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December 05, 2018

Progress report on 2017 Rome Action Plan

October 23, 2018

Progress Report on 2017 Rome Action Plan 

July 30, 2018

Dear colleagues,

During the April webinar, we requested the project management team to prepare an overview of progress on the Rome Action Plan. The assessment showed that the stakeholders who adopted the Rome Action Plan are largely taking their commitments seriously, leading to improvements along the spectrum of paediatric ARV research, development, and uptake. Out of the 52 action points and commitments, significant progress has been observed on 13%, good progress made on 42%, and partial progress has been noted in 25%. In addition, real progress is needed on one item, and there are no updates on 10 items.  The most notable developments have been:

• clarifying regulatory requirements to accelerate completion of pediatric plans;

• communicating to research networks, pharma, and SRAs on the need to focus on prioritized ARVs;

• fostering greater attention to children among networks of people living with HIV;

• organizing formal and informal meetings on diagnostics, with a planned high-level meeting in the fall;

• and revising treatment guidelines to enable use of more potent drugs in children.

Good progress has been made in:

• encouraging procurement of optimal drugs and formulations;

• collaborating on planning for country introduction of soon to be available products;

• and ensuring their availability in larger quantities and at access price.

Partial progress has been observed in:

• expediting regulatory review (both SRA and NRA) of priority formulations;

• and on the development of specific drugs.

The slowest progress has been on compressing pharma’s R&D timeframes for specific priority pediatric ARVs, many of which are falling behind schedule and one of which is not proceeding in accordance with the spirit of the Action Plan. In several other areas stakeholders have not yet reported on progress.  While many of the activities outlined above represent the continuation of previous efforts, the Rome Action Plan has provided an important opportunity to strengthen or expedite action, as well as to spur complementary steps that would not have otherwise been taken.

Please find below the updates on actions taken over the last month:

​

FOCUS

• Action 4: Experts met in June to update the optimal pediatric formulary

• Action 5: PADO priorities and Rome Action plan communicated to IMPAACT and PENTA members with active collaboration to accelerate completion of DTG plan.

• Action 7: GAP-f members developing proposals to communicate to FDA and EMA on priority review of PADO-related PSPs and PIPs dAction 10: The ARV Procurement Working Group created a website that could facilitate the provision of reliable forecasts and heighten awareness of the continued procurement of less optimal products:

ACCELERATE

• Action 11:

• Action 21: Unitaid is exploring options to facilitate rapid introduction of paediatric DTG in early adopting countries, leveraging the Optimal ARV Project in collaboration with CHAI.

• Action 25: UNICEF, in collaboration with USG (USAID, CDC & PEPFAR), UNAIDS and WHO, is planning multi-country meetings for the WCA & ECA for 3rd and 4th quarter to build capacity in countries for availability and use of age, sex and geographic disaggregated data for planning and programming. Paediatric scale up in WCA is proceeding with a recent large multicountry workshop hosted by UNICEF and partners to promote adoption of family based index case testing policies. This workshop was followed by targeted TA visits to countries to develop SOPs and protocols for rapid rollout of family-based index testing.

• Action 26: All the 10IATT optimal paediatric formulations needed to provide WHO recommended preferred and alternative first- and second- line regimens for all children have been placed on UNICEFs products list of ARV formulations, and UNICEF SD continues to advocate for countries to procure optimal paediatric formulations. UNICEF SD has long-term arrangements with manufacturers for 9 out of the 10 IATT formulations. Raltegravir 100mg chewable tablets is procured through adhoc tenders. UNICEF tenders issued for HIV POC diagnostics in 2018 also seeks to promote the POC pipeline through inclusion in the tender scope of products that are expected to enter the market as well as those that are already available. In April 2018 UNICEF launched a tender which would serve as an instrument for piloting all-inclusive pricing contracts for Nucleic Acid testing services, uniform across assay types (HIV Quant, HIV Qual, HCV, HBV and HPV), in four selected early-adopter countries: Malawi, Tanzania, Uganda, and Zimbabwe.

COLLABORATE

• Action 31: The Pediatric HIV Treatment Initiative (PHTI) met on 7-8 June to discuss collaboration on the registration, introduction, and roll-out of formulations expected to become available in 2019.

• Action 35: UNAIDS worked with the UN Human Rights Council to ensure the language of an upcoming resolution on human rights and HIV included strong language on access to optimal drugs for children.
  UNAIDS has provided funding to community-based organizations in a number of countries, including Cameroon, DRC, Mozambique, Uganda to support women during pregnancy and breastfeeding to remain in care and on treatment, and to encourage them to have their infants and other children tested for HIV.  Lessons learned from these networks may provide best practices in encouraging families to have their children tested.
  UNAIDS is supporting countries on launches of the OAFLA/AU Free to Shine Campaign, including a launch with the First Lady of Mozambique in June.

PEPFAR included pediatric treatment targets in all 2018 COPs. UNAIDS is working with countries on setting pediatric treatment targets within NSPs, including the recently released NSP in Swaziland. 

Individual Commitments

• In May, the FDA issued draft guidance entitled which includes “recommendations on when sponsors should initiate pediatric formulation development and begin pediatric studies to evaluate antiretroviral drug products for the treatment of HIV infection.” The draft guidelines closely parallel the commitments made in Rome, so if issued as drafted, they will provide a clear public reinforcement of these commitments.

We count on you to keep the team updated on steps you have been taking to implement the Action Plan. Please send updates to tgabelnick@pedaids.org, Francesca.Merico@wcc-coe.org, or penazzatom@who.int.  We also encourage you to visit the online tracker to see whether the status of your actions is up to date and to learn about progress on other items: https://www.paediatrichivactionplan.org/

Best regards,

Gottfried Hirnschall and Chip Lyons, AIDS Free Working Group Co-Chairs

May 09, 2018

Dear Colleagues,

We are pleased to share with you the latest update on the implementation of the Rome Action Plan on Pediatric HIV Treatment and Diagnosis. We would also like to take this opportunity to thank the large number of people who actively participated in the first webinar on the Action Plan, held on 24 April. As heard on the webinar and summarized below, it is clear that the positive energy from the Vatican meeting continues to inspire action across the three thematic areas and on  individual commitments. We look forward to hearing about additional steps forward in the coming weeks and months.

Below please find a synopsis of some of the actions taken since our last update, including many of the elements reported in the 24 April Rome Action Plan webinar. A more comprehensive overview, including further details on the points below, is available on the tracking website: https://www.paediatrichivactionplan.org/ . Please remember to send regular updates to our project management team (tgabelnick@pedaids.org or Francesca.Merico@wcc-coe.org) so they can properly reflect your efforts and accomplishments.

Best regards,

Gottfried Hirnschall and Chip Lyons, AIDS Free Working Group co-chairs

​

FOCUS

• Action 3: PAWG has provided input to Gilead on the TAF development plan, recommending faster development of the PADO prioritized formulation (F/TAF alone), especially for younger children.

• Action 5: IMPAACT and PENTA have been collaborating (including sharing data and expertise) to accelerate the final dosing plan for pediatric DTG (adolescents down to newborns)

• Action 6 : ViiV has committed additional resources in Pediatrics with the appointment a Head of Pediatric Strategy (Bill Collier) who has convened a cross-functional team to address possible ways to accelerate development of pediatric DTG.

ACCELERATE

• Action 8:  PEPFAR is working with the GAP-f and PAWG to determine where support is needed to advance priority pediatric drug development.  PEPFAR is looking at opportunities to support practical studies evaluating program experiences with introduction of Raltegravir granules for newborns and young infants. PEPFAR has also been working directly with originator manufacturers (Merck, ViiV, J&J) on their plans to be the direct supplier of optimal pediatric ARV products in PEPFAR-supported HIV programs until those products are available from other sources.

• Action 9: Since 2017, PEPFAR has taken direct action to ensure that PEPFAR funds are not used to purchase ARVs that are no longer standard of care (eg, PEPFAR funds should no longer be used to purchase nevirapine products for treatment in older children and adults). Its COP18 guidance stated, “For children, PEPFAR supports use of currently preferred regimens (e.g. lopinavir/ritonavir-based first-line regimens for children under 3 years old or 30 kg.) in child-friendly formulations and will support rapid introduction of new drugs and formulations for children (e.g.dolutegravir) as they become available and recommendations are updated. “ [page 56, https://www.pepfar.gov/reports/guidance/c77910.htm ]

• Action 10: The ARV Procurement Working Group (APWG) met on 16 April to discuss pediatric ARV procurement patterns and forecasting.

• Action 11: WHO is finalizing an open letter to EMA and FDA that includes feedback from PAWG on PIPs for EMA. The messages of the letter will be communicated to relevant companies on dedicated calls with PAWG members to facilitate dialogue. PAWG members will remain available to discuss specific products with relevant innovators. PAWG recommendations will be posted on WHO’s website.

• Action 13: ViiV will be further increasing resources in Pediatrics by appointing a Medicine Development Lead to promote pediatric medicines across their R&D portfolio.

• Action 18: ViiV has new data sets for pediatric DTG and will be requesting a meeting with FDA early this summer to review development plans. J&J reported on work with CHAI and University of Liverpool on a pediatric Darunavir FDC, possibly using nanotechnology. See also updates from Cipla and Mylan, below.

• Action 21: PEPFAR provides funds to implementing partners for activities that include, as appropriate, provision of technical assistance and training for introduction of new drug regimens for adults and children.  It is working with partners to ensure that plans for TLD roll-out include children down to 30kg.

• Action 24: A first draft of a PAWG toolkit for pediatric drug and formulation development, developed by WHO in collaboration with Unitaid, IMPAACT, PENTA-Id and other partners, has been shared with manufactures and regulators for review, and the final version will be made available in July 2018. GAP-f is working on a pediatric forecasting model, with a prototype due to be launched in July.

• Action 29: GNP+ has had early conversations with ICW about collaborating to mobilize communities of mothers and parents. Currently, GNP+ is trying to add a focus on children into its existing work plans and it is trying to identify some joint resource mobilization activities in order to do more. GNP+ has also conducted a survey of approximately 800 PLHIV from more than 90 countries on ARVs, including pediatric ARVs. The official release of the data will be at AIDS 2018.

COLLABORATE

• Action 35: UNAIDS continues to work with the AU Free to Shine initiative to highlight the work on pediatric treatment.

• Action 37: Webinar: On 24 April, the AIDS Free Working Group co-chairs hosted a webinar among Vatican meeting participants and other key stakeholders to provide an update on their efforts to monitor  implementation of the Rome Action Plan and to allow those who make commitments to provide brief updates directly to the group. The webinar was well-attended and showed that activities are ongoing on the majority of action points. As suggested during the call, an overall assessment of implementation status across the Action Plan will be done in the coming weeks to identify any significant gaps. A recording of the webinar is available upon request (send requests to tgabelnick@pedaids.org).

• Action 38: Milestones have been developed for most action points, all available online at https://www.paediatrichivactionplan.org/

• Action 40:  The Global Accelerator for Pediatric formulations (GAP-f) launched a new website where a variety of resources related to pediatric drug and formulation optimization can be found, as well as information on the activities of the GAP-f and its partners: www.gap-f.org . GAP-f partners published a peer-reviewed commentary in JIAS on “Shortening the decade‐long gap between adult and paediatric drug formulations: a new framework based on the HIV experience in low‐ and middle‐income countries” is now published (here).

• Action 41: On March 29, 2018, PEPFAR convened diagnostics companies, donors, and select implementing partners for a one-day Consultation meeting in New York City on strategies to improve access to HIV (and TB) diagnostics for infants and children in lower middle income countries (LMICs). Ambassador Birx provided opening remarks and participated in side meeting discussions with key attendees. The meeting ended up with concrete action items for diagnostic manufacturers to address to ensure cost efficient and uninterrupted diagnosis services for children and adolescents. On 19-20 April, on the margins of the UNAIDS/WHO Annual Consultation with Pharmaceutical Companies, Partner Organizations and Stakeholders meeting in Geneva, AFWG members met bilaterally with diagnostics companies to discuss challenges and opportunities for expanding access to pediatric diagnostics. As noted in the previous update, these consultations and others planned this summer are intended to culminate in a high-level meeting on pediatric diagnosis with a set of commitments across key stakeholders, which is likely to be held at the Vatican in early fall 2018.

Individual Commitments:

• PEPFAR included pediatric treatment targets in its country plans to maintain pressure for expanded access to ARVs. It has developed a website that makes program data available for review and analysis: https://data.pepfar.net/. PEPFAR and FDA have been working on mechanisms that would enable making FDA review documents available to WHO and/or national drug regulatory authorities for tentatively approved products to facilitate more timely regulatory approval of those products for use in PEPFAR-supported HIV programs. PEPFAR has also been working with WHO in advance of the upcoming WHO Guidelines meeting to advance optimal ARV regimens for children.

• ViiV: See actions 6, 13, and 18, above

• Cipla reported that in January, it filed with FDA for approval of a new process for its 2-in-1 pellets (LPV/r) that would multiply by 5 its current production capacity. Regarding the 4-in-1 (ABC/3TC/LPV/r) granules, clinical trials are beginning in Uganda in May and BE study underway. If BE data is deemed sufficient by regulators, the filing can be done in August, but if clinical data is needed, it will be filed in January 2019.

• Mylan reported that it filed for approval of 2-in-1 (LPV/r) granules with WHO PQ in December 2017 and with FDA in February 2018.

• Merck is working with PEPFAR and WHO to increase availability of Raltegravir for infants and to further simplify formulations for young children.

• Additional commitment: MPP The Medicines Patent Pool (MPP) committed to facilitating 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

March 12, 2018

Dear Participants of the Rome High-Level Dialogue on Pediatric Formulations and Diagnostics,
 
Please find below the second brief summary of recent activities reported to us by the partners of the AIDS Free Working Group. Again, we would appreciate if you could keep us informed of any additional or planned activities so we may continue to report on them to the wider group.
 
FOCUS

• Action 1: Two webinars were held on Feb 5th by ILF/IAS in collaboration with WHO to disseminate the key outcomes of the PADO3 review to manufacturers and key stakeholder. Recordings and slides from webinars are available from ILF/IAS - http://www.iasociety.org/HIV-Programmes/Programmes/Industry-Liaison-Forum/Events/ILF-Webinar-Report-back-on-PADO-3-review . A summary report on the PADO3 review (held December, 12 2017) was sent to representatives from pharmaceutical companies and to PADO members which include key stakeholders, regulators and key funders. The meeting report is available for dissemination (see document PADO3 review summary).

• Action 3: PAWG bi-monthly meetings for 2018 restarted on February 12th, 2018. A follow-up call with Gilead is being planned to review implementation of their paediatric plan for TAF.

• Action 5: PENTA-Id and IMPAACT research networks have disseminated the Rome Action Plan to their members which is being considered for planning of future research projects.

 
ACCELERATE

• Action 19: IMPAACT and PENTA-Id are continuing collaborative work on the P1093 and ODYSSEY studies to expedite the determination of appropriate dosing for DTG in children below 30 kg. Both studies are investigating WHO weight bands- based dosing.

• Action 21: UNITAID continues to support acceleration of the development and introduction of priority products. Efforts are ongoing to plan for facilitating rapid introduction of paediatric DTG in early adopting countries, leveraging the Optimal ARV Project in collaboration with CHAI.

• Action 24: PAWG is developing a toolkit to support manufactures and stakeholders involved in pediatric ARV development to ensure accelerated research, development, and introduction of priority pediatric formulations. A first draft of the toolkit, developed by WHO in collaboration with UNITAID, IMPAACT, PENTA-Id and other partners is been shared with manufactures and regulators for review, and the final version will be made available in July 2018.

• Action 27, 28 and Individual Commitment 10:

1. The Global Network of People Living with HIV (GNP+) launched a survey, The State of People Living with HIV at the end of 2017. This survey included questions on infants and childrens’ early diagnoses and optimal HIV treatment and care in their country as well as, information regarding stock outs of ARVs. Results of the survey are being analysed. GNP+ is planning to release the results at AIDS 2018.

2. GNP+ launched a new webinar series to provide treatment updates to people living with HIV. The first webinar focused on access to dolutegravir (DTG) and viral resistance to first-line ARVs (2 March). Access to paediatric versions of DTG was discussed.  The DTG webinar recording is now available at www.gnpplus.net/civil-society-speaks-fighting-for-universal-access-to-dolutegravir-dtg/

COLLABORATE

• Action 35: The Free to Shine Campaign was launched by the Organization of African First Ladies Against HIV/AIDS (OAFLA) and the African Union on the sidelines of the 30th Ordinary Session of the African Union in Addis Ababa, Ethiopia (January 29). UNAIDS, WHO, Abbott, EGPAF, United Nations Children's Fund, UNDP and  AIDS Accountability International, are partners in supporting the Campaign. UNAIDS has also instructed their country offices to support the in-country offices of the First the Lady to establish teams that will plan national activities and rapidly move the Free to Shine Campaign forward. http://www.unaids.org/en/resources/presscentre/featurestories/2018/february/20180106_OAFLA

• Action 40: GAP-f will continue to map the partners’ landscape outside of HIV, and is developing an updated concept note and business plan to be released by WAC 2018. A website is being established to facilitate the sharing of resources on pediatric formulation research, development, and introduction.

• Action 41: PEPFAR organized a technical meeting in early February to share best practices and discuss new strategies for identifying children living with HIV; in particular, finding well children and looking beyond traditional, facility-based settings. PEPFAR plans to convene a technical consultation on diagnostics for end March. WHO is organizing a follow-up diagnostics meeting during AMDS (April 19-20)
  A concept paper for the diagnostics consultation has been developed by partners within the AIDS Free Working Group; plans for the consultations and preparatory meetings are ongoing.

 
 
Best regards,
Gottfried Hirnschall, WHO and Chip Lyons, EGPAF
Co-Chairs, AIDS Free Working Group

January 28, 2018

Dear Participants of the Rome High-Level Dialogue on Pediatric Formulations and Diagnostics,

In Rome we committed as co-chairs of the AIDS Free Working Group to keep participants regularly informed of developments related to the Action Plan. We’re pleased to let you know that implementation has gotten off to a strong start, with stakeholders taking a variety of steps to follow through on their commitments, as well as to promote or facilitate the completion of actions by others.  It is clear that the enthusiasm expressed by so many people in Rome for greater focus, acceleration, and collaboration is quickly is translating into concrete actions. On our side, we have put together a small task team made up of representatives from EGPAF, PEPFAR, WHO, and the World Council of Churches (WCC-EAA) that will be responsible for proactively monitoring progress on the Action Plan and working with the AIDS Free Working Group (AFWG) on those actions committed to by the AFWG co-chairs.

Please find below a summary of recent activities reported to us. We would be grateful if you could keep us informed of any additional or planned activities so we may report on them to the wider group.

FOCUS

• Action 1: WHO convened a virtual meeting of the Pediatric ARV Drug Optimization (PADO) group in December to review the list of PADO3 pediatric ARV formulations and develop implementation considerations related to current priority products. Two webinars for dissemination of the key outcomes to manufactures and key stakeholders will be organized on February 5th by ILF/IAS in collaboration with WHO.

• Actions 2 & 4: WHO is working towards holding a Guidelines revision meeting  during the week of April 30th to review 1st and 2nd line regimens for neonates, infants and children, potentially including integrase inhibitors for first line use. Revised guidelines should be made publicly available at IAS in July. Plans are to update the ARV Optimal Formulary in May to ensure full alignment with any potential guidelines change that may occur.

ACCELERATE

• Actions 18 and 22: GAP-f partners have been discussing with ViiV and regulatory authorities to determine the best regulatory pathways for pediatric DTG (10 mg scored and 50 mg scored tablets) and ways to accelerate registration and introduction of DTG and RAL at country level. In November, CHAI issued in collaboration with ViiV an RFP for development of generic pediatric formulations of DTG, with the announcement of manufacturers selected expected in February.

• Action 20 and Additional commitment #1: In a letter to PEPFAR, FDA reiterated its general acceptance of the principles agreed in Rome to accelerate successful completion of pediatric plans (see attached letter). They should be communicated formally in the near future. WHO reached out to EMA to determine their interest in committing to similar rules.

• Action 24: PAWG is developing a toolkit to support manufactures and stakeholders involved in pediatric ARV development to ensure accelerated research, development, and introduction of priority pediatric formulations. A first draft of the toolkit, developed by WHO in collaboration with UNITAID, IMPAACT, PENTA and other key stakeholders, will be shared with manufactures and regulators for review in the next couple of months and final version will be made available in July 2018.

COLLABORATE

• Action 40: GAP-f will develop an updated concept note and business plan by IAS, and will soon establish a website to facilitate the sharing of resources on pediatric formulation research, development, and introduction (more details can be found in the attached update)

• Action 41:  PEPFAR will organize a technical meeting in early February to share best practices and discuss new other strategies for identifying children living with HIV, particularly around finding well children and around looking beyond traditional, facility-based settings. WHO, EGPAF, PEPFAR, and WCC have begun discussions on one or more additional meetings on pediatric diagnostics in Q2 of 2018.

Additional commitments:

3. CHAI has developed draft plans to accelerate in-country uptake of new pediatric ARVs in collaboration with other stakeholders.

5 and 7. PEPFAR has been in touch with ViiV and Merck about their commitments to make pediatric drugs available to LMIC. The companies confirmed their intention to provide them at access pricing until generics were available, and potentially beyond.

9. Mylan submitted its pediatric LPV/r formulation to WHO PQ in December, and is now working on submitting to the Global Fund ERP. It plans to submit to FDA shortly.

Best regards,

Gottfried Hirnschall, WHO and Chip Lyons, EGPAF

Co-Chairs, AIDS Free Working Group

December 14, 2017

Subject: Follow-Up on 17 November Rome High-Level Dialogue

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Dear Participants of the Rome Consultation,

We would like to thank you again for your contributions to the highly constructive High-Level Dialogue on Scaling Up Early Diagnosis and Treatment of Children and Adolescents on 17 November and for the efforts many of you are already undertaking to carry forward the commitments of the Action Plan that was adopted at the meeting.

We are pleased to inform you that the Action Plan was made public on World AIDS Day (1 December) and profiled in web stories by the meeting organizers. They can be found online at:

Rome Action Plan: http://www.pedaids.org/page/-/Rome_Action_Plan_2017.pdf

Caritas: https://www.caritas.org/2017/12/progress-for-hiv-positive-children/

EGPAF: http://pedaids.org/blog/entry/taking-action-on-better-treatment-for-children-living-with-hiv

PEPFAR: https://www.pepfar.gov/press/releases/2017/276171.htm

UNAIDS: http://www.unaids.org/en/resources/presscentre/featurestories/2017/november/20171117_vatican

WCC-EAA: http://www.oikoumene.org/en/press-centre/news/range-of-organizations-commit-to-improve-hiv-diagnosis-and-treatment-for-children-and-adolescents

WHO: http://www.who.int/hiv/mediacentre/news/paediatric-hiv-rome-meeting/en/

We would also like to briefly inform you about how we are planning to put in place Action 37, in which we commit as co-chairs of the AIDS Free Working Group to monitor implementation of the commitments. A small project management (PM) team, co-led by WHO and EGPAF and including representatives from PEPFAR and the faith-based community, will support the AIDS Free co-chairs to ensure systematic follow-up and communication on the Action Plan. The PM team will actively track progress on all commitments, engage in bilateral conversations as needed, and communicate consistently with Rome Dialogue participants. The PM team will provide updates during the AIDS Free Working Group’s monthly meetings, a summary of which will be circulated to the broader group of stakeholders. Webinars will also be organized on a quarterly basis to ensure effective dissemination of information and foster continued dialogue among Rome Dialogue participants. At any time, we would welcome your updates on steps taken to meet the Action Plan commitments or news on related developments. With this in mind, we hope that ALL stakeholders will be able to report on their individual progress during the first webinar to be scheduled in late March/early April (exact date will be communicated shortly).

We look forward to your continued engagement in this process, which we are certain will lead to meaningful improvements for children living with HIV.

We will be in touch early in the new year to inform you on the next steps. In the meantime, we wish you a wonderful holiday and a very happy and healthy 2018.

Gottfried, Msgr. Bob, and Chip