Drug updated on 5/17/2024
Dosage Form | Tablet (oral; 600 mg) |
Drug Class | Nitroimidazole antimicrobials |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of both first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg.
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Summary
- Fexinidazole is indicated for the treatment of both first-stage and second-stage human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older, weighing at least 20 kg.
- The information was derived from three systematic reviews/meta-analyses studies. These studies provide a comprehensive comparison regarding the safety and effectiveness of Fexinidazole compared to other drugs used in treating HAT.
- Compared to existing treatments such as eflornithine, melarsoprol, and nifurtimox-eflornithine combination therapy (NECT), Fexinidazole offers an effective oral medication option with a simpler administration route, making it more convenient than the intravenous or combined regimens required for other treatments.
- However, there are concerns over higher mortality rates and relapse observed with Fexinidazole compared to NECT, based on one study included in these studies. This indicates that while Fexinidazole may be easier to administer, its overall efficacy might not surpass that of NECT.
- In terms of drug resistance - a significant threat against HAT elimination efforts - resistances have been noted against pentamidine, melarsoprol, nifurtimox, and eflornithine, underscoring the need for new treatments like Fexinidazole despite potential drawbacks related to mortality rate and relapse frequency.
- While adverse effects are associated with both Fexinidazole and NECT without significant difference between them, gastrointestinal complaints were specifically noted among side effects caused by NECT, whereas specific adverse events linked directly with the use of Fexinidazole were less detailed within the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Fexinidazole (fexinidazole) Prescribing Information. | 2021 | Sanofi-Aventis U.S. LLC, Bridgewater, NJ |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Systematic review and meta-analysis on human African trypanocide resistance. | 2022 | Pathogens |
Efficacy and toxicity of fexinidazole and nifurtimox plus eflornithine in the treatment of African Trypanosomiasis: a systematic review. | 2021 | Cureus |
Chemotherapy for second-stage human African trypanosomiasis: Drugs in use. | 2021 | Cochrane Database of Systematic Reviews |
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
New WHO guidelines for treatment of gambiense human African trypanosomiasis including fexinidazole: substantial changes for clinical practice. | 2020 | The Lancet Infectious Diseases |
WHO interim guidelines for the treatment of gambiense human African trypanosomiasis. | 2019 | WHO |