Research is not a luxury but a necessity to end TB

Author:

Shobha Shukla

More than 1000 participants, including the President of Russian Federation Vladimir Putin, ministers from over 75 countries, donors, researchers, civil society representatives, and other stakeholders, had met at the first-ever "WHO Global Ministerial Conference on Ending TB in the Sustainable Development Era: A Multisectoral Response" which was held in Moscow on 16-17 November 2017, to forge stronger inter-sectoral partnerships for accelerating action to end TB.

Dr Tedros Adhanom Ghebreyesus, Director General of the WHO, said that "Political attention is vital to end TB, but it is not enough. Through a multisectoral approach we have to expand access to services, ensure sustainable financing and invest in R&D [research and development]. It is no longer a call for commitment, but a call for action."

A world without TB may not be possible without a holistic TB prevention strategy that includes new diagnostics, new drugs, and better prevention tools such as a new effective TB vaccine. One of the three pillars of the WHO End TB Strategy is intensified research and innovation. Speaking on the landscape of TB research, Dr Anthony Fauci, a noted immunologist who has made substantial contribution to HIV/AIDS research and as Director of US-based National Institute of Allergy and Infectious Diseases (NIAID), said that a comprehensive TB research portfolio revolves around generic TB research (including multidrug-resistant TB (MDR-TB) and TB/HIV co-infection) for pathogenesis, diagnostics, therapeutics and prevention/vaccines. Dr Fauci has earlier played a key role in shaping the US President's Emergency Plan for AIDS Relief (PEPFAR).

IS TREATMENT BECOMING WORSE THAN DISEASE ITSELF?

The current TB treatment regimens are lengthy and complex, with cure rates varying from 83% (in newly diagnosed drug sensitive TB patients) to 54% in MDR-TB and 30% in XDR-TB cases. Add to this adherence and monitoring issues and the debilitating side effects of drugs, as well as drug-drug interactions with drugs being used as part of anti retroviral therapy (ART) for people living with HIV (PLHIV). For some, the treatment can be worse than the disease itself, lamented Dr Fauci

ARE WE AT DOORSTEP OF MAJOR BREAKTHROUGH IN TREATING TB?

Dr Melvin (Mel) Spigelman, President and CEO of TB Alliance (Global Alliance for TB Drug Development) kindled the hope that a new treatment standard for all TB patients is imminent and a robust therapeutics pipeline, showing promise of a short and all-oral treatment for all types of TB is in the offing within a few years. He put on record that the TB research community was at the doorstep of major breakthroughs in treating TB: "With sufficient funding, we will be able to deliver, within the next 3-4 years, regimens (including for MDR-TB) that would not require more than 6 months of once daily, all oral, affordable and highly effective treatment. Also, perhaps in the next 5 to 10 years we will be in a position to treat all patients with TB with a highly effective and safe single uniform once a day all oral, short (potentially 3 months) regimen."

TB endemic countries would have to strengthen their clinical study capacities and regulatory systems. Finding something new is critically important, but getting it out to the people who need it, as quickly as possible, is equally important - something which is not happening right now. While investing in tomorrow’s cure for TB, is an ethical imperative, it is equally vital to actually provide universal health coverage for economic prosperity, said Dr Mel.

He cautioned that while a global commitment to research and development, can dramatically make TB a relic of history, without sufficient investment we will fall short of our efforts to end TB.

MOST SETTINGS STILL USE ANTIQUATED DIAGNOSTICS

Despite availability of molecular diagnostic tools like the GeneXpert, only 58% (28 out of 48) of the high TB burden nations had adopted it, lamented Dr Fauci. Most settings still use antiquated diagnostics. We need a simple cheap and accurate point of care test that can detect TB in clinical specimens from multiple body sites, and not just the sputum.

Said Catharina Boehme, CEO, Foundation for Innovative New Diagnostics (FIND) "Early and accurate diagnosis is key to starting patients on the right treatment and cutting the cycle of transmission. In 2016, only 6 million people of the estimated 10 million with TB were diagnosed, and a majority of the MDR-TB patients were not identified. We need a true point of care test that can be used at the primary healthcare level to find the 4 million missing patients every year. She mentioned three action points to reach full diagnostic coverage:

- Accelerate implementation of the already available molecular diagnostic tools at country level, and prepare better to be able to adopt the new tools faster in future;

- Fill the funding gaps for research and development (R&D) of new technologies that are cheap, accurate and can be used at primary healthcare level;

- Strengthen global funding and focus national research efforts not only on R&D side but also on operational research."

CAN WE END A MAJOR INFECTIOUS DISEASE LIKE TB WITHOUT A VACCINE?

The currently available BCG vaccine is only moderately effective in preventing severe TB in infants and young children, cannot prevent adult pulmonary TB and is no longer recommended in HIV co-infected children. The good news is that there are 12 different TB vaccine candidates in various stages of clinical studies today, and data from multiple mid- and late-stage efficacy studies is expected over the next 3 years, that would help optimize and accelerate TB vaccine development.

Speaking on behalf of Aeras and TuBerculosis Vacine Initiative (TBVI), Jacqueline Shea who is the CEO of Aeras, said that it would be near impossible to eradicate a major infectious disease like TB without an effective vaccine. “The good news is that there are 12 different TB vaccine candidates, in the global vaccine clinical pipeline, in various stages of clinical studies today. Data from multiple late-stage efficacy studies of novel vaccine candidates would become available in the next 3 years, that would help optimize and accelerate TB vaccine development. However, a rapid success in this requires sustained global financial support and TB vaccines must feature prominently in global TB policies and strategies”, she said.

FULLY FUND EFFORTS TO END WORLD'S DEADLIEST INFECTIOUS DISEASE

TB is the world’s deadliest infectious disease and yet TB science is woefully underfunded and plagued with lack of investment. WHO reports that despite accounting for about 2% of deaths globally (TB took 1.67 million lives in 2016), TB receives only 0.25% of the estimated USD 265 billion spent worldwide on medical research each year.

Vytenis Andriukaitis, European Commissioner for Health and Food Safety, European Union, strongly advocated for taxing tobacco products heavily and putting that money into TB research.

Let us hope that funding and political will not hold back science in achieving a TB free world.

Shobha Shukla, CNS (Citizen News Service)

(Shobha Shukla is the Managing Editor of CNS (Citizen News Service) and has written consistently on health and gender justice for several years. With support from the Global Alliance for TB Drug Development (TB Alliance) this article is part of her in-depth thematic coverage of the "WHO Global Ministerial Conference: Ending TB in the sustainable development era: A multisectoral response". Follow her on Twitter @Shobha1Shukla or visit www.citizen-news.org)

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