The Pharmaceutical Journal
Vol 268 No 7188 p311-320
9 March 2002

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The Lancet (www.thelancet.com)

Abacavir-containing regimens for HIV effective for treatment of children

Regimens that contain abacavir (Ziagen) are more effective than those containing zidovudine (Retrovir) and lamivudine (Epivir) in previously untreated children with human immunodeficiency virus-1, according to researchers from the Paediatric European Network for Treatment of AIDS.

The researchers conducted a trial involving 128 children to assess the safety and efficacy of three combinations of nucleoside analogue reverse-transcriptase inhibitors (NRTIs), with or without a protease inhibitor. The children were randomly assigned to receive either zidovudine and lamivudine, zidovudine and abacavir or lamivudine and abacavir. In addition, symptom-free children (n=55) received either nelfinavir or placebo and children with symptoms (n=73) received open-label nelfinavir.

The researchers found that, at 48 weeks, the largest viral load decrease was seen in the lamivudine/abacavir group. The availability of both of these formulations in a tolerable-tasting liquid might have improved adherence and therefore contributed to the effectiveness of this combination, they say. A larger decrease in viral load was seen in the nelfinavir group than in the placebo group at 24 but not 48 weeks. This pattern might be explained by an initially suboptimal dose of nelfinavir that could have led to resistance, say the researchers.

A total of 24 serious adverse events occurred. Four children stopped abacavir because of a possible hypersensitivity reaction, although two of these were subsequently attributed to acute infections.

The researchers conclude that abacavir-containing regimens could provide a good NRTI backbone for use with protease inhibitors and non-nucleoside reverse transcriptase inhibitors. "Because children have fewer treatment options than adults do, a potent first-line antiretroviral treatment regimen that is well tolerated is urgently needed," they conclude (Lancet 2002; 359:733).