Charles Gore, Executive Director of the Medicines Patent Pool, Geneva

This time last year, global agencies, including the World Health Organization (WHO), Elizabeth Glaser Pediatric AIDS Foundation and UNAIDS, joined key stakeholders for a High-Level Dialogue on Scaling Up Early Diagnosis and Treatment of Children and Adolescents, convened by the Vatican. The meeting discussed reducing mortality among children living with HIV and, through the resulting action plan, committed to prioritising the development of child-friendly formulations of antiretroviral drugs (ARVs).

The Medicines Patent Pool (MPP) will be participating in the follow-up meeting – also at the Vatican – on 5-6 December 2019. HIV in children remains one of the world’s urgent public health crises. Latest data show that there are an unacceptable 1.8 million children under the age of 15 years of age living with HIV. Three hundred children die of the virus every day.[1] Although approximately 936,000 children were on antiretroviral therapy in 2017, there were still 180,000 new infections in the same year, despite the success of prevention of mother to child transmission programmes.[2] But this is not just a disease of numbers. Each statistic represents personal stories of the impact on families and their communities – and a devastating waste of life.

Treatment options for HIV-positive children are insufficient. More investment and efforts to develop effective child-friendly versions are needed. Current versions are difficult to administer, especially in younger children, and can have toxic side effects, seriously undermining treatment initiation and attempts to suppress the virus. Better paediatric formulations would save hundreds of lives every day. And yet…the world lags behind in developing them.

The action plan from the meeting in Rome acknowledges this reality and states “an improved first-line therapy for children under three years of age would be safe, easy to administer, well-tolerated and palatable, heat-stable, readily dispersible, and dosed once daily or less.”

In that same plan, the MPP committed to continue facilitating access to the best available medicines for children through intellectual property and knowledge sharing, and through its work with the pharmaceutical industry and public health stakeholders. In the short-term, this commitment translates in our work with licensees to deliver paediatric formulations identified by WHO. To date, we have licensed 13 ARVs, four of them for children. In the longer-term, the MPP will continue reaching the necessary agreements to ensure newer priority products are made available as quickly as possible.

In 2019, new paediatric formulations from the pharmaceutical industry, some of them developed by MPP sub-licensees, will be submitted for regulatory approval or will be entering the market. For example, new formulations of lopinavir/ritonavir, including a ‘four in one’ combination with abacavir and lamivudine; the fixed dose combination composed of abacavir/lamivudine/efavirenz; and the first dispersible tablets of dolutegravir. These products should contribute to better implementation of the WHO treatment guidelines, simplifying the regimens in some cases or providing formulations that are better adapted for children.

However, new products mean new challenges regarding how the transition to updated treatments is made. For example, how to ensure that countries adapt their treatment guidelines; that treatment providers become familiar with the new therapies and are trained in dispensing them; that parents and families support the transition; and that HIV programmes are able to absorb and deliver the changes. Traditional barriers to access in low- and middle-income countries (LMICs) must also be factored in: chronic poverty, weak healthcare infrastructure, stigma and discrimination.

On 5-6 December, I will be joining a follow-up meeting convened once more by the Vatican where our partners will be addressing why children continue to be an after-thought in the HIV response and to follow through on the commitments made last year. This meeting is a critical opportunity to prioritise children in an accelerated HIV response. It’s an opportunity that must not be missed.

[1] World Health Organization

[2] UNAIDS