Preliminary experiences with triple therapy including nelfinavir and two reverse transcriptase inhibitors in previously untreated HIV-infected children

Objective: In an intent-to-treat study increase in CD4 cell count, reductio n of viral load, clinical benefit and adverse reactions were examined in HI V-infected previously treatment-naive children taking triple therapy. Methods: sixteen HIV-infected children in category A or B on antiretroviral triple therapy were followed-up for a period of 12 months. In group I eigh t patients received zidovudine, lamivudine and nelfinavir; in group II eigh t patients received stavudine, didanosine and nelfinavir. Viral load and CD 4 cell count were measured every 4-8 weeks. Plasma nelfinavir levels were a ssessed once in all patients at baseline and monitored in patients with inc reasing viral load. Results: No significant differences were observed between treatment groups in terms of CD4 cell counts and viral load. A median viral load reduction o f 2.8 log(10) (range, 1.4-4.2 log(10)) was achieved over a period of 12 mon ths in both groups. Viral load < 500 copies/ml was found in 69% of patients and viral load < 50 copies/ml in 44% of patients after 12 months. Median C D4 cell count increased from 656 x 10(6) to 850 x 10(6) cells/l after 3 mon ths and was maintained at 813 x 10(6) cells/l after 12 months of treatment. Main side-effects were diarrhoea, rash and hyperlipidaemia. Except for app lication problems, both regimens were well tolerated. Appropriate formula a nd individual counselling must be performed during the first weeks of treat ment in order to achieve good compliance in paediatric patients. Conclusion: Triple antiretroviral therapy shows a stronger and more sustain ed reduction of viral load in HIV-infected children compared with studies c ombining two nucleoside analogues. (C) 1999 Lippincott Williams & Wilkins.