Paediatric ARVs and formulations

Dolutegravir (DTG)-based HIV treatment regimens are recommended by the World Health Organization for children living with HIV (CLHIV) who weigh at least 3 kg. In 2020, the United States Food and Drug Administration (US FDA) granted tentative approval of paediatric DTG 10 mg scored, dispersible tablets (pDTG) for CLHIV weighing a minimum of 3 kg and at least four weeks of age. In early 2021, national HIV programmes in low- and middle-income countries (LMICs) began to transition CLHIV from treatment regimens containing non-nucleoside reverse transcriptase inhibitor (NNRTI) and lopinavir/ritonavir to pDTG. As of the last quarter of 2022, at least 73 countries have already placed or received orders for pDTG1 and an estimated 130,000 children have transitioned to pDTG. pDTG currently is administered along with optimised backbone antiretrovirals (ARVs) such as abacavir/lamivudine 120/60 mg scored dispersible tablets (pABC/3TC) per the WHO’s 2021 Consolidated HIV Guidelines.

This brief aims to inform the transition from pDTG + pABC/3TC to the new fixed-dose combination (FDC) dispersible tablet of paediatric ABC/3TC/DTG 60/30/5 mg (pALD).

EGPAF, with funding and support from Unitaid and DNDi, is bringing new-to-market pediatric ARV formulations to full-scale implementation in eight African countries. We gathered and documented lessons learned from these eight project countries to inform, streamline and accelerate the introduction and roll-out of new, child-friendly ARVs so that all children living with HIV have access to optimal, WHO-recommended treatment and care.

In 2019 it was estimated that 1.2 million children (0-14) were living with HIV in Eastern and Southern Africa, yet more than a half million of these children (504,000) were not receiving lifesaving treatment. Children with HIV need to achieve viral load suppression if they are to lead long and healthy lives. Population-based surveys in Malawi, Uganda and Zimbabwe found that children on treatment fare worse in achieving viral load suppression compared to adults; 42 per cent vs 67 per cent, 39 per cent vs 84 per cent and 47 per cent vs 86 per cent respectively. Ending AIDS will not be possible without accelerating progress for children.

UNICEF, in collaboration with governments and partners, supported a mixed method study that included literature review, assessment of laboratory data in Malawi, Uganda and Zimbabwe and interviews with health workers and caregivers in Malawi to find out what is behind these low rates. The study found that one out of every three children who had a viral load test had not achieved viral load suppression. Support networks for caregivers and children improved adherence and made a difference towards outcome. The full report describes the methodology, key findings, challenges and proposes concrete recommendations to improve treatment outcomes for children with HIV. The accompanying advocacy brief summarizes the key findings and provides action-oriented next steps

At a high-level meeting in Dakar, Senegal in January 2019, UNAIDS, UNICEF and WHO urged countries in Western and Central Africa to strengthen their commitments towards EMTCT and universal coverage for paediatric testing and treatment for HIV.

Countries and partners renewed their commitment to the 2015 Dakar Call to Action for Accelerating the Elimination of New HIV Infections in Children and Access to Treatment for Children and Adolescents Living with HIV by 2020.

The WHO 2018 guideline update promotes the use of optimal treatment regimens in all populations. Though new, more effective and better tolerated options with a higher genetic barrier to resistance are now available for adults, optimized treatment options for children lag significantly behind.

This fifth edition of the Optimal Formulary and Limited-use List supports the transition to optimal WHO-recommended regimens for infants and children, while giving due consideration to the rapidly evolving treatment landscape and the risks inherent in the uncertain timelines for paediatric drug development.

To achieve an AIDS-free generation, optimal treatment options for all infants and young children living with HIV must be available, tolerable and most importantly, effective. Since 2013, the WHO has recommended that all infants and children under three years initiate ritonavir-boosted lopinavir (LPV/r)-based regimens. However, the transition to preferred pediatric regimens has been slow, and one-third of children remain on a sub-optimal regimen of zidovudine (AZT), lamivudine (3TC) and nevirapine (NVP).

Only 20 percent receive the WHO preferred regimen despite resistance to non-nucleoside reverse transcriptase inhibitors (NNRTIs) becoming a major concern for infants and young children. While efavirenz (EFV) is increasingly used, NVP-based regimens are also very common in children older than three years. As a result, overall virological suppression reported in program settings continues to be sub-optimal and particularly poor in young children below five years.

This is part of a series of 12 policy briefs by the Child Survival Working Group on scaling up key interventions for children and adolescents living with HIV. Learn more.

Urgent and ambitious 2020 global targets are on the horizon, yet there has been insufficient progress in paediatric and adolescent HIV to date. Scaling up HIV services for all children and adolescents is needed, in alignment with the UNAIDS super-fast-track framework. It’s time to make sure that nobody is left behind.

This series of 12 policy briefs by the Child Survival Working Group (CSWG) looks at scaling up key interventions for children and adolescents living with HIV. They present evidence, policy and monitoring considerations, implementation guidance and tools necessary to scale up 12 key interventions which have proven successful in identifying, linking and supporting children and adolescents to access and remain in quality care and treatment.

They are designed for program managers in government and civil society programs, particularly at country-level, and provide practical information and direction.

Learn more in the Foreword and download the briefs below. 

• Addressing the service delivery needs of children of key populations

• Strategies to improve retention of mother-baby pairs in PMTCT programs

• A child-centred approach for HIV programs

• Providing differentiated service delivery to children and adolescents

• Point-of-care testing as a solution for timely early infant diagnosis

• Complementary and connected: Engaging community and faith-based organizations to deliver PMTCT and pediatric HIV services

• Sensitizing health workers to providing responsive care for adolescents and young people living with HIV

• Family-based index case testing to identify children with HIV

• Meaningful engagement of adolescents and young people in national and local HIV programming

• Scaling up optimal antiretroviral treatment for children: A long overdue intervention

• Preventing and treating tuberculosis among children living with HIV

• Providing peer support for adolescents and young people living with HIV

The West and Central Africa Catch-up Plan provides a framework for political advocacy and accelerated action for countries to adapt and scale up effective approaches and innovations that will reduce inequity in access to HIV treatment. Twelve countries have adapted this regional initiative to their national contexts and developed country catch-up plans, with the support of the World Health Organization (WHO), UNAIDS and UNICEF.

At the 19th International Conference on AIDS and STIs in Africa (ICASA), country representatives and partners took part in a meeting convened by UNICEF and UNAIDS to reflect on the shortfalls within West and Central Africa country catch-up plans and to agree on ways to sharpen acceleration strategies and interventions that will increase access to paediatric ART.

The meeting at ICASA had three high-level strategic objectives:

1. Call greater attention to the gap in paediatric HIV testing, including EID, and paediatric treatment within the West and Central African country catch-up plans
2. Define the priority actions for children in country catch-up plans in 2018, with a focus on: (a) expanding access to paediatric HIV testing through improved EID and rapid testing at other entry points; (b) improving immediate linkages to care and treatment; and (c) task-shifting to enable nurses within maternal, neonatal and child health facilities to treat children
3. Galvanize partnerships in support of country catch-up plans

More information can be found in this meeting report.