New Initiative To Address Lack Of Paediatric-Specific HIV Treatments

As the World Health Assembly, a new partnership has been launched by three major public health actors in the field of HIV treatment. The initiative is meant to find improved treatments for children suffering from HIV/AIDs. Although all actors agree that significant progress has been made on adult treatments, children-specific medicines are still lacking.

UNITAID, the Drugs for Neglected Diseases initiative (DNDi), and the Medicines Patent Pool (MPP) are joining forces to ensure that appropriate HIV treatments are available for children. A major concern, according to speakers, is the lack of specific single-dose combinations of drugs for infants, children and adolescents.

The Paediatric HIV Treatment Initiative (PHTI) will focus on three areas, according to the PHTI: Research & development for new treatments; intellectual property – sharing patents and knowledge; and market-shaping – availability of treatment regiments for children living with HIV/AIDS.

Out of more than 3 million children living with HIV/AIDS, only 647,000 are treated with antiretroviral therapy, according to PHTI.

Several health ministers were invited to share their view of the PHTI and their national experiences at a high-level ministerial cocktail event on 18 May, during which the PHTI was launched. There will be a further launch during the WHA this week.

Brazilian Health Minister Arthur Chioro said the country saw a significant drop in vertical transmission of the virus (mother to child). In Brazil, he said, universal access to antiretroviral medicines is guaranteed by law but access for children is restricted by the lack of appropriate paediatric medications. He stressed the need for developing countries to get support from multilateral organisations, such as UNITAID.

Helia Molina, the Chilean minister of health, said small children have rights and one basic right is achieving their maximum potential.

South Africa Health Minister Aaron Motsoaledi insisted on the “very little incentive for industry” for paediatric fixed-dose combinations in developing countries.

Medicines Patent Pool Executive Director Greg Perry said the PHTI was seeking to accelerate development and delivery of appropriate innovative fixed-dose combinations for children by bringing together all the actors needed in the initiative. He mentioned the pharmaceutical industry, funders, generic manufacturers, procurement agencies, and people living with HIV/AIDS.

The PHTI means to “create a holistic approach,” Perry said, adding that the initiative “can only work if we all work together with that one objective.” The key role of the MPP is to work with industry to share the intellectual property, he explained. He also announced new open negotiations with Merck on paediatric medicines.

DNDi Executive Director Bernard Pecoul said infants born with HIV/AIDS have to take a series of medicines twice a day, alcohol-based syrup, with a repulsive taste. Those medicines also need a cold chain. All those represent a series of obstacles to overcome, he said.

The PHTI seeks to develop a fixed-dose combination that would address major challenges, such as solving the nasty taste of the treatment, making it suitable for infants under three years old, and TB-compatible, and avoiding the need for a cold chain.

Dominique Limet, CEO of ViV Healthcare, a company specialising in new HIV medicines, said the company is extremely engaged in collaborating with MPP and UNITAID. “We really have a role to play,” he said, so that “no patient is left behind.”

The Executive Director of the Global Network of People living with HIV/AIDS, Suzette Moses-Burton, said 35 years into the epidemic, “we are still failing children with HIV,” with two-thirds of the children in need of treatment left behind. The fact that vertical transmission has been reduced might induce the feeling that the issue of children with HIV/AIDS is already solved, she said.

The meaningful involvement of communities of people living with HIV/AIDS is of primary importance, she said, adding that in the past it has been challenging for communities to engage with some of the stakeholders, in particular on prices and voluntary licences.

A number of representatives of international and civil society organisations, such as the World Health Organization, UNAIDS, UNICEF, Médecins Sans Frontières, and the Clinton Health Access Initiative, also expressed support for the PHTI.

According to a PHTI document, the initiative “will operate through a series of synergistic working groups to address” the three key areas. “These product-specific working groups will, in turn, convene key players in the ARV [antiretroviral] medicines and paediatrics fields to pool knowledge, talent, resources and IP for the ultimate goal of developing and delivering better paediatric formulations, and ensuring they are accessible.”

“Pharmaceutical companies with key paediatric ARV products will be invited to join the initiative to share appropriate intellectual property rights, know-how, knowledge, and experience for the development of WHO’s priority products for children,” the document says.