Paediatric drug development and evaluation: Existing challenges and recommendations.

Despite various international regulatory initiatives over the last 20 years, many challenges remain in the field of paediatric drug development and evaluation. Indeed, drug research and development is still focused essentially on adult indications, thereby excluding many paediatric patients, limiting the feasibility of trials and favouring competing developments. Off-label prescribing persists and the development of age-appropriate dosage forms for children remains limited.

Interruption of cART in clinical practice is associated with an increase in the long-term risk of subsequent immunosuppression in HIV-1-infected children.

Background: Antiretroviral treatment interruption (TI) is not recommended in HIV-infected children. We aimed to evaluate the context and consequences of TI in clinical practice.

Methods: We investigated the probability and risk factors of a first TI in the 483 children treated with combined ART (cART) in the ANRS French national pediatric cohort.

A three-source capture-recapture estimate of the number of new HIV diagnoses in children in France from 2003-2006 with multiple imputation of a variable of heterogeneous catchability.

Background: Nearly all HIV infections in children worldwide are acquired through mother-to-child transmission (MTCT) during pregnancy, labour, delivery or breastfeeding. The objective of our study was to estimate the number and rate of new HIV diagnoses in children less than 13 years of age in mainland France from 2003-2006.

Methods: We performed a capture-recapture analysis based on three sources of information: the mandatory HIV case reporting (DOVIH), the French Perinatal Cohort (ANRS-EPF) and a laboratory-based surveillance of HIV (LaboVIH).

Population pharmacokinetics of atazanavir/ritonavir in HIV-1-infected children and adolescents.

Aims: To investigate atazanavir (ATV) population pharmacokinetics in children and adolescents, establish factors that influence ATV pharmacokinetics and investigate the ATV exposure after recommended doses.

Methods: Atazanavir concentrations were measured in 51 children/adolescents during a mean therapeutic monitoring follow up of 6.6 months.

[Prophylaxis for contacts of an index case of hepatitis A: immunoglobulins or vaccination?].

France has changed from a country where hepatitis A is endemic to one where residents are at risk of hepatitis A infection: in 20 years, the seroprevalence in 20-year-olds has fallen from 50% to less than 10%. Prophylaxis for close contacts of an index case has therefore become a major problem because their risk of hepatitis A is high. Polyvalent immunoglobulins are recommended in several countries, but no immunoglobulins are approved for this indication in France.