New shorter treatment for latent TB not recommended for HIV+ people on ART
Expert panels that put together the Department of Health and Human Services antiretroviral therapy (ART) guidelines have advised that the shorter and simpler combination regimen for latent tuberculosis (TB) recently recommended by the Centers for Disease Control and Prevention (CDC) is not suitable for people being treated for HIV.
Data from randomized controlled trials showed that a once-weekly regimen of the anti-TB drugs isoniazid and rifapentine taken as directly observed therapy (DOT) for 3 months is as effective as the standard 9-month daily regimen of isoniazid monotherapy in preventing latent TB infection from progressing to active disease. Based on these findings, the CDC recommended the short combination regimen for U.S. adults, as described in the December 9, 2011, Morbidity and Mortality Weekly Report.
This week, however, the DHHS adult and pediatric guidelines panels cautioned that the new short regimen is not recommended for people with HIV receiving ART, because adequate pharmacokinetic data on the interactions between these TB medications and antiretroviral agents are not yet available.
A study published this summer (July 7, 2011 New England Journal of Medicine) showed that the once-weekly isoniazid/rifapentine regimen for 3 months worked as well as isoniazid monotherapy for 6 months in HIV positive people with latent TB infection in South Africa, but patients in that study had a relatively high CD4 T-cell count (median 484 cells/mm3) and were not yet taking ART.
The DHHS statement makes the following recommendations:
- HIV-infected patients receiving antiretroviral therapy SHOULD NOT receive the 3-month weekly isoniazid+ rifapentine regimen for treatment of latent TB infection, unless given in the context of a clinical trial.
- Patients receiving ART should receive latent TB treatment according to current recommendations in the guidelines for treatment and prevention of opportunistic infections.
- HIV-infected patients 12 years of age or older who are not receiving ART can be prescribed either a 9-month isoniazid regimen or the 3-month once-weekly isoniazid+ rifapentineDOT regimen as recommended in the new CDC guidelines, but data on the efficacy and safety of the latter regimen in HIV positive patients is limited.
- For HIV-infected children 2 to 11 years of age who are not receiving ART, the standard 9-month regimen of daily isoniazid monotherapy is preferable, but the 3-month isoniazid/rifapentineregimen can be considered on a case-by-case basis.
- The 3-month isoniazid/rifapentineregimen is not recommended for children younger than 2 years.
The full statement, "Short-Course (3-Month) Therapy with Weekly Isoniazid-Rifapentine Is NOT RECOMMENDED for HIV-Infected Patients Receiving Antiretroviral Therapy," is available online.
By Liz Highleyman
Source
Department of Health and Human Services. Short-Course (3-Month) Therapy with Weekly Isoniazid-Rifapentine Is NOT RECOMMENDED for HIV-Infected Patients Receiving Antiretroviral Therapy. December 20, 2011.
HIVandHepatitis.com
