TB Alliance

Last updated
The Global Alliance for TB Drug Development
AbbreviationTB Alliance
EstablishedFebruary 2000
Type Nonprofit
Legal statusActive
Headquarters New York City, Pretoria
Chief Executive Officer
Mel Spigelman
Website www.tballiance.org

TB Alliance (formally The Global Alliance for TB Drug Development) is a not-for-profit product development partnership (PDP) dedicated to the discovery and development of new, faster-acting and affordable tuberculosis (TB) medicines. Since its inception in 2000, TB Alliance has worked to grow the field of available treatments for TB and now manages the largest pipeline of new TB drugs in history. [1] It was founded in Cape Town, South Africa, and has since expanded. It is headquartered in New York City and has a regional office in Pretoria. [2]

Contents

Background

Tuberculosis is the leading cause of infectious death worldwide, [3]  killing approximately 1.6 million people each year. [4] However, research and development for new TB drugs came to a virtual standstill after the 1960s. Today, a four-drug combination therapy exists, but it takes six months or more to be effective. This requires a degree of monitoring (See Direct Observational Therapy, Short-course) beyond the capacity of the health infrastructure in many countries, and adequate TB treatment is not available to more than half of the most infectious cases. This can inhibit control of the disease and fuel the rise of drug resistance (See antimicrobial resistance).

About 29% of deaths caused by antimicrobial infections today are due to drug-resistant TB. [5] [6] When infections become resistant to first-line drugs, more expensive therapies must be used to treat them. Lengthier treatment, often in hospitals, substantially increases health care costs as well as the economic burden on families and societies. The cost of treating a single case of multidrug-resistant TB (MDR-TB) or extensively drug-resistant TB (XDR-TB) can be thousands of times more expensive than treating drug-sensitive TB. [7]

TB is also the number one killer of people with AIDS, but it is generally agreed that current TB treatments do not work well with the antiretroviral drugs used to treat HIV. New, improved TB treatments are urgently needed. However, the TB drug market lacks sufficient financial incentives to stimulate broad-based investment from pharmaceutical companies to invest in the new research required to sustain a treatment pipeline. The TB epidemic is concentrated in developing countries where drugs must be low in cost to remain accessible. [8] It does not generate the kind of revenue streams that private companies usually deem necessary to justify the research costs and strategic risks involved in pharmaceuticals. TB Alliance was designed to be the primary instrument to fill this vacuum and to ensure that new anti-TB drugs are affordable and accessible in endemic countries.

History

TB Alliance was conceived at a February 2000 meeting in Cape Town, South Africa, where 120 representatives from academia, industry, major government agencies, non-governmental organizations and donors gathered to discuss the problems of tuberculosis treatment. Participants stressed the need for faster-acting, novel TB drugs and highlighted the scientific opportunities involved. The resulting "Declaration of Cape Town" [9] provided a road map for TB drug development and outlined the need for creation of the TB Alliance. Maria Freire was appointed as the first Chief Executive Officer and President in 2001 and served in that capacity until 2008, when she left the TB Alliance to become President of the Lasker Foundation. The current CEO and President is Melvin Spigelman. [10]

Program

TB Alliance is a non-profit product development partnership (See public-private partnership). A PDP builds partnerships between the public, private, academic and philanthropic sectors to drive the development of new products for underserved markets. PDPs retain direct management oversight of their projects, though much of the laboratory and clinical work is done though external research facilities and contractors. This model minimizes costs, including overhead and investments in infrastructure, while optimizing scientific capability to speed new TB drug development.

TB Alliance has the largest pipeline of TB drugs in history [1] and part of TB Alliance's stated mission is to ensure that any new treatments are affordable and accessible in the developing world, and that they are adopted as soon as they become available. [11] Pricing terms are included in all licensing contracts and end products are designed to be easy for patients to take. TB Alliance also collaborates with national and international partners, working to ensure that new therapies are adopted and accessible to healthcare providers and patients via local channels.

In February 2019, TB Alliance's application for the novel tuberculosis (TB) medicine pretomanid was accepted for review by the U.S. FDA. [12] In August 2019, TB Alliance's tuberculosis (TB) medicine pretomanid was approved by the U.S. FDA, to be used in combination with two other antibiotics, bedaquiline and linezolid, for the treatment of extensively drug-resistant (XDR) TB as well as treatment-intolerant or nonresponsive multidrug-resistant (MDR) TB. [12]

Treating drug-resistant TB

Combination therapies are essential for treating active tuberculosis infections. Currently, there are four first-line tuberculosis drugs given as a combination therapy over an extended period of time. Some strains of the tuberculosis pathogen are resistant to two (called MDR-TB) or at least four (called XDR-TB) first-line tuberculosis drugs. [13] Due to the contagious nature of tuberculosis, drug resistance is considered to be a serious public health issue, particularly among people with an already weakened immune system, for example people living with HIV.

Donors

The TB Alliance has a diverse set of global partnerships with both public and private sector donors that fund the company's work. The organization operates with the support of: [14]

Related Research Articles

<span class="mw-page-title-main">Antimicrobial resistance</span> Resistance of microbes to drugs directed against them

Antimicrobial resistance (AMR) occurs when microbes evolve mechanisms that protect them from the effects of antimicrobials. All classes of microbes can evolve resistance to the point that one or more drugs used to fight them are no longer effective. Fungi evolve antifungal resistance, viruses evolve antiviral resistance, protozoa evolve antiprotozoal resistance, and bacteria evolve antibiotic resistance. Together all of these come under the umbrella of antimicrobial resistance.

<span class="mw-page-title-main">Tuberculosis</span> Infectious disease

Tuberculosis (TB), also known colloquially as the "white death", or historically as consumption, is an infectious disease usually caused by Mycobacterium tuberculosis (MTB) bacteria. Tuberculosis generally affects the lungs, but it can also affect other parts of the body. Most infections show no symptoms, in which case it is known as latent tuberculosis. Around 10% of latent infections progress to active disease which, if left untreated, kill about half of those affected. Typical symptoms of active TB are chronic cough with blood-containing mucus, fever, night sweats, and weight loss. Infection of other organs can cause a wide range of symptoms.

<i>Mycobacterium tuberculosis</i> Species of pathogenic bacteria that causes tuberculosis

Mycobacterium tuberculosis, also known as Koch's bacillus, is a species of pathogenic bacteria in the family Mycobacteriaceae and the causative agent of tuberculosis. First discovered in 1882 by Robert Koch, M. tuberculosis has an unusual, waxy coating on its cell surface primarily due to the presence of mycolic acid. This coating makes the cells impervious to Gram staining, and as a result, M. tuberculosis can appear weakly Gram-positive. Acid-fast stains such as Ziehl–Neelsen, or fluorescent stains such as auramine are used instead to identify M. tuberculosis with a microscope. The physiology of M. tuberculosis is highly aerobic and requires high levels of oxygen. Primarily a pathogen of the mammalian respiratory system, it infects the lungs. The most frequently used diagnostic methods for tuberculosis are the tuberculin skin test, acid-fast stain, culture, and polymerase chain reaction.

Directly observed treatment, short-course is the name given to the tuberculosis (TB) control strategy recommended by the World Health Organization. According to WHO, "The most cost-effective way to stop the spread of TB in communities with a high incidence is by curing it. The best curative method for TB is known as DOTS." DOTS has five main components:

<span class="mw-page-title-main">Management of tuberculosis</span> Disease treatment

Management of tuberculosis refers to techniques and procedures utilized for treating tuberculosis (TB), or simply a treatment plan for TB.

Multiple drug resistance (MDR), multidrug resistance or multiresistance is antimicrobial resistance shown by a species of microorganism to at least one antimicrobial drug in three or more antimicrobial categories. Antimicrobial categories are classifications of antimicrobial agents based on their mode of action and specific to target organisms. The MDR types most threatening to public health are MDR bacteria that resist multiple antibiotics; other types include MDR viruses, parasites.

Latent tuberculosis (LTB), also called latent tuberculosis infection (LTBI) is when a person is infected with Mycobacterium tuberculosis, but does not have active tuberculosis (TB). Active tuberculosis can be contagious while latent tuberculosis is not, and it is therefore not possible to get TB from someone with latent tuberculosis. The main risk is that approximately 10% of these people will go on to develop active tuberculosis. This is particularly true, and there is added risk, in particular situations such as medication that suppresses the immune system or advancing age.

<span class="mw-page-title-main">Extensively drug-resistant tuberculosis</span> Tuberculosis that is resistant to the most effective drugs

Extensively drug-resistant tuberculosis (XDR-TB) is a form of tuberculosis caused by bacteria that are resistant to some of the most effective anti-TB drugs. XDR-TB strains have arisen after the mismanagement of individuals with multidrug-resistant TB (MDR-TB).

<span class="mw-page-title-main">Multidrug-resistant tuberculosis</span> Medical condition

Multidrug-resistant tuberculosis (MDR-TB) is a form of tuberculosis (TB) infection caused by bacteria that are resistant to treatment with at least two of the most powerful first-line anti-TB medications (drugs): isoniazid and rifampicin. Some forms of TB are also resistant to second-line medications, and are called extensively drug-resistant TB (XDR-TB).

The National Tuberculosis Elimination Programme (NTEP), earlier known as the Revised National Tuberculosis Control Programme (RNTCP), is the Public Health initiative of the Government of India that organizes its anti-Tuberculosis efforts. It functions as a flagship component of the National Health Mission (NHM) and provides technical and managerial leadership to anti-tuberculosis activities in the country. As per the National Strategic Plan 2017–25, the program has a vision of achieving a "TB free India",with a strategies under the broad themes of "Prevent, Detect,Treat and Build pillars for universal coverage and social protection". The program provides, various free of cost, quality tuberculosis diagnosis and treatment services across the country through the government health system.

The 2007 tuberculosis scare occurred when a personal-injury lawyer from Atlanta, Andrew "Drew" Speaker, while infected with multidrug-resistant tuberculosis (MDR-TB), flew on several international flights bound for France, Greece, Italy, Czech Republic and Canada, before returning to the United States. The Centers for Disease Control and Prevention believed at the time that Speaker was suffering from extensively drug-resistant tuberculosis (XDR-TB), but failed to inform Speaker of this worsened sickness before his travels abroad. The incident sparked a debate in Congress on the failure of federal customs agents to stop him. Upon Speaker's return to the United States, the CDC placed him under involuntary isolation using a provision of the Public Health Service Act. With this action, Speaker became the first individual subjected to a CDC isolation order since 1963.

<span class="mw-page-title-main">Bedaquiline</span> Medication used to treat tuberculosis

Bedaquiline, sold under the brand name Sirturo, is a medication used for the treatment of active tuberculosis. Specifically, it is used to treat multi-drug-resistant tuberculosis along with other medications for tuberculosis. It is taken by mouth.

<span class="mw-page-title-main">Pretomanid</span> Chemical compound

Pretomanid is an antibiotic medication used for the treatment of multi-drug-resistant tuberculosis affecting the lungs. It is generally used together with bedaquiline and linezolid. It is taken by mouth.

<span class="mw-page-title-main">Tuberculosis in China</span>

Tuberculosis is a serious public health problem in China. China has the world's third largest cases of tuberculosis, but progress in tuberculosis control was slow during the 1990s. Detection of tuberculosis had stagnated at around 30% of the estimated total of new cases, and multidrug-resistant tuberculosis was a major problem. These signs of inadequate tuberculosis control can be linked to a malfunctioning health system. The spread of severe acute respiratory syndrome (SARS) in 2003, brought to light substantial weaknesses in the country's public health system. After the government realized the impact that the SARS outbreak had on the country, they increased leadership in their health department. After the SARS epidemic was brought under control, the government increased its commitment and leadership to tackle public health problems and, among other efforts, increased public health funding, revised laws that concerned the control of infectious diseases, implemented the world's largest internet-based disease reporting system to improve transparency, reach and speed, and started a program to rebuild local public health facilities and national infrastructure.

Multidrug resistant Gram-negative bacteria are a type of Gram-negative bacteria with resistance to multiple antibiotics. They can cause bacteria infections that pose a serious and rapidly emerging threat for hospitalized patients and especially patients in intensive care units. Infections caused by MDR strains are correlated with increased morbidity, mortality, and prolonged hospitalization. Thus, not only do these bacteria pose a threat to global public health, but also create a significant burden to healthcare systems.

Totally drug-resistant tuberculosis (TDR-TB) is a generic term for tuberculosis strains that are resistant to a wider range of drugs than strains classified as extensively drug-resistant tuberculosis. Extensively drug resistant tuberculosis is tuberculosis that is resistant to isoniazid and rifampicin, any fluoroquinolone, and any of the three second line injectable TB drugs. TDR-TB has been identified in three countries; India, Iran, and Italy. The term was first presented in 2006, in which it showed that TB was resistant to many second line drugs and possibly all the medicines used to treat the disease. Lack of testing made it unclear which drugs the TDR-TB were resistant to.

<span class="mw-page-title-main">Tuberculosis in India</span> Health issue in India

Tuberculosis in India is a major health problem, causing about 220,000 deaths every year. In 2020, the Indian government made statements to eliminate tuberculosis from the country by 2025 through its National TB Elimination Program. Interventions in this program include major investment in health care, providing supplemental nutrition credit through the Nikshay Poshan Yojana, organizing a national epidemiological survey for tuberculosis, and organizing a national campaign to tie together the Indian government and private health infrastructure for the goal of eliminating the disease.

<span class="mw-page-title-main">Multidrug-resistant bacteria</span>

Multidrug-resistant bacteria are bacteria that are resistant to three or more classes of antimicrobial drugs. MDR bacteria have seen an increase in prevalence in recent years and pose serious risks to public health. MDR bacteria can be broken into 3 main categories: Gram-positive, Gram-negative, and other (acid-stain). These bacteria employ various adaptations to avoid or mitigate the damage done by antimicrobials. With increased access to modern medicine there has been a sharp increase in the amount of antibiotics consumed. Given the abundant use of antibiotics there has been a considerable increase in the evolution of antimicrobial resistance factors, now outpacing the development of new antibiotics.

Phumeza Tisile is a healthcare activist from South Africa who advocates for making tuberculosis medication inexpensive and widely available. Tisile survived extensively drug-resistant tuberculosis (XDR-TB), enduring three years and 8 months of treatment. Tisile's initial misdiagnoses led to months of incorrect treatment, which caused her to become deaf. As an activist, Tisile advocates for improved access to tuberculosis (TB) diagnosis and treatment, improved counseling for patients, research into better treatments, and elimination of TB stigma.

References

  1. 1 2 "Clinical Portfolio | TB Alliance". www.tballiance.org. Retrieved 2019-04-25.
  2. ↑ "Home". TB Alliance 2016 Annual Report. Retrieved 2019-04-25.
  3. ↑ "WHO | Tuberculosis (TB)". WHO. Retrieved 2019-04-25.
  4. ↑ "Tuberculosis (TB)". www.who.int. Retrieved 2019-04-25.
  5. ↑ "WHO | Drug-resistant TB: global situation". WHO. Archived from the original on December 12, 2015. Retrieved 2019-04-25.
  6. ↑ The Review on Antimicrobial Resistance. "Tackling Drug-Resistant Infections Globally: Final Report and Recommendations" (PDF).
  7. ↑ "WHO | Global tuberculosis report 2018". WHO. Retrieved 2019-04-25.
  8. ↑ WHO. "TB burden estimates, notifications and treatment outcomes" (PDF).
  9. ↑ "The Cape Town Declaration of the Working Alliance for TB Drug Development" (PDF). www.tballiance.org. Cape Town, South Africa. February 8, 2000.
  10. ↑ "Global Alliance for TB Drug Development Appoints Respected Scientist and Director of R&D as New Chief Executive". www.tballiance.org. 9 October 2008. Retrieved 9 October 2008.
  11. ↑ "About TB Alliance". TB Alliance. Retrieved 2019-04-25.
  12. 1 2 "TB Medicine Pretomanid Enters Regulatory Review Process in the United States | TB Alliance". www.tballiance.org. 8 March 2019. Retrieved 2019-04-25.
  13. ↑ "Antimicrobial resistance". www.who.int. Retrieved 2019-04-25.
  14. ↑ "Donors". TB Alliance. 15 July 2015. Retrieved 2017-06-20.
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