Direct acting antivirals (DAAs) have revolutionized treatment for hepatitis C. Combi-
nations of DAAs can cure infection with HCV in 12 weeks, are highly effective and
have limited side-effects. Affordability of DAAs has improved significantly, but access remains lim-
i...ted. Initially, due to their high prices, affordability of DAAs was limited in high-, middle- and low-
income countries alike. Now there is a divide between those countries where, because of intellectual
property barriers, prices have remained (very) high and other countries where generics are, or can be,
available at much lower prices. The result is a dual market
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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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Evaluation report
September 2014
Antimicrobial resistant (AMR) organisms are increasing globally, threatening to render existing treatments ineffective against many infectious diseases. In Africa, AMR has already been documented to be a problem for HIV and the pathogens that cause malaria, tuberculosis, typhoid, cholera, meningitis..., gonorrhea, and dysentery. Recognizing the urgent need for action, the World Health Assembly adopted the Global Action Plan on Antimicrobial Resistance in May 2015. In accordance with the Global Action Plan and to meet needs specific to Africa, Africa CDC will establish the Anti-Microbial Resistance Surveillance Network (AMRSNET). AMRSNET is a network of public health institutions and leaders from human and animal health sectors who will collaborate to measure, prevent, and mitigate harms from AMR organisms.
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Interim Assessement Report
The EMA review was started by the Agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infecte...d with the Ebola virus:
BCX4430 (Biocryst);
Brincidofovir (Chimerix);
Favipiravir (Fujifilm Corporation/Toyama);
TKM-100802 (Tekmira);
AVI-7537 (Sarepta);
ZMapp (Leafbio Inc.);
Anti-Ebola F(ab’)2 (Fab’entech).
The amount of information available for the seven treatments is highly variable. For some compounds there is no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans, albeit for the treatment of other viral diseases.
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MSF provides treatment for HIV and tuberculosis (TB) in more than 20 countries around the world. The report Burden sharing or burden shifting? How the HIV/TB response is being derailed examines the situation in nine countries where MSF runs programmes: Central African Republic, Democratic Republic ...of Congo, Eswatini, Guinea, Kenya, Malawi, Mozambique, Myanmar and Zimbabwe. With a focus on the financial resources available, this report highlights the current risks and gaps in HIV and TB service delivery in these countries.
Given the findings of gaps in diagnosis, prevention and care services and dwindling resources, MSF calls for a robust assessment of the needs and the resource capacity of each affected country, and calls on international donors to ensure that the financial burden is shared, rather than shifted onto those countries worst affected by the diseases.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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Mood disorders
Chapter E.2
User GuideThe toolkit is composed of three sections: Hospital and Health System Resources - includes a readiness assessment tool, the starting point in developing or enhancing a successful Antimicrobial Stewardship Program (ASP). The tool, a checklist developed by the CDC, should be shared with se...nior management, a senior leader for quality, purchasing directors, clinic managers, nurse managers, key physician leaders, risk managers, pharmacy leaders, infection preventionists and hospital epidemiologists, laboratory staff and information technology staff. For ease of use, it is divided into two sections, one for those just beginning a program, the other for those who wish to enhance an existing program. Clinician Resources - includes webinars, clinical evidence supporting appropriate use of antibiotics, implementation guides and related articles.Patient Resources - includes frequently asked questions, pamphlets and handouts on how patients can best engage in their care and resources on appropriate use of antibiotics.
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Responding to Outbreaks of Antimicrobial-resistant Pathogens in Health-care Facilities: Guidance for the Western Pacific Region is developed following requests from Member States in the Western Pacific Region for additional information and support in managing AMR outbreaks. It aims to provide: a ste...p-by-step guide for health-care facilities to respond to AMR outbreaks; a practical resource for health-care workers to support AMR outbreak response in low- and middle-income countries; and practical guidance to implement effective AMR outbreak response policies and procedures in clinical settings.
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The Mapping Antimicrobial Resistance and Antimicrobial Use Partnership (MAAP) project has conducted a multi-year, multi-country study that provides stark insights on the under-reported depth of the antimicrobial resistance (AMR) crisis across Africa and lays out urgent policy recommendations to addr...ess the emergency.
MAAP reviewed 819,584 AMR records from 2016-2019, from 205 laboratories across Burkina Faso, Cameroon, Eswatini, Gabon, Ghana, Kenya, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, Uganda, Zambia, and Zimbabwe. MAAP also reviewed data from 327 hospital and community pharmacies and 16 national-level AMC datasets.
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