Paediatric HIV Implementation

 

  • Target disease: Paediatric HIV
  • Main partners (since project start): Department of Health and Department of Science and Technology, South Africa; Stellenbosch University and Tygerberg Children’s Hospital, South Africa; Perinatal HIV Research Unit, University of Witswatersrand, South Africa; Shandukani Research Centre, Wits Reproductive Health and HIV Institute, South Africa; Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, South Africa; Enhancing Care Foundation, South Africa; Division of Clinical Pharmacology, Department of Medecine, University of Cape Town, South Africa.
  • Project Start: 2012
  • Funding (since project start): French Development Agency (AFD), France; Médecins Sans Frontières/Doctors without Borders, International/Norway; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; UBS Optimus Foundation, Switzerland; UNITAID, Switzerland.

 

Overall Objective:

  • Continue to support implementation of and access to a stand-alone pharmacokinetic ritonavir (RTV) enhancer/booster formulation, to be added to any PI-based paediatric ARV regimen for the treatment of HIV-TB co-infected children.

 

 

In Africa, a large proportion of HIV-positive infants and children are co-infected with tuberculosis (TB). Rifampicin is commonly used to treat TB in children, however it has negative interactions with protease inhibitors (PIs) included in treatments used to combat HIV infection: concomitant administration of rifampicin leads to a decrease in LPV/r exposure of up to 90%. To counteract this effect, the amount of ritonavir (RTV) in the LPV/r combination must be quadrupled in a procedure known as super-boosting. A stand-alone RTV booster formulation is needed that can be added to any PI-based paediatric ARV regimen. Like LPV/r, RTV has a high alcohol content, is unstable, and completely unpalatable.

A pharmacokinetic study has been carried out in infants and young children co-infected with TB and HIV at five sites in South Africa to supplement existing information and evaluate the effect of the ‘super-boosting’ strategy.

Supported by interim results from the study, ‘super-boosting’ ritonavir was recommended by WHO in its antiretroviral guidelines in 2016. In 2017, a follow-on study currently awaiting ethical approval will examine the safety and efficacy of super-boosting with ritonavir powder and other solid antiretovirals including LPV/r pellets and dual NRTI dispersible tablets.
At the end of November 2015 all 96 patients had been included. Interim results show that LPV exposure during TB/HIV cotreatment using the super-boosting approach is as good as that when children return to standard LPV/r based therapy. Super-boosting was safe and well tolerated. Results were shared with WHO to support a change in guidelines for the management of TB/ HIV co-infections in children.


Last update: February 2017