Geneva – A first generic version of the paediatric formulation of dolutegravir (DTG) as a 10 mg scored dispersible tablet is now ready to be supplied to low- and middle-income countries through the Medicines Patent Pool (MPP) generic manufacturing partner Viatris (through its subsidiary Mylan). Already more than ten countries have placed orders with the company, and the paediatric HIV medicine is starting to be delivered in Benin, Côte d’Ivoire, the Democratic Republic of the Congo, Haiti, Kenya, Malawi, Nigeria, Uganda, Zambia, Zimbabwe, as well as other sub-Saharan African countries through a pooled procurement mechanism.

1.8 million children around the world live with HIV, but in 2019 only 53% of them received antiretroviral therapy of which many were sub-optimal formulations[1]. In 2018, the World Health Organization (WHO) recommended DTG as part of preferred first- and second-line regimens for children. However, at that time, there was no adapted formulation for infants and young children. Thanks to the financial and technical support of international partners such as the partnership between Unitaid, the Clinton Health Access Initiative (CHAI) and ViiV Healthcare (the DTG patent holder), an access-oriented public health voluntary licence signed between ViiV Healthcare  and MPP, and ViiV Healthcare agreeing to share technical knowledge to MPP sublicensees, by November 2020, Viatris had received U.S. Food and Drug Administration (U.S. FDA) tentative approval for their generic formulation of DTG 10 mg scored dispersible tablet. In March 2021, MPP generic manufacturing partner Macleods received U.S. FDA tentative approval too for the child-friendly formulation. Both formulations can be used for children as young as four weeks and weighing at least 3kg and the WHO-convened Paediatric ARV Working Group (PAWG) encourages transition to DTG-based regimens for all children on first- and second-line antiretroviral therapy, as outlined in the sixth edition of the Optimal Formulary and Limited-use List released last week[2]. Macleods is now ready to join forces and take orders too.

A pricing agreement negotiated by Unitaid and CHAI was announced in December 2020, making the WHO-recommended first-line and second-line paediatric HIV treatment available at an affordable price to the 121 countries covered by the ViiV Healthcare-MPP licence. MPP together with Global Accelerator for Paediatric Formulations (GAP-f) partners are actively collaborating to support rapid rollout and ensure that all children in need can have access to DTG.

 

Access the ViiV Healthcare-MPP licence on dolutegravir (paediatric)

Read more on MPP’s commitment to address children’s needs (including as a founding member of GAP-f)

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