HIV-HIV organ transplants approved in US

Johns Hopkins recently has received approval from the United Network for Organ Sharing to be the first hospital in the United States to perform HIV-positive to HIV-positive organ transplants. The institution will be the first in the nation to do an HIV-positive to HIV-positive kidney transplant and the first in the world to execute an HIV-positive to HIV-positive liver transplant.

"This is an unbelievably exciting day for our hospital and our team, but more importantly for patients living with HIV and end-stage organ disease. For these individuals, this means a new chance at life,� says Dorry L. Segev, MD, PhD, associate professor of surgery at the Johns Hopkins University School of Medicine.

This announcement brings to fruition the exhausting two-year effort Segev put into helping draft and push through the 2013 HOPE Act � a bill signed by President Obama that made it possible for HIVpositive individuals to donate organs.

Approximately 122,000 people are on the transplant waiting list in the US at any one time. Thousands die each year, many of whom may have lived had they been provided the organ they needed. Meanwhile, Segev estimates that each year, about 500 to 600 HIV-positive, would-be organ donors had organs that could have saved more than 1,000 people � if only the medical community was allowed to use the organs for transplant.

The antiquated law, which the HOPE Act reversed, prevented doctors from using organs from HIV-positive donors, even if they were intended to be given to an HIV-positive patient desperately in need of the organ. Despite very positive outcomes in non-HIV transplants in HIV-positive recipients and proven results of HIV-positive to HIV-positive kidney transplants in South Africa, HIV-positive to HIV-positive transplant in the US was not a possibility until now.

�Organ transplantation is actually even more important for patients with HIV, since they die on the waiting list even faster than their HIV-negative counterparts. We are very thankful to Congress, Obama and the entire transplant community for letting us use organs from HIV-positive patients to save lives, instead of throwing them away, as we had to do for so many years,� says Segev.

The first approved HIV-positive to HIVpositive transplant could take place as soon as a suitable organ should become available and a recipient is successfully identified and prepared.

MSF launches vaccination campaign for 222,000 Central African children

M�cins Sans Fronti�s (MSF) has launched a vaccination campaign of unprecedented scale targeting some 220,000 Central African children. Initiated last July in cooperation with the Ministry of Health in the north of the country, the campaign in January moved to sub-pr�cture Berberati in southwest CAR and will gradually be extended to all 13 sub-prefectures where MSF runs medical programmes. It is set for completion by the end of 2016.

In addition to this large-scale vaccination campaign, MSF is to enhance and scale-up vaccination services in the health facilities where it works. These two strategies will enable the organisation to provide under five-year olds not yet fully immunised with up to nine antigens. Furthermore, preventive measures such as distributions of Vitamin A, bed nets and anti-parasite treatment and malnutrition screening will be implemented according to each sub-prefecture�s specific needs.

Official Ministry of Health figures show that the political and military crisis that began in 2013 is the cause of the collapse in immunisation coverage rates. Between 2012 and 2014, the number of Central African children vaccinated against measles fell from 64% to 25% and against acute respiratory infections from 52% to 20%. By the end of 2013, only 13% of one-year olds had been fully immunised.

�This preventive vaccination campaign is the biggest ever undertaken by MSF in CAR and one of the first aimed at protecting unworldwide monitor Update from around the globe der five-year olds against so many diseases,� explained MSF vaccination advisor Dr Pauline Lechevalier. �Given the situation in CAR right now, the risk of epidemics and therefore deaths from vaccine-preventable diseases is extremely high. It is vital that as many children as possible be provided protection against these illnesses.�

As part of its campaign, MSF is administering pneumococcal conjugate vaccine (PCV), which, because of its prohibitive cost, humanitarian aid agencies have not yet been able to use on a large-scale.

�For the time being we are benefiting from a donation made by pharmaceutical laboratory Pfizer, one of the two manufacturers of PCV. Without it, we would have to spend several million dollars just to purchase the vaccine,� continues Lechevalier. �But donations aren�t a viable solution. The vaccine has to be made available at a fair price so that it can be used when and where health professionals consider it necessary.�

Since December 2013, MSF has doubled its medical relief operations in order to respond to the continuing crisis in CAR. Operating in CAR since 1996, MSF now has over 300 international and more than 2,000 Central African staff deployed in the country. The organisation currently runs 15 programmes, some of which provide assistance to Central African refugees in neighbouring countries Chad, Cameroun and Democratic Republic of Congo.

WHO, OIE launch new global framework to eliminate rabies

A new framework to eliminate human rabies and save tens of thousands of lives each year has been launched in December by WHO, the World Organization for Animal Health (OIE), the Food and Agriculture Organization of the United Nations (FAO) and the Global Alliance for the Control of Rabies (GARC).

The framework calls for three key actions � making human vaccines and antibodies affordable, ensuring people who get bitten receive prompt treatment, and mass dog vaccinations to tackle the disease at its source.

�Rabies is 100% preventable through vaccination and timely immunization after exposure, but access to post-bite treatment is expensive and is not affordable in many Asian and African countries. If we follow this more comprehensive approach, we can consign rabies to the history books,� said Dr Margaret Chan, WHO Director-General.

Tens of thousands of people die from rabies each year and, worldwide, 4 out of every 10 people bitten by suspected rabid dogs are children aged under 15 years. One person dies every 10 minutes, with the greatest burden in Asia and Africa.

The cost of vaccines to protect humans from rabies is, however, beyond the reach of many of those who may need it. And treatment for people who are bitten can cost US$40-50, representing an average of 40 days of wages in some of the affected countries. Recognizing that human vaccination is currently not always affordable, the new framework emphasizes prevention through vaccinating dogs � whose bites cause 99% of all human rabies cases. A dog vaccine costs less than US$1.

�Vaccinating 70% of dogs regularly in zones where rabies is present can reduce human cases to zero. Eliminating canine rabies through dog vaccination is the most cost-effective and only long-term solution,� states OIE Director-General Dr Bernard Vallat. �Human deaths can be prevented when mass dog vaccination is combined with responsible pet ownership and stray dog population management, both complying with OIE intergovernmental standards, as well as with bite treatment, as recommended by WHO.�

Whilst vaccinating dogs will be key in the new approach, the elimination of rabies � and saving the lives of those who are bitten � will not be possible without more widely-available human vaccines.

Currently, about 80% of people exposed to rabies live in poor, rural areas of Africa and Asia with no access to prompt treatment should they be bitten.

Bringing treatment closer to victims and providing wider access to affordable vaccines and potent rabies immunoglobulins, which neutralize the rabies virus before it can get a hold in the body, are vital to achieving zero rabies deaths. Bringing down the cost of human rabies vaccines and treatments will require strong international collaboration to make quality-assured vaccines and rabies immunoglobulin available to health centres in regions where rabies is endemic.

As of 2015, WHO and the OIE Vaccine Bank have delivered more than 15 million doses of canine rabies vaccines in many countries.

Oral cholera vaccines to double to 6 million doses after UN health agency approves new supplier

Faced with a global shortage of oral cholera vaccines (OCV), the United Nations health agency announced in January that supply should double this year to six million doses, with further increases later, after it approved a third producer to fight a disease that kills up to 142,000 people annually.

Last year, Sudan and Haiti asked the WHO for supplies to conduct pre-emptive vaccination campaigns, but the requests could not be filled because of the global shortfall.

The new producer, a company in the Republic of Korea, was approved under the WHO�s pre-qualification programme, which ensures that drugs and vaccines bought by countries and international agencies such as the UN Children�s Fund (UNICEF) meet acceptable standards of quality, safety and efficacy.

The additional capacity will help reverse a vicious cycle of low demand, low production, high price and inequitable distribution, to a virtuous cycle of increased demand, increased production, reduced price and greater equity of access, WHO said in a statement.

Cholera is an acute diarrhoeal disease that can kill within hours if left untreated. There are between 1.4 million and 4.3 million cases a year, with up to 142,000 deaths. Cholera is endemic in over 50 countries, but usually only gains international attention during emergencies, such as the outbreak among refugees in Goma, Democratic Republic of the Congo, in 1994 that killed tens of thousands.

Climate change and the El Ni�eather phenomenon that causes droughts or flood in various parts of the world, may also be contributing to more frequent cholera outbreaks.

OCVs have been used in mass campaigns in emergencies since 1997. But because the disease disproportionately affects poor communities who are often unaware that the vaccines exist, there has historically been little demand for the products. In 2013 the WHO created the world�s first stockpile, pledging to buy and use two million doses a year to create demand.

Vaccination requires two doses, meaning the stockpile is sufficient to cover one million people.

Access to OCV has been further improved by a five-year, US$115-million commitment from Gavi, the public-private vaccine alliance, to expand availability and use in countries with endemic cholera.

Since the stockpile was created more vaccines have been distributed and used than in the previous 15 years. A total of 21 OCV deployments of about 4 million doses to 11 countries have been used in various contexts: humanitarian crises in Cameroon, Haiti, Iraq, Nepal, South Sudan, and Tanzania; outbreaks in Guinea and Malawi; and endemic hotspots such as Bangladesh and Democratic Republic of the Congo.

Insulin remains out of reach for many people living with diabetes worldwide

More than 90 years after it was first discovered, and despite being listed as an essential medicine by the WHO since 2007, the lifesaving diabetes drug, insulin, remains very expensive and beyond the reach of many people with type 1 and 2 diabetes who need it globally, say leading experts writing in The Lancet Diabetes & Endocrinology journal.

�Insulin access is a complex challenge,� explains author Dr David Beran from the Geneva University Hospitals and University of Geneva in Switzerland. �A wide variety of issues affect access including the global insulin market being dominated by three multinational manufacturers; import duties and taxes affecting the price at which insulin enters different counties; and mark ups in the public and private sectors that also make insulin expensive.�

The Review is the first stage of the study, �Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS)�, being led by Health Action International in collaboration with Boston University�s School of Public Health and the Geneva University Hospitals and University of Geneva [2]. The ACCISS Study is a comprehensive and pioneering approach to gain a greater understanding of the complexity and challenges of poor access to insulin and enable countries to develop a tailored solution to address the challenge.

Insulin is essential for people with type 1 diabetes to stay alive and is needed by around a quarter of people with type 2 diabetes to control blood sugar.

With just three multinational companies having a near monopoly on the market, competition has been limited and impacted the price of insulin. Access and affordability to insulin is a challenge in both high-income settings, such as the US, where the medicine can cost up to US$400 a month, as well as in sub-Saharan Africa, where the life expectancy of a child with type 1 diabetes is just 1 year because of poor access to affordable insulin.

Over the past decade, there has also been a record rise in the use of analogue (synthetic) insulin which now makes up two-thirds of all insulin used in high-income countries, adding to rises in cost.

�We have seen a trend in the insulin market with animal insulin disappearing and being replaced by human insulin. A concern is whether a similar trend in which human insulin is replaced by analogue will occur,� explains Beran. The authors note that this trend exists despite a 2011 report by the WHO�s 17th Expert Committee on the Selection and Use of Essential Medicines that found no evidence that the more costly analogue forms work better than the cheaper, older insulin.

Increased costs of insulin for health systems are due to this increasing use of analogue insulin as well as increasing numbers of people using insulin. In the UK, for example, the number of people using insulin trebled between 1991 and 2010, mainly due to a large increase in the number of people with type 2 diabetes using the drug. Between 2000 and 2010, the UK NHS paid out an astounding �2732 million on insulin. The key driver of this expenditure was the spiraling use of analogue insulin that rose from �18.2 million, or 12% of the total in 2000, to �305 million or 85% of the total in 2010.

According to the authors, over half of active patents on insulin are linked to the delivery pen devices and not the insulin itself, so intellectual property is not a barrier to entry in the market. �Although patents on the first analogue insulin expired in 2014, these newer forms are harder to copy. Unlike antiretrovirals and other chemical drugs, lengthy approval processes and the numerous procedures involved in making an exact copy of the biological product drive up the costs of making generic or biosilmilar versions of insulin. It can cost hundreds of millions of pounds to bring a new drug to market,� explains Richard Laing, co-author and Professor of international health at Boston University�s School of Public Health in the US.

�Addressing the challenges and constraints of insulin supply will require interventions to be tailored to individual countries. Some lower-income countries, like Nicaragua, are doing very well at providing insulin for free for its population, while other countries, such as Mali are charging high prices for it even in the public sector,� says Beran.

The authors hope that this Review will raise awareness of the issue and inspire action. Co-author Margaret Ewen from Health Action International in Amsterdam, The Netherlands, explains: �The issue of access to insulin lacks a global voice and global mobilization of resources. Over the past three decades, HIV/AIDS has attracted global attention with civil society truly getting behind the issue of universal access to antiretrovirals. The lessons from the successful treatment of HIV/AIDS need to be applied to ensure universal access to insulin.�

US NIH funds new research in antibiotic alternatives in face of drug-resistant bacteria

The National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health, has awarded approximately US$5 million in funding for 24 research projects seeking to develop non-traditional therapeutics for bacterial infections to help address the growing health threat of antibiotic resistance. Advancing new therapeutic options to combat drug-resistant bacteria is a key goal of the US President�s National Action Plan for Combating Antibiotic- Resistant Bacteria.

�The discovery, development and deployment of antibiotics have transformed medicine; however, microbes continually evolve and become resistant to these lifesaving drugs,� said NIAID Director Anthony S. Fauci, M.D. �New strategies are desperately needed to treat patients with antibioticresistant infections that often are deadly. These new NIAID grants will provide funding to researchers developing unique, nontraditional therapies that could complement or even replace currently available antibiotics that are losing effectiveness.�

Increasing resistance to antibiotics coupled with the slow pace of new antibiotic development threatens to erode the past 70 years of progress in fighting life-threatening bacterial infections. The overuse and abuse of antibiotics drives this issue and, as a consequence, bacteria adapt to antibiotics designed to destroy them, making the drugs less effective and allowing antibiotic-resistant strains to survive and multiply.

A non-traditional therapeutic is an antibacterial treatment that works differently than traditional antibiotics, which typically target one or more essential pathways, such as those involved in cell-wall and protein synthesis, to directly kill or inhibit the growth of many types of bacteria. One non-traditional approach, called therapeutic bacteria, uses good bacteria found in or added to the human microbiome to target or control the growth of harmful bacteria. Another alternative approach is bacteriophage or phage therapy, which uses viruses that only affect bacteria to reduce or eliminate those bacteria in humans. Other examples of non-traditional approaches include adding decoy targets to prevent bacterial pathogens from producing disease, enhancing human immune responses to pathogens, and developing drugs that incapacitate the pathogen�s ability to adapt and compete.

The 24 phased innovation awards were made to 18 academic institutions and three industrial organizations. The awards provide support for two years with the possibility of three additional years of funding for the most accomplished projects.

MSF speaks out against current strategies to combat disease outbreaks

Five diseases with the potential to become epidemics in 2016 were highlighted by international aid organisation M�cins Sans Fronti�s/Doctors Without Borders (MSF), when the World Health Organization�s executive board met in Geneva in January. Without proper investment in preventing and responding to outbreaks of cholera, malaria, measles, meningitis and a group of often-overlooked diseases spread by viruses and parasites, they are likely to pose an ever greater threat to people�s health in the year ahead.

Current strategies to prevent major outbreaks of disease show only limited success. Epidemics continue to occur, often with devastating consequences for some less developed countries. Epidemics open up cracks in national health systems, exhaust available resources and, in many cases, kill large numbers of people.

�We know that thousands of lives will be at risk in the year to come, although the means exist to prevent these deaths,� said Dr Monica Rull, operational health advisor for MSF. �Epidemics of cholera, malaria, measles and meningitis take place every year, incapacitating and killing many � and this needs to stop. At the same time, the threat posed by emerging and re-emerging virus and parasite-spread diseases � such as dengue fever, Zika, Ebola and Kala Azar � needs to be faced.�

Along with prevention measures, resources must be provided to build effective emergency response systems. This must be part of a broader effort to help countries strengthen their health infrastructure and capabilities and provide health education to local communities.

Rapid alert mechanisms must be accompanied by rapid response activities once a disease breaks out, with free and quality medical care provided to all those affected.

The research and development agenda must be reoriented towards the greater public good, with a recognition that market forces cannot be counted on to deliver effective, accessible and affordable tools for under-served population groups.

MSF emphasises that the first step to global health security is individual health security, including for the sickest and most vulnerable people.

�Current outbreak response strategies are failing the very people they are designed to help,� said Dr Rull. �If we don�t make significant changes, we will be doomed to repeat past mistakes, and must take responsibility for the consequences.�

UN warns world underestimates risk of global health threat

The world underestimates the risk of a health threat worse than Ebola, and its capacity to prepare and respond is �woefully insufficient,� according to a highlevel panel appointed by United Nations Secretary-General Ban Ki-moon to look at improvements based on lessons learned during the recent outbreak.

The scope of West Africa�s Ebola outbreak in September 2014 led to the UN�s first-ever special mission to address a public health crisis. Appointed in April 2015, the six-member group was led by Tanzanian President Jakaya Mrisho Kikwete.

Before making its findings and recommendations, the full panel met six times last year and held six roundtable meetings. The group�s unedited, 95-page advance report, dated 25 January, is posted on the United Nations� Web site.

In the foreword to the report, the panel emphasized that its review isn�t a critique of the Ebola response, but rather a wake-up call that comes with a set of critical recommendations designed to improve the global response to the next crisis.

The authors noted that recent outbreaks of 2009 H1N1, H5N1, SARS (severe acute respiratory syndrome), and Middle East respiratory syndrome coronavirus (MERSCoV) show that emerging diseases can be a challenge even for sophisticated healthcare systems in developed countries.

Based on what it learned during its factfinding, the panel said the emergence of a highly pathogenic flu strain that could kill millions isn�t an unlikely scenario. It noted that because Ebola is transmitted by infected body fluids, though devastating, it would be easier to contain than an airborne disease such as pandemic flu.

�The greatest concern is the emergence of a virulent strain of a highly communicable pathogen � such s influenza virus � that could result in millions of deaths,� the report says, noting that the impact could far outweigh the 1918 flu pandemic.

To avert the devastating toll of a future pandemic, the authors made 27 recommendations, including several that cut across different governance levels and require input and action from all sectors of society.

However, they recommended three toppriority steps that can be taken immediately and require global cooperation. The first is creation by the World Health Organization of a new �Centre for Emergency Preparedness and Response� that has real command and control capacity and can access the personnel and resources it needs to respond.

Also, countries should meet their required International Health Regulations capacities, and those that aren�t able should receive global support to implement them, the panel advised. The third key recommendation covers financing in three areas: helping countries meet their IHR obligations, funding the proposed new WHO emergency centre, and supporting the research and development of vaccines, drugs, and diagnostics.

To oversee progress in meeting the recommended measures and implementing reforms, the group proposed that the United Nations establish a high-level council on global health crises within its General Assembly and help prepare to convene a summit meeting on such crises in 2018.

Protecting Humanity from future health crises

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