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Georgia trials could revolutionize treatment of drug-resistant TB

By Sophie Edwards, 26 September 2018 –

TBILISI, Georgia — As world leaders gear up for a landmark United Nations meeting on tuberculosis this week, two pivotal trials in the small Eurasian country of Georgia are promising to break new ground in the fight against multidrug-resistant TB.

July saw the launch of the SimpliciTB trial at the National Center for Tuberculosis and Lung Disease in the capital, Tbilisi, which combines four new medications and aims to slash treatment times by a third or more.

A pill in a hand. Photo by: rawpixel

It comes on the back of the ZeNix trial, launched last November, which targets patients with the most resistant form of the disease and is already showing signs of success in cutting treatment times. Both trials are being run by the TB Alliance in a country that has one of the highest prevalence rates for drug-resistant TB in Europe.

At the same time, advocates are preparing for the first United Nations high-level meeting on TB in New York on Wednesday, which they hope will help drive political and financial commitments toward the disease.

According to the World Health Organization’s latest TB report, published last week, it killed 1.6 million people in 2017, down from 1.7 million in 2016, making it the most deadly infectious disease worldwide. Advocates say progress is not happening fast enough to reach the End TB milestones by 2020.

Drug-resistant TB has become a growing problem, with an estimated 558,000 new patients in 2017. The majority of these patients are classed as having multidrug-resistant TB — or MDR-TB — meaning they are resistant to more than one first-line drug. Treatment in these cases can be lengthy, complex, and expensive, with severe side-effects. As a result, only 55 percent of MDR-TB patients are cured, according to WHO.

Countries of the former Soviet Union, including Georgia, have the highest rates of drug-resistant TB, but infection rates have been increasing rapidly in parts of Africa and Southeast Asia.

While there have been innovations in treatment, these have taken time to approve and are still not widely available, especially for poorer patients.

The Tbilisi drug trials offer hope for patients with drug-resistant TB by giving them access to combined oral-only regimens — in place of older, injection-based treatments — which are less toxic and require a shorter treatment time.

Patients on the ZeNix trial, set to run for four years, are already showing promising results almost a year in, according to lead clinician Lali Mikiashvili. Eight patients have now finished the six-month treatment and have been “cured,” she said, although they will be kept under close observation for signs of relapse for a further 18 months. The remaining nine patients are still on treatment but are responding well, she said.

“It is a revolutionary regimen; it’s unbelievably simple and short,” Mikiashvili said, adding that while the trial is ongoing and will be formally evaluated at a later date, so far “every patient has responded quickly, showed high efficacy and tolerability … [and] none have shown serious side effects.”

“If successful, this is the future treatment for hundreds of thousands of patients suffering from one of the most dangerous diseases in the world,” she said.

While ZeNix focuses on patients with highly-resistant TB, SimpliciTB is for those with both ordinary TB and MDR-TB. The trial is testing a regime of four drugs, all of which can be taken orally, known as BPaMZ, to see whether it can cut and simplify the treatment process down to four months for those with drug-sensitive TB, and six months for those with more resistant strains. Current treatment times for MDR-TB can be up to two years.

Marika Eristavi, who is leading the SimpliciTB trial, said patients are responding well to the new treatment. If successful, it could “reduce the rate of TB in Georgia as well as worldwide,” she said.

Other SimpliciTB trials are also being set up, with the aim of treating 450 people across 10 countries in Africa, Asia, Europe, and Latin America.

TB Alliance, a nonprofit that works to accelerate the development and affordability of new TB drugs, is managing both trials.

“As resistance to current TB treatments continues to grow, we need to introduce all-oral drug regimens that can treat every person with TB in six months or less, regardless of their resistance profile,” said Mel Spigelman, president and CEO at TB Alliance. “If proven successful in SimpliciTB, the BPaMZ regimen would represent a major step toward this goal.”

Eristavi told Devex she hopes the forthcoming high-level meeting on TB can help secure more funds for research and development.

“R&D will help … discover new medicines, treatment regimens, and vaccines, which is essential to tackle this disease,” she said.

But while both trials offer hope, Mikiashvili pointed out that TB is one of the oldest diseases in the world and has a history of defeating so-called cures, including streptomycin, to which the disease showed resistance within months of it being introduced in the 1940s.

“The TB bacteria is very flexible … It has the ability to acquire resistance to all medications,” she said. “When streptomycin was introduced it was said it was the end of TB … worldwide, but who now remembers streptomycin?”

NCDs. Climate change. Financing. Read more of Devex’s coverage from the 73rd U.N. General Assembly here.


The United Nations High-Level Meeting on Tuberculosis

On 26 September in New York, global leaders gathered at the first ever United Nations High-Level Meeting on Tuberculosis.

Tuberculosis (TB) knows no boarders – it affects all countries and all age groups! In the latest 2018 Global Tuberculosis Report released by World Health Organisation (WHO), burden of TB is falling worldwide but not fast enough to reach the first 2020 milestones of the End TB Strategy. In 2017, there were an estimated 10 million new cases of TB and about 1.6 million deaths were recorded.

Under the theme ‘United to end tuberculosis: An urgent global response to a global epidemic,’ this meeting served as an opportunity for Heads of State to make clear commitments to fight tuberculosis and reaching all affected people with prevention and care. In attendance of this highly anticipated meeting was Bill Gates, co-chair of Bill and Melinda Gates Foundation, who commended the need for ‘A higher degree of political leadership and more concrete actions are required’ in order to speed up progress towards 2030 goals. Over 15 Heads of State addressed the opening plenary session with nearly 80 Ministers of Health and Ministers of Foreign Affairs addressing the plenary, many from high TB-burden countries appealing the world to take note. For instance, in his speech South Africa President Cyril Ramaphosa echoed that:

We need new tools for TB as well as universal health coverage because those who are most affected by TB are those who have most difficulty accessing health care,’ South Africa President, Cyril Ramaphosa

Read more of the statements here

Speaking at the opening session on behalf of communities affected by TB, Nandita Venkatesan urged global leaders to back up this declaration with tangible actions. She expressed this further in her statement ‘For those that need care, scientific progress must reach all those who need it quickly,’ receiving a two-minute ovation for her powerful remarks. Significant highlights of this first-ever high-level meeting saw world leaders endorsing a UN Political Declaration on TB.  Member states agreed to nearly double global levels of TB funding to reach the target of USD13 billion per year by 2022 and to reach $2 billion in R&D funding. Apart from world leaders’ commitment to diagnosing and treating 40 million people with TB successfully and providing 30 million people with preventive treatment of TB by 2022, this political declaration factored in many of the key asks and targets launched by Stop TB Partnership and key TB stakeholders earlier this year.

Inasmuch as world leaders endorsed the political declaration, there were no commitments to a robust and independent mechanism of ensuring accountability. However, WACI Health together with other civil society and TB affected communities, will be closely monitoring progress and holding governments accountable for delivering on their commitments. There is still a huge gap in funding towards research – as civil society, we still call on our governments invest a certain percentage of annual expenditure on research and development in TB.


South Africa National Tuberculosis Caucus launch

Despite being Africa’s second largest economy, South Africa has over the past five years seen serious economic pressures including political uncertainty and high unemployment levels. Inasmuch as the government has been addressing challenges related to inequality, poverty and access to public services; tuberculosis remains a huge problem!

South Africa is among countries with the highest burden of tuberculosis worldwide. According to World Health Organisation (WHO Global TB Report) – about 438 000 people fell ill with TB in 2016, 19 000 people developed Multi-drug resistant TB and 124 000 died due to TB.

WACI Health and other South African civil society under the leadership of TB-HIV Care have been putting pressure on government – advocating for a high political profile and development of more inclusive and sustainable health and social protection policies which ensure that no TB patient is left behind.


4 September saw the launch of South Africa’s Tuberculosis Caucus. The South Africa TB Caucus is a national constituent of the Global TB Caucus which consists of over 2 300 parliamentarians from 130 countries around the world. Members of the caucus adhere to the principles outlined in the founding document, the Barcelona Declaration.

Hosting this event was the Minister of Health, Dr. Aaron Motsoaledi. Parliament nominated patrons Ms. Baleka Mbete (Speaker of the National Assembly) and Ms. Thandi Modise (Chairperson of the National Council of Provinces) for the South Africa Tuberculosis Caucus (SA TB Caucus) and they will jointly take lead. Moreover, they signed the declaration on stage at the close of the evening.

Key highlights of the declaration included committing to finding missing cases, development of new and innovative tools for TB, prevention for TB including vaccines, and access & affordability of TB treatment.

Read more of the declaration  SA TB Caucus Declaration

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