February 2002

From Lancet

Abacavir could play important future role in treatment of children with HIV-1

N.B. Please note that if you are outside North America the embargo date for Lancet press material is 0001hours UK time Friday 1st March 2002.

Results of the Paediatric European Network for Treatment of AIDS (PENTA) 5 Trial, published in this week's issue of THE LANCET, suggest an important future role for the drug abacavir in the treatment of children with HIV-1.

Antiretroviral HIV-1 drug treatment for adults in more-developed countries usually involves combination therapy with two nucleoside reverse-transcriptase inhibitors (NRTIs) in combination with either a protease inhibitor or a non-NRTI; however, treatment options for children with HIV-1 are limited. The PENTA investigators compared the activity and safety of three different NRTI dual combinations with or without a protease inhibitor in previously untreated children with HIV-1.

128 children from 9 countries took part in the study. They were randomly allocated treatment with one of three dual NRTIs: zidovudine/lamivudine (36 children); zidovudine/abacavir (45 children); lamivudine/abacavir (47 children). 55 children who were symptom-free were randomly assigned either the protease inhibitor nelfinavir or placebo. The 73 children with more advanced disease received nelfinavir .

The children had an average HIV-1 RNA concentration of 5.0 log copies/mL at enrolment to the trial. At 48 weeks, in the zidovudine/lamivudine, zidovudine/abacavir, and lamivudine/abacavir groups, average HIV-1 RNA decreases were 1.71, 2.19, and 2.63 log copies/mL, respectively.

Diana Gibb (one of the investigators) comments: "Results of our PENTA 5 trial have shown that of the dual NRTI regimens compared, abacavir-containing regimens are more effective than zidovudine/lamivudine in children with HIV-1 who have not previously been treated. These combinations could provide a good NRTI backbone for use with protease inhibitors and non-nucleoside reverse-transcriptase inhibitors. Because children have fewer treatment options than do adults, a potent first-line antiretroviral treatment regimen that is also well tolerated is urgently needed. Our results with abacavir in this trial suggest that the safety profile in children is similar to that in adults."

Contact: Dr Diana M Gibb, MRC Clinical Trials Unit,222 Euston Road, London, NW1 2DA,UK;T) +44 (0) 20 7670 4714;F) +44 (0) 20 7670 4815;E) sab@CTO.MRC.AC.UK











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