Effective treatment options are crucial for patients with Chagas disease who show serious or life-threatening symptoms. According to Infectious Disease Advisor, a Phase 2 study in its proof-of-concept phase evaluated fexinidazole for those infected with Trypanosoma cruzi (T. cruzi), the parasite which causes Chagas disease. Altogether, 47 patients enrolled in the study.
During the course of the study, patients received either a placebo, 1200mg fexinidazole daily, or 1800mg fexinidazole daily. Researchers hoped to understand how effective the treatment was in destroying and eliminating T. cruzi, with the primary endpoint being sustained parasitic clearance for up to 1 year following treatment.
Data, published in Clinical Infectious Diseases, found that:
- 75% of those taking fexinidazole experienced some sort of neuropsychiatric side effects. These included insomnia, anxiety and depression, and neuropathy. Unfortunately, the depression led to suicide in one individual.
- Neuropsychiatric side effects were most common in the first week of treatment.
- 4 patients discontinued treatment due to severe neutropenia (low white blood cell counts). Additional side effects included liver injury.
- All patients who finished the trial saw sustained parasitic clearance for at least one year after treatment, even those who received less than one week’s worth of treatment.
Currently, the researchers recognize that the data shows that fexinidazole is not yet safe for treating individuals with chronic Chagas disease. However, they question whether lower doses of fexinidazole, as well as shorter treatment periods, could maintain efficaciousness while reducing safety issues. In the future, more research is needed to determine whether this could eventually become a possible therapeutic option.
What is Chagas Disease?
Chagas disease is a parasitic illness that occurs in the Americas, with a large number of those infected located in Latin America. When the triatomine bug, also known as the kissing bug, feeds on infected humans and animals, the bug becomes infected with T. cruzi. The parasite is then spread through the triatomine bugs’ infected feces. Outside of this, transmission can take place during pregnancy (from mother to child), through accidental lab exposure, consuming contaminated food or water, or from organ transplants or blood transfusions.
The acute phase of Chagas disease means that there are many parasites in someone’s blood. At this stage, there are many people who are either asymptomatic or experience mild flu-like symptoms such as fever, nausea and vomiting, fatigue and lethargy, appetite loss, rashes, or swelling near the infection site. Patients may also present with swollen glands, an enlarged liver or spleen, or swollen eyelids.
When Chagas disease progresses to the chronic phase, most people do not have symptoms. However, 20-30% of people may have an enlarged heart, colon, or esophagus, experience difficulty eating, or have heart rhythm abnormalities. Some may go into cardiac arrest, which can be fatal.