Infectious Diseases - Q1 2023

Infectious Diseases

“Multidrug-resistant TB has further complexified how we manage and treat it.”

Greg Perry, Assistant Director General, IFPMA Page 02

“The COVID-19 pandemic showed the world how fast science can move.”

John Alter, Head of External Affairs, AMR Action Fund Page 06

The image shows former TB patient Isaac Asobola, five, who had finished six months’ TB treatment, his mother Nalukwago Mayimunea and his sister Lucy, during the DETECT Child TB project trip on the outskirts of Kampala, Uganda.

kncvtbc.org

Tuberculosis (TB) knows no borders. It kills 1.6 million people per year.

Together we can end TB!

Javier Galeano / The Union

IN THIS ISSUE

Stepping up research and innovation to beat TB

In a year dedicated to progressing the fight against tuberculosis — with the upcoming United Nations High-Level Political Meeting — the evidence casts a bleak outlook. But there’s hope.

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In 2021, 10.6 million people were estimated to have contracted tuberculosis (TB), and 1.6 million people — including almost 200,000 people living with HIV — died, according to 2022 WHO Global TB Report. Due to the challenges created by the COVID-19 pandemic, critical resources were redirected away from necessary, life-saving TB services. It was the first time in years, — especially since the political commitments that were collectively made to reduce TB deaths by 90% as part of the Sustainable Development Goals — that we saw progress lost in the fight to end TB.

Building on COVID-19 lessons learned Apart from COVID-19, TB has been the record holder as the deadliest infectious disease.

Multidrug-resistant TB has further complexified how we manage and treat it. At the same time, it is preventable and curable where there are innovations, systems and resources in place to support its diagnosis and treatment.

World

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While progress feels slow and disjointed, it is not all doom and gloom. Global attention is turning toward how innovations and partnerships can help to tackle TB as they did for COVID-19.

At the start of this year, WHO announced the TB Accelerator to investigate how to apply lessons learned during COVID-19 to renew urgent investment in TB vaccine development. Already, there are 16 vaccine candidates in clinical trials to protect against TB.

Improving TB diagnostics

The private sector has continued to be a dedicated investor in continued R&D across TB’s care continuum, including diagnostics. Companies, social enterprises and nonprofits are putting attention and resources toward TB diagnostic solutions that are quick to detect and identify TB, including multidrug-resistant TB, and committing to greater access so that everyone — especially vulnerable populations in high-burden countries — can benefit.

It’s clear we still need new tools to fight TB, including shorter, simpler and better-tolerated treatment regimens and TB preventive therapy, as much as vaccines and diagnostics, but there is hope.

During the pandemic, TB was a neglected disease, like many others. But, with the upcoming UN High-Level Meeting on TB in New York, alongside new initiatives, innovations and partnerships to stimulate innovation for and access to care, TB is in the spotlight. Together, let’s step up our collective efforts to beat TB.

Greg Perry Assistant Director General, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

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“Community-wide screening for TB, followed by effective treatment for all those found to have active TB is a key part of the answer.”

Professor Guy Marks President and Interim Executive Director, International Union Against Tuberculosis and Lung Disease

“Chronic viral hepatitis is the leading cause of liver cancer globally.”

Danjuma Adda President,

Hepatitis Alliance

Global attention is turning toward how innovations and partnerships can help to tackle TB as they did for COVID-19.

Multidrug-resistant tuberculosis revives the urgency for action

With cases of multidrug-resistant tuberculosis on the rise across the globe, there is an urgent need to leverage newly available treatments.

Developing new drug treatments and educating patients on their correct use are critical in the fight against tuberculosis

(TB). This is particularly the case for multidrug-resistant tuberculosis (MDR TB), where the bacteria is resistant to certain medicines.

Figures show that TB remains one of the world’s deadliest infectious diseases, primarily among those who are marginalised, economically and socially excluded or impacted by conflict.

Multidrug-resistant tuberculosis

Abhijit Barve, MD, PhD, Chief Medical Officer of Viatris — one of the largest suppliers of medicines globally, including HIV medications to low-to-middleincome countries (LMICs) — also emphasises that simply developing new drugs is not enough. Treatments need to be accessible to those who need them, along with education on completing the course of medication.

As most patients see their coughing and wheezing symptoms ease during initial months of treatment, many stop their medicines. “But that has been the biggest problem because the bacteria is still sitting in their system, and it mutates to cause drug resistance,” says Barve. Underlining the importance of education, he emphasises that patients need support in continuing to take the medication for several months after symptoms ease to avoid further serious health issues.

Collaborating on shorter treatment courses

Key to resolving this challenge is the need for shorter treatment courses. Barve outlines how the company is advancing access to shorter treatment courses and drugs specifically for MDR TB. In 2019, Viatris joined TB Alliance as its global commercialisation partner — aiming to improve access to a cost-effective treatment in LMICs and advance research.

“Diagnosing early is essential,” he adds. “Better diagnosis; introducing newer drugs specifically to address MDR TB; improving access to treatment; and increasing funding for education and adherence support are important.”

He highlights the value of multisectoral partnerships, such as between Viatris and the TB Alliance. “Collaboration with multiple partners is critical, bringing our diverse skills to the table to develop solutions,” continues Barve.

TB Alliance Chief Medical Officer Maria Beumont says: “TB demands action from a range of partners around the world. TB Alliance collaborates closely with private sector partners, governments, academia, advocates, civil society organisations, people with TB and others to achieve our vision of a world in which no one dies of TB.”

Progress being made

“There are around half a million cases of MDR TB annually, growing at about 3% a year, resulting in close to 200,000 deaths a year, but only about one-third of these patients are receiving treatment for MDR TB for various reasons,” he says.

“MDR TB is the prime example of how antimicrobial resistance (AMR) is impacting people today. How we combat MDR TB is central to our ability to get ahead of AMR.” Untreated, TB can spread from person to person through the air, potentially spreading resistant strains.

Empowering patients through education

Most TB drugs were developed decades ago, and it is only recently that newer drugs are becoming available. Older treatment regimens can be nine months or longer while new, shorter-duration therapies have become available.

Beumont says there has been progress against fighting drug-resistant TB as new, shorter-duration anti-TB treatments are being made accessible to patients.

“TB is a deadly infectious disease that is difficult to treat even under the best circumstances,” says Beumont, “but national TB programmes can now be better equipped to help patients as the all-oral shorter-duration regimens are now prioritised by the World Health Organization for appropriate patients. This approach, pioneered by the TB Alliance, has been shown to be effective in both clinical trials and real-world settings.”

Moreover, she underlines the importance of medicines reaching vulnerable patients. “We will continue to advance access such that every patient in need is able to access the best possible treatment.”

Abhijit Barve Chief Medical Officer, Viatris

Maria Beumont Chief Medical Officer, TB Alliance

Paid for by Viatris

Underlining the importance of education, he emphasises that patients need support in continuing to take the medication for several months after symptoms ease to avoid further serious health issues.

WRITTEN BY Mark Nicholls

By eliminating hepatitis, more lives can be saved from liver cancer

Liver cancer related to hepatitis is on the rise around the world, especially in low and middle-income countries.

There is a significant lack of awareness that chronic viral hepatitis is the leading cause of liver cancer globally and is accountable for over a million deaths every year. Globally, more than 350 million people are still living with viral hepatitis. Sadly, most people living with hepatitis are unaware of their diagnosis before it is too late.

Although there is a cure and vaccine for hepatitis C and effective treatment for hepatitis B, we continue to see stigma and discrimination as barriers to care and challenges around access to preventative testing and treatment services, especially among under-served populations.

Hepatitis advocacy progress

The year 2022 saw a significant development with more opportunities for countries to request support for hepatitis-related services from the Global Fund than ever before. Furthermore, World Hepatitis Alliance (WHA) and other global organisations called on Gavi, the Vaccine Alliance, to immediately start their hepatitis B birth dose vaccine programme. With each additional year of delay in supporting hepatitis B birth dose vaccination programmes,

Tuberculosis

We have the tools to find, cure and prevent tuberculosis (TB). Yet, it is still wreaking havoc on the lives of millions every year.

Not enough effort is devoted to finding and treating everyone with TB. This is not just to benefit those with TB now but also to protect others from acquiring it.

To make matters worse, there has been an increase in the number of people falling ill with TB (10.6 million in 2021) and a rise in deaths (1.6 million in 2021) for the first time in many years. We need the same resolve to tackle the scourge of TB that we achieved to deal with COVID-19. We can look to the past for inspiration.

Reducing tuberculosis cases globally

After WWII, many countries in Europe, North America, Australasia and the Far East mounted campaigns to end TB. In

hundreds of thousands more children will acquire hepatitis B at birth and face an uncertain future with the ever-present threat of developing liver cancer.

Collaboration and integrated care

The World Health Organization’s new Global Health Sector Strategy (GHSS) on HIV, viral hepatitis and sexually transmitted infections (STIs) promotes the disease-specific goals to end AIDS and the epidemics of viral hepatitis and STIs by 2030.

The new strategy also sets out interim 2025 targets that countries will need to work towards. If countries are able to implement these strategies, this integrated elimination effort will not only prevent infections but also save future generations.

Eliminating viral hepatitis will prevent hundreds of thousands of lives lost to liver cancer and other liver diseases as a result of chronic hepatitis. The global health community must continue to amplify the voice, needs and visibility of people living with hepatitis to motivate action and drive change. Collaborated efforts can save more lives. Hepatitis can’t wait!

Community-wide screening for TB, followed by effective treatment for all those found to have active TB is a key part of the answer.

We conducted a trial of this strategy in Vietnam. By screening 60,000 people annually for four years, we were able to reduce the prevalence of TB (number of people with TB) by 44% and the incidence (number of new cases developing) by 57%.

Professor Guy Marks President and Interim Executive Director, International Union Against Tuberculosis and Lung Disease

Australia, this included free X-ray screening aiming to diagnose and treat all cases, a TB pension to reduce the financial impact on affected individuals and research funding.

They were so successful that, by the mid-1970s, there were few cases to find, and the campaign was abandoned. Unfortunately, adopting similar policies in the Global South, where TB is common, was deemed unaffordable — a decision that condemned people to continue to live, and die, with the disease.

Trialling new strategies against tuberculosis

We cannot continue to make the same mistakes. The world needs new strategies to end TB.

These dramatic reductions are encouraging, but we need further evidence of this approach in low and middle-income countries. We believe this approach has the potential to see the end of TB. We cannot continue to refuse to acknowledge the deadly threat of TB. Renewed commitment and intense global scrutiny need to pave the way for investment in new strategies. We need to make TB history.

is still on the rise in low to middle-income countries

We cannot continue to make the same mistakes. The world needs new strategies to end TB.

Eliminating viral hepatitis will prevent hundreds of thousands of lives lost to liver cancer and other liver diseases as a result of chronic hepatitis.

Danjuma Adda President, World Hepatitis Alliance

Find out more at worldhepatitis alliance.org

Why the world needs to start managing TB as a healthcare crisis

Interventions that will make a difference in TB eradication

There is some encouraging news. Last year, international financing and partnership organisation — The Global Fund — announced that its Seventh Replenishment would total $15.7 billion to fight AIDS, malaria and tuberculosis.

But Gidado is clear that if the world is ever to reverse the alarming TB trends, more must change. “We need to bring back a sense of urgency,” he says. “We need to manage TB as a crisis, and we must stop ‘normalising’ TB.”

Three key interventions will make a huge difference, he explains. “First, we need to scale up the use of our existing tools because they are working. Secondly, we need game-changing rapid point-of-care tests to ensure early diagnosis and break the transmission of TB. And, of course, the third is vaccines.”

“The only effective vaccine we have was introduced over 100 years ago. But there has been a significant amount of attention and energy in this direction — and, right now, there is optimism that, before 2025, we may see a new vaccine.”

Reviving political will and increasing financial investment

Increased political will and financial investment — plus the application of lessons learned from the ongoing COVID-19 pandemic — are vital in tackling the scourge of tuberculosis (TB).

Every year, the world looks for evidence that it is winning the fight against tuberculosis — a lethal disease which is preventable, treatable and curable. And every year, the world is gravely disappointed.

estimated global total of 10.6 million (up from 10.1 million in 2020),” says Gidado.

Director,

“I would like to have good news for you,” says Mustapha Gidado, Executive Director of KNCV TB Plus (formerly known as KNCV Tuberculosis Foundation), which contributes to a TB-free world by developing effective, efficient and sustainable strategies that accelerate the decline of the epidemic. “Unfortunately, based on the 2022 WHO Global TB Report, we are seeing an increase in TB deaths for the first time this decade.”

The prevalence of tuberculosis: how bad is it?

In 2021, 1.6 million deaths were recorded from TB, up from 1.5 million in 2020. “There has also been an increase in the number of people affected by TB to an

“Sadly, because of the impact of the global COVID-19 pandemic and other crises, we have only been able to detect and notify 6.4 million.” The remainder, known as ‘the missing millions,’ are undiagnosed, not receiving care and transmitting TB.

The sobering fact is that — despite a commitment from world leaders to end TB by 2030 — tuberculosis targets had been blown off course before COVID-19 struck. Since the pandemic, however, political and financial attention has been significantly diverted from the TB cause.

“We have also seen significant disruptions in healthcare services,” says Gidado. “The area most hit was the utilisation of health services and laboratory services, and there was an increase in fear and stigma of visiting healthcare facilities during the pandemic. All these variables set progress in reverse.”

While we are waiting, a massive screening programme is vital. We must screen the people who are in contact with every TB patient, says Gidado; while anyone with a TB infection should have the opportunity to receive preventive treatment.

Ultimately, success rests on reviving political will and increasing financial investment — but the world can also take on board the lessons learned from COVID-19. “The pandemic proved that, if we come together, we can overcome a major health crisis,” notes Gidado.

“It highlighted the need for good screening tools, a good surveillance system and a good laboratory network and showed the importance of community engagement, community awareness and engagement with the media. It also demonstrated that if the political will is there, finances will follow — and if science is given the appropriate resources, it will come up with the solution. If that happens with TB, I am optimistic that we can end this disease in my lifetime.”

Paid for by KNCV TB Plus

Mustapha Gidado Executive

KNCV TB Plus

Image from the ‘No More Pandemics’ project provided by KNCV TB Plus/Labmicta.

WRITTEN BY Tony Greenway

Why we won’t be able to ‘warp speed’ our way through antibiotics

There’s no quick fix to antimicrobial resistance. But smart policies that encourage innovation and investment could give us a fighting chance against superbugs.

The COVID-19 pandemic showed the world how fast science can move. Not long after the pandemic was declared, the US Government launched ‘Operation Warp Speed’ — a nearly $20 billion effort that helped deliver a vaccine in record-breaking time.

Disparity in antibiotics response

However, Operation Warp Speed only succeeded because private investors had, for years, been pouring money into messengerRNA, the technology underlying some of the most widely used COVID-19 vaccines. Long before anyone had heard of COVID-19, Moderna had raised more than $1 billion from private investors and approximately $600 million more when it became a publicly traded company.

Unfortunately, antibiotics don’t garner that type of investor interest. Between 2011 and 2020, venture capital funds invested $1.6 billion in antibacterial companies compared with $16.6 billion in oncology companies, according to the Biotechnology Innovation Organization.

One reason for this disparity is because when a new antibiotic is approved, to conserve its effectiveness, it is held in reserve and used only when older, first-line antibiotics will not work. While this is good for public health, it severely constrains the commercial prospects of the drug. For most investors, putting their money into a company that’s doing high-risk research and development to yield a product that will have inherently limited sales just isn’t good math.

Governments around the world need to pursue policies that reward companies for successfully developing new antibiotics.

Attracting antibiotic investment

To help bring private investment back into this critical field of medicine, governments around the world need to pursue policies that reward companies for successfully developing new antibiotics, such as the proposed subscription models in the US or the UK. These types of incentives send a clear signal to the investment community that antibiotics are a viable opportunity and worth the risk.

Policymakers must act now because, without timely interventions, investors will continue putting their money into other therapeutic areas; antibiotic companies will go bankrupt; and patients will continue suffering.

What we don’t want is to land in a situation where we must try to warp speed our way out of this crisis because we will almost certainly come up short, losing millions of lives in the process.

John Alter Head of External Affairs, AMR Action Fund

Predicting the unpredictable: how to prepare for a pandemic

As of February 2023, COVID-19 is on the death certificate of over 218,000 people in the UK. Furthermore, anxiety and depression increased by 25% in the first year of the pandemic. Last year, it was estimated that the cost of UK government spending due to COVID-19 was £376 billion.

demonstrates the importance that planning and preparedness play in protecting populations from pandemics.

WRITTEN BY Marc Lacey Global Pandemic Head, CSL Seqirus

The value of pandemic preparedness

Pandemic preparedness, at its core, is the surveillance and risk assessment of pathogen threats supported by rigorous planning. CSL Seqirus’ preparation is driven by the ‘100-day mission’, an industry-wide goal which aims to make vaccines available for novel infectious diseases within 100 days of pandemic declaration.

However, preparation is different from implementation. In March 2020, the COVID-19 pandemic was declared. The first COVID-19 vaccine was approved 285 days later. By contrast, in 2009, only 111 days were needed for EMA approval of a vaccine targeting swine flu. This is thanks to the preparation afforded by a ‘mock-up’ licence.

Each day past ‘Day 100’ without a vaccine

Recently, attention has turned to the threat of avian influenza. Across industry, this has put a ‘One Health’ approach at the forefront of activity. Global research must remain vigilant and prepare for an overlap between animal and human infection. The latest warnings from health groups on the dangers of mammalian spill-over of avian flu show that being ready to act is essential.

Collaboration, collaboration, collaboration

By collaborating with public health teams, we can lead vaccine advances. Exciting partnerships between health organisations and vaccine manufacturers can identify viruses and strains presenting the greatest risk. This enables us to learn how ‘manufacturable’ a vaccine is before that virus poses a threat.

We have an opportunity to collaborate and make the unpredictable, predictable. We must work together on the front line to anticipate what threat might be just around the corner.

Paid for by CSL Seqirus

Most people living with hepatitis are unaware of their diagnosis before it is too late.

~Danjuma Adda, President, World Hepatitis Alliance

Pandemics have wide-reaching effects, restricting a nation’s success and happiness. Preparedness is the strategic process of protecting a nation’s health, and wellbeing.

Last year, it was estimated that the cost of UK government spending due to COVID-19 was £376 billion.

©Will Boase / The Union

In 2021, 10.6 million people were estimated to have contracted tuberculosis.

~Greg Perry, Assistant Director General, IFPMA

©Javier Galeano / The Union