This is a detailed manual giving a step by step approach to undertaking the pharmacovigilance of antiretrovirals. It is intended to be a source of practical advice for Pharmacovigilance Centres and health professionals involved in HIV/AIDS prevention and treatment programmes. A number of WHO publica...tions are available that provide a background to pharmacovigilance and, as far as possible, that material will not be repeated here. Health officials, planners, the staff of Pharmacovigilance Centres, public health teams and all health workers should become familiar with these publications, which are: • Safety of Medicines: A guide to detecting and reporting adverse drug reactions
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The goal of this addendum is to help management and staff
minimize the risk of TB transmission at facilities in resource limited settings in which a.) HIV-infected persons receive diagnosis, care, treatment,
and/or support, and b.) there is a high prevalence of HIV infection, both known
and... undiagnosed, in settings such as prisons, jails, other
detention centers, and drug rehabilitation centers.
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The Best practice portal is a resource for professionals, policymakers and researchers in the drugs field. We provide information on the available evidence on drug-related prevention, treatment and harm reduction, focusing on the European context. The evidence is compiled following an explicit metho...dological process.
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The Best practice portal is designed to help you find practical and reliable information on what works (and what doesn’t) in the areas of prevention, treatment, harm reduction and social reintegration. It will help you identify tried and tested interventions quickly, allocate resources to what's e...ffective, and improve interventions applying tools, standards and guidelines.
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This publication seeks to describe the best treatments and practices based on the scientific evidence available at the time of writing as evaluated by the authors and may change as a result of new research. Readers need to apply this knowledge to patients in accordance with the guidelines and laws o...f their country of practice. Some medications may not be available in some countries and readers should consult the specific drug information since not all the unwanted effects of medications are mentioned.
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Specific measures are being taken within the National Tuberculosis Control Programme (NTP) to address the MDR TB problem through appropriate management of patients and strategies to prevent the propagation and dissemination of MDR TB.
The term "Programmatic Management of Drug Resistant TB" (PMD...T) refers to programme based MDR TB diagnosis, management and treatment. This guideline promotes full integration of basic TB control and PMDT activities under the NTP, so that patients with TB are evaluated for drug resistance and are placed on the appropriate treatment regimen and properly managed from the outset of treatment, or as early as possible. The guidelines also integrate the identification and treatment of more severe forms of drug resistance, such as extensively drug resistant TB (XDR TB).
At the end, the guideline introduces new standards for registering, monitoring and reporting outcomes of multidrug resistant TB cases.
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This guide is a resource for physicians and other health care professionals who provide care and treatment to patients with drug-resistant tuberculosis.
Multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant
tuberculosis (XDR-TB) increasingly occur in resource-constrained settings.
In the context of a national response to MDR- and XDR-TB, health workers in
TB clinics (in district hospitals and some accredited health centres) wil...l need
to diagnose MDR-TB, initiate second-line anti-TB drugs, and monitor MDRTB
treatment.
Management of MDR-TB: a field guide was created to help health workers
carry out these tasks. It is a job aid that medical officers and TB nurses
are meant use frequently during the day for quick reference. This module
is closely related to other clinical guideline modules in the Integrated
Management of Adolescent and Adult Illness (IMAI) series. In particular, the
approach to chronic disease management is taken from General principles
of good chronic care in the IMAI series.
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This report provides an update on the key facets of HIV treatment access, including the latest HIV treatment guidelines from World Health Organization (WHO), an overview on pricing for first-line, second-line, and salvage regimens, and a summary of the opportunities for – and threats to – expand...ing access to affordable antiretroviral therapy (ART).
The report is supplemented by 11 drug profiles that contain more detailed information on pricing trends and patent barriers for key antiretroviral drugs and fixed-dose combinations. Also included is an annex of conditions that define eligibility for reduced prices from 15 pharmaceutical companies.
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Meeting Report 27-29 October 2020
The overall goal of the meeting was to discuss recent changes in treatment regimens and diagnostics for drug-resistant TB and to determine how these impact on the definition of XDR-TB, with a view to revising this definition. The pre-existing definition of XDR-TB w...as formulated in 2006 at a meeting of the Global Taskforce on XDR-TB, convened by WHO, and has been in use for clinical and surveillance purposes, since this time.
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Ivermectin is an antiparasitic drug approved for the treatment of parasitic infections, including strongyloidiasis and onchocerciasis in humans. There is a reported increase in the use of ivermectin for the prevention and treatment of COVID-19 by the public in African Union Member States.
Currently..., there is:
1. No scientific evidence from pre-clinical studies on the therapeutic effect of ivermectin for the management of COVID-19;
2. No evidence of its clinical efficacy for the management of patients with asymptomatic, mild, moderate or severe COVID-19; and
3. No safety data regarding the use of ivermectin for COVID-19 in the majority of the published studies.
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The consolidated guidelines are complemented by an operational handbook which is designed to assist with implementation of the WHO recommendations by Member States, technical partners and others who are involved in the management of patients with DR-TB. The WHO Operational Handbook on Tuberculosis, ...Module 4: Treatment - Drug-Resistant Tuberculosis Treatment provides practical guidance on how to put in place the recommendations at the scale needed to achieve national and global impact.
The operational handbook provides practical information and tools that complement the recommendations in the guidelines. The strategies described in the operational handbook are based on the latest WHO recommendations which were formulated by Guideline Development Groups using the GRADE approach. In many cases however, the recommendations in their current form lacked sufficient clinical and programmatic detail, which is important for implementation. This operational handbook complements the guidelines with practical advice based on best practices and knowledge from the fields such as pharmacokinetics, pharmacodynamics, microbiology, pharmacovigilance and clinical and programmatic management.
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In 2019, an estimated 10 million individuals fell ill with tuberculosis (TB) and 3 million of them were not reported to have beendiagnosed and notified. The gap is proportionately even wider for drug-resistant TB. Of the estimated 465 000 patients with rifampicin-resistant and multi-drug resistant T...B (RR/MDR-TB), only 206 030 (44%) were diagnosed and notified.For the first time, the World Health Organization (WHO) has provided global estimates of the incidence of isoniazid resistance: in 2019, there were 1.4 million incident cases of isoniazid-resistant TB, of which 1.1 million were susceptible to rifampicin. Most of these people were not diagnosed with drug-resistant TB and did not receive appropriate treatment.
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Protocol for the management of specialized centres for the treatment of people with alcohol and other drug abuse problems (CETAD) in the framework of the COVID-19 pandemic. Version 1.
Nat Commun 9, 5370 (2018). https://doi.org/10.1038/s41467-018-07804-8. Mycobacterium ulcerans is the causative agent of Buruli ulcer, a neglected tropical skin disease that is most commonly found in children from West and Central Africa. Despite the severity of the infection, therapeutic options are... limited to antibiotics with severe side effects. Here, we show that M. ulcerans is susceptible to the anti-tubercular drug Q203 and related compounds targeting the respiratory cytochrome bc1:aa3. While the cytochrome bc1:aa3 is the primary terminal oxidase in Mycobacterium tuberculosis, the presence of an alternate bd-type terminal oxidase limits the bactericidal and sterilizing potency of Q203 against this bacterium. M. ulcerans strains found in Buruli ulcer patients from Africa and Australia lost all alternate terminal electron acceptors and rely exclusively on the cytochrome bc1:aa3 to respire. As a result, Q203 is bactericidal at low dose against M. ulcerans replicating in vitro and in mice, making the drug a promising candidate for Buruli ulcer treatment.
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After 100 years of chemotherapy with impractical and toxic drugs, an oral cure for human African trypanosomiasis (HAT) is available: Fexinidazole. In this case, we review the history of drug discovery for HAT with special emphasis on the discovery, pre-clinical development, and operational challenge...s of the clinical trials of fexinidazole. The screening of the Drugs for Neglected Diseases initiative (DNDi) HAT-library by the Swiss TPH had singled out fexinidazole, originally developed by Hoechst (now Sanofi), as the most promising of a series of over 800 nitroimidazoles and related molecules. In cell culture, fexinidazole has an IC50 of around 1 µM against Trypanosoma brucei and is more than 100-fold less toxic to mammalian cells. In the mouse model, fexinidazole cures both the first, haemolymphatic, and the second, meningoencephalitic stage of the infection, the latter at 100 mg/kg twice daily for 5 days. In patients, the clinical trials managed by DNDi and supported by Swiss TPH mainly conducted in the Democratic Republic of the Congo demonstrated that oral fexinidazole is safe and effective for use against first- and early second-stage sleeping sickness. Based on the positive opinion issued by the European Medicines Agency in 2018, the WHO has released new interim guidelines for the treatment of HAT including fexinidazole as the new therapy for first-stage and non-severe second-stage sleeping sickness caused by Trypanosoma brucei gambiense (gHAT). This greatly facilitates the diagnosis and treatment algorithm for gHAT, increasing the attainable coverage and paving the way towards the envisaged goal of zero transmission by 2030.
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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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HIV, viral hepatitis and STI epidemics, particularly among people who inject drugs and other key populations, continue to be fuelled by laws and policies criminalizing sex work; drug use or possession; diverse forms of gender expression and sexuality; stigma and discrimination; gender discrimination...; violence; lack of community empowerment and other violations of human rights. These sociostructural factors limit access to health services, constrain how these services are
delivered and diminish their effectiveness.
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Of the more than 10 million people estimated to have fallen ill with tuberculosis (TB) in 2022, just over 400 000 people developed TB resistant to rifampicin (RIF), and 1.3 million people developed TB resistant isoniazid (INH). Drug resistance must be detected rapidly and accurately to initiate appr...opriate and effective treatment.
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The Global status report on alcohol and health and treatment of substance use disorders presents a comprehensive overview of alcohol consumption, alcohol-related harm and policy responses as well as treatment capacities for alcohol and drug use disorders worldwide. The report is based on data collec...ted by WHO from Member States and organized in accordance with the Sustainable Development Goals health target 3.5 which calls on countries to strengthen “the prevention and treatment of substance abuse, including narcotic drug abuse and harmful use of alcohol”. The chapter on alcohol and health continues the series of WHO global status reports on alcohol and health and presents the latest available data on the status of, and trends in, alcohol consumption, as well as estimates of the alcohol-attributable disease burden and descriptions of policy responses worldwide. On the basis of data collected from countries on the treatment of substance use disorders the report describes the status of key components of treatment responses to alcohol and drug use disorders and proposes a new service capacity index for these disorders as an additional contextual indicator for monitoring progress in this domain of SDG health target 3.5. The report concludes with broad directions for international action to accelerate progress towards achievement of SDG health target 3.5.
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