Paediatric European Network for Treatment of AIDS (PENTA) Guidelines for Treatment of Paediatric HIV-1 Infection 2015

Optimizing Health in Preparation for Adult Life

A Bamford; A Turkova; H Lyall; C Foster; N Klein; D Bastiaans; D Burger; S Bernadi; K Butler; E Chiappini; P Clayden; M Della Negra; V Giacomet; C Giaquinto; D Gibb; L Galli; M Hainaut; M Koros; L Marques; E Nastouli; T Niehues; A Noguera-Julian; P Rojo; C Rudin; HJ Scherpbier; G Tudor-Williams; SB Welch

Disclosures

HIV Medicine. 2018;19(1):e1-e42. 

In This Article

Pipeline and Upcoming Trials

There are considerable incentives and/or penalties from regulatory agencies to ensure that any new drug that might be of benefit to children must be studied in this population. This is mandatory with both the EMA, which enforces penalties for companies that do not provide a paediatric investigational plan as part of their application (or request a waiver), and the FDA, which also extends 6-month patent protection to companies that perform requested paediatric studies (voluntary).

Companies must include PK data for all age groups of children, efficacy, tolerability, and differences in side effects. They must have stability and palatability data for formulations and demonstrate that they are able to achieve PK targets associated with efficacy in adults. Most paediatric development programmes take a staggered approach, starting with the older cohorts of children and working down in age. The studies are conducted in children as soon as there are sufficient data from studies in adults. The current paediatric antiretroviral pipeline is shown in Table 8; greater detail can be found in the annually updated i-Base/TAG Pipeline Report (available at http://www.pipelinereport.org). Planned PENTA studies will look at two new drugs for children in the integrase inhibitor class: DTG and EVG.

processing....