disfiguring injuries, very large wounds on the skin. But although it is disfiguring in the most serious cases, the disease is not usually lethal. It is a disease that is serious, has an important social impact, but it is unlikely that a person will die as a result of this disease.”

Manual

The latest manual from the Ministry of Health that regulates leishmaniasis treatment standards is from 2017. A new manual should be published by 2025. The previous one already included intralesional treatment, but still with many restrictions, indicated only for very small and unique lesions. Lyra wants to see the new treatment for larger injuries included in the manual, in patients with a greater number of injuries. “As it was very restricted (in the previous manual), practically no one did that. By expanding the recommendations, we will cover a greater number of people.”

For the researcher, in terms of public health, it is positive to see more people using intralesional treatment, as it reduces lethality and side effects. “The treatment is cheaper because, as it is done directly on the lesion, the amount of medicine applied is around 10% to 15% of what is done in conventional treatment. Above all, it saves money. This is everything the Ministry of Health wanted: there is a medicine that is cheaper, safer, as effective or more effective. Conventional treatment does not benefit anyone.”

The work of the dermatologist and Fiocruz researcher was awarded at the 76th Brazilian Congress of the Brazilian Society of Dermatology (SBD). The scientific article “A Randomized, Controlled, Non-inferiority and Multicenter Trial of Systemic vs Intralesional Treatment with Meglumine Antimoniate for Cutaneous Leishmaniasis in Brazil”, was also considered one of the ten most important publications in the area of ​​parasitic diseases at the European Congress on Microbiology Clinic and Infectious Diseases (ECCMID), recently held in Barcelona, ​​Spain. The study was recognized for minimizing the side effects of conventional treatment of leishmaniasis and, therefore, preventing deaths, reducing morbidity and at a lower cost. The work was published in 2023 in the journal Clinical Infect Disease, specialized in infectious diseases. The awards, according to Marcelo Lyra, give credibility to make the necessary changes in the country.

Lyra lamented that there is no interest from a large part of the international community in the topic because it is a disease in poor countries, especially because this type of treatment does not generate money for anyone. It reverts to public health by reducing costs. As no medicines or vaccines will be sold, the topic does not have major promoters of this type of research, she explained.

Patient

Fernando Correa Losada, civil engineer and lawyer, 65 years old, was referred to Fiocruz, through the Municipal Epidemiology Service, in September 2023, with suspected leishmaniasis. He had an ulcerated lesion on the back of his left hand without pain or itching. He was used antibiotic therapy, without clinical success. In the consultation held the following month at Fiocruz, Marcelo Lyra performed the only biopsy that confirmed the disease.

After the positive result, Losada’s treatment began on November 6 last year. As he has left heart branch block, he underwent intralesional treatment, because traditional treatment was contraindicated. “The response was excellent”, assured the patient.

He reported that in the last serology test for leishmaniasis, carried out at the beginning of February this year, the result was non-reactive. “I’m cured,” celebrated Losada. The monitoring he will have to do includes consultations and blood tests, at longer intervals.

Source: CNN Brasil

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