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New antiretrovirals for infants and children still needed
Carole Leach-Lemens, 2012-07-25 02:50:00

Promising new formulations of antiretroviral agents including tenofovir, fosamprevanir, dolutegravir, etravirine and raltegravir for treating the often neglected needs of infants, children and adolescents with HIV were presented today in an oral abstract session at the 19th International AIDS Conference (AIDS 2012) in Washington DC.

Improving the range of antiretroviral formulations available for the treatment of infants and children in low- and middle-income settings has been an important theme of the conference, with several satellite meetings and a major scientific session devoted to the subject.

Jaydeep Gogtay of Cipla, in a joint Drugs for Neglected Disease initiative (DNDi) and IAS-ILF satellite session on Sunday, presented plans to develop a four-in-one paediatric antiretroviral drug combination for HIV-infected children under three years of age, including those infected in the womb as well as those co-infected with TB.

Using data from the CHAPAS-2 trial, DNDi and Cipla plan to produce an optimised first-line therapy in a fixed-dose combination of Lopimune (lopinavir/ritonavir, 40/10mg) sprinkles, combined with two alternative nucleoside reverse transcriptase inhibitor combinations, abacavir/lamivudine (3TC) or zidovudine/lamivudine (AZT/3TC). Registration is anticipated by 2015.

Nevertheless, a critical need for dosing for pre-term babies persists, stressed Lynn Mofenson of the US National Institutes of Health, a co-moderator at the satellite.

A number of speakers highlighted concerns that treatment for children, and especially the development of new antiretroviral formulations, risk being neglected as governments focus on the target of achieving an AIDS-free generation through improvements in prevention of mother-to-child transmission.

Of the estimated 3.4 million children living with HIV, 95% live in sub-Saharan Africa. Fewer than 25% of children have access to treatment, compared to 54% of adults worldwide. Without treatment, 50% of children will die before their second birthday. Effective care and treatment in resource-rich settings has virtually eliminated vertical transmission.

Approval of a new formulation for paediatric use can take an average of 6.5 years after approval for use in adults. Even when drugs are approved for children, the youngest children will have to wait the longest because investigations for appropriate paediatric formulations are done according to de-escalated age bands, with infants and newborns the last to benefit.

See this related article for further information on dolutegravir, raltegravir and etravirine.

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