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Children Who Begin Combination Antiretroviral Treatment As Newborns Show Lower HIV Levels at Four Years Old, Study Says

June 10, 2004

Infants who receive combination antiretroviral treatment before three months of age are two times as likely to have low HIV blood levels at age four, compared with infants who began antiretroviral therapy later, according to a study published in the June 10 issue of the New England Journal of Medicine, Reuters reports (Reuters, 6/9). Dr. Katherine Luzuriaga of the University of Massachusetts Medical School and colleagues examined the safety, tolerability and activity of three regimens of antiretroviral drugs among 52 HIV-positive infants who were enrolled in the study between May 1997 and November 1998 at 25 clinical sites in the United States and Puerto Rico. Researchers separated participants into groups of children younger than three months and children older than three months and assigned participants to receive one of three treatment combinations. Participants received treatment for up to 200 weeks if their HIV viral load levels were less than 1,000 copies per milliliter by 16 weeks. Researchers tested HIV viral load levels before treatment began, every four weeks until week 24, every eight weeks until week 56 and every 12 weeks until week 200. Researchers found that HIV viral load fell from a median of 199,526 copies per mL before beginning treatment to less than 1,000 copies per mL at 16 weeks among 32 of the participants. HIV viral loads were below 400 copies per mL among 26 participants at 48 weeks and among 23 participants at 200 weeks. Researchers found that 30% of the participants in the delayed-treatment group and 60% in the early-treatment group had HIV viral load levels of less than 400 copies per mL at 200 weeks. In addition, researchers found that more of the children who received a combination of stavudine, lamivudine, nevirapine and nelfinavir had viral load levels of less than 400 copies per mL at 48 weeks and 200 weeks, compared with children who received only reverse transcriptase inhibitors.

Conclusions
The researchers concluded that beginning treatment with stavudine, lamivudine, nevirapine and nelfinavir in HIV-positive infants before they reach three months is associated with better long-term suppression of HIV. However, they said that further research is required to determine the "optimal time" to begin therapy and the "optimal regimen" for infants (Luzuriaga et al., NEJM, 6/10). Luzuriaga said that the findings "provide increasing evidence that several regimens of antiretroviral therapy are safe, effective and well-tolerated during years of administration when started in infancy." The study could help to determine the optimal HIV treatment regimen for the 2,000 HIV-positive infants born each day throughout the world, Reuters reports. U.S. guidelines currently suggest combination treatment for children younger than one year of age who are HIV-positive but do not have symptoms of the disease, according to Reuters (Reuters, 6/9).

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