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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 

Gilead, building on the progress made by removing contraception requirements for ongoing long acting lenacapavir (LEN) prevention studies and allowing women who become pregnant in LEN HIV prevention trials to consent to stay on study drug, commits to: 

29. Provide PK and safety data for lenacapavir in lactating and pregnant women from ongoing prevention studies by 2026.


30. Remove contraception requirements from other ongoing and planned treatment studies with LEN, and permit women who become pregnant in LEN trials to remain on study drug upon consent (contingent on supportive safety data for the agent(s) partnered with LEN).


31. Support conducting a dedicated safety study in pregnant women to evaluate potential adverse effects of LEN used for treatment in pregnant women, birth outcomes, and at least short-term follow-up of infants after birth (contingent on supportive safety data for the agent(s) partnered with LEN).


26. June 2024: Completion of EFD studies by the end of Phase 2 studies is Gilead’s standard practice for compounds in the HIV treatment pipeline.   

27. June 2024: Implementation of completing PPND studies by the end of Phase 2 studies is ongoing for compounds in the HIV treatment pipeline.  

28. June 2024: Generating PK and early safety data in pregnancy for new drugs by the end of Phase 3 clinical trial completion is Gilead’s standard practice, provided here are no contraindications to use in pregnancy. 

29. June 2024On track to provide PK and safety data for LEN in lactating and pregnant women enrolled in prevention studies by 2026. 

 PURPOSE-1 evaluating LEN for PrEP in adolescent girls and young women in South Africa and Uganda completed enrolment with more than 5300 participants in September 2023. PURPOSE-2 enrolled over 3000 cisgender men, transgender women, transgender men, and gender nonbinary people ≥ 16 years of age. Participants are not required to use contraception and those who become pregnant may remain on study drug upon consent.   

30. June 2024: Removing contraception requirements and permitting women who become pregnant in treatment studies to remain on study drug upon consent is the standard for ongoing and planned trials with LEN, provided there is supportive safety data for the LEN partner agent(s). This has been implemented in the Phase 3 program with the fixed dose combination of bictegravir/lenacapavir (BIC/LEN).

31. June 2024: A dedicated study in pregnant women taking LEN for treatment is pending the identification of a long-acting partner for LEN.  



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.




Gilead commits to:

230. Prioritizing development of low dose F/TAF tablet for oral suspension (TOS) and completing investigation of low dose F/TAF TOS paediatric dose for children 3-<25kg older than 4 weeks by end of 2025.


231. Supporting generic development, manufacturing, and regulatory approval of the prioritized paediatric low-dose F/TAF paediatric formulation (as needed beyond what is already allowed through the MPP-Gilead licence for TAF). 


232. Fulfilling ongoing PSPs and PIPs for lenacapavir with collaboration and feedback from the GAP-f partners and collaborating to evaluate the potential investigation of lenacapavir in children with multi-drug resistant HIV infection.


233. Collaborate on the design of a platform trial and development of appropriate neonatal formulation(s) to assess innovative options to deliver postnatal prophylaxis and evaluate neonatal PK.


234. Collaborate with GAP-f partners to develop an enhanced monitoring and safety data platform for new and existing paediatric ARV drugs.


235. Make publicly available synopses of PSPs, similar to publicly available PIP summaries, for PADO priority products to enable a more transparent clinical trial ecosystem. 


230. June 2024: The pediatric study evaluating F/TAF TOS is ongoing and enrolling children 4 weeks of age and older who weigh 3-<25kg ( NCT02016924)

231. June 2024: Support of the development and registration of a low dose F/TAF pediatric formulation is ongoing. 

232: June 2024: Work is ongoing to identify a long-acting partner for LEN to be evaluated in children with multi-drug resistant HIV infection. 

233. June 2024: Gilead participated in the workshops on postnatal prophylaxis coordinated by WHO and IMPAACT to consider innovative study designs to evaluate postnatal prophylaxis.

234. June 2024: Pending

235. June 2024: Work has initiated to prepare and make available current PSP synopses for key products in development. 

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