Drug Criteria & Outcomes-Efavirenz available for children and teens with HIV
Oral liquid formulation is more convenient
With more than 10,000 HIV-infected children in the United States, clinicians continue to look for new and improved antiretroviral treatments that will help this population.
Now physicians have another option in HIV treatment of youths. The drug efavirenz (Sustiva) is available to children and adolescents through age 16 as part of an expanded access program.
A recent study has shown that those children who take efavirenz along with one or two other antiretroviral medications have an excellent antiviral response over a 48-week period, says Stuart Starr, MD, professor of pediatrics at the University of Pennsylvania School of Medicine in Philadelphia. Starr also is the chief of immunologic and infectious diseases at the Children's Hospital of Philadelphia.
Because the children enrolled in the study had to be able to take capsules, many younger children were excluded. However, efavirenz now is available in an oral liquid formulation that is being studied under the expanded access program as an open-label, multicenter study of children and adolescents who are unable to swallow capsules. The liquid formula is clear and has a strawberry/mint flavor.
Guidelines for children
The package contains an oral dosing device with detailed instructions for parents. Dosing depends on the child's body weight. The drug has not been studied in children weighing less than 10 kg or younger than 3 years of age, so these children are excluded from receiving the drug.
The efavirenz protocol is open to antiretroviral-experienced and treatment-naive children ages 3 to 16.
The Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection, released by the Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children, recommend the use of efavirenz as a first-line therapy for HIV-infected children in combination with two nucleoside reverse transcriptase inhibitors.1
In the pediatric trial that used efavirenz capsules, the types of adverse events observed were similar to those commonly observed in adult patients, except there was a higher incidence of rash among children. Rash occurred in 40% of the children, as opposed to 26% of adults taking the drug.
Other adverse events were diarrhea/loose stools in 39% of children, fever in 26%, cough in 25%, nausea/vomiting in 16%, and nervous system symptoms in 9%.
For additional information on prescribing efavirenz, contact Wilmington, DE-based DuPont Pharmaceuticals Co. at the company's Web site: www. sustiva.com or by calling this toll-free number: (800) 4PHARMA [(800) 474-2762].
Reference
1. Working Group on Antiretroviral Therapy and Medical Management of HIV-Infected Children. Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection. Convened by the National Pediatric and Family HIV Resource Center, the Health Resources and Services Administration, and the National Institutes of Health. January 2000.
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