HIV TREATMENT
2020
Action 27. Mobilize their networks and work with communities to help build treatment literacy, generate demand, and expand access to ARVs among children.
Action 34. Increase efforts to share information on the roll-out of new paediatric formulations, including lessons learned.
Paediatric HIV & TB : Rome Action Plan
2022 Rome Action Plan on Paediatric HIV & TB
UNITAID
Funders commit to promote the implementation of the Call To Action principles through their investments, this includes:
52. Fund clinical trials of adequate size to assess the safety in pregnancy of high priority new agents with expected broad use by young women for treatment and prevention of HIV such as CAB LA, LEN and ISL.
53. Support country action and a global platform to strengthen active surveillance of safety of HIV agents (such as TAF, DRV/r and CAB LA) in pregnancy, building harmonization and linkages between surveillance networks, with a focus on the most-affected countries and populations.
Unitaid commits to:
54. Continue to provide funding through the WHO enabler grant to support the work on the development of the R&D framework for studying ARVs during pregnancy and breastfeeding to ensure that mothers and their offspring benefit from most optimized treatments.
54. June 2023: New Enabler funding awarded to WHO up to 2027 to support the work on the development of the R&D framework for studying ARVs during pregnancy and breastfeeding to ensure that mothers and their offspring benefit from most optimized treatments.
Donors commit to:
105. Work towards reducing disease funding silos for diagnostics in order to encourage and support more comprehensive diagnostic strategies, including person-centred care, diagnostic integration and network optimization.
106. Support improved global and national coordination across donors, including funding mechanisms, pooling procurement volumes in negotiations with diagnostic manufacturers, and other activities.
107. Prioritize and re-invigorate paediatric-specific funding for strengthened implementation of HIV and TB diagnostics and support of person-centred diagnostic technologies (ie. point-of-care infant diagnosis, simplified TB sample types).
108. Support current efforts to transition from outright instrument procurement to all-inclusive bundles, or other novel pricing model to ensure in-country harmonization of commodity procurement.
109. Support in a transparent manner, including key performance indicators, the procurement of commodities and operational costs to maintain and further scale-up POC infant diagnosis, as well as viral load testing for infants, children, and pregnant and breastfeeding women and advanced HIV disease diagnostics, including TB, as an integral part of optimized and integrated national diagnostic networks and in accordance with national plans and targets.
110. Continue (and expand) support to WHO PQ to broaden their mandate as planned and to shorten timelines for review and minimize time to national registration.
Unitaid commits to:
123. Continue work on accelerating the availability and affordability of innovative diagnostic tools, including those that benefit children living with HIV, TB and other co-infections – either through funding late-stage development or product adaptations (including sample approaches) that will adapt to the settings these tools are needed.
124. Continue direct support to WHO within the enabler grant for diagnostic activities, as well as direct support to WHO PQR for quality and regulatory priorities.
125. Pursue opportunities to strengthen regional manufacturing of diagnostics, as part of Untaid’s new strategy (2023 – 2027).
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.
124. June 2023: New Enabler funding awarded to WHO up to 2027 to support this work
Unitaid commits to:
198. Catalyse the evaluation and uptake of new tools and approaches to reduce the case detection gap through market acceleration, accuracy trials, operational research, and optimised implementation algorithms.
199. Support operational and implementation research to increase case-finding through new tools, testing procedures and algorithms, and the scale-up of product procurement in high TB burden countries.
200. Continue work on accelerating the availability and affordability of innovative diagnostic tools, including those that benefit children living with HIV, TB and other co-infections – either through funding late-stage development or product adaptations (including sample approaches) that will adapt to the settings these tools are needed.
201. Ensure that catalytic pilots for diagnostic introduction will promote efforts for diagnostic network optimization to accelerate a multi-disease approach, as part of efforts to further integrate laboratory networking and reduce disease silos.
202. Continue direct support to WHO within the enabler grant for diagnostic activities, as well as direct support to WHO PQR for quality and regulatory priorities.
199. June 2023:
-
New round of Dx investments awarded in late 2022, to support this work. (Suggest expanding a bit on the LSTM component and specific pediatric work there).
-
The protocol to test the accuracy, feasibility and cost effectiveness of diagnostics combinations at point of care has been approved and will start enrollment in 7 countries in September 2023. Pediatric populations are included, including generating evidence for the use of CAD.
202. June 2023:
-
A number of consultations were led by WHO to inform protocol development, governance and coordination between and outside Unitaid’s investments.
-
New Enabler funding awarded to WHO up to 2027 to support this work.
Unitaid commits to:
288. Support the study of appropriate dosing and safety of DTG dispersible tablets and the DTG oral film in neonates, as well as acceptability amongst care-givers by the end of 2024.
289. Continue to support WHO and partners on the development and introduction of optimal ARV formulations, such as generic ALD, paediatric DRV/r FDC and paediatric TAF, and on the roll out of a paediatric Advanced HIV Disease (AHD) package of care – including associated treatment literacy and training, and enhanced monitoring & safety data platform for new and existing paediatric ARV drugs.
288. June 2023: Study protocol amendment and IRB submissions ongoing
289. June 2023:
-
New Enabler funding awarded to WHO up to 2027 to support this work
-
RFP to reduce paed and adult deaths due to AHD closed in Jan 2023. Two applicants selected and new grants in development, with the aim of implementing projects and implementation research to generate evidence on optimized delivery of STOP-AIDS Toolkit
-
Generic ALD development work ongoing with 2 manufacturers, USFDA submission done in Q1 2023, approval expected in Q3 2023
-
Paed DRV/r FDC BE studies ongoing
-
Paed TAF: Prototype development concluded
Unitaid commits to:
423. Extend its funding to IMPAACT4TB project to generate evidence on co-administration of rifapentine and dolutegravir among children under the age of five who are exposed to TB.
424. Invest in studying the dosage and safety of rifapentine in HIV-infected and HIV-uninfected children (0-12 years of age) with TB infection.
425. Promote a head-to-head comparison on use of 3HP versus 1HP in HIV-infected and HIV uninfected children
426. Support the rapid adoption of shorter TPT preventive treatment, reducing the price of rifapentine and rolling out 3HP and 1HP in 12 project countries and beyond, and facilitating supplies of 1 HP.
427. Continue to invest through the BENEFIT Kids Project in improved formulations to treat drug-resistant TB including moxifloxacin (MFX), linezolid (LZD), optimization of dosing of drug-resistant TB, and testing the effectiveness of levofloxacin as prevention of MDR-TB in children.
428. Support WHO on the rapid adoption of new shorter all oral regimens for DR-TB using new drugs (i.e., bedaquiline, pretomanid, and delamanid) assuring availability of adaptations and options for children and adolescents.
423. June 2023: The Dolphin Kids study on co-administration of rifapentine and dolutegravir among children under the age of five who are exposed to TB started enrollment in June 2023. A 3HP pediatric formulation is expected to be submitted for WHO PQ in late 2023. In parallel a Crush study will inform how adult formulations can be used in children.
424. June 2023: The TBTC 35 study completed enrollment in Phase 1 will present interim results in June 2023
425. June 2023: The 1 to 3 study is planned to start enrollment in June 2023
426. June 2023: The price of 3HP FDC dropped to US$14.25 and US$18.90 for 1HP.
427. June 2023:
-
Costed extension granted up until Dec 2024, expanding the project scope to include the establishment of a WHO-backed data platform for DR-TB patients.
-
Ongoing preference assessment (taste and acceptability) of Moxifloxacin and Linezolid formulations’ use in children.
428. June 2023: The endTB operational research data was used towards the comparator to evaluate and recommend the new BPAL/M regimen and will deliver efficacy and safety data on 5 short regimens for multiple groups not currently eligible for BPAL/M.