Effects of highly active antiretroviral therapy with nelfinavir in vertically HIV-1 infected children: 3 years of follow-up. Long-term response to nelfinavir in children

Abstract

Background: Antiretroviral treatment (ART) in children has special features and consequently, results obtained from clinical trials with antiretroviral drugs in adults may not be representative of children. Nelfinavir (NFV) is an HIV-1 Protease Inhibitor (PI) which has become as one of the first choices of PI for ART in children. We studied during a 3-year follow-up period the effects of highly active antiretroviral therapy with nelfinavir in vertically HIV-1 infected children.

Methods: Forty-two vertically HIV-infected children on HAART with NFV were involved in a multicentre prospective study. The children were monitored at least every 3 months with physical examinations, and blood sample collection to measure viral load (VL) and CD4+ cell count. We performed a logistic regression analysis to determinate the odds ratio of baseline characteristics on therapeutic failure.

Results: Very important increase in CD4+ was observed and VL decreased quickly and it remained low during the follow-up study. Children with CD4+ <25% at baseline achieved CD4+ >25% at 9 months of follow-up. HIV-infected children who achieved undetectable viral load (uVL) were less than 40% in each visit during follow-up. Nevertheless, HIV-infected children with VL >5000 copies/ml were less than 50% during the follow-up study. Only baseline VL was an important factor to predict VL control during follow-up. Virological failure at defined end-point was confirmed in 30/42 patients. Along the whole of follow-up, 16/42 children stopped HAART with NFV. Baseline characteristics were not associated with therapeutic change.

Conclusion: NFV is a safe drug with a good profile and able to achieve an adequate response in children.

Figure 1

Summary of viral load (VL) and %CD4⁺ evolution during follow-up. A: mean of log₁₀ VL (copies/ml) and CD4⁺ T-cells percentage. B: mean of CD4⁺ T-cells percentage according to CD4⁺ at baseline (< or > 25%). C: percentage of HIV-infected children with VL ≤400 copies/ml and VL >5000 copies/ml.

Figure 2

Summary of Kaplan-Meier curves of HIV-infected children on HAART during follow-up. A: to achieve VL <400 copies/ml for the first time or to achieve a decrease of -1 log₁₀ VL. B: rebound of viral load after achieving VL ≤400 copies/ml. C: to change NRTI or additional NNRTI or PI in HAART regimen in the first line of HAART; or stop HAART with nelfinavir.