By Sophie Edwards, 26 September 2018 – www.devex.com
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.
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?”
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