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
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.
-
MPP commits to:
316. Continue to facilitate access to the best available medicines for children. Specifically, the MPP will continue to work with patent holders to in-license paediatric drugs as prioritized by the WHO/PADO, and to sublicense to generic manufacturers to ensure that appropriate formulations are rapidly developed, registered and made available in as many developing countries as possible.
317. Continue to inform all countries in the paediatric license group on the status of paediatric ARV patents.
318. Expand its quarterly reported information on the progress of priority paediatric drug formulations, sharing not only the list of countries with regulatory filings, regulatory approvals, and supplies of paediatric DTG (10 mg scored dispersible tablets), but also reporting for paediatric ALD (ABC/3TC/DTG 60/30/5 mg) as an important upcoming addition to the paediatric HIV treatment toolbox. In addition, this reporting will include anonymized regulatory filing plans and timelines, as well as quarterly country-by-country volumes of medicines supplied across all countries covered by the MPP-ViiV Healthcare licence for paediatric DTG.
318. June 2023: As committed at the Vatican in December 2022, MPP expanded its quarterly reported information on the progress of priority paediatric drug formulations. This expanded information, which is obtained from MPP licensees, is now available as a downloadable Excel document, from our MPP’s website at: https://medicinespatentpool.org/what-we-do/addressing-childrens-needs
pALD introduction and roll-out: MPP has contributed to the collaborative development of a GAP-f partner memo on pALD introduction and rollout planning considerations for national programmes (which is available in multiple languages from: https://pedaids.org/resource/paediatric-abacavir-lamivudine-dolutegravir-pald-fixed-dose-combination ).
The GAP-f partner pALD transition planning memo is also available from the CHAI website at: https://www.newhivdrugs.org/post/gap-f-brief-pald-introduction-and-rollout-planning-considerations and will be available soon from the GAP-f website at: https://www.who.int/initiatives/gap-f .
318. October 2023: MPP expanded its quarterly information on the progress of priority paediatric HIV drug formulations. This data is obtained from MPP licensees and is available as a downloadable Excel document, from MPP’s website at: https://medicinespatentpool.org/what-we-do/addressing-childrens-needs. It includes, for both paediatric DTG (DTG 10 mg scored dispersible tablets – pDTG) and for paediatric ALD (ABC/3TC/DTG 60/30/5 mg dispersible tablets – pALD), quarter-by-quarter lists of countries in terms of: regulatory filing plans, ongoing regulatory reviews, regulatory approvals, and product supplies (including actual volumes supplied for each country-quarter pair). The table below summarizes progress by the end of June 2023.
Indicators
(at the end of June 2023)
Stringent regulatory approval
-
FDA Tentative Approval
-
WHO Prequalification
-
Expert Review Panel (period of validity)
pDTG
-
Macleods, Viatris
-
Macleods
-
–
pALD
-
Aurobindo, Viatris
-
–
-
Cipla (2023-12-13)
Countries where manufacturers were planning to file
pDTG: 12 countries
pALD: 43 countries
Countries where regulatory review was ongoing
pDTG: 15 countries
pALD: 11 countries
Countries where regulatory approval had been obtained
pDTG: 20 countries
pALD: No country yet
Countries where supplies had taken place
pDTG: 89 countries
(see *)
pALD: No country yet
Volumes supplied so far
pDTG: 5,445,735 packs
(of 90 tablets, see **)
pALD: No pack supplied yet
* For pDTG, 9 countries were supplied for the first time in the latest quarter (2023-Q2): Albania, Argentina, Equatorial Guinea, Eritrea, Gabon, Lebanon, Malaysia, Morocco, and Pakistan.
** For pDTG, 584,581 packs of 90 tablets were supplied in the latest quarter (2023-Q2) only.