ViiV Healthcare announces FDA approval of first-ever dispersable HIV medication

ViiV Healthcare announces FDA approval of first-ever dispersable HIV medication

The U.S. Food and Drug Administration (FDA) has approved Tivicay PD, a dolutegravir tablet used for treatment of infants and young children living with HIV. Tivicay PD is the first HIV inhibitor available as a dispersible tablet, now making it easier for young children to take this medication by dispersing the tablet in water.

Availability, affordability and accessibility

This approval will expand the use of dolutegravir (DTG) by providing an age-appropriate formulation to the youngest. It will help to close the gap between HIV treatment options available for adults and children. Rouzeh Eghtessadi, SAfAIDS Executive Director in Zimbabwe, says: “A welcome innovation, Tivicay PD will truly serve its purpose if made available, affordable, accessible and at scale, for our children living in resource-poor settings. It has the potential to offer them greater opportunity to thrive and develop into healthy productive citizens.”

In terms of pricing, in all least-developed, low-income and sub-Saharan African countries, ViiV Healthcare’s commitment is to provide DTG for the public market at the cost of production plus distribution until generics are available.

Next steps: roll out and demand creation

Aidsfonds congratulates ViiV Healthcare on the FDA approval. Sabrina Erné, Senior Advisor Children Affected by HIV, says: “The release of the paediatric dispersible formulation of DTG is an extremely important development for the vulnerable children we serve. This tailored kind of paediatric HIV treatment will help meet the urgent needs of children living with HIV.”

In terms of the logistics of supply, the key issue is making sure countries are ready with guidelines that permit procurement and roll out. Now is the time for a quick scan and to make it real. Stock outs of generic lopinavir/ritonavir for children have been widespread because of COVID-19. Aidsfonds and partners are ready to support the shortening of the time to market by creating awareness to increase demand from the communities, mothers, caregivers and their children.

WHO welcomes the FDA approval

”The lack of optimal antiretroviral medicines with suitable paediatric formulations has been a longstanding barrier to improving health of children living with HIV, contributing towards low treatment coverage, and poor virological suppression,” says Dr Meg Doherty, Director of Global HIV, Hepatitis and STI Programmes of World Health Organization. “This approval will greatly expand the use of dolutegravir among children and adolescents, providing them relatively rapid access to an optimal drug that has so far only been available to adults.”

Children and HIV

Children aged 0 to 14 years are left behind in HIV care. In 2018 alone, 273 children died of AIDS and over 400 became HIV-infected each day. Worldwide 1.7 million children live with HIV, 46% are not on treatment. Without treatment, 50% of children born with HIV die before age two. 40% of children receiving treatment are on adult formulations.

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