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2022 Rome Action Plan on Paediatric HIV & TB



Gilead, ViiV Healthcare and MSD commit to implement the principles of the Call to Action (CTA)[1] launched on 1st December 2021 by stakeholders[2] involved in studying antiretroviral agents for treatment and prevention of HIV to support greater inclusion of pregnant women and breastfeeding and contribute to a more equitable investigation of new HIV agents.This includes:

26. Committing to complete embryo-fetal development (EFD) studies for new antiretroviral (ARV) drugs by end of Phase 2 clinical trials.


27. Committing at aiming to complete pre- and post-natal development studies (PPND) for new ARV drugs by the time of early Phase 3 clinical trial enrolment.


28. Committing to generate pharmacokinetic (PK) and early safety data in pregnancy for new drugs by end of Phase 3 clinical trial completion, in the assumption that there are no contraindications to use in pregnancy from pre-clinical studies.  


[1] Idem 7  

[2] Idem 8 

MSD commits to:

36. Should a woman become pregnant, continue to permit participants enrolled in the doravirine and islatravir phase 3 program to continue in the clinical trial, if they reconsent to do so. 


37. Collect doravirine and islatravir PK as part of the phase 3 development program in participants who become pregnant and reconsent to remain in the clinical trial. Birth outcomes will also be collected, and infant follow-up will be conducted through the first year of life. 


38. Facilitate studies that generate data on pregnancy, birth and infant outcomes for doravirine and islatravir in pregnancy and lactation via MSD-supported studies.





All partners commit to: 


163. Address inequities by tackling the stigma and discrimination in communities, schools, and healthcare settings that prevent children living with HIV from accessing testing and treatment. 

164. Increase literacy about CD4 testing and viral load and promote a client-centred approach to support expansion of access to viral load for pregnant and breastfeeding women and children on treatment, including at the point-of-care. 

165. Review and assess emerging co-infections for immunocompromised infants and children, including those with advanced HIV disease, such as severe bacterial infections, fungal infections, and others for country consideration and implementation.

166. Engage affected communities for input and guidance on investment and programmatic priorities, provide support to in-country civil society organizations to engage in advocacy and demand creation for new tools, and ensure data is publicly available to support communities and civil society to monitor progress regarding uptake and implementation of essential diagnostic tools.




MSD commits to:

243. Make publicly available the PSP for PADO priority products to enable a more transparent clinical trial ecosystem.


244. Explore collaborations with GAP-f partners to accelerate the generation of evidence on child-friendly formulations of ISL, using weight bands and with concurrent testing of age groups making use of PAWG and GAP-f input on PSPs and PIPs.  



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