2022 Rome Action Plan on Paediatric HIV & TB
Gilead, ViiV Healthcare and MSD commit to implement the principles of the Call to Action (CTA) launched on 1st December 2021 by stakeholders 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.
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ViiV Healthcare, building on ongoing work to support generation of data during implementation research of CAB LA, commits to:
32. Support investigators to allow women who become pregnant while taking CAB LA to continue CAB LA in pregnancy, following a discussion with their healthcare provider on the benefits and risks, and guided by the approved label.
33. Collect and report safety and birth outcomes (including pregnancy and neonatal outcomes) in women who receive CAB LA PrEP or CAB/RPV LA treatment during pregnancy.
34. Support, facilitate and generate data on pregnancy, birth, and infant safety outcomes for CAB-LA in pregnancy and during lactation via ongoing clinical, non-interventional and implementation science studies and if needed with rapid initiation of additional dedicated studies.
35. Collect PK and safety data in women who become pregnant and elect to stay in the Phase 3 clinical study.
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.
ViiV Healthcare commits to:
245. Collaborate with key PAWG members and research networks to support ViiV to undertake appropriate modelling to inform the use of CAB LA for perinatal and postnatal prophylaxis.
246. Advance research and collaborate with WHO and research networks on the investigation of CAB LA injectables in the context of PNP and treatment for children and adolescents.
247. Contribute to the implementation of a platform trial to assess innovative options to deliver postnatal prophylaxis.
248. Collaborate with GAP-f partners to design and set up a dedicated platform for neonatal PK studies.
249. Support long-term follow up in the ODYSSEY trial, including long-term safety profile data by Q1 2024.
250. Collaborate with GAP-f partners to develop an enhanced monitoring and safety data platform for new and existing paediatric ARV drugs.
251. Shipping (GSK/ViiV Healthcare) study drugs (DTG) for DOLPHIN Kids in Q1 2023.
252. Advance research and contribute to collaborations and coordination designed to ensure more efficient and timely investigation of bNABs in the context of PNP and paediatric treatment.
 DOLPHIN-Kids is primarily a drug interaction study between DTG and the TB drug rifapentine in children and adolescents living with HIVin South Africa. ViiV is supporting this study by drug donation of DTG clinical trials’ material.
ViiV commits to:
407. Support the study the possible interaction between Dolutegravir and Rifapentine.