Hello, I am Dr. Kenneth Castro,
Director of the Division of Tuberculosis Elimination
at the Centers for Disease Control and Prevention.
I am excited to share with you today the release of
CDC guidelines for the use of a new regimen
for the treatment of persons with latent tuberculosis
infection.
Preventing TB disease by treating those with latent
TB infection is a cornerstone of the U.S.
strategy for TB elimination.
This new regimen, referred to as the 12-dose regimen
for treatment of latent TB infection,
is a combination of isoniazid and rifapentine given
once weekly in 12 doses under directly observed therapy.
This regimen is one of the biggest breakthroughs
in treatment for latent TB infection since the 1960s,
as it reduces treatment from 270 daily doses
over nine months to 12 once-weekly doses given
over three months.
A recent large randomized control trial found
the 12-dose regimen to be as effective for preventing
TB as other regimens.
The new regimen is also more likely to be completed than
the current U.S. standard regimen of nine months
of isoniazid daily without directly observed therapy.
It's important to realize that the new regimen does
not replace other recommended options for
treatment of persons with latent TB infection.
This regimen is recommended as an equal
alternative for otherwise healthy persons, 12 years
12 years of age and older, who have latent TB infection
and factors that are predictive of progressing
to TB disease, such as, recent exposure to a
person with infectious TB disease, or who have a
tuberculin skin test conversion or a positive
blood test for TB.
HIV-infected people who are otherwise healthy and
not taking antiretroviral medicines are included in
this category.
The regimen also can be considered for other groups
when it offers practical advantages,
such as completion within a limited timeframe.
This regimen is not recommended for children
younger than 2 years of age, HIV-infected people
taking antiretroviral therapy, pregnant women or
women who expect to become pregnant during treatment,
and people who have latent TB infection with presumed
isoniazid or rifapentine - resistance.
These people should be treated with other
available regimens for latent TB infection.
The choice between the 12-dose regimen and other
approved latent TB infection treatment regimens
depends on several factors, including
the feasibility of providing directly
observed therapy; resources for drug
procurement; program operations, including
patient monitoring; expectance of treatment
completion while considering the medical
and the social circumstances of the
patient; and the preferences of the patient
and the prescribing physician.
Directly observed therapy is recommended for this
12-dose regimen.
Outreach workers should be trained
on potential medication side effects and how
to educate patients about this new regimen.
Persons using the 12-dose regimen should undergo
monthly clinical monitoring, including
inquiries about side effects and a physical
assessment for signs of adverse effects.
Although blood tests are not recommended for
everyone, baseline and subsequent tests should be
done for certain groups.
While the 12-dose regimen was well tolerated in
three reported treatment trials, severe adverse effects,
which is defined as effects requiring
hospital admission or fatalities, should be
reported to the Federal Drug Administration
MedWatch and local and state health departments
immediately for inclusion in CDC's surveillance
system for adverse effects associated with treatment
for latent TB infection.
More information about latent TB infection,
the available treatment options, and educational
materials for health care professionals is available at
w-w-w-dot-cdc-dot-g-o-v-forward slash-tb
Thank you.