Major donors and health agencies developing Global Accelerator for Paediatric Formulations (GAP-f)

By David Jamieson

As we have discussed in news blogs last year, limited treatment options and sub-optimal formulations have contributed to poor adherence and outcomes for children living with HIV. To improve coordination in tackling the barriers to research and development that remain, major global players are developing an initiative called the Global Accelerator for Paediatric Formulations (to be known as GAP-f), working to build consensus and define the working group’s structure. Formal launch is planned for later this year.

Figure 1 below shows how the GAP-f formalizes collaboration across sectors to ensure accelerated development and uptake of the most-needed drugs and formulations for children.

Figure 1. The GAP-f formalizes collaboration across sectors to ensure accelerated development and uptake of the most needed drugs and formulations for children. SRAs: stringent regulatory authorities. NRAs: national regulatory authorities (in high-burden countries). Source: Penazzato et al. Shortening the decade-long gap between having optimal adult and paediatric drug formulations, JIAS, In press.

In November 2017, at a meeting convened by His Eminence Peter Kodwo Appiah Cardinal Turkson, Prefect of the Dicastery for the Promotion of Integral Human Development, key principles of the GAP-f set the basis for commitments to be known as the Rome Action Plan, which promote three key principles:

  • Focusing on priority paediatric drugs and formulations;
  • Accelerating development, review, and introduction of paediatric formulations; and
  • Collaborating to expedite the development and introduction of paediatric products.

Figure 2 below shows how these principles align with the foundations of GAP-f to address challenges in paediatric drug formulation development.

Figure 2. The GAP-f represents an opportunity to address challenges in paediatric drug formulation development. Challenges are grouped around three areas: dependence on adult drug development, paediatric formulation requirements, and paediatric ARV market. Progress to date in addressing these challenges is depicted along a funnel originating from precursor mechanisms (the existing initiatives that are unified under the GAP-f) and leading up to the GAP-f collaborative model. Legal framework challenges are placed outside of the funnel because of the limited influence of the GAP-f to directly address these. Source: Penazzato et al. Shortening the decade-long gap between having optimal adult and paediatric drug formulations, JIAS, In press.

The team behind the GAP-f is an evolving collaboration between a number of partner organizations, including:

PFSCM is committed to supporting initiatives that will improve the position of children living with HIV, and has supplied paediatric ARVs to many countries. Wesley Kreft, PFSCM’s Director of Global Supply Chain, currently serves as an advisor to the GAP-f initiative in his role as co-chair of the ARV Procurement Working Group (APWG). PFSCM is also part of the team that has prepared and published the IATT Optimal Formulary List of Paediatric ARVs.

Big gains in treatment of children living with HIV

Treatment rates for pediatric patients have always lagged behind adults, but now programs like PEPFAR’S ACT Initiative show this doesn’t have to be the case


by David Jamieson, PFSCM Senior Supply Chain Advisor


In May, we reported on new opportunities for viral load testing of babies and young children at, or close to, the clinic where they see their doctor. In this blog post, we look at how results from PEPFAR’s Accelerating Children’s Treatment (ACT) program show that, with the right policies and a focused approach, rates of treatment of children living with HIV (CLWH) could be as good as those for adults.

When Ambassador Deborah Birx of PEPFAR launched the $200 million ACT initiative in August 2014, the aim was to double pediatric treatment rates in nine African countries in just two years, which would bring 300,000 new patients on antiretroviral (ARV) treatment.

By September 2016, the number of children on treatment worldwide had grown to an estimated 900,0001 with 561,000 patients on treatment in the ACT countries. Even more importantly, the number of children on treatment continues to grow, proving that the ACT program and other initiatives are creating sustained change.

Across the nine ACT countries, the number of children on antiretroviral treatment (ART) increased by 44%. In Kenya, an estimated 73% of CLWH are on treatment; in Zimbabwe, the figure is even higher at 80%, showing that the goal of 90% of known CLWH being on treatment is achievable.

Globally, PEPFAR supports nearly 1.1 million children (0-19 years old) on ART — a 97% increase since 2014.

Though ACT, PEPFAR and the Children’s Investment Fund Foundation focused efforts in high-risk areas, working with local implementers to identify babies, children, and adolescents with HIV and to get them onto treatment without delay, often within a day.

Other barriers tackled included:

  • Training and job aids to overcome health care providers’ lack of confidence in treating pediatric patients.
  • Advocating to change restrictive treatment access policies.
  • Improving the child-friendliness of the medicines — some pediatric solutions tasted bad, making it difficult to get very young children, who could not swallow pills, to take the medicines.


The supply chain for ARVs: A critical component

PEPFAR tasked PFSCM, through the Supply Chain Management System project, with ensuring that the drugs would be available at the health facilities when needed. Identifying CLWH and encouraging parents and caretakers to start children on treatment is an enormous effort. If stock levels were not properly maintained at clinics, all the effort would be in vain.

Managing the supply chain for CLWH is challenging because it involves more drugs than for adults, the formulations change as children grow, and, in many countries, the total requirements are small. It is also necessary to strike a balance between preventing stockouts and not overstocking, which could result in products expiring before being used.

Globally, PFSCM engaged in two important supply chain initiatives. We became founding members of the Pediatric ARV Procurement Working Group (PAPWG), an effort to pool the requirements for pediatric ARVs to create and manage sufficient demand to keep the market attractive to suppliers. By coordinating the demand of major purchasers — such as PFSCM and the Global Fund to Fight AIDS, Tuberculosis and Malaria — with demand from smaller countries, supply became more consistent and flexible.

PAPWG results are described on PFSCM’s website and in a paper published on the Global Fund’s website. The PAPWG — now known as the ARV Procurement Working Group (APWG) and chaired by PFSCM’s Director of Global Supply Chain Wesley Kreft — has expanded to include adult formulations in low demand.

To address the challenge of multiple pediatric ARV formulations, PFSCM also joined a team from the UNICEF Inter-Agency Task Team (IATT) for the Prevention and Treatment of HIV Infection in Pregnant Women, Mothers and Children to draw up an optimal formulary of pediatric ARVs. From more than 65 approved pediatric ARVs, the team created a formulary of 10 optimal formulations, as well as a list of a further 10 limited-use products.

The IATT team has also advocated for and supported the development and introduction of small pellets that young children can take in soft food to replace the bad-tasting liquid for Lopinavir/Ritonavir, an ARV essential in treating very young children.


What’s next

To build on the achievements of PEPFAR’S ACT program and the other recent progress, the global community is continuing to innovate. Current initiatives include:

  • Start Free, Stay Free, AIDS Free: The ACT Initiative’s lessons are key to UNAIDS’ Start Free, Stay Free, AIDS Free framework — a super-fast-track approach to ending AIDS among children, adolescents, and young women by 2020. The framework is based on the fundamental principle that everyone living with HIV should have access to ART.
  • DREAMS: To address the high risk of contracting HIV for girls and young women, PEPFAR — in collaboration with private sector partners the Gates Foundation, Girl Effect, Johnson & Johnson, Gilead Sciences, and ViiV Healthcare — is driving the ambitious Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe (DREAMS) Partnership.

The global community is also continuing to:

  • Update and promote the use of the pediatric ARV optimal formulary.
  • Develop child-friendly effective medicines.
  • Support introduction of new products.

PEPFAR’s 2017 report states: “Saving the lives of children with HIV is not only the right thing to do; it is the smart thing. By treating children early in their HIV infection, they can stay healthy and thrive. Healthy children who can pursue their dreams will grow economies, create jobs and strengthen their communities for decades to come.”

We can’t say it any better, and will continue to do all we can to ensure supply chains support increased treatment for children.

Based on UNAIDS 2017 report of 2.1 million children living with HIV, of whom 43% are on treatment

Now is the time to take testing of newborns closer to their mother

Pilots have shown that early infant diagnosis can be moved closer to the point of care

by David Jamieson, PFSCM Senior Supply Chain Advisor

We have known for years that if babies born with HIV do not receive treatment, more than 50 percent will die before their second birthday, but we also know that when treated, they can grow into healthy adults. Until very recently, a big challenge has been reaching mothers and their new babies soon enough, testing baby, and getting the results back to mom. Reliable diagnosis could only be completed in larger laboratories, meaning blood samples had to be transported to the lab, kept fresh for testing, and then the results returned — by which time, mother and baby were probably back in their village and might never get the result.

Photo credit: Fabrice Duhal

Recent work by WHO, CDC, and UNITAID means that this is all about to change. WHO and CDC have pre-qualified two point-of-care (POC) instruments: the Alere™q and the Cepheid GeneXpert® (both are and WHO Prequalified). And UNITAID is funding an Early Infant Diagnosis (EID) Consortium, initially to pilot test POC EID in Kenya, Malawi, Mozambique, Tanzania, South Africa, and Zimbabwe, and then to scale up the model if the pilot proved the concept.

The great news is that, yes, the pilot was successful, and as the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) reports, now is the time to accelerate scale-up and usage. UNITAID’s EID Consortium, EGPAF, Clinton Health Access Initiative (CHAI), UNICEF, and Médecins Sans Frontières (MSF) are now working with local governments and stakeholders to get the rollout moving, but we can all be involved.

Although these new instruments get a lot closer to mother and baby, it is not practical to put a machine in every location. The experience of the rollout of CD4 POC instruments is that many lay idle for long periods because of low demand. With EID, it will be important to learn the lessons from CD4. One thing that is clear is that to accelerate EID, we will need multiple inputs from many stakeholders.

How PFSCM can contribute to scaling up POC EID

PFSCM has always been firmly committed to improving the care, detection, and treatment of the youngest patients. Drawing on our expertise in managing global supply chains and optimizing laboratory networks, our contribution will be to ensure that the supply chain doesn’t let these patients down; that smart network design places these new instruments where they will make the most difference; and that results get back to mom and her health caregivers at the earliest opportunity. Specifically, we can:

  • Use software and GIS technology to design smart networks of laboratory-based instruments and POC diagnostics to reach as many mothers and babies as possible;
  • Consolidate supply chains to deliver complete packages of commodities needed for each and every test; and
  • Apply our expertise in data management and mobile technology to get the results back to mother and baby quickly.

The growing success of PMTCT (prevention of mother-to-child transmission) means that fewer babies are being born with HIV, but for those who are, EID is essential. And PFSCM can help ensure that pediatric antiretrovirals (ARVs) are available to treat babies born with HIV. (We will cover pediatric treatment in subsequent blog posts.)

PFSCM strongly supports the goal of an AIDS-free generation, and the three “frees” — start free, stay free, AIDS free.




















Dare to Innovate – Meeting the Supply Chain Challenge of 90-90-90

PFSCM IAS luncheon flyer FINAL 2UNAIDS’ ‘‘90-90-90’’ strategy calls for 90% of people with HIV to be diagnosed, 90% of those diagnosed to be on anti-retroviral therapy (ART) and 90% of those on ART to achieve sustained virologic suppression. Additionally, growing numbers of countries are adopting the universal test and treat model, in which all people diagnosed with HIV receive ART regardless of CD4 level.  It is widely recognized that these strategies will challenge public health systems in resource-limited settings, including global and local supply chain systems.

For supply chains, each of the ‘‘90s’’ presents complications and challenges in getting to 90-90-90 by the 2020 target date. Ensuring that 90% of people with HIV know their status will require a large increase in access to HIV tests, often in unconventional settings. The number of people living with HIV and on treatment must rise from the current level of around 17 million to close to 30 million by 2020, a near doubling of the demand for anti-retroviral (ARV) drugs.  Similarly, monitoring those on treatment means an unprecedented scale-up of viral load testing.

The Partnership for Supply Chain Management (PFSCM) will host a luncheon and panel discussion at the International AIDS Conference in Durban, South Africa to discuss the procurement, supply chain and logistics challenges in reaching each of the 90-90-90 targets (see below for event details).  Funding will obviously be key, and innovative solutions and reforms to the supply chain in developing countries will be essential, but we believe it can be done.

It is important that the fight against HIV continues to be led by governments, primarily through the Ministry of Health, but also include Ministries of Finance and Trade or similar institutions, to set policy and goals, although it is not necessary for the response to be solely from the public sector.  The private sector and voluntary and community groups also have much to offer.  This is especially true for supply chains.

The commercial private sector is already essential to combating HIV, whether by producing drugs, diagnostics and other health commodities or by transporting those products from the manufacturer to the countries heavily affected by the pandemic.  But there is much more that the private sector, for-profit, and not-for-profit organizations can do, especially in supporting and extending in-country supply chains to the so called “last mile,” before the drugs get to patients.  There are also many lessons we can learn from the commercial sector in creating and sustaining flexible, responsive supply chains that keep essential goods in constant supply.  We are confident that the supply chain can respond as needed, but it won’t be easy and will need dedication, planning, daring, and innovation.

The supply chain challenges and opportunities in treating all those living with HIV and reaching the 90-90-90 targets are further discussed in a new paper from PFSCM published in the Journal of the International AIDS Society entitled “The 90 90 90 strategy to end the HIV Pandemic by 2030: Can the supply chain handle it?”

If you are at the International AIDS Conference in Durban, please join us for lunch and the panel discussion on Wednesday, July 20, 12:45-14:00 at the Rainbow Terrace Restaurant of the Hilton Hotel.  We look forward to seeing you there!

Adult ARV supply market for developing countries adapts to new WHO guidelines, but challenges remain

“Tenofivir and zidovudine-based products, including fixed-dose combinations, are in good supply, although there are some challenges with the zidovudine active pharmaceutical ingredient (API) market out of China. Demand for stavudine-based products is dropping fast and suppliers are exiting the market for these products.”

These were the conclusions from a recent visit to India and China by the PFSCM procurement strategy team. Continue reading