DNDi and Cipla advance development of pediatric 4-in-1 ARVs to fulfill new WHO guidelines

June 30, 2013

The World Health Organization's new HIV treatment guidelines, released today at the 2013 International AIDS Society (IAS) Conference, include new antiretroviral (ARV) therapy (ART) recommendations for HIV-infected children, and will mean that more children will be on better treatments. The Drugs for Neglected Diseases initiative (DNDi) applauds the new guidelines and, with Cipla Ltd. and other partners, is expediting the development of urgently needed 4-in-1 ARVs adapted for babies and toddlers with HIV, to be delivered by 2015.

The new 2013 WHO Consolidated Guidelines on the Use of Antiretroviral Drugs for Treating and Preventing HIV Infection were released today at the 7th IAS Conference on HIV Pathogenesis, Treatment and Prevention. The updated guidelines call for immediate ART for all HIV-infected children under five years of age, regardless of clinical or immunological status, which will greatly broaden the pediatric HIV patient population on treatment and thus increase demand. Importantly, the guidelines also recommend the use of potent protease inhibitor-based first-line ARV regimens, ideally in a fixed-dose combination (FDC), for all children under three years old.

'The new international guidelines call for getting many more with HIV on the best treatment with no delay', said Dr Bernard Pécoul, Executive Director of DNDi. ''We are reassured that the pediatric ARV formulation we are striving to deliver to babies and toddlers with HIV is completely aligned with the WHO's new recommendations.'

Welcoming the new international HIV , Dr Jaideep A Gogtay, Chief Medical Officer of Cipla, said, 'Cipla reinforces its commitment towards HIV/AIDS and will continue to develop novel and child-friendly formulations to ensure wider access of ARV drugs to HIV-infected children.'

An estimated 3.3 million children (<15 years old) live with HIV/AIDS, but only 28% of those in need of treatment are receiving it, compared with 54% of adults (2011 data). Without treatment, half of all HIV-positive children will die before the age of two, and 80% will die before they turn five years old.

DNDi entered the field of pediatric HIV in 2011 due to the critical unmet need of an appropriate ARV formulation for infants and young children. Current formulations of protease inhibitors for children too young to swallow tablets are in an alcohol-based liquid form. These formulations taste terrible, are difficult to store and transport, and require refrigeration, which is a hindrance in many developing countries. Additionally, administering the correct dose of medicine is challenging since it involves measuring precise amounts of various liquid formulations, which risks errors in dosing. Undesirable interactions with drugs for tuberculosis, the most common co-infection with HIV, pose further challenges.

To fulfill the need for better pediatric formulations, DNDi is partnering with the Indian drug manufacturer Cipla Ltd. to develop two 4-in-1 ARV FDCs designed specifically for children under three years of age, or until they are able to swallow tablets. This new formulation comprises tiny granules, which fit into a capsule that can be opened to spread the medicine onto soft food or be mixed with milk. The ARVs are 'taste-masked', require no refrigeration, and are easy to dose according to the child's weight.

'Since its creation in 2006, UNITAID has been addressing pediatric HIV by creating the market for child-friendly antiretroviral treatments as previously there was no incentive for pharmaceutical companies to invest in developing these medicines and so none existed', said Philippe Douste-Blazy, Chair of the Board of UNITAID. 'The international community must continue to commit to developing the best possible treatments to avoid childhood HIV becoming a neglected disease. UNITAID's investment in this project with DNDi is already a vital contribution.'

The two '4-in-1' combinations contain lopinavir/ritonavir + zidovudine + lamivudine (LPV/r/AZT/3TC) and lopinavir/ritonavir + abacavir + lamivudine (LPV/r/ABC/3TC), respectively. An additional formulation of ritonavir granules is being developed for babies and young children who require treatment for both HIV and tuberculosis. The goal is to make these new FDCs available by 2015, by working closely with health professionals in the field and research organizations in the most affected countries.

'We are racing against the clock to ensure rapid delivery of a new 4-in-1 ARV medicine for young children,' said Dr Marc Lallemant, Head of DNDi's Pediatric HIV Program. 'Yet getting from the recommendations to actual implementation and access will require the full support of donors, international and national regulatory authorities, national HIV programs, civil society, and people living with HIV themselves to make this a reality for HIV-infected .'

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