March 2019 digital v1

BATTLE FOR BEDAQUILINE
Bedaquiline is the first anti-TB drug
developed in over four decades.
The cost of the treatment goes up to
$30,000 for a six-month course.
A diarylquinoline
antimycobacterial agent, bedaquiline’s
cure rates for patients have been
reported at over 80%.
The drug also has fewer sideeffects
compared to the old anti-TB
injectable drugs which can even
cause deafness.
By 2016, at least 35 countries
have introduced shorter regimens
for treatment of MDR/RR-TB and 89
countries and territories had started
using bedaquiline, shows WHO Global
TB Report 2017.
Nevertheless, the drug still
remains out of reach for most lowand
middle-income countries. To
date, only 25,000 people around the
world have received bedaquiline and
two-thirds of these patients have
been in South Africa. South Africa
is among those small number of
countries which have negotiated a
greatly reduced price of $400 from
Johnson & Johnson, the maker of the
drug.
The drug maker Johnson &
Johnson, in its latest filing, seeks
extended patent protection to
bedquiline in India. The company›s
current patent expires in 2023. If
granted, the drug will enjoy exclusive
marketing rights till 2027.
Since India is considered the hub
of generic medicines of the world, the
additional patent could further delay
the availability of low-priced versions
of this life-saving medicine and will
also indirectly impact many countries
in the world, say those opposing the
patent in India.
Activists demanded J&J to
slash the price for the blockbuster
tuberculosis drug at the opening of
49th Union World Conference on
Lung Health in the Netherlands in
October last year.
There is a greater chance
of curing MDR-TB patients who
otherwise look at an abysmal curerate
of 50 percent, but this can only
happen if J&J cuts the price for
bedaquiline to a dollar a day, they
maintained.
J&J said in a statement that
their new price of $400 per course
is “genuinely a special effort that we
set to encourage rapid scale-up of
bedaquiline in countries with a high
TB burden”.
Controversies over pricing have
the potential to further damage an
already fragile environment for TB
research and development.
Since its approval as part of
USFDA’s Fast Track accelerated
approval process in 2012, J&J
has donated 60,000 bedaquiline
treatments to patients in such
high-TB-burden countries as China,
India and South Africa, the company
said.
In 2017, J&J formed a
collaboration with India’s Institute
of Microbial Technology (IMTech),
focused on discovering safer, more
effective oral treatments and multidrug
regimens for MDR-TB.
J&J has tied up with the
International Union Against
Tuberculosis and Lung Disease
to include bedaquiline in the STREAM
study, a multicentre international trial
to evaluate the medicine in patients
with MDR-TB. Final study results are
expected as early as 2023.
are receiving immunosuppressive therapy and a child born to
a mother who was diagnosed to have TB during pregnancy.
The health ministry is likely to allow the import of
rifapentine for the treatment of LTBI, waiving off the local
clinical trials requirement that is mandatory for all new drugs
introduced in India, according to reports.
A weekly regimen of rifapentine with isoniazid for three
months has been found effective in the prevention of active
tuberculosis
But the implementation of treating LTBI can still be
challenging as people without any obvious symptoms have to
adhere to a months-long regimen of multiple pills which often
have undesirable side-effects.
“If you start checking, you will come to know that a good
proportion of the Indian population has asymptomatic TB.
We have systems in place to rapidly detect the disease with
nearly 100% accuracy. And we have effective medicines
to treat even MDR TB. But the question is, will everybody
detected with asymptomatic, latent TB be willing to follow
the treatment course,” asks Dr Sunil Nair, Assistant Professor,
Pulmonary Medicine, Medical College, Trivandrum. Places like
Kerala have brought down TB cases dramatically through
effective intervention. The situation, however, is not so in
other parts of the country, where the infection is more
rampant.
Unlike earlier days, we now have GeneXpert machines
March 2019 / FUTURE MEDICINE / 25