EQUITABLE ACCESS Balasegaram, Manica; Cohn, Jennifer
International journal of infectious diseases,
20/May , Letnik:
130
Journal Article
Recenzirano
Odprti dostop
The COVID-19 epidemic has once again highlighted the challenges to achieve equitable access to critical antimicrobials and vaccines. The problem is particularly acute for antimicrobials.
Despite ...recent investments improving the pipeline for new treatments, most new treatments are not available to populations most in need, especially in low- and middle-income countries. Once a drug is approved a range of factors may hinder access, from lack incentives to register and commercialize products due to unattractive market potential to unfunded national action plans that can help improve the uptake and appropriate use of new tools to combat antibiotic resistance. Previous studies have shown that the majority of the 18 new antibacterials approved and launched between 2010-2020 were accessible in only 3 out of 14 high-income countries (Sweden, UK, and US). In low- and middle-income countries, the problem is even worse, with only 10 of the 25 new antibiotics that entered the market between 1999 and 2014 registered in more than ten countries.
While lack of equitable access to life-saving medicines, diagnostics, and vaccines is not a new problem for infectious diseases, emerging opportunities and innovative approaches can help improve access globally. This talk will review promising recent developments in governance and collaborations, policies, economic models and initiatives that may help correct deadly inequities.
For example, the objectives of the Access to COVID-19 Tools Accelerator may serve as model that convenes diverse actors to mount a coordinated access response which may be applied to access to other antimicrobials and vaccines. In addition, novel licensing agreements for access and stewardship to cefiderocol, an antimicrobial that is on the WHO Essential Medicines List can help serve as a pathfinder to accelerate equitable access to novel antimicrobials. The talk will also surface critiques of ongoing initiatives and raise questions for further study and discussion.
When microorganisms (such as bacteria or viruses) are highly exposed to antimicrobial drugs, they can develop the capacity to defeat the drugs designed to eradicate them. Long-term accumulation of ...adaptations to survive drug exposure can lead to the development of antimicrobial resistance (AMR). The success of antibiotics has led to their widespread overuse and misuse in humans, animals and plants.
AMR is a global concern and solutions are not vertical actions in a single buy business model. Even if a transectoral approach is key, there is a lack of multi-disciplinary partnerships that allow for strategic cooperation between different sectors such as the pharmaceutical industry, agro-alimentary complex, patient care and education, NGOs and research and development. Global public health voices should lead this integration to align the progress of existing AMR successes. Maintaining the public's trust in preventive medicine, health systems and food production safety, together with public health driven, non-profit drug development, is a key factor. In its "Call for integrated action on AMR", signed by about 70 national and international organizations the World Federation of Public Health Associations (WFPHA) called "on all governments, the private sector, non-governmental organizations, health professionals, public and private research organizations, and all stakeholders to ensure that public health remains at the centre of all policy and scientific endeavours in the field of antimicrobial resistance".
The "Global Charter for the Public's Health", developed by the WFPHA in association with WHO, is proposed in this article as a tool for implementation of complex public health actions such as AMR.
Combination therapy for visceral leishmaniasis van Griensven, Johan, MD; Balasegaram, Manica, MD; Meheus, Filip, MSc ...
The Lancet infectious diseases,
03/2010, Letnik:
10, Številka:
3
Journal Article
Recenzirano
Summary Combination therapy for the treatment of visceral leishmaniasis has increasingly been advocated as a way to increase treatment efficacy and tolerance, reduce treatment duration and cost, and ...limit the emergence of drug resistance. We reviewed the evidence and potential for combination therapy, and the criteria for the choice of drugs in such regimens. The first phase 2 results of combination regimens are promising, and have identified effective and safe regimens as short as 8 days. Several phase 3 trials are underway or planned in the Indian subcontinent and east Africa. The limited data available suggest that combination therapy is more cost-effective and reduces indirect costs for patients. Additional advantages are reduced treatment duration (8–17 days), with potentially better patient compliance and lesser burden on the health system. Only limited data are available on how best to prevent acquired resistance. Patients who are coinfected with visceral leishmaniasis and HIV could be a reservoir for development and spread of drug-resistant strains, calling for special precautions. The identification of a short, cheap, well-tolerated combination regimen that can be given in ambulatory care and needs minimal clinical monitoring will most likely have important public health implications. Effective monitoring systems and close regulations and policy will be needed to ensure effective implementation. Whether combination therapy could indeed help delay resistance, and how this is best achieved, will only be known in the long term.
Summary Diagnostics are crucial in mitigating the effect of disease outbreaks. Because diagnostic development and validation are time consuming, they should be carried out in anticipation of ...epidemics rather than in response to them. The diagnostic response to the 2014–15 Ebola epidemic, although ultimately effective, was slow and expensive. If a focused mechanism had existed with the technical and financial resources to drive its development ahead of the outbreak, point-of-care Ebola tests supporting a less costly and more mobile response could have been available early on in the diagnosis process. A new partnering model could drive rapid development of tests and surveillance strategies for novel pathogens that emerge in future outbreaks. We look at lessons learned from the Ebola outbreak and propose specific solutions to improve the speed of new assay development and ensure their effective deployment.
Summary Access to quality-assured antimicrobials is regarded as part of the human right to health, yet universal access is often undermined in low-income and middle-income countries. Lack of access ...to the instruments necessary to make the correct diagnosis and prescribe antimicrobials appropriately, in addition to weak health systems, heightens the challenge faced by prescribers. Evidence-based interventions in community and health-care settings can increase access to appropriately prescribed antimicrobials. The key global enablers of sustainable financing, governance, and leadership will be necessary to achieve access while preventing excess antimicrobial use.
Globally, infectious diseases remain a major cause of morbidity and mortality in children,1 and an estimated 214 000 newborn babies died from drug-resistant bacterial infections in 2015.2 In ...addition, guidelines and evidence-based treatments are scarce to help manage the full range of life-threatening paediatric infections, and paediatric specialists often resort to prescribing off-label and unlicensed drugs on the basis of clinical experience.3 For example, ampicillin or benzylpenicillin, with gentamicin have remained the treatment regimen recommended by WHO for neonatal and paediatric sepsis for 50 years, despite very high rates of reported resistance to aminopenicillins and aminoglycosides,4–6 because no new studies have been done that would result in updated guidelines. ...for both old and new drugs, additional strategic clinical trials are needed targeting key population groups and public health needs, so evidence-based guidelines can be developed for their appropriate use, including use in combination with, or co-administered with other drugs. ...to ensure all these recommendations can be applied in ways that take account of sub-populations, geographies, and diverse resistance patterns, an international antibiotic clinical trial network should be developed for newborn babies, infants, and children.
Treatment of second-stage gambiense human African trypanosomiasis relied on toxic arsenic-based derivatives for over 50 years. The availability and subsequent use of eflornithine, initially in ...monotherapy and more recently in combination with nifurtimox (NECT), has drastically improved the prognosis of treated patients. However, NECT logistic and nursing requirements remain obstacles to its deployment and use in peripheral health structures in rural sub-Saharan Africa. Two oral compounds, fexinidazole and SCYX-7158, are currently in clinical development. The main scope of this article is to discuss the potential impact of new oral therapies to improve diagnosis-treatment algorithms and patients' access to treatment, and to contribute to reach the objectives of the recently launched gambiense human African trypanosomiasis elimination program.