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Associate Professor and Residency Director, Department of Family Medicine, University of California-Irvine, Irvine
This article is intended for primary care clinicians, infectious disease specialists, and other specialists who care for young children with HIV infection.
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As an organization accredited by the ACCME, Medscape, LLC, requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.
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Associate Professor and Residency Director, Department of Family Medicine, University of California-Irvine, Irvine
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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."
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.
