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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In many low- and middle-income countries, there is a wide gap between evidencebased recommendations and current practice. Treatment of major CVD risk factors remains suboptimal, and only a minority of patients who are treated reach their target levels for blood pressure, blood sugar and blood choles...terol.
In other areas, overtreatment can occur with the use of non-evidence-based
protocols. The aim of using standard treatment protocols is to improve the quality
of clinical care, reduce clinical variability and simplify the treatment options,
particularly in primary health care. Standard treatment protocols can be developed by preparing new national treatment guidelines or by adapting or adopting international guidelines.
The Evidence-based protocols module uses hypertension and diabetes screening
and treatment as an entry point to control cardiovascular risk factors, prevent target organ damage, and reduce premature morbidity and mortality. A comprehensive risk- based approach for integrated management of hypertension, diabetes, and high cholesterol is included in the Risk-based CVD management module.
This module includes clinical practice points and sample protocols for:
1. hypertension detection and treatment
2. type 2 diabetes detection and treatment
3. identifying basic emergencies – care and referral.
HEARTS emphasizes adaptation, dissemination, and use of a standardized set of
simple clinical-management protocols, which should be drug- and dose-specific,
and include a core set of medications. The simpler the protocols and management tools, the more likely they are to be used correctly, and the higher the likelihood that a programme will achieve its goals.
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The recommendations in these guidelines promote the use of simple, non-invasive diagnostic tests to assess the stage of liver disease and eligibility for treatment; prioritize treatment for those with most advanced liver disease and at greatest risk of mortality; and recommend the preferred use of n...ucleos(t)ide analogues with a high barrier to drug resistance (tenofovir and entecavir, and entecavir in children aged 2–11 years) for first- and second-line treatment. Recommendations for the treatment of HBV/HIV-coinfected persons are based on the WHO 2013 Consolidated guidelines on the use of antiretroviral drugs for treating and preventing HIV infection, which will be updated in 2015.
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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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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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The purpose of this document is to stop to irrational use/ over prescription of this reserve/
experimental/ emergency use authorisation drug Remdesivir. For this reason, Joint
Monitoring Group under Chairmanship of DGHS took into consideration findings of the
followi...ng studies to issue this advisory:
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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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The protozoan parasite Trypanosoma cruzi causes Chagas disease, an important public health problem throughout Latin America. Current therapeutic options are characterised by limited efficacy, long treatment regimens and frequent toxic side-effects. Advances in this area have been compromised by gaps... in our knowledge of disease pathogenesis, parasite biology and drug activity. Nevertheless, several factors have come together to create a more optimistic scenario. Drug-based research has become more systematic, with increased collaborations between the academic and commercial sectors, often within the framework of not-for-profit consortia. High-throughput screening of compound libraries is being widely applied, and new technical advances are helping to streamline the drug development pipeline. In addition, drug repurposing and optimisation of current treatment regimens, informed by laboratory research, are providing a basis for new clinical trials. Here, we will provide an overview of the current status of Chagas disease drug development, highlight those areas where progress can be expected, and describe how fundamental research is helping to underpin the process.
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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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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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