Call for an urgent country scale-up of access to optimal HIV treatment for infants living with HIV

Global partners working to eradicate childhood AIDS are coming together to call on countries to quickly increase access to optimal, child-friendly HIV treatments for infants and children. Partners include the United Nations Children’s Fund, the World Health Organization (WHO), UNAIDS, the US President’s Emergency Plan for AIDS Relief, the World Fund for Fighting AIDS, Tuberculosis and Malaria, United, Elizabeth Glaser Children’s AIDS Foundation, and the Clinton Health Access Initiative (CHAI).

Children living with HIV continue to be left behind by global AIDS control. In 2019, only 53% (950,000) of the 1.8 million children (0-14 years) living with HIV worldwide will be diagnosed and treated. In contrast, 68% of adults.[1] The remaining 850,000 children living with HIV have not been diagnosed and have not received life-saving HIV treatment. Two-thirds of missing children are 5-14 years old and do not regularly attend traditional medical facilities. To find and treat disappeared children, you need to engage with the community and the families of people with HIV, tuberculosis, and other related illnesses and provide family services.

In 2019, an estimated 95,000 children died of AIDS-related illnesses. This is partly due to the lack of early diagnosis of HIV between infants and children and the immediate connection to the optimal HIV treatment regimen. If untreated, 50% of babies infected with HIV at birth or before and after birth die before the age of two.[1]

The US Food and Drug Administration recently tentatively approved the first generic version of dolutegravir (DTG) 10 mg dispersible tablets.[2] This approval is the result of an innovative partnership between Unitaid, CHAI, ViiV Healthcare and generic suppliers, accelerating the development timeline by several years. Shortly after approval, a groundbreaking agreement was announced on World AIDS Day between Unitide and Chai. This will reduce the cost of HIV treatment for children in low- and middle-income countries by 75%, and DTG 10 mg dispersible tablets will be available in 90-count bottles at a cost of US $ 4.50.^[3]

This is because the WHO recommended first-line DTG-based antiretroviral treatment is now available in a more affordable, child-friendly generic formulation for infants aged 4 weeks and weighing over 3 kg. Means.[4] A rapid transition to this optimal treatment plan, in combination with improved HIV diagnosis and other support measures for children, will help urgently reduce 95,000 preventable AIDS-related deaths in children.

DTG-based HIV treatment leads to better results for children. DTG is less susceptible to drug resistance and achieves faster viral load control. Child-friendly dispersible tablets are less burdensome and easier to administer, improving compliance. These factors help children achieve and maintain viral load control, the gold standard for measuring the effectiveness of HIV treatment. DTG-based treatment is the standard treatment for adults. Starting this regimen in infancy reduces the need to change treatments as it matures into childhood, adolescence, and adulthood. Fewer regimen and regimen changes simplifies healthcare management, improves inventory management, and reduces waste.

WHO recommends DTG-based HIV treatment for all infants since 2018.[4] In July 2020, we provided the recommended dose for infants and children aged 4 weeks and older and over 3 kg.[5]

Supplier is demonstrating its ability to meet its global scale-up ambitions. Accurate forecasting of demand is important for notifying production planning and delivery timelines. Therefore, the national program will begin to include DTG 10 mg dispersible tablets in its new procurement plan, review existing non-DTG treatment inventories and orders for children, share forecasts with HIV treatment procurement partners and suppliers, and as soon as possible. It is important to order.

Partners accelerate from existing suboptimal HIV treatments to DTG-based treatments for infants and children, including advocacy of political commitments, mobilization of international and domestic resources, new policies and guidelines, and control of drug supply. We promise to assist governments in developing their transition plans. Sensitization and involvement of healthcare professionals and affected communities to ensure the demand and treatment literacy of children living with HIV and their caregivers to ensure rapid intake of these new formulations to hold.

Further guidance on national programs and partners is available from WHO.[5] The CHAI HIV New Product Introduction Toolkit has dedicated resources to help countries move to pediatric DTG.[6]

Quote from partner

“This could be a true game changer for children with HIV,” said Megdherty, director of the WHO Global HIV, Hepatitis and STI Program. “We must do our utmost to ensure that the country delivers this new pediatric DTG 10 mg to all children in need.”

UNAIDS Executive Director Shannon Hader said: “Governments, field partners, and affected communities need to work together to find and treat children and babies who can save lives with these new drugs.” New drugs are current treatments for infants. It’s cheaper, more effective, and child-friendly than the law. Now we need to take them to the clinic to save lives. “

“Providing antiretroviral drugs to people living with HIV is at the core of support for the country’s HIV program,” said Peter Sands, Executive Director of the World Fund for the Fight against AIDS, Tuberculosis and Malaria. “This new and affordable child-friendly HIV treatment is a major step forward in improving and saving the lives of the most vulnerable people in society, the HIV-infected infants. We are quick to move on to these new drugs. We promise to support each country in making a successful transition. “

“Children in low- and middle-income countries often wait years to get the same medications as adults, which can hinder their quality of life and even lead to preventable death. Unitaid Executive Director PhilippeDuneton said, “We are proud to work with our partners on this groundbreaking agreement to provide children with quality-guaranteed, decentralized DTG at a record pace. Ensuring access to this treatment will change the lives of children living with HIV and help them continue treatment and save thousands of lives. “

“For the first time, children living with HIV in low- and middle-income countries will have access to the same primary antiretroviral drug at the same time as children in high-income countries,” said Ian Burton, CEO. Stated. Clinton Health Behavior Initiative. “The partnership should serve as a model for removing barriers to the development of pediatric formulations to deliver top-line medicines quickly and affordably.”

Chip Lions, President and Chief Executive Officer of the Elizabeth Glaser Pediatric AIDS Foundation, said: “If the treatment gap between adults and children continues, we will not be able to achieve an AIDS-free generation.” Children living with HIV around the world are in urgent need of age-appropriate, effective and readily available formulations. The approval of decentralized DTG is a big step forward, but it doesn’t make sense if this new formulation doesn’t reach the infants and young children who need it most quickly. The Elizabeth Glaser Pediatric AIDS Foundation is global and regional. , And working with regional leaders to support the rapid deployment, uptake, and delivery of new and optimal pediatric antiretroviral drugs. “

Chewe Luo, Associate Director and HIV Chief of the United Nations Children’s Fund, said: “The United Nations Children’s Fund welcomes global efforts and progress in developing better diagnostic approaches and optimal regimens for children to improve outcomes.”

References

[1] UNAIDS. Free Stay Free AIDS Free – 2020 Report Starts. July 7, 2020.https://www.unaids.org/en/resources/documents/2020/start-free-stay-free-aids-free-2020-progress-report

[2] https://www.accessdata.fda.gov/drugsatfda_docs/pepfar/214521PI.pdf

[3] UNITAID press release.Breakthrough contracts reduce costs by 75%
An overview of HIV treatment for children in low and middle income countries.https://unitaid.org/news-blog/groundbreaking-agreement-reduces-by-75-the-cost-of-hiv-treatment-for-children-in-low-and-middle-income-countries/#en

[4] World Health Organization Latest Recommendations for Primary and Secondary Antiretroviral Therapy and Post-Exposure Prevention and Recommendations for Early Infant Diagnosis of HIV.. Provisional guidance. December 1, 2018.