UNGASS 2016 OUTCOME IMPLEMENTATION
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention
Division of Tuberculosis Elimination
Accessed: 08.10.2019
The present Consolidated guidelines include a comprehensive set of WHO recommendations for the treatment and care of DR-TB, derived from these WHO guidelines documents. The consolidated guidelines include policy recommendations on treatment regimens for isoniazid-resistant TB (Hr-TB) and MDR/RR-TB, ...including longer and shorter regimens, culture monitoring of patients on treatment, the timing of antiretroviral therapy (ART) in MDR/RR-TB patients infected with the human immunodeficiency virus (HIV), use of surgery for patients receiving MDR-TB treatment, and optimal models of patient support and care.
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Report: A survey conducted among the 27 high MDR-TB burden countries.
March – July 2015
Stop TB Partnership in collaboration with Medecins Sans Frontieres (MSF).
Accessed November 2017.
Drug registration in Kenya started in 1982; the process mainly involves an evaluation committee at the Kenya Pharmacy and Poisons Board (PPB) that aims to approve products based on quality, safety and efficacy.
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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The Lancet olume 395, ISSUE 10232, P1259-1267, April 18, 2020. Buruli ulcer is a neglected tropical disease caused by Mycobacterium ulcerans infection that damages the skin and subcutis. It is most prevalent in western and central Africa and Australia. Standard antimicrobial treatment with oral rifa...mpicin 10 mg/kg plus intramuscular streptomycin 15 mg/kg once daily for 8 weeks (RS8) is highly effective, but streptomycin injections are painful and potentially harmful. We aimed to compare the efficacy and tolerability of fully oral rifampicin 10 mg/kg plus clarithromycin 15 mg/kg extended release once daily for 8 weeks (RC8) with that of RS8 for treatment of early Buruli ulcer lesions.
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Phillips and colleagues have shown that rifampicin combined with clarithromycin is non-inferior to RS8, and is safer. This much anticipated trial provides us with a high degree of confidence that an 8-week course of oral rifampicin and clarithromycin should now be the cornerstone of the treatment of... Buruli ulcer everywhere. However, this finding does not mean that
Buruli ulcer is cured at 8 weeks.
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The power of the Global Drug Policy Index lies in its key objective: to score and
rank how countries are faring in different areas of drug policy as identified in the
UN report ‘What we have learned over the last ten years: A summary of knowledge
acquired and produced by the UN system on drug-r...elated matters’,1 and derived
from the landmark UN System Common Position on Drug
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The Global Programme to Eliminate Lymphatic Filariasis (LF) is using mass drug administration (MDA) of antifilarial medications to treat filarial infections, prevent disease and interrupt transmission. Almost 500 million people receive these medications each year. Clinical trials have recently shown... that a single dose of a triple-drug combination comprised of ivermectin, diethylcarbamazine and albendazole (IDA) is dramatically superior to widely used two-drug combinations for clearing larval filarial parasites from the blood of infected persons. A large mul-
ticenter community study showed that IDA was well-tolerated when it was provided as MDA. IDA was rapidly advanced from clinical trial to policy and implementation; it has the potential to accelerate LF elimination in many endemic countries.
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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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Little progress has been made since the 1960s and 1970s to widen the therapeutic arsenal against Trypanosoma cruzi, the causative pathogen of Chagas disease, which remains a frustrating and perplexing infectious disease. This chapter focuses on the strategic and operational challenges in the clinica...l drug development of a novel antitrypanosomal agent for Chagas disease. The various elements that contribute to a robust assessment of treatment effect including dose selection, choice of patient population, trial methodology, endpoint measures, and regulatory perspectives are discussed. The learnings herein should serve as resource to help researchers and other stakeholders optimize their clinical development plans and speed delivery of new medicines to patients with Chagas disease.
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Soil-transmitted helminths (STH) affect 1.45 billion people worldwide, and high intensity infections are associated with anemia, undernutrition and impaired cognition, particularly among children. Mathematical models suggest it may be possible to interrupt the transmission of STH in a community by e...xpanding mass drug administration (MDA) from targeted high-risk groups (primarily school-aged children and women of child-bearing age) to all community members with high coverage. The DeWorm3 Project will test the feasibility of this approach to interrupting the transmission of STH using a series of cluster randomized trials in Benin, India and Malawi. Each study area (population 80,000) will be divided into 40 clusters and randomized to community-wide or standard-of-care targeted MDA for three years. Two years following the final round of MDA, prevalence of STH will be compared between arms and transmission interruption assessed in each cluster. The DeWorm3 trials will provide stakeholders with information regarding the potential to switch from STH control to a more ambitious and sustainable strategy.
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