Magazine article Drug Topics

For Kids Only

Magazine article Drug Topics

For Kids Only

Article excerpt

New guidelines and experts offer insight into pediatric HIV

God and the universe are perhaps the great mysteries of life. But a child's physiological response to drugs is a far more urgent puzzle to solve. Because of a lack of such data, thousands of HIVinfected kids are left to make do with five of the 11 available antiretrovirals-and more therapeutic questions than answers. But one document, currently in the works, is sure to offer some insight into the matter.

The Health Resources & Services Administration (HRSA) has proposed guidelines for the use of antiretroviral agents in pediatric HIV infection. A peek into the draft version reveals a favoritism toward triple-druR combination therapy. And it's no wonder. Having displayed the ability to sink viral loads below detectable levels, the famous cocktails-consisting of a protease inhibitor and two nucleoside analogs-have clearly become the regimen of choice in adult HIV-infected patients. But why is the transition to that approach in pediatrics lagging behind?

Deficiency of pediatric clinical data comparing monotherapy to dual-drug or triple-drug combos was one reason offered by Robert C. Stevens, Pharm.D., associate professor of clinical pharmacy at the University of Tennessee. Although monotherapy has been proven over and over to produce rapid viral resistance, the investigator for the Pediatric AIDS Clinical Trial Group at St. Jude Children's Research Hospital revealed that until recently the approach was still very acceptable in the pediatric population. The shift toward combo therapy at his institution was fully instituted only within the past six months, due to a study confirming the inferiority of didanosine (Videx, BristolMyers Squibb) monotherapy, compared with a combination of zidovudine (Retrovir, Glaxo Wellcome) and lamivudine (Epivir, Glaxo Wellcome). Of course, the observed success of triple cocktails in HIV-infected adults helped the move as well. "More and more physicians are prescribing triple therapy to pediatric patients," but dual therapy-consisting commonly of zidovudine and lamivudine or zidovudine and didanosinestill prevails, noted Stevens.

Ironically, infants-who are the most vulnerable to disease progression-are the predominant pediatric patients suffering from the hesitation to prescribe triple cocktails. The babies "are ideal candidates for aggressive therapy with protease inhibitors," said Stevens. So why don't the tiny patients get what they need? A major reason is lack of pharmacokinetic data that define optimal dosing in infants, especially for those under three months of age, he noted. …

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