Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection


Book Description

These guidelines provide guidance on the diagnosis of human immunodeficiency virus (HIV) infection, the use of antiretroviral (ARV) drugs for treating and preventing HIV infection and the care of people living with HIV. They are structured along the continuum of HIV testing, prevention, treatment and care. This edition updates the 2013 consolidated guidelines on the use of antiretroviral drugs following an extensive review of evidence and consultations in mid-2015, shared at the end of 2015, and now published in full in 2016. It is being published in a changing global context for HIV and for health more broadly.




Report of the meeting to review the paediatric antituberculosis drug optimization priority list


Book Description

The Paediatric Antituberculosis Drug Optimization (PADO-TB) meetings provide a forum for clinicians, researchers, financial and technical partners and other relevant key stakeholders to work together, to ensure that priority optimal paediatric formulations of TB medicines are investigated, developed and made available to children in a timely manner. After the first meeting (PADO-TB1) in February 2019, WHO hosted an interim review of the PADO-TB1 priorities. The review considered the latest WHO recommendations and other relevant developments since February 2019, such as results of clinical trials, results of pharmacokinetics and pharmacodynamics studies, new formulations available and advancements of key drugs in the TB research and development pipeline. The 4.5-hour virtual review was attended by more than 50 experts including clinicians, researchers, representatives of national TB programmes (NTPs) from high TB burden countries, community representatives, financial and technical partners, members of the Child and Adolescent TB Working Group and representatives from various international agencies, including WHO. This report summarizes the main developments presented for various TB medicines and the decisions taken with regard to the PADO-TB priority list.




Buruli Ulcer


Book Description

A major objective of this open access book is to summarize the current status of Buruli Ulcer (BU) research for the first time. It will identify gaps in our knowledge, stimulate research and support control of the disease by providing insight into approaches for surveillance, diagnosis, and treatment of Buruli Ulcer. Book chapters will cover the history, epidemiology diagnosis, treatment and disease burden of BU and provide insight into the microbiology, genomics, transmission and virulence of Mycobacterium ulcerans.




Report of the Paediatric Regulatory Network meeting, 12-13 May 2022


Book Description

The Paediatric Regulatory Network was initially created as a global paediatric working group in February 2010 in response to a recommendation from the 2008 International Conference on Drug Regulatory Authorities and as part of the World Health Organization (WHO) Better Medicines for Children Project in collaboration with the Bill & Melinda Gates Foundation, to offer a platform for discussion on paediatric regulatory considerations for national regulatory authorities. The Network was reactivated in December 2019 as a global paediatric network supporting the availability of quality-assured medical products for children, by facilitating communication, collaboration, training and regulatory harmonization across the development, registration and pharmacovigilance of paediatric medical products. The Network’s activities contribute efficiently to the implementation of World Health Assembly resolutions WHA60.20 (2007) on better medicines for children, WHA69.20 (2016) on promoting innovation and access to quality, safe, efficacious and affordable medicines for children, WHA67.20 (2014) on regulatory system strengthening for medical products and WHA67.22 (2014) on access to essential medicines.




Paediatric drug optimization standard procedure


Book Description

The aim of this document is to provide guidance on how to undertake a paediatric drug optimization (PADO) exercise and identify key priority products for research and development. This guidance is for all technical units undertaking a PADO exercise, all stakeholders involved in PADO processes as well as interested organizations and experts involved in the research and development of therapeutics in the public and private sectors.




HIV drug resistance


Book Description

This brief report summarizes recent information on HIV drug resistance (HIVDR) in the era of integrase-strand transfer inhibitors (INSTI) for HIV prevention and treatment. In this report, WHO documents high levels of HIV viral load suppression (>90%) in populations receiving dolutegravir (DTG)-containing antiretroviral therapy (ART). However, recent observational data reveal that HIVDR to DTG is emerging at levels exceeding those observed in clinical trials. Few countries have reported people not achieving viral suppression while receiving DTG-containing ART. However, amongst the surveys reported, levels of DTG resistance ranged from 3.9% to 8.6%, with levels as high as 19.6% observed among highly treatment-experienced people who transitioned to a DTG-containing ART while having high HIV viral loads. Levels of observed DTG resistance in real world populations receiving ART appear to be higher than anticipated from clinical trials. WHO recommends that countries routinely implement standardised surveillance of HIVDR to follow the prevalence and patterns of resistance among people not achieving suppressed viral load. The use of long acting cabotegravir (CAB-LA) for pre-exposure prophylaxis (PrEP) greatly reduces the risk of acquiring HIV. However, INSTI resistance has been observed in some cases with recent CAB-LA exposure, and delayed detection and confirmation of HIV infection can increase the risk of selection of INSTI drug resistance–associated mutations. Despite the possible risk, the roll-out of CAB-LA for PrEP should not be hindered. Scale-up of PrEP should be accompanied by standardized surveillance of drug resistance among people testing positive for HIV while receiving PrEP.




Disease Control Priorities, Third Edition (Volume 6)


Book Description

Infectious diseases are the leading cause of death globally, particularly among children and young adults. The spread of new pathogens and the threat of antimicrobial resistance pose particular challenges in combating these diseases. Major Infectious Diseases identifies feasible, cost-effective packages of interventions and strategies across delivery platforms to prevent and treat HIV/AIDS, other sexually transmitted infections, tuberculosis, malaria, adult febrile illness, viral hepatitis, and neglected tropical diseases. The volume emphasizes the need to effectively address emerging antimicrobial resistance, strengthen health systems, and increase access to care. The attainable goals are to reduce incidence, develop innovative approaches, and optimize existing tools in resource-constrained settings.




WHO consolidated guidelines on drug-resistant tuberculosis treatment


Book Description

Tuberculosis (TB) strains with drug resistance (DR-TB) are more difficult to treat than drug-susceptible ones, and threaten global progress towards the targets set by the End TB Strategy of the World Health Organization (WHO). There is thus a critical need for evidence-based policy recommendations on the treatment and care of patients with DR-TB, based on the most recent and comprehensive evidence available. In this regard, the WHO consolidated guidelines on drug-resistant tuberculosis treatment fulfil the mandate of WHO to inform health professionals in Member States on how to improve treatment and care for patients with DR-TB. Between 2011 and 2018, WHO has developed and issued evidence-based policy recommendations on the treatment and care of patients with DR-TB. These policy recommendations have been presented in several WHO documents and their associated annexes, including the WHO treatment guidelines for multidrug- and rifampicin-resistant tuberculosis, 2018 update, issued by WHO in December 2018. The policy recommendations in each of these guidelines have been developed by WHO-convened Guideline Development Groups (GDGs), using the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to summarize the evidence, and formulate policy recommendations and accompanying remarks. 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.




Disease Control Priorities, Third Edition (Volume 2)


Book Description

The evaluation of reproductive, maternal, newborn, and child health (RMNCH) by the Disease Control Priorities, Third Edition (DCP3) focuses on maternal conditions, childhood illness, and malnutrition. Specifically, the chapters address acute illness and undernutrition in children, principally under age 5. It also covers maternal mortality, morbidity, stillbirth, and influences to pregnancy and pre-pregnancy. Volume 3 focuses on developments since the publication of DCP2 and will also include the transition to older childhood, in particular, the overlap and commonality with the child development volume. The DCP3 evaluation of these conditions produced three key findings: 1. There is significant difficulty in measuring the burden of key conditions such as unintended pregnancy, unsafe abortion, nonsexually transmitted infections, infertility, and violence against women. 2. Investments in the continuum of care can have significant returns for improved and equitable access, health, poverty, and health systems. 3. There is a large difference in how RMNCH conditions affect different income groups; investments in RMNCH can lessen the disparity in terms of both health and financial risk.