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2022 Rome Action Plan on Paediatric HIV & TB



WHO commits to: 

55. Continue to convene and facilitate a standing expert group to enable timely prioritization of new HIV agents and provide guidance on research priorities and surveillance for use of HIV agents in pregnant and breastfeeding women as integral part of the Conference for ARV Drug Optimization (CADO) process.


56. Continue to support and host the HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group (HHS PTWG) to ensure development and updating of appropriate standards, tools and policies to support implementation of accelerated approaches in research and innovations in surveillance to generate high-quality evidence for new HIV agents in pregnancy. 


57. Continue to convene and develop norms and standards for new indications for the use of new ARVs for HIV treatment and prevention in pregnant and breastfeeding women in the updating process of the WHO guidelines on the use of ARVs for HIV prevention and treatment – Within a public health approach.


58. Continue to convene and implement a collaborative framework for strengthening the surveillance of existing and new ARVs during pregnancy (including regular reporting to the WHO Advisory Safety Committee of Medical Products).


59. Build on existing accountability frameworks, such as The Global R&D Observatory or the Global R&D Hub, to monitor R&D efforts to promote earlier generation of evidence to support use of new antiretrovirals in pregnant and breastfeeding women. 


60. Ensure alignment and represent WHO activities in the discussion and work of the ICH informal working group E21 on “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials".

WHO and Research networks[1] commit to:

61. Working together to collaboratively develop standards to strengthen systematic population data collection, registries, and master protocols to promote alignment and harmonization of studies in pregnant women across studies within the work of the WHO HIV, Hepatitis and STIs Pregnancy and Breastfeeding Therapeutics Working Group (HHS PTWG) . 


62. Ensure appropriate consultation and engagement of community members and community-based organizations through the research cycle for new therapeutics.


[1] Engaged in supporting the CTA principles (see section under research networks above and in annex section (Rome 6)


55. June 2023: Ongoing discussions (WHO-HHS)

56. June 2023: Ongoing work on standardization of maternal, pregnancy and infant endpoints and definitions for research studies and surveillance programs; Ongoing production of a tool kit with key materials for research in PLW for different stages of research (eg. Pk and dosing, clinical studies, ethical considerations, community engagements) (WHO-HHS)

57. June 2023: Task Team on Adult Treatment hosted in February 2023 in Seattle post CROI 2023 with review of new evidence in PLW
HHS Adult ARV working group & HHS PTWG meeting Q42023 in preparation on 2nd and 3rd line incl. PLW  (WHO-HHS)

58. June 2023: December 2022 report to ASCoMP on new data on DTG showing the NTD signal was no longer significant
New collaborative framework for active surveillance for CAB LA PrEP  during pregnancy adopted (London, May 2023) with  technical partners, MoHs, and civil society implementing research studies with WHO convening role (with annual reporting to ASCoMP) (WHO-HHS)

60. June 2023: WHO focal point nominated (WHO has an observer role) and HHS PTWG expert names provided to ICH for contribution to the drafting of new guidelines (WHO-HHS)

61. June 2023: WHO PTWG: Research agencies contributing to harmonization/standardization of endpoints and approaches work (WHO and Research Networks)

62. June 2023: WHO PTWG: Ongoing consultations with community and civil society representatives (WHO and Research Networks)


WHO commits to: 


126. Continue to work with countries and partners to implement and scale-up access to key diagnostics for infants and children, especially including point-of-care infant diagnosis, viral load, and diagnostics for advanced HIV disease, encouraging an optimized, integrated diagnostic network while doing so.


127. Develop and publish additional guidance on the treatment monitoring algorithm and associated thresholds for viral suppression and treatment failure.


128. Support users to detect product problems for IVDs (including through external quality assessment and 3rd party quality control) to enhance post-market surveillance for IVDs.


129. Support development of national Essential Diagnostics Lists to include HIV and TB diagnostics, particularly point-of-care infant diagnosis and LF-LAM in decentralized non-laboratory settings.


130. Implement and prioritize a sustainable and affordable collaborative registration procedure for diagnostics and support national regulatory bodies to make use of it to streamline their national regulatory procedures. 


131. Subject to support from donors (see 15 above), reinforce the capacity of its Prequalification of In Vitro Diagnostics programme, so that additional resources can help to expand its mandate and support efficient review of HIV-related diagnostic products (including advanced HIV disease diagnostics). 

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.


126. June 2023: Policy brief on HIV viral suppression launched at IAS 2023

127. June 2023: Policy brief on HIV viral suppression launched at IAS 2023

128. June 2023: Collaborating with WHO Prequalification department

129. June 2023: Ongoing

130. June 2023: Collaborating with WHO Prequalification department

131. June 2023: Ongoing


WHO commits to:

203. With appropriate evidence, prioritise the review of additional urine-based lateral flow assays, molecular technologies (point-of-care and laboratory-based), alternative (non-sputum based) specimen types, and novel testing approaches to provide better tools for paediatric TB detection and encourage and introduce market competition.


204. Timely processing of submissions by WHO pre-qualification of molecular TB diagnostics and expand to include other tests while also supporting national regulatory bodies by making WHO assessments available.


205. Generate target product profiles for TB screening and diagnostics with inclusion of specific considerations for children and adolescents. 


206. Develop WHO programmatic standards for TB diagnostics that ensure the best available tools are accessible and used to impact patient care. 


206. June 2023:

  • In April 2023 WHO published a new WHO standard on universal access to rapid TB diagnostics. The WHO Standard: Universal access to rapid tuberculosis diagnostics sets benchmarks to achieve universal access to WHO-recommended rapid diagnostics (WRDs), increase bacteriologically confirmed tuberculosis and drug resistance detection, and reduce the time to diagnosis. WHO-recommended rapid diagnostics are highly accurate, cost-effective, reduce the time to treatment initiation, and impact patient-important outcomes. 

  • The WHO Standard comprises twelve benchmarks to be computed by countries in the four steps of the diagnostic cascade: identifying presumptive tuberculosis, accessing testing, being tested, and receiving a diagnosis. Mapping of enablers, approaches, and solutions to scale up the use of WRDs is provided to assist countries in meeting the standard and related benchmarks. Specific investment considerations are also provided, as well as two country case studies providing real-world examples of implementation Universal access to tuberculosis diagnostics will result in better health for all and reduce the unacceptably high mortality due to this curable and preventable disease. It will require investment and concerted work by countries, partners, donors and civil society. The WHO Standard is available here:


WHO commits to:

290. Continue to host the Paediatric ARV Drug Optimization (PADO) process and update the list of priority products with a view to providing a consistent, clear, and harmonized set of products for communication to industry and regulators in a timely manner, with inclusion in the WHO Expression of Interest list as soon as dosing is provided.


291. Continue to use the Paediatric ARV Working Group (PAWG) mechanism to provide recommendations on optimal dosing and ratios for HIV paediatric drug formulation development.


292. In collaboration with other partners, continue to revise the Optimal ARV Formulary and ensure its inclusion in the WHO Model List of Essential Medicines List for Children by end of 2023 and 2024 respectively.


293. By the end of 2023, update treatment guidelines on sequencing ART regimens for children and adolescents with treatment failure to ensure that more effective drugs in age-appropriate formulations are recommended for children who experience treatment failure. 


294. Promote and facilitate operational and implementation research on treatment failure and HIV drug resistance that may adversely impact WHO preferred regimens for infants, children and adolescents, including acquired and transmitted resistance and selected drug resistance in infants exposed to maternal ART and post-natal infant antiretroviral prophylaxis (PNP). 


295. Promoting and gathering evidence from research on continuation of abacavir when changing a failing NNRTI or PI-based regimen to a DTG regimen in children below 30 kg.

296. By the end of 2023, in collaboration with appropriate partners, undertake forecasting exercises for antiretroviral drugs and formulations for sequencing of the regimens in children and adolescents with confirmed treatment failure following adherence interventions.


297. Define, in collaboration with PAWG members, principles to guide evidence generation for policy revision to include novel agents, innovative delivery methods and strategies for PNP.


298. Convene and promote coordination and collaboration among key stakeholders engaged with investigation and development of broadly neutralizing antibodies (bNabs) for treatment and prevention of HIV in infants and children by Q1 2023.


299. Convene efforts to facilitate generation and gathering of evidence on causes of mortality in children living with HIV and on how to optimize the package of care in diagnosis, prevention and treatment of advanced HIV disease (AHD) in children and adolescents.


300. Work via its regional offices and in collaboration with all partners (Global Fund, PEPFAR, GAP-f, etc.) to support transition plans and ensure rapid uptake of optimal ARVs globally, including low burden and lower volume countries. 


301. With PAHO leadership, leverage PAHO Strategic Fund to support rapid country adoption of ALD and DRV/r novel Paediatric formulations. 


302. Convene and collaborate with MOHs and all partners (PEPFAR, Global Fund, GAP-f and other implementing partners) to strengthen and expand efforts to rapidly monitor safety and effectiveness of novel Paediatric ARVs including DTG, ALD and co-formulated DRV/r.


303. Continue supporting the implementation of the STOP-AIDS toolkit for the AHD in children.


290. June 2023: ONGOING COMMITMENT - plans to integrate PADO with CADO- include discussion of PNP and pipeline options for infants and young children

291. June 2023: Ongoing discussions on optimal dosing of ARVs (small molecules) for neonatal dosing

292. June 2023: Plans for revision of Optimal Formulary in Q4 of 2023 with submission of new products to EML in 2024

293. June 2023: Treatment failure in children and adolescents with perinatally-acquired HIV - systematic review to be commissioned in preparation for guidelines revision

294. June 2023: Paediatric HIV treatment failure systematic review to be commissioned alongside adult treatment failure review in preparation for guidelines revision

298. June 2023: WHO virtual consultation on bNAbs for PNP scheduled for October, 2023

300. June 2023: Global Alliance to End Paediatric AIDS launched and technical working groups for Pillar 1 and 4 formed

303. June 2023: Paeds AHD ECHO webinar planned for December 5, 2023

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