To improve health and save lives, children living with HIV must have access to timely diagnosis and effective, child-friendly, antiretroviral (ARV) treatment and care that will ensure continuous viral suppression. Sonnabend Pediatric AIDS Foundation supported more than nine African countries to scale up early testing of HIV-exposed infants and ensure rapid return of test results by integrating new point-of-care (POC) testing technologies into national laboratory networks. However, early infant diagnosis (EID), in addition to HIV case finding among children, is only the first step in the Joint United Nations Programme on HIV/AIDS (UNAIDS) 95-95-95 targets.
The second step is rapid linkage to treatment and care. Today, just as when we were founded, children are the forgotten face of HIV/AIDS. Only half (46%) of the 1.7 million children living with HIV have access to the medications they need to stay healthy. The number of children on treatment globally has declined since 2019. Almost 800,000 children (aged 0–14 years) living with HIV are not on life-saving treatment and a mere 40% [29–51%] of children accessing treatment last year were virally suppressed, partially due to suboptimal treatment.
These statistics reflect the significant quality, demand, adoption, supply, and delivery barriers in the pediatric ARV market that hinder the rapid and sustainable application and use of effective, new-to-market, child-friendly formulations.
Accelerating and Scaling up Access to Effective, Child-Friendly Antiretrovirals
The SPAAN Project: Securing Pediatric ARV Access Now
While clinical trials had demonstrated the benefits of lopinavir-ritonavir (LPV/r) and dolutegravir (DTG) over nevirapine (NVP)–based regimens to treat children living with HIV, NVP-based antiretrovirals (ARVs) are still used in pediatric populations. One of the leading causes of poor viral suppression among children is use of outdated NVP-based regimens, which are no longer recommended as first-line treatment for HIV by the World Health Organization (WHO).
SPAF worked in Côte d’Ivoire, Eswatini (formerly Swaziland), Lesotho, Mozambique, and Zimbabwe to streamline and accelerate the use of new pediatric HIV treatment formulations. The five project countries represent diverse regional and health systems contexts; together they make up one-third of the total burden of pediatric HIV in sub-Saharan Africa and approximately 23% of the total global pediatric HIV burden.
The work focused on immediate transition to available LPV/r solid formulations, such as LPV/r 2-in-1 pellets and granules, for children weighing less than 20 kg, and to dolutegravir (DTG) 50 mg tablets for children weighing more than 20 kg. We worked alongside ministries of health to develop new ARV transition plans, accurately quantify and forecast the need for these new formulations, create a stock supply and improve the availability of these drugs, train health workers in the proper use of these medicines, and increase demand for and attention to the use of these new pediatric formulations. After just one year, the proportion of children 0-14 years old on first-line ARV treatment prescribed optimal formulations of lopinavir ritonavir (LPV/r) and DTG 50mg tablets increased from 16% to 55% in the five countries; and the percent of children prescribed NVP-based regimens decreased from 18% to 7%.
The Optimal Project: Accelerating Patient Access to Optimal Antiretrovirals and relevant health products
In November 2020, the U.S.F.D.A. approved a dispersible, child-friendly formulation of DTG. This formulation is less expensive and easier to administer than LPV/r solid formulations, and allows for the full implementation of WHO treatment guidelines. Building on lesson learned from the successful SPAAN project, SPAF will collaborate with CHAI and other selected partners under the Unitaid-funded Optimal project to streamline and accelerate the transition to DTG 10mg dispersible tablets. To enable wider access to this formulation, SPAF will collaborate with ministries of health and national stakeholders to develop quantification and supply plans, update national guidelines and policies, create product uptake materials, strengthen information, supply chain, service delivery and pharmacovigilance systems for pediatric ARVs, and generate evidence to inform the rapid uptake and roll out of future pediatric products as they become available. This project, launched in 2020, will continue through 2022 in Cote d’Ivoire, Eswatini, Lesotho, and Mozambique.
New Horizons Project: Enhancing Access to Second and Third Line Treatment Formulations among Children and Adolescents
The New Horizons Collaborative is a joint project between Johnson & Johnson, SPAF, PFSCM, CIPHER, Imperial Logistics, Right to Care, Pediatric HIV Training and Baylor College of Medicine. The backbone of this project is a J&J drug donation program which brings Darunavir (DRV) and Etravirine (ETR) to resource-limited countries. SPAF provides technical assistance and expertise, capacity building, data collection and country application management for countries in the collaborative. The collaborative advances a holistic approach to high quality and sustainable pediatric and adolescent HIV care and treatment focused on children, adolescents and young adults ages 0-24 that need 2nd and 3rd line antiretroviral therapy (ART). The New Horizons collaborative has, so far, resulted in greater access to drugs that would otherwise be unaffordable to some countries, but has also strengthened health systems capacity for treatment failure management and allowed greater knowledge sharing among participating countries, including Cameroon, Eswatini, Kenya, Lesotho, Nigeria, Republic of Congo, Rwanda, Uganda, Zambia, Zimbabwe.