- Category: HIV Treatment Guidelines
- Published on Tuesday, 08 March 2016 00:00
- Written by HIVandHepatitis.com
The U.S. Department of Health and Human Services has updated its Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Reflecting recent data from the START and PENPACT1 trials, the guidelines now recommend that all children with HIV start antiretroviral therapy (ART) regardless of CD4 T-cell count, viral load, or clinical symptoms.
The latest revisions update theprior pediatric guidelines fromMarch 5, 2015. Comments on the new guidelines will be accepted through March 15, 2016, and can be sent to JLIB_HTML_CLOAKING .
Selected key changes include the following:
- Virological testing at 1-2 months of age should be scheduled for 2-4 weeks after stopping neonatal antiretroviral prophylaxis, either at 6 weeks (in the case of 4 weeks of prophylaxis) or at 2 months (in the case of 6 weeks of prophylaxis).
- Based on data from the multinational START and PENPACT1 trials, the guidelines panel now recommends ART for all HIV-infected children, regardless of clinical symptoms, viral load, or CD4 count, while acknowledging that fewer data are available regarding the benefits and risks of therapy for asymptomatic children compared to adults with HIV.
- The panel has added the new Genvoya fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide (TAF) -- a new formulation easier on the kidneys and bones -- as a preferred integrase inhibitor regimen for adolescents age 12 years and older.
- Dolutegravir (Tivicay) is now considered a preferred integrase inhibitor for adolescents age 12 and older, while raltegravir (Isentress) is preferred for children aged 2 to 12 years.
- Ritonavir-boosted darunavir (Prezista) is now considered a preferred protease inhibitor for children and adolescents age 3 years and older.
- The older antiretrovirals fosamprenavir (Lexiva), nelfinavir (Viracept), unboosted atazanavir (Reyataz), and stavudine (d4T or Zerit) and should not be used for first-line treatment.
- Information has been added about Evotaz, a fixed dose combination of atazanavir and cobicistat.
- Information has been added about a recent study of nevirapine (Viramune) pharmacokinetics in premature infants and an investigational dose for babies less than 1 month of age born at 34-37 weeks gestation.
- Based on a study demonstrating lower bioavailability of lamivudine (3TC or Epivir) oral solution versus tablets in children, the guidelines now emphasize that once-daily administration of the oral solution is not generally recommended for infants and young children.
- The guidelines clarify that adolescents in early puberty should receive pediatric dosing, while those in late puberty should follow adult dosing guidelines.
- Content has been added about timing and selection of ART, adherence concerns, and sexually transmitted infections for adolescents living with HIV, as well as guidance for improving retention in care and minimizing the risk of ART interruptions during the transition from pediatric to adult care.
DHHS Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Updated March 1, 2016.