2021
2021

New pediatric formulation for HIV treatment hits the ground in six African countries

A mother in a yellow dress smiles down at her baby, who is bundled in blankets. She sits across from a doctor at a desk with a computer.

Child starting pediatric DTG 10mg at a health facility in Malawi. Credit: Lighthouse Trust

Access for the youngest children

On World AIDS Day 2020, Unitaid and the Clinton Health Access Initiative (CHAI) announced a groundbreaking deal that would see the very best HIV treatment made available to the youngest children for the first time.

Almost two million children around the world live with HIV, the majority in low- and middle-income countries. Only 53 percent of these children are diagnosed and on treatment, while 80,000 babies and toddlers die each year from AIDS.

Ensuring access to treatments specifically designed for children is a key priority for Unitaid–and the agreement announced on Dec. 1, 2020 saw the price for pediatric HIV treatment reduced by 75 percent with a new 10mg scored, dispersible formulation of dolutegravir (DTG).

“To see this new pediatric formulation of DTG hitting the ground in six initial countries–and knowing that so many more are to come–is a huge moment for all the partners involved, and the communities that will benefit,” said Unitaid Executive Director Dr. Philippe Duneton. “Making the very best treatments available to the youngest children is at the heart of what Unitaid does and is vital if we are to achieve the global goals for HIV.”

It’s all in the taste

The strawberry-flavored formulation of the WHO’s recommended first-line treatment for HIV has been designed to overcome many of the barriers that stop young children taking their medication properly.

A lack of appropriate pediatric medicines has meant that tablets are often unpalatable to children, due to a bitter taste or use of adult formulations being crushed or broken for children.

The collaboration between Unitaid, CHAI, originator ViiV Healthcare, and generic manufacturers Viatris and Macleods also led to the generic version of the medication receiving the fastest-ever United States FDA tentative regulatory approval.

“As a result of this unique collaboration alongside ministries of health and impacted communities, thousands of children in need will now receive the best HIV treatment available in the fastest time ever for a pediatric medication,” said Joy Phumaphi, interim co-CEO of CHAI. “It is so exciting to see patients now accessing this lifesaving medication which has the potential to transform HIV care for children across low- and middle-income countries and save countless lives.”

Reaching those who need it most

A group of brightly dressed mothers stand in a semi-circle. Some of the women hold their infants. They are smiling. The courtyard has terracotta walls and is filled with sun.

Mothers of children living with HIV and key community leaders met at a workshop organized by the Community Advisory Board in Senegal. The meeting aimed to raise awareness about the availability and benefits of pediatric DTG and increase demand for the medicine. Credit: AfroCAB

In May 2021, 100,000 packs of 10mg scored, dispersible DTG started hitting the ground in six African countries that were the target of a catalytic procurement by CHAI and Unitaid–Nigeria, Malawi, Uganda, Kenya, Zimbabwe, and Benin.

Despite the difficulties of operating during the COVID-19 pandemic, CHAI–in close collaboration with Ministries of Health and national stakeholders–worked with procurement agent i+ Solutions to facilitate the purchase and delivery of the product in each of the six countries.

“The catalytic procurement by Unitaid and the support from CHAI has been a game changer, allowing faster introduction of this child friendly formulation to our young ones. This easy to administer formulation of pDTG is more efficacious, tastes better for the young palates, with more rapid viral load suppression and fewer side effects,” said Dr. Angela Mushavi, National Prevention of Mother-to-Child Transmission and Pediatric HIV Care and Treatment Coordinator at the Ministry of Health and Child Care, Zimbabwe. “The catalytic procurement is already being implemented in 13 high volume sites, and is expected to generate early experience, enabling younger children under 20kgs access to the clinically superior benefits of DTG. Lessons learnt during first phase of implementation will inform national scale-up.”

This initial procurement is designed to kick start the demand in countries and help get the medication to as many of the 1.8 million children living with HIV who could benefit as possible.

Sister Mary Owens is the executive director of Nyumbani, an organization dedicated to providing HIV/AIDS services to children and affected families in Kenya since 1991.

Nyumbani children were among the first to receive the new DTG formulation, through Unitaid and CHAI’s catalytic procurement.

“Since the National AIDS Conference in Durban in 2016, I have been lobbying for access to DTG for our children. Since then, 102 of our children have been optimized as a result of our work alongside CHAI and Unitaid and the support of NASCOP to deliver these lifesaving medications,” said Sister Mary. “I am unable to express adequately our unbelievable joy that Nyumbani younger children can now access DTG 10mg–and are the first in Kenya and in Africa. We are already seeing the great benefit.”

CHAI’s partnership with communities through the Optimal Community Advisory Board (CAB) is building demand and increasing patient treatment literacy on pediatric DTG 10mg.

Jacque Wambui, AfroCAB and CHAI-Unitaid Optimal CAB said: “It is important for communities and caregivers to be literate on pediatric DTG and how it is administered so as to maximize the benefits of using this formulation”.

The future

Major donors, including PEPFAR and the Global Fund, have rapidly moved to sustainable onward procurement, which will enable national scale-up and widespread access for all eligible children at an unprecedented pace.

The rollout of pDTG 10 mg dispersible, scored tablets is accelerating; more than 30 countries have plans for adoption and rapid rollout.

A map of Africa shows pediatric procurement across the continent.

“Enabling sustainable access to pediatric DTG for all children living with HIV is a game changer and will greatly improve the health of children living with HIV worldwide,” said Dr. Angeli Achrekar, Acting U.S. Global AIDS Coordinator at PEPFAR.

Read more about how pediatric DTG is transforming treatment for young children living with HIV.

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