Hello, I am MDR TB counselor from Nikshay Foundation. I am excited to share with you today the new drugs for Latent TB Patients 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 India. 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 break trough’s 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.
Its 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 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; expectancy 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 forever one, 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 Med Watch and local and state health departments immediately for inclusion in surveillance system for adverse effects associated with treatment for latent TB infection.
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