News and Features
HHS Guidelines Panels Issue Statement on Treating Latent Tuberculosis Infection in People Infected with HIV Receiving Antiretroviral Therapy
The HHS Panel on Antiretroviral Guidelines for Adults and Adolescents and the HHS Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children have issued a statement on treating latent tuberculosis infection in people infected with HIV who are receiving antiretroviral therapy.
Click here to see the statement: “Short-Course (3-Month) Therapy with Weekly Isoniazid-Rifapentine Is NOT RECOMMENDED for HIV-Infected Patients Receiving Antiretroviral Therapy.”
This communication is made in consultation with the HHS Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Adults and Adolescents and the HHS Panel on Guidelines for the Prevention and Treatment of Opportunistic Infections in HIV-Infected Children.
FDA Approves Oral Suspension Formulation of Darunavir (Prezista) and Updates Product Label
“On December 16, 2011, The Food and Drug Administration approved an oral suspension formulation of Prezista (darunavir). Prezista is now available as a 100 mg/mL oral suspension.
“Additionally, the product labeling was updated to provide dosing recommendations for pediatric patients ages 3 to less than 6 years of age and for adult and pediatric patients greater than 6 years of age who can not swallow Prezista tablets. …
“Section 6 Adverse Reactions (ADRs) was update to reflect clinical trial experience in pediatric patients from Study TMC1140C228 …
“Section 12.3 Pharmacokinetics was updated to provide population pharmacokinetic estimates of darunavir exposure in pediatric patients.
“Section 14: Clinical Studies was updated to reflect the results from the pediatric trial ... .”
The updated label will be available at the FDA Web site.
More information is available:
- FDA: Press release
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