[e-drug] RESIST-TB: new clinical trials for MDR-TB drugs now possible

E-DRUG: RESIST-TB: new clinical trials for MDR-TB drugs now possible
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New protocols now mean clinical trials for MDR-TB drugs are possible
Funding urgently needed to start trials

Cancun / Mexico, 5 December, 2009 ¨C RESIST-TB, an expert initiative focused
on expanding research on multidrug-resistant tuberculosis (MDR-TB), has
presented protocols at the Union World Conference on Lung Health that will
help test new drugs for their use in treating MDR-TB. RESIST-TB warns,
however, that unless funding agencies make them a priority, these
much-needed clinical trials will not happen.

The World Health Organization (WHO) estimates that approximately 120,000
people die from MDR-TB every year. One and a half million people are
currently afflicted by MDR-TB and an estimated six million cases of MDR-TB
will emerge by 2015. To date, fewer than five percent of patients with
MDR-TB are treated and fewer than seventy percent of those treated are
cured.

Failure to improve and shorten current MDR-TB treatments, which last up to
two years and often have toxic side effects requiring additional
medications, will limit the effective expansion of MDR-TB treatment
programmes. It will also lead to an increasing burden of extensively
drug-resistant forms of TB (XDR-TB), a virtual death sentence when it
develops in people living with HIV.

Now several new TB drugs are moving through the drug development pipeline
and offer hope for an improved and shortened MDR-TB treatment regimen. For
people with MDR-TB to benefit, it is critical to understand how to use
these drugs to treat specifically multidrug-resistant forms of
tuberculosis.

Clinical trials are necessary to determine the optimal use of the new drugs
to treat MDR-TB. Such trials must answer questions related to treatment
duration, optimal companion drugs, and their use in MDR-TB prevention. The
three new clinical trial protocols produced by RESIST-TB address these
questions as a crucial first step to identifying the best regimens.

¡°In May 2009, the World Health Assembly committed to universal access to
diagnosis and treatment of MDR- and XDR-TB. Improving drug-resistant TB
treatment through research is critical in order to achieve this goal,¡± said
Robert Horsburgh, Chair of the RESIST-TB Steering Committee. ¡°With the
development of new TB drugs, we have an important opportunity to improve
MDR-TB and XDR-TB regimens. We now know what trials need to be done. What
is needed is for funding to be fast tracked by donor agencies.¡±

Two of the RESIST-TB protocols address the questions of treatment duration
and optimal companion drugs for two scenarios. One scenario assumes that
one drug will become available several years ahead of the others and will
need to be tested on its own; the other scenario assumes that two drugs
will become available simultaneously and will be tested together. The third
protocol addresses how a new drug can be used to create an effective
'preventive therapy' regimen that could be given to close contacts of
persons with infectious MDR-TB. Such treatment would have a critical impact
on decreasing the number of persons with MDR-TB who need treatment.

With new drugs in development and clear scientific direction, what is
needed now are the will and resources necessary to move these essential
research studies forward as rapidly as possible.

Research Excellence to Stop TB Resistance (RESIST-TB) was formed in June
2008 by a coalition of TB researchers, governmental and non-governmental
organizations, and national TB programs. Its mission is to promote research
on the treatment and prevention of drug-resistant tuberculosis. RESIST-TB
is supported by the following organizations: World Health Organization,
Treatment Action Group, Partners In Health, M§Ûdicins Sans Fronti§Úres, KNCV
Tuberculosis Foundation, Potts Foundation, the Centers for Disease Control,
The Union, and the Stop TB Partnership.

The new MDR-TB research protocols can be downloaded here:
http://resisttb.org

For more information, please contact:
Vera Belitsky, RESIST-TB, +1-617-432-7135
drtbworkshop@gmail.com
http://resisttb.org

posted by
James Arkinstall

Senior Communications Officer
Medecins Sans Frontieres - Campaign for Access to Essential Medicines
www.msfaccess.org
+33 1 40 21 2837 (office)
+33 6 13 99 7751 (mobile)
James ARKINSTALL <James.ARKINSTALL@paris.msf.org>