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FDA Approvals: Efavirenz Expanded to Young Children With HIV

  • Authors: News Author: Megan Brooks
    CME Author: Charles P. Vega, MD, FAAFP
  • CME/CE Released: 6/18/2013
  • Valid for credit through: 6/18/2014, 11:59 PM EST
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Target Audience and Goal Statement

This article is intended for primary care clinicians, infectious disease specialists, and other specialists who care for young children with HIV infection.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe the epidemiology of perinatal transmission of HIV.
  2. Assess the use of efavirenz among young children with HIV infection.


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  • Megan Brooks

    Megan Brooks is a freelance writer for Reuters Health.


    Disclosure: Megan Brooks has no relevant financial relationships to disclose.


  • Laurie E. Scudder, DNP, NP

    Nurse Planner, Continuing Professional Education Department, Medscape, LLC; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC


    Disclosure: Laurie E. Scudder, DNP, NP, has disclosed no relevant financial relationships.

CME Author(s)

  • Charles P. Vega, MD, FAAFP

    Associate Professor and Residency Director, Department of Family Medicine, University of California-Irvine, Irvine


    Disclosure: Charles P. Vega, MD, FAAFP, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Joi Tisdale

    CME Program Manager, Medscape, LLC


    Disclosure: Joi Tisdale has disclosed no relevant financial relationships.

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FDA Approvals: Efavirenz Expanded to Young Children With HIV

Authors: News Author: Megan Brooks CME Author: Charles P. Vega, MD, FAAFPFaculty and Disclosures

CME/CE Released: 6/18/2013

Valid for credit through: 6/18/2014, 11:59 PM EST


Clinical Context

The perinatal transmission of HIV has decreased in the United States in recent years, but substantial differences in the risk for HIV persist among different racial/ethnic groups. In a 2010 report from the Centers for Disease Control and Prevention, the rates of perinatally acquired HIV infection decreased by at least 25% among whites, Latinos, and African Americans between 2007 and 2009. However, the respective rates of HIV infection per 100,000 live births among these racial/ethnic groups were 0.1, 1.7, and 9.9, respectively.

The use of non-nucleoside reverse transcriptase inhibitors has improved the outcomes of HIV infection among adults. The US Food and Drug Administration (FDA) has now approved the use of the non-nucleoside reverse transcriptase inhibitor efavirenz for children as young as 3 months. The rationale for this decision and practical advice for the application of this therapy are summarized in "Study Highlights."

Study Synopsis and Perspective

The FDA has expanded the approval of efavirenz (Sustiva) to HIV-1 infected children as young as 3 months and weighing at least 3.5 kg, the agency announced on May 2.

For pediatric patients who cannot swallow capsules, the capsule contents can be sprinkled on a small amount of food (1 - 2 teaspoons) or put in infant formula, the FDA said. However, use of infant formula for mixing should only be considered for those young infants who cannot reliably consume solid foods. Detailed information about the "capsule sprinkle" method will be provided in the instructions for use at the end of the patient information section of the package insert.

The updated labeling includes a table for once-daily dosing along with the corresponding number of capsules or tablets and strength to administer. Capsules can be administered intact or as sprinkles. Tablets must not be crushed.

Table. Recommended dosing

Body weight Daily dose Number of capsules or tablets and strength to administer
3.5 to less than 5 kg 100 mg Two 50-mg capsules
5 to less than 7.5 kg 150 mg Three 50-mg capsules
7.5 to less than 15 kg 200 mg One 200-mg capsule
15 to less than 20 kg 250 mg One 200-mg + one 50-mg capsule
20 to less than 25 kg 300 mg One 200-mg + two 50-mg capsules
25 to less than 32.5 kg 350 mg One 200-mg + three 50-mg capsules
32.5 to less than 40 kg 400 mg Two 200-mg capsules
At least 40 kg 600 mg One 600-mg tablet or three 200-mg capsules

Efavirenz, a non-nucleoside reverse transcriptase inhibitor, was approved in the United States in 1998 to treat HIV-1 infected children 3 years of age or older and weighing at least 10 kg.

According to the FDA, the new indication for efavirenz was based on results from 3 open-label studies of the drug in combination with other antiretroviral agents in 182 HIV-1 infected pediatric patients aged 3 months to 21 years. Virologic and immunologic response was observed across all ages at the end of the studies, as measured by HIV RNA and CD4 cell count.

The FDA said adverse reactions observed in the 3 pediatric trials were similar to those observed in adult clinical trials, except for rash, which was more common in pediatric patients and more severe.

Rash was reported in 59 (32%) of 182 pediatric patients treated with efavirenz; 2 pediatric patients experienced grade 3 rash (confluent rash with fever, generalized rash), and 4 had grade 4 rash (erythema multiforme). Five pediatric patients (2.7%) discontinued from the study because of rash. Prophylaxis with appropriate antihistamines before initiating therapy with efavirenz in pediatric patients should be considered, the FDA advises.

The agency also says use of efavirenz in patients younger than 3 months or less than 3.5 kg body weight is not recommended because its safety, pharmacokinetics, and antiretroviral activity have not been evaluated in this age group and there is a risk for the development of HIV resistance if efavirenz is underdosed.

The revised labeling is now available on the FDA Web site.

Study Highlights

  • Efavirenz has been evaluated in several open-label studies as part of combination therapy for children with HIV infection. The proportions of children who achieved an HIV RNA level of less than 50 copies/mL varied between 43% and 70% in these studies. The median increase in the CD4+ count on efavirenz was 5% to 13%.
  • However, 16% to 27% of children in these studies discontinued therapy before the end of the research period.
  • Rash has been reported in 32% of children treated with efavirenz. The median time to the onset of rash on treatment was 28 days. Rash is more likely to occur among children vs adults treated with efavirenz, and the rash is more likely to be severe among children vs adults.
  • The FDA has expanded the indication for treatment with efavirenz to include children who are at least 3 months old and weigh at least 3.5 kg. The daily dose of efavirenz for children between 3.5 and 5 kg in weight is 100 mg, with increases in the daily dose to 150 and 200 mg for children between the weights of 5 to 7.5 kg and 7.5 to 15 kg, respectively.
  • For very young children, mixing the contents of the efavirenz capsule with soft food is preferred vs mixing with formula. The capsule of efavirenz should be held horizontally over the target food and opened carefully by twisting to prevent unnecessary spills.
  • If formula feeding is necessary, efavirenz should be mixed with 10 mL of formula and administered in a syringe.
  • After administration of efavirenz to young children, a small amount of food should be reconstituted in the delivery container and fed to the child to ensure complete dosing of the medication.
  • No additional food should be consumed for at least 2 hours after the administration of efavirenz.
  • The bioavailability of efavirenz appears similar in comparing fasting consumption of the capsule vs the food-mixing preparation of efavirenz.
  • The efficacy and safety of efavirenz remain unproven among infants younger than 3 months.

Clinical Implications

  • The prevalence of HIV infection associated with perinatal transmission has decreased among major racial/ethnic groups but remains higher for African Americans vs whites and Latinos.
  • The FDA has now approved the use of efavirenz among children as young as 3 months with HIV infection.

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