News and Features
Corrections to Adult and Adolescent ARV Treatment Guidelines
On March 29, 2012, corrections were made to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents to rectify inconsistencies between the HTML and PDF versions of the guidelines. In general, the changes were stylistic in nature and did not alter the meaning of guideline contents, but three substantive corrections made are noted below.
In the HTML version of the guidelines, in the Initiating Antiretroviral Therapy in Treatment-Naive Patients section, information from a previous iteration of the guidelines that suggested a 50/50 split in expert opinion on recommendation on initiating ARV treatment in people with CD4 counts above 500 cells/mm3 was inadvertently included. The erroneous information was deleted from the HTML version of the section. The HTML and PDF versions of the Initiating Antiretroviral Therapy in Treatment-Naive Patients section now correspond and are correct.
In the HTML version of the guidelines, in Table 15a. Drug Interactions between Protease Inhibitors and Other Drugs under Benzodiazepines, a row with information on the drugs alprazolam and diazepam was inadvertently deleted from the table. The error was rectified with insertion of the missing row. The HTML and PDF versions of Table 15a now correspond and are correct.
In the PDF version of the guidelines, in Table 15b: Drug Interactions between Non-Nucleoside Reverse Transcriptase Inhibitors and Other Drugs under Hormonal Contraceptives, a row with information on the drug levonorgestrel (for emergency contraception) was inadvertently deleted from the table. The error was rectified with insertion of the missing row. The PDF and HTML versions of Table 15b now correspond and are correct.
The correction notice is available on the AIDSinfo website.
AIDSinfo regrets errors made during the publication of the Adult and Adolescent ARV Treatment Guidelines in PDF and HTML format.
FDA Approves New Pediatric Dosing Recommendations for Etravirine (Intelence)
“On March, 26, 2012, the Food and Drug Administration approved dosing recommendations for INTELENCE® (etravirine) for treatment-experienced pediatric patients 6 to 18 years of age and weighing at least 16 kg. In addition a new scored 25 mg tablet was approved for use in pediatric patients. …
“The recommended dose of Intelence for pediatric patients 6 years to less than 18 years of age and weighing at least 16 kg is based on body weight not exceeding the recommended adult dose. Intelence tablet(s) should be taken orally, following a meal. …
“The safety assessment in children and adolescents is based on the Week 24 analysis of the single-arm, Phase 2 trial TMC125-C213 in which 101 antiretroviral treatment-experienced HIV-1 infected subjects 6 years to less than 18 years of age and weighing at least 16 kg received Intelence in combination with other antiretroviral agents … . The frequency, type and severity of adverse drug reactions in pediatric subjects were comparable to those observed in adult subjects, except for rash which was observed more frequently in pediatric subjects. …
“Treatment with Intelence is not recommended in children less than 6 years of age. The pharmacokinetics, safety, tolerability and efficacy of Intelence in children less than 6 years of age have not been established.”
The updated label will be available at the FDA website.
More information is available:
- FDA: Press release
CDC Updates “HIV Surveillance by Race/Ethnicity” Slide Set
The Centers for Disease Control and Prevention (CDC) recently updated the “HIV Surveillance by Race/Ethnicity (through 2010)” slide set. The slide set provides statistical information on diagnoses of HIV infection and AIDS in the United States and dependent areas, broken down by race/ethnicity.