Full Perscribing information on Fexinidazole Tablet for oral use
INDICATIONS AND USAGE
Fexinidazole Tablets are indicated for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in pati...ents 6 years of age and older and weighing at least 20 kg.
Limitations of Use
Due to the decreased efficacy observed in patients with severe second stage HAT (cerebrospinal fluid white blood cell count (CSF-WBC) >100 cells/μL) due to T. brucei gambiense disease, Fexinidazole Tablets should only be used in these patients if there are no other available treatment options [see Warnings and Precautions (5.1)]
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Since 2000, concerted efforts by national programmes, supported by public–private partnerships, nongovernmental organizations, donors and academia under the auspices and coordination of the World Health Organization (WHO), have produced important achievements in the control of human African trypan...osomiasis (HAT). As a consequence, the disease was targeted for elimination as a public health problem by 2020. The Sixty-sixth World Health Assembly endorsed this goal in resolution WHA66.12 on neglected tropical diseases, adopted in 2013.
National sleeping sickness control programmes (NSSCPs) are core to progressing control of the disease and in adapting to the different epidemiological situations. The involvement of different partners, as well as the support and trust of long-term donors, has been crucial for the achievements.
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The development of this target product profile (TPP) was led by the WHO Department of Control of Ne-
glected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to
identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG)
was... formed, and different subgroups were created to advise on specific NTDs, including a subgroup
working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of in-
dependent experts included leading scientists, public health officials and endemic-country end-user rep-
resentatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of
the available products and of the development pipeline was conducted, and the salient areas with unmet
needs were identified
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PLoS Neglected Tropical diseases August 16, 2021 https://doi.org/10.1371/journal.pntd.0009697
Chagas disease, also known as American trypanosomiasis, is a neglected tropical disease transmitted by triatomine insects, first identified in 1909. Chagas disease affects approximately 6–7 million peop...le globally and is highly prevalent in Latin America where most cases are reported. However, there is increasing evidence that Chagas disease is now an important public health issue outside the “classical” endemic countries due to population migration. Our understanding of Chagas disease, including its pathologies and factors relating to progression, remains to date limited, and is also challenged by lack of diagnosis and highly effective treatment. This systematic review aims to describe studies with Chagas patients receiving antiparasitic treatment. Databases were searched for relevant studies published after 1997, and the results of these searches were screened.
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Parasites Vectors 14, 50 (2021). https://doi.org/10.1186/s13071-020-04555-8
The twentieth century ended with human African trypanosomiasis (HAT) epidemics raging across many parts of Africa. Resistance to existing drugs was emerging, and many programs aiming to contain the disease had ground to a halt, given previous success against HAT and the competing priorities associat...ed with other medical crises ravaging the continent. A series of dedicated interventions and the introduction of innovative routes to develop drugs, involving Product Development Partnerships, has led to a dramatic turnaround in the fight against HAT caused by Trypanosoma brucei gambiense. The World Health Organization have been able to optimize the use of existing tools to monitor and intervene in the disease. A promising new oral medication for stage 1 HAT, pafuramidine maleate, ultimately failed due to unforeseen toxicity issues. However, the clinical trials for this compound demonstrated the possibility of conducting such trials in the resource-poor settings of rural Africa.
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La enfermedad de Chagas, también conocida como tripanosomiasis americana, es una enfermedad potencialmente mortal causada por un grupo de parásitos llamados Trypanosoma cruzi (T. cruzi).
Human African trypanosomiasis (HAT) has been an alarming global public health issue. The disease affects mainly poor and marginalized people in low-resource settings and is caused by two subspecies of haemoflagellate parasite, Trypanosoma brucei and transmitted by tsetse flies. Progress made in HAT ...control during the past decade has prompted increasing global dialogue on its elimination and eradication. The disease is targeted by the World Health Organization (WHO) for elimination as a public health problem by 2020 and to terminate its transmission globally by 2030, along-side other Neglected Tropical Diseases (NTD). Several methods have been used to control tsetse flies and the disease transmitted by them. Old and new tools to control the disease are available with constraints.
Currently, there are no vaccines available. Efforts towards intervention to control the disease over the past decade have seen considerable progress and remarkable success with incidence dropping progressively, reversing the upward trend of reported cases. This gives credence in a real progress in its elimination. This study reviews various control measures, progress and a highlight of control issues, vector and parasite barriers that may have been hindering progress towards its elimination.
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Les progrès remarquables réalisés dans la lutte contre la forme à T. b. gambiense reposent sur le dépistage et le traitement curatif, une stratégie qui interrompt la transmission en réduisant le réservoir de parasites chez l’être humain. Parfois, cette
approche a été combinée avec des... activités de lutte antivectorielle. L’objet de ces lignes directrices est donc de la plus haute importance pour la poursuite des progrès en vue de l’élimination de la THA.
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Human African trypanosomiasis (HAT), or sleeping sickness, is an endemic disease in 36 sub-Saharan African countries, typically occurring in underdeveloped areas, where
health systems face significant difficulties of diverse natures.
A clear understanding of the knowledge, attitudes and practices (KAP) of a particular community is necessary in order to improve control of human African trypanosomiasis (HAT).New screening and diagnostic tools and strategies were introduced into South Sudan, as part of integrated delivery of primar...y healthcare. Knowledge and awareness on HAT, its new/improved screening and diagnostic tools, the places and processes of getting a confirmatory diagnosis and treatment are crucial to the success of this strategy.
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Arsenical monotherapies were previously very successful for treating human African trypanosomiasis (HAT).
Melarsoprol resistance emerged as early as the 1970s and was widespread by the late 1990s.
Melarsoprol resistance represents the only example of widespread drug resistance in HAT patients wher...e the genetic mechanism has been established.
The current goal of elimination of HAT as a public health problem by 2020 may be undermined by the emergence and spread of resistance to current or new drugs.
Insights into potential resistance mechanisms for current and new drugs will facilitate predictions of the likelihood of resistance and will also facilitate rational approaches to minimizing, monitoring, and tackling the future emergence of resistance.
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Video. Human African Trypanosomiasis, also known as sleeping sickness is a devastating parasitic disease. It is a neglected tropical disease affecting communities in Africa. In this video we take a look at the disease, how it presents and and ways to control it.
The Lancet Volume 390, Issue 10110p2397-2409November 25, 2017.
Human African trypanosomiasis (HAT), also called sleeping sickness, is a parasitic infection that almost invariably progresses to death, unless treatment is provided. HAT caused devastating epidemics during the 20th century. Thanks to ...sustained and coordinated efforts during the past 15 years the number of reported cases has fallen to a historic low. Fewer than 3,000 cases were reported in 2015, and the disease is targeted for elimination by the World Health Organization. Despite recent success, HAT still poses a heavy burden on the rural communities where this highly focal disease occurs, most notably in Central Africa. Since patients are also reported from non-endemic countries outside Africa, HAT should be considered in differential diagnosis for all travellers, tourists, migrants and expatriates who have visited or lived in endemic areas. In the absence of a vaccine, disease control relies on case detection and treatment, and vector control. Available drugs are sub-optimal, but ongoing clinical trials give hope for safer and simpler treatments.
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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This analysis focused on the chronic form of HAT caused by T. b. gambiense, as it contributes to the majority of disease burden. Information from the literature review,
product development landscape, and stakeholder interviews was compiled to:
- Identify use cases and understand current diagnosti...c practices and tools associated with each use case.
- Analyze progress toward robust diagnostics for HAT across different biomarkers.
- Develop recommendations for steps to improve the availability, access, and adoption of HAT diagnostic tools.
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Sleeping sickness is controlled by case detection and treatment but this often only reaches less than 75% of the population. Vector control is capable of completely interrupting HAT transmission but is not used because of expense. We conducted a full scale field trial of a refined vector control tec...hnology. From preliminary trials we determined the number of insecticidal tiny targets required to control tsetse populations by more than 90%. We then carried out a full scale, 500 km2 field trial covering two HAT foci in Northern Uganda (overall target density 5.7/km2). In 12 months tsetse populations declined by more than 90%. A mathematical model suggested that a 72% reduction in tsetse population is required to stop transmission in those settings. The Ugandan census suggests population density in the HAT foci is approximately 500 per km2. The estimated cost for a single round of active case detection (excluding treatment), covering 80% of the population, is US$433,333 (WHO figures). One year of vector control organised within country, which can completely stop HAT transmission, would cost US$42,700. The case for adding this new method of vector control to case detection and treatment is strong. We outline how such a component could be organised.
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Un comité OMS d’experts sur la trypanosomiase humaine africaine (THA) : lutte et surveillance, s’est réuni à Genève (Suisse), du 22 au 26 avril 2013. Le Dr H. Nakatani, sous-directeur général pour le VIH/SIDA, la tuberculose, le paludisme et les maladies tropicales négligées, a ouvert la... réunion au nom du Dr M. Chan, directeur-général de l’OMS.
La THA est une maladie qui afflige les populations rurales de l’Afrique, là où prolifère la mouche tsé-tsé (ou glossine), vecteur des trypanosomes qui en sont la cause. On distingue deux formes de THA : la forme à T. b. gambiense ou forme gambienne, endémique en Afrique de l’Ouest et en Afrique centrale et qui
représente actuellement 95 % des cas, et la forme à T. b. rhodesiense ou forme rhodésienne, endémique en Afrique de l’Est et en Afrique australe, à laquelle sont dus les 5 % restants.
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The previous report of the WHO Expert Committee on this disease
followed a meeting in 1995. Intensive, coordinated efforts against HAT during
the intervening 18 years have resulted in a decrease in incidence to a point at
which elimination is considered feasible. This report provides informati...on about
new diagnostic approaches, new therapeutic regimens and better understanding
of the distribution of the disease with high-quality mapping. The roles of human
and animal reservoirs and the tsetse fly vectors that transmit the parasites are
emphasized. The new information has formed the basis for an integrated strategy
with which it is hoped that elimination of HAT will be achieved. The report also
contains recommendations on the approaches that will lead to elimination of the
disease.
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