Ending Pediatric AIDS: The Role of Innovative Diagnostics and Child-friendly Treatments

By Patricia Fassinou, Maria Buser and Rebecca Bailey

“Access to point-of-care diagnostic technologies for children is a child survival strategy that nobody should question, because we have the data to demonstrate its effectiveness”, said Dr. Chewe Luo, UNICEF’s Chief of HIV/AIDS, during a satellite session at the 2017 International Conference on AIDS and STIs in Africa (ICASA 2017) that was jointly organized by the African Society for Laboratory Medicine (ASLM), the Clinton Health Access Initiative (CHAI), the Drugs for Neglected Disease Initiative (DNDi), the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF), UNICEF and Unitaid.

Chewe Luo, Chief of HIV/AIDS, UNICEF

While the World Health Organization (WHO) recommends that all HIV-exposed infants receive a virologic test for HIV within two months of birth, only 43 percent were tested in 2016. In addition, studies across several countries suggest that approximately 50 percent never receive their test results, and for those who do weeks or months often pass before caregivers learn the test outcome. Of those infants who received their results and were diagnosed with HIV, only half were placed on treatment.

Without treatment, up to 50 percent of HIV-infected children will die by their second birthday, with a peak mortality at two to three months of age. For infants who are diagnosed as HIV-positive, one of the major barriers to the initiation of treatment is the lack of child-friendly antiretroviral (ARV) formulations. For these reasons, the ICASA 2017 satellite session gathered together stakeholders from international organizations, universities, ministries of health and civil society to share evidence and experience in point-of-care (POC) diagnosis of HIV in infants as well as HIV medicines specially designed for children.

Saving infants’ lives through point-of-care diagnostic technologies

Infant diagnosis is more complicated than adult diagnosis, requiring Nucleic Acid Testing (NAT). Multi-country evaluations and the subsequent routine use of innovative technologies for point-of-care early infant diagnostic (POC EID) across eight countries (Cameroon, Côte d’Ivoire, Kenya, Lesotho, Mozambique, Rwanda, Swaziland and Zimbabwe) have demonstrated impressive results, with more than 99 percent of test results returned to caregivers – usually on the same day.

The ICASA satellite session highlighted the results of routine POC EID testing in Côte d’Ivoire, where health workers as well as infant caregivers were discouraged by poor access to EID and long turnaround times to receive test results. “Thanks to POC EID, 80 percent of infants tested got their results before the critical two months of age”, said Dr. Patricia Fassinou, Scientific and Programmatic Director and Country Implementation Manager, EGPAF Côte d’Ivoire.

With funding and support from Unitaid, partners are working in collaboration with ministries of health and national technical working groups to scale up POC EID in 15 countries. According to Seth McGovern, Senior Manager for HIV Diagnostics, CHAI, scale up requires significant resources and effort to ensure that POC equipment is strategically integrated into laboratory networks.

Valery Nzima, POC EID Country Implementation Manager, EGPAF, Cameroon presented POC EID implementation models and cost estimates. They included a ‘hub and spoke’ model, where one diagnostic machine can service additional smaller health centres within a local radius as well as an integrated testing model where a POC instrument can be used to diagnose multiple diseases, such as tuberculosis and HIV. Dr Nzima also noted that the price of POC EID test kits make POC EID testing appear more expensive at first glance. However, when overall operating costs and the higher rate of test results return are compared with conventional testing, the cost is estimated to be the same or lower for POC EID: at approximately $20-$41 per test result returned for conventional, and $21-$33 for POC.

Valery Nzima, EGPAF-Cameroon

Quality assurance is essential when implementing programs at POC level. Lara Vojnov, Diagnostics Advisor, WHO, said, “the most important factor is making sure infants receive the right test result.” Training and mentorship for instrument operators and health workers are essential to ensure accuracy and efficiency. Remote device monitoring of the test machines helps to assure the quality of testing in decentralized health facilities.

Towards improved pediatric formulations

The most compelling argument for POC EID was heard from a mother, Maurine Murenga, who endured the agony of waiting months for her children’s test results. Today Maurine is an activist and Executive Director of Lean on Me in Kenya. Maurine also described how she struggled to administer medicine to her HIV-positive child. Due to a lack of child-friendly doses, she improvised by splitting an adult treatment in two and giving it to her child with food. The child hated the taste. According to Maurine, ”better medicine for infants will make everyone’s life easier.”

Lara Vojnov, Diagnostics Advisor, WHO, Geneva, and Maurine Murenga, Executive Director, Lean on Me, Kenya (from left to right)

Dr. Victor Musiime, an expert on virology, spoke of the need to close the gap between those children who access treatment and those who do not. Starting and maintaining infants on HIV treatment is challenging for several reasons: drug formulations are unpalatable, require refrigeration and have to be administered with food. Stigma around HIV persist and poverty prevents many from following a strict drug regimen. However, new drug formulations are becoming available for infants that require no refrigeration and are in pellet form, which is easier to give to infants

Dr. Musiime described a pellets pilot that was recently concluded in Zimbabwe, responding to a demand from health workers and from infants’ caregivers for more tolerable medicine. Rudo Kuwengwa, Ministry of Health, Zimbabwe noted that health workers are already overburdened and need support and better supplies. He added that the study results are positive and give hope that optimized treatments will be available soon.

Victor Mussime, Senior Lecturer at Makerere University, Uganda

 

The way forward

POC EID partners, with funding and support from Unitaid, are driving a collective effort to harness innovations in diagnostic technologies, strengthen health systems and ensure HIV-positive infants have appropriate treatment. When HIV tests are performed locally, with tests designed for infants, almost all HIV-positive infants receive lifesaving treatment. During the session, Antonie Gasasira of The Global Fund noted that resources are available to support the scale-up of testing, treatments, and service optimization. Session participants agreed that, with funding available, and implementing partners at the ready, countries are encouraged to act now to include new technologies, such as POC EID, in their national plans and budgets. In addition, the Medicines Patent Pool, launched in 2014 by Unitaid and DNDi, is working to accelerate the development of child friendly treatments that have not yet reached the market, but have potential to be highly effective. The challenge now is to ensure that more health centers can provide innovative testing and child-friendly treatments, so more lives can be saved.

Patricia Fassinou, EGPAF, Côte d’Ivoire, meets with audience members after the session

Point-of-Care Early Infant Diagnosis

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