A new drug trial aimed
at finding faster, more effective treatment for drug-resistant tuberculosis was launched this week in Georgia.
The trial, which uses a
combination of four drugs, will test whether multi-drug resistant (MDR) TB can
be treated in six months not 24. It will also test whether patients with some
drug resistance can be cured of TB in four months, not six.
Resistance continues to grow
In addition, the
trial – initiated by the TB Alliance –
will give patients oral medication instead of injections, which are currently a
key part of MDR TB treatment.
“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 of TB
The trial, called SimpliciTB,
will test the efficacy of the combination of drugs bedaquiline, pretomanid,
moxifloxacin and pyrazinamide.
for drug-resistant TB is extremely complicated, expensive, and lengthy,
involving a wide variety of medicines that have debilitating side-effects, can
include injectable drugs, and are administered for nine months to two years or
longer,” said the TB Alliance. “People with MDR-TB often go untreated,
and of those who do receive treatment only about half are cured.”
TB becoming more deadly
The four-drug regimen has
already shown positive results in a Phase 2b study called NC-005, in which
people with MDR-TB cleared TB bacteria from their lungs up to three times
faster than TB patients treated with the standard treatment.
NC-005 was an eight-week
trial conducted at 10 sites across South Africa, Uganda and Tanzania.
SimpliciTB builds on these results, testing BPaMZ over a longer duration, in
more people and across more sites, and against both drug-sensitive and MDR-TB.
The first patients have
been enrolled at the National Center for Tuberculosis and Lung Disease in
Tbilisi, Georgia. SimpliciTB is expected to enroll 450 people with TB,
including up to 150 with MDR-TB across at least 26 centres in 10 countries in
Africa, Asia, Europe and Latin America.
According to the World
Health Organization’s most recent Global
Tuberculosis Report, there is growing resistance to available drugs,
which means the disease is becoming more deadly and difficult to treat. The WHO
estimates that in 2016 there were 600 000 new cases with resistance to
rifampicin – the most effective first-line drug – of which 490 000 had MDR-TB. –
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