2020 HIV DIAGNOSTICS

3. Ensure all children of parents living with HIV are offered HIV testing services in collaboration with implementing partners and faith-based partners.

Updates

Commitment 3:

April 2021

Work continues in all PEPFAR countries to improve pediatric case finding through mentoring and supervision, training of HCW focusing on index testing, including through the use of self testing, and improving efficiencies through optimizing PITC and use of screening tools.

2018 HIV DIAGNOSTICS

12. Discourage and refrain from funding national evaluation studies that would be duplicative of studies done for WHO PQ listing or SRA approval.

13. Fund impactful technologies and interventions quickly.

14. Support in a transparent manner the procurement of commodities and operational costs to maintain and further scale-up POC EID, as well as viral load testing for infants, children, and pregnant and breastfeeding women, as an integral part of optimized and integrated national laboratory networks and in accordance with national EID and VL plans and targets.

15. Support the development of a competitive, healthy, and sustainable market for POC and laboratory technologies.

16. Continue to support WHO PQ to shorten timelines for dossier review and minimize time to national registration.

Updates

Commitment 12:

PEPFAR ensures that its funds are not used to repeat in each country evaluations of diagnostics or drugs that have already undergone appropriate evaluation for WHO PQ and/or other SRA approval.

Commitment 13:

October 2020

  • Oraquick studies: The OraQuick studies will explore the acceptability, feasibility and impact of caregiver-assisted HIV oral screening in children. The OraQuick study in Zambia has received CDC IRB and local IRB approvals. The study team, supported by Macha Research Trust, will conduct site activation activities in October 2020. The Uganda study, supported by Makerere University School of Public Health, expects to receive CDC IRB approval in October and conduct site activation activities in November 2020. 

  • Risk Screening: In Zambia and Uganda, risk screening has been rolled out country-wide for children 18-months – 14- years of age. FASTER continues to support IPs through mentorship and Continuous Quality improvement Initiatives to use of HIV risk screening tools. 

 

Index Testing: These updates are from ~250 pediatric priority sites across Nigeria, Uganda, Tanzania and Zambia. Despite COVID19, the proportion of children under the age of 15 tested for HIV using index testing out of all HIV testing, increased from 6% (2019Q1) to 27% (2020Q3). Similarly, the proportion of HIV positive children under the age of 15 identified via index testing out of all HIV testing increased from 18% (2019Q1) to 53%(2020Q3). 

 

Previous

PEPFAR has convened discussions with OraSure, WHO and other experts to develop a plan for evaluation of home-based oral fluid testing of children as a novel strategy to increase case identification of children. PEPFAR funding to CRS, through CDC, will support this evaluation and protocol development is underway. CDC has awarded PEPFAR funds to CRS to support this work, and this work is underway (April 2020). 

As part of the PEPFAR/CDC award, CRS will also promote other effective and novel strategies to identify children through faith based and other community based platforms in Uganda, Zambia, Nigeria and Tanzania.

As part of a broader Faith Based Initiative, additional resources will be provided to faith-based organizations to promote case finding and better treatment outcomes for children through faith-based platforms in PEPFAR supported countries.

Commitment 14:

April 2021

PEPFAR has included use of POC for EID and VL in COP21 and continues to work with countries to ensure appropriate placement and complementary use of these instruments.

Previous

PEPFAR made clear in its COP19 guidance its support for use of POC (1)  for EID where 2-month testing rates and rates for linkage to ART for infected infants are not on track to reach 90-95%and (2) for VL in PBF to help ensure that women maintain virologic suppression through pregnancy and breastfeeding. PEPFAR reinforced throughout the COP19 development process the importance of optimizing use of POC platforms for these purposes where performance gaps in EID persisted or could not be met by conventional laboratory platforms.

In COP 20 guidance, PEPFAR stated support of POC VL for unsuppressed PLHIV including children and adolescents.

Ongoing efforts to map and optimize VL machines/equipment.

Commitment 15:

April 2021

PEPFAR continues to play a leading role within the Integrated Diagnostic Consortium (IDC) to support countries in conducting diagnostic network optimization (DNO) necessary to ensure that the WHO led integrated diagnosis and multiplex testing guidelines are followed so instruments can be efficiently used for testing of EID, VL, TB an COVID-19 and other diseases.  PEPFAR also continues to work with other stakeholders to ensure all-inclusive pricing for EID and VL through the RFP.

Previous

PEPFAR continues to communicate with global partners and industry to promote development and uptake of laboratory technologies essential for diagnosis and management of HIV in children.

Apart from support for POC for EID and VL mentioned above, PEPFAR continues to work with manufacturers and other stakeholders within IDC to ensure comprehensive  and efficiency lab network optimization and transition to all-inclusive procurement pricing approach that guarantees improved access to EID. There are also discussions within PEPFAR, stakeholders and manufacturers for accelerated development and use of multi-diseases testing platforms to ensure integrated diagnostics. PEPFAR continue to work with WHO to support evaluations and PQ of platforms, including Hologic to support EID. The Hologic platform is currently used only for VL.

Commitment 16:

April 2021

  • Disease diagnostics using POC technology; improve sample referral networks to integrate POC and conventional technologies to maximize coverage and optimize laboratory testing platforms. In Tanzania, supported introduction of 47 POC thermomixers for EID testing. in Uganda supported expansion of the POC network from 33 to 130. 

  • Oraquick study in Zambia began in February and >400 positive parents accepted enrollment and use of the ST for over 680 eligible biological children. The study in Uganda is awaiting local IRB approval expected the 3rd week of April. 

October 2020

  • FASTER is supporting the adoption of streamlined regulatory review and approvals for new drugs and diagnostics, using HCW administered OraQuick and DTG10mg as use cases for diagnostics and drugs respectively. 

  • Supported the Tanzania Medicines and Medical Devices Authority to review registration time for diagnostics and medicines which is incorporated in the Client Service Charter (CSC). The number of days needed to register WHO pre-qualified products (including ARVs) reduced from 240 to 90 days ensuring timely access to new molecules and diagnostics. 

  • Uganda has approved the use of DTG 10mg and in Uganda and included DTG in the national guidelines. In Nigeria and Tanzania, discussions are underway to introduce DTG10mg once available. In Uganda, FASTER is implementing the HCW administered Oraquick oral test. These tests are targeted for key/priority populations who do not usually interface with the health facilities. 

  • FASTER countries have successfully registered POC/EID diagnostics. FASTER is supporting the scale-up and optimization of these platforms to enhance the identification of HIV infected children and the monitoring of viral load suppression trends. Tanzania is focusing on prioritizing POC platforms for pregnant and lactating mothers in sites with both testing platforms (conventional/POC). 

  • Launched an online Diagnostics Evidence Hub (https://aslm.org/diagnostic-hub/) hosted by African Society for Laboratory Medicine (ASLM) that serves as a repository for technical and performance data on WHO-prequalified, innovative diagnostics including Point-of-Care devices and HIV self-tests. This resource will allow country stakeholders to more easily access prior evaluations and validations to expedite in-country registration and scale up of innovative diagnostic technologies. Information hosted on the hub will include intended use, WHO PQ details and links to PQ reports, and summarized and linked data from relevant peer-reviewed studies and abstracts, including performance evaluations and feasibility studies. Under FASTER, CHAI will continue to work with ASLM and WHO to socialize the Diagnostics Evidence Hub through virtual meetings and webinars. 

 

 

Previous

As part of its PEPFAR funded CDC award, CRS is supporting work with national governments to assist them in streamlining their review and approval processes for use of new diagnostic technologies.   Work is focused in Uganda, Zambia, Nigeria and Tanzania. CDC has awarded PEPFAR funds to CRS.

2020 HIV TREATMENT

52. Support DTG global roll-out plan in collaboration with GAP-f partners by placing orders to enable early procurement of the DTG 10mg dispersible tablet formulation to ensure early and widespread roll-out .

53. Provide additional support for country programs to transition, including wastage of legacy products (e.g., NNRTIs) and funds to procure optimal formulations including pediatric DTG, and as needed, LPV/r fomulations.

Updates

Commitment 52:

June 2021

  • PEPFAR is reviewing various combination antiretroviral products to extend the indication down to at least 14kg (2 years old and older).

April 2021

  • PEPFAR has provided countries with specific guidance to continue with rapid introduction of pDTG for CLHIV who weigh < 20 kg in FY21 and achieve full transition ≤12 months from when pDTG first arrives in country and pDTG transition should not be delayed or extended to mitigate LPV/r waste. 

Commitment 53:

April 2021

  • Through Faster, PEPFAR has worked to ensure rapid use of DTG 10 mg DT as soon as available with updating of guidelines, training tools, forecasting and procurement planning and HCW trainings. 

  • COP 21 funds will be allocated for procurement of DTG 10 mg DT and wastage of legacy products.

2018 HIV TREATMENT

21. Support catalytic procurement of all or part of initial validation batches from manufacturers such that product availability is not delayed once approval or tentative approval is achieved.

22. Incentivize commercialization of new pediatric ARV products “at risk” to accelerate introduction and scale up of new paediatric ARV product such that product is available at time of approval/tentative approval/prequalification.

28. Partner on the assisted introduction of RAL granules for neonates, starting with the MoH of Eswatini, followed by other countries beginning early 2019, donating sufficient supplies at the outset of the project and then selling at no profit in low income and sub-Saharan African countries to ensure sustainability of the initiative.

45. Contribute to the funding of the secretariat of the Global accelerator for 2 years, plus additional funding upon achievement of milestones.

Updates

Commitment 21 & 22

April 2021

  • Additional manufacturing capacity for LPVr granules and LPVr pellets, from Viatris and Cipla, was realized in CY20Q1. 

  • Cipla did not commercialize RTV 25 mg tablets. As an alternative solution, PEPFAR worked with Viatris to review product dossier information for RTV 25 mg, in order to allow for procurement of this formulation, which is not FDA tentatively approved. 

October 2020

  • PEPFAR is working with ViiV to facilitate rapid uptake of DTG 5 mg DT in Haiti. 

  • Based on the expectation of tentative US FDA approval of DTG 10 mg DT, PEPFAR is working with manufacturers and multiple partners to assure rapid uptake of this formulation, including use of initial validation batches. 

  • PEPFAR continues to contribute to timely revisions of pediatric formulations on the PADO list. 

  • PEPFAR HQ has widely disseminated to its Operating Units WHO's July 2020 Policy Brief Considerations for introducing new antiretroviral drug formulations for children. 

  • PEPFAR 2019 and 2020 Country Operational Plan guidance calls for programs to promptly phase out NNRTIs (NVP by the end of 2019 and EFV by September 2020). 

  • PEPFAR has informed host countries of the anticipated arrival of DTG 10 mg DT in 2021 and hosted a webinar for PEPFAR staff and stakeholders on 1 October 2020. 

  • PEPFAR has disseminated a DTG Readiness Questionnaire to its Operating Units and is currently compiling and analyzing responses to inform technical assistance. 

 

PEPFAR is committed to working with operating units to ensure supplies of pediatric LPV/r formulations do not impede rapid transition to pediatric DTG. 

Commitment 21:

PEPFAR placed a catalytic procurement of the recently approved lopinavir/ritonavir granules at the end of December 2018.

 

PEPFAR is working with Global Fund and other partners on additional methods to optimize supply of pediatric lopinavir/ritonavir products this year to support the urgent effort to use LPV/r instead of nevirapine for children weighing less than 20kg.  PEPFAR has already prevented use of its funds for procurement of nevirapine based treatment regimens for children and has worked closely with GF and host country governments to promote phase-out of nevirapine-based treatment for children this year. In addition, PEPFAR, in close coordination with WHO, has requested in official COP19 guidance that country programs adopt use of DTG50mg tablets beginning at body weight of 20kg in children and is working closely with country partners to ensure this recommendation is taken up.

PEPFAR and Global Fund gave Mylan and Cipla information on the expected demand for LPV/r granules and pellets (respectively), which enabled Mylan and Cipla to consider ramping up production.

PEPFAR and Global Fund have worked with Cipla and Mylan to support an increase in production capacity of LPV/r granules and pellets and we expect capacity to meet demand by FY 20, Q2.

 

PEPFAR’s prioritization of eliminating NVP in treatment regimens and of adopting policy to give DTG 50mg FCT to children down to 20kg is being implemented in a number of country programs and we continue to track and push remaining countries to adopt this policy.

 

PEPFAR also acknowledges its Vatican meeting commitment to pursue greater access of DRV 75mg and RTV 25 mg for children served in PEPFAR-supported programs.

PEPFAR is working with Janssen to make DRV 75 mg available. Through PEPFAR’s work with Janssen, DRV 75 mg will be available and orders are being placed.

PEPFAR with GAP-f is working with Cipla to accelerate the availability of RTV 25 mg. 

PEPFAR has been working with Viiv and CHAI to make DTG dispersible tablets available for kids through regular meetings to track progress on study/regulatory approval and anticipatory planning to accelerate access/uptake of pediatric DTG in country programs.

Commitment 22:

​​

June 2020

PEPFAR stands ready to act on this commitment for optimal pediatric ARV products, particularly if new gaps are identified.

PEPFAR has worked closely with ViiV and CHAI to prepare countries for an accelerated introduction and scale up of pediatric DTG dispersible tablets (5 mg, 10 mg) (to be distinguished from DTG 10 mg film coated). PEPFAR COP 20 guidance states that - as new pediatric DTG dosing recommendations and pediatric DTG formulations become available - country programs should promptly make these products available, including ensuring implementing partners have work plans with clear steps for transition to DTG for younger patients when formulations become available. Countries submitted an update of their progress towards pediatric treatment optimization efforts including an update on the plan to include DTG dispersible tablets in the next iteration of the national treatment guidelines. PEPFAR will use the pediatric treatment optimization updates in order to guide plans for HQ technical assistance to the countries. 

Commitment 28:

October 2020

Although there were delays due to COVID-19, 14 facilities in Zimbabwe have received training on raltegravir (RAL) granules and several HIV-positive newborns identified at birth and started on RAL granule-based ART regimens. Evaluation on acceptability and feasibility of the use of RAL granules in newborns is ongoing, with results anticipated in mid-2021. 

June 2020

Training workshops were conducted for 60 Healthcare workers in 6 provinces on dosage calculation and caregiver education.

April 2020

Having challenges with transport of RAL granules for neonates and also PIMA cartridges, there is reluctance to transport these to hospitals and clinic sites for use of these with neonates.  Resolving this by working with MOH to find other transport sources.  Also having challenges with multi-month dispensing for young children who need more frequent weight-based changes.

 

Using PEPFAR funding through a CDC award, CRS is supporting EGPAF to develop and roll out a program to introduce RAL granules for infants who test positive at birth, starting in one country in 2019, and then expanding to others. Merck produced and donated the initial batch of product for this program. Eswatini is currently focused on other priorities in its program and so we will start off in a different country that should be identified by May 2019. Zimbabwe was prepared to start this project but trainings have been delayed due to COVID-19.

MSD confirmed RAL granules and chewable tablets will be available for use by end Q2 2019.

Commitment 45:

PEPFAR has provided funding through the CDC award to CRS that will be used to support a portion of the Global Accelerator (GAPf) secretariat.

2017 HIV TREATMENT

Action 8: Support and fund clinical and implementation research to inform development and approval as well as use of paediatric formulations included in the PADO list.

Action 9: Only fund the procurement of drugs and formulations recommended by WHO that are included in the Optimal Formulary.

Action 21: Provide funding to support actions required for quickly introducing and scale-up new, optimal paediatric formulations.

Action 35. Provide high level political leadership and advocacy at global, country and regional levels to scale up access to paediatric HIV medications for children; production of high quality data to support implementation; and Country level support to roll out.

Action 36. Continue to convene and coordinate stakeholders at a high level, including the pharmaceutical industry, FBO and civil society service providers, national governments and multilateral partners, and partners in the Start Free, Stay Free, AIDS Free Framework.

2. (individual commitment) PEPFAR committed to work with countries on a system of shared data and rotating locations for implementation studies; to develop a proposal for further expediting the regulatory approval process; and to fund the procurement of only optimal paediatric ARVs.

Updates

Action 9

April 2021

PFAR has supported the 2020 revision of the OF.

Action 35

UNAIDS: The global AIDS update report was published and launched in July 2018 with full tables in the back on the 2017 data.  UNAIDS is working with countries on setting pediatric treatment targets within NSPs. 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. ​

The annual 3 Frees report, with 2017 data, is expected for Q3 or Q4. 

The 2019 addition of the 3 Free's report will be realist in June 2019, including with the new 2018 PMTCT/PEDS data.

 

PEPFAR included pediatric treatment targets in all 2018, 2019, and 2020 COPs.

Action 36

PEPFAR has been in touch with ViiV and Merck & Co., Inc., 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.

 

On February 9, 2018, PEPFAR convened over fifty technical experts in Washington, D.C. to address challenges in pediatric HIV case finding, and specifically identification of pre-adolescent children with HIV before they present to facilities with illness. Specifically, the meeting focused on finding younger asymptomatic children living with HIV (<10-12 years old) outside the usual facility-based testing (PITC) and routine PMTCT programs with special interest in using OVC, faith-based, school, and other community platforms. This remains a significant issue for all implementing partners. By the end of the meeting the group developed recommendations for: Effective strategies that can be widely adopted, perhaps with adaptation to context; Strategies that show promise in pilot or small-scale, which should be further evaluated and/or scaled up; and Creative, novel ideas that can be piloted and tested.

Notes: George Siberry led and moderated the discussion. Ambassador Birx provided opening remarks. Others in attendance were representatives from CMMB, Elizabeth Glaser Pediatric AIDS Foundation, ELMA, FHI360, ICAP, Jhpiego, John Snow, Inc., Mothers2Mothers, Management Sciences for Health, Save the Children, UNICEF, University Research Co., LLC (URC) & Center for Human Services (CHS), ViiV Positive Action, WCC-EAA, World Education Inc., World Health Organziation, and World Vision International.

On March 29, 2018, PEPFAR convened diagnostics companies, donors, and select implementing partners for a one-day Consultation meeting in New York City on shared issues related to pediatric treatment such as strategies to improve access to HIV (and TB) diagnostics for infants and children in lower middle income countries (LMICs). This meeting served as a follow-on meeting to the November 2017 High-Level Dialogue on Scaling-Up Early Diagnosis and Treatment of Children and Adolescents. 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.

Notes: Ambassador Birx provided opening remarks and participated in side meeting discussions with key attendees. The meeting was attended by individuals from Abbott/Alere, Becton Dickinson, CDC – International Laboratory Branch, Cepheid, Clinton Health Access Initiative, DRW, EGPAF, ELMA, Hologic, Holy See, Orasure, Roche, Columbia University, UNAIDS, UNICEF, UNITAID, WCC-EAA, World Health Organization, and the U.S. Food and Drug Administration.

Individual Commitment 2

April 2021

PEPFAR disseminated DTG Readiness Questionnaires to assess current regulatory and policy barriers impeding the introduction of pDTG; working with ISMEs and country teams to address these barriers. 

Previous

PEPFAR has developed a website that makes program data available for review and analysis: https://data.pepfar.net/   PEPFAR is developing a mechanism for addressing requests from external stakeholders and partners for more detailed program data to use in important analyses. PEPFAR has not yet developed sites for implementation studies.

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.

See also action 9.