Drug updated on 9/4/2024
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 (fexinidazole) is 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.
- This summary is based on the review of three systematic review(s)/meta-analysis(es). [1-3]
- Fexinidazole, compared to NECT, showed higher mortality rates (9/264 vs. 2/130) and relapse rates (14/264 vs. 0/130) in the treatment of g-HAT over 24 months, despite its ease of oral administration.
- Both fexinidazole and NECT are more effective and safer than older monotherapies, with melarsoprol showing a treatment failure rate of 41.49% and eflornithine 6.56%.
- The population studied included adults and children with second-stage g-HAT, located in the Democratic Republic of the Congo and the Central African Republic.
- Common adverse events were reported in 247/264 with fexinidazole and 121/130 with NECT, while serious adverse events occurred in 31/264 with fexinidazole and 13/130 with NECT.
- Fexinidazole and NECT are both considered safer than older therapies like eflornithine and melarsoprol, with fexinidazole generally preferred due to its oral administration, despite higher mortality and relapse rates. NECT reported common gastrointestinal complaints and rare convulsions.
- There is no population types or subgroups information available in 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 |