Joint statement calling for urgent expansion of access to optimal HIV treatment for infants and children living with HIV in the country

Global partners committed to ending childhood AIDS have come together to urge countries to accelerate access to optimal, child-friendly HIV treatment for infants and children. Partners include the UN Children’s Fund, the World Health Organization (WHO), UNAIDS, the President’s AIDS Plan, the Global Fund to Fight AIDS, Tuberculosis and Malaria, Unitaid, the Elizabeth Glaser Children’s AIDS Foundation and the Clinton Health Access Initiative (CHAI).

Children living with HIV still lag behind in the global response to AIDS. In 2019, only 53% (950,000) of the 1.8 million children living with HIV (aged 0-14) were diagnosed globally and are in treatment, compared to 68% of adults.[1] The remaining 850,000 children living with HIV have not been diagnosed and are not receiving life-saving HIV treatment. Two-thirds of missing children are aged 5-14 and do not routinely attend traditional health facilities. Engaging communities and families of people living with HIV, tuberculosis and other related diseases and providing family services are needed to find and begin therapy for missing children.

It is estimated that 95,000 children died from AIDS-related illnesses in 2019, in part due to a lack of early diagnosis of HIV in infants and children and a direct link to optimal HIV treatment regimens. Untreated, 50% of newborns infected with HIV during or around the time of birth will die before the age of two.[1]

The U.S. Food and Drug Administration recently approved the first generic formulation of dolutegravir (DTG) 10 mg dispersible tablets.[2] This approval is the result of an innovative partnership between Unitaida, CHAI and ViiV Healthcare, along with generic suppliers, which has accelerated the development timeframe by several years. The approval was quickly followed by the announcement on World AIDS Day of a groundbreaking agreement negotiated by Unitaid and CHAI that reduces the cost of HIV treatment by 75% for children in low- and middle-income countries, where DTG 10 mg dispersible tablets will be available at a price of $ 4.50 for a bottle of 90 numbers.^[3]

This now means that the preferred first-line DTG-based antiretroviral treatment recommended by the WHO is now available in more affordable and child-friendly generic formulations for young children and infants up to four weeks of age and weighing more than 3 kg.[4] A rapid transition to this optimal treatment regimen, combined with improved HIV diagnosis for children and other supportive measures, will help urgently reduce the 95,000 deaths of AIDS-related children.

DTG-based HIV treatment leads to better outcomes for children. DTG is less likely to affect drug resistance and achieve viral load suppression sooner; child-friendly dispersible tablets improve adhesion due to lower tablet load and easier administration. 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 of care for adults. Starting with this regimen from childhood, the need for changes in treatment decreases as they mature through childhood, adolescence, and adulthood. Fewer regimes and regime changes simplify health care management, improve inventory management, and reduce waste.

Since 2018, the WHO has recommended DTG-based HIV treatment to infants and children[4] and provided dosing recommendations for infants and children older than four weeks and over 3 kg in July 2020.[5]

Suppliers have demonstrated their ability to meet the ambitions of global expansion. Accurate demand forecasts are key to informing production planning and delivery times. It is therefore crucial that national programs start including DTG 10 mg dispersible tablets in their new procurement plans, review stocks and orders for existing treatment for non-DTG children, share forecasts with HIV treatment partners and suppliers, and order as soon as possible possible.

Partners are committed to supporting national governments as they develop plans for a rapid transition from existing suboptimal HIV treatment to DTG-based infant and child care, including advocacy for political commitment, mobilization of international and domestic resources, new policies and guidelines, drug supply management, distribution and stockpiling, training health workers, and sensitizing and engaging affected communities to ensure demand and literacy for the treatment of children living with HIV and their carers to ensure rapid adoption of these new formulations.

Further guidance for national programs and partners is available from the WHO.[5] The CHAI HIV New Introduction Toolkit has dedicated resources to help countries transition to child DTG.[6]

Partner quotes

“This could potentially be a real change in play for children with HIV,” said Meg Doherty, director of the WHO’s Global HIV, Hepatitis and STI Programs. “We must do everything in our power to help countries get this new pediatric DTG 10 mg to all their children who need it.”

“National governments, field partners and affected communities must work together to find and treat children and infants whose lives can be saved with these new drugs,” said Shannon Hader, UNAIDS executive director for the program. “New drugs are cheaper, more effective and more suitable for children than current treatments for newborns and young children. We need to put them in clinics to save lives now. ”

“Providing antiretroviral drugs to people living with HIV is at the core of our support for national HIV programs,” said Peter Sands, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria. “This new and affordable child-friendly treatment for HIV is a tremendous step forward that will improve and save the lives of some of the most vulnerable in society – young children infected with HIV. We are committed to supporting countries in the rapid transition to these new drugs. “

“Children in low- and middle-income countries often wait years to access the same drugs as adults, disrupting their quality of life or even resulting in preventable death. We are proud to have worked with partners on this revolutionary agreement that will bring children a record-breaking quality dispersed DTG with record speed, ”said Philippe Duneton, CEO of Unitaida. “Providing access to this treatment will transform the lives of children living with HIV, helping them stay on treatment and saving thousands of lives.”

“For the first time, children living with HIV in low- and middle-income countries will have access to the same first-line antiretroviral drugs at the same time as those in high-income countries,” said Iain Barton, chief executive of the Clinton Health Action Initiative. “The partnership should serve as a model for removing barriers to the development of children’s formulations for fast and affordable delivery of premium drugs.”

“The continuing gap in the treatment of adults and children prevents us from achieving a generation without AIDS,” said Chip Lyons, president and CEO of the Children’s AIDS Foundation Elizabeth Glaser. “Children living with HIV around the world urgently need age-effective, effective and accessible formulations. The approval of dispersive DTG is an important step forward, but pointless if this new formulation does not quickly reach babies and young children who desperately need it. The Elizabeth Glaser Children’s AIDS Foundation is committed to supporting the accelerated introduction, introduction and delivery of new, optimal pediatric antiretroviral drugs in partnership with global, regional and local leaders. ”

“The continuing gap in the treatment of mothers and children is unacceptable with new scientific advances that are substituting for us to change trajectory,” said Chewe Luo, associate director and head of HIV, United Nations Children’s Fund. “The United Nations Children’s Fund welcomes global commitments and the progress made in developing better diagnostic approaches and optimal regimens for children to improve their outcomes.”

References

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

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

[3] UNITAID press release. The milestone agreement reduces the cost of HIV treatment for children in low- and middle-income countries by 75%.
https://unitaid.org/news-blog/breakthrough agreementreduces-by-75-the-price-hiv-treatment-for-children-in-lower-middle income countries / #in

[4] World Health Organization Updated recommendations for first and second line antiretroviral regimens and post-exposure prophylaxis and recommendations for early diagnosis of HIV newborns. Interim guidelines. December 1, 2018