HEALTH: New Drug Formulas Needed for Children With AIDS

By IPS Correspondents Reprint | | Print |

Katherine Stapp

NEW YORK, Sep 16 2004 (IPS) - With HIV-infected children dying much faster than adults – shockingly, one-half by their second birthday – doctors are scrambling to design new treatment protocols that work even in the most resource-poor settings.

And in many cases, they are meeting with measurable success.

In Romania, which two years ago had more than half of all pediatric HIV/AIDS cases in Europe, a new initiative has seen mortality rates reduced from 15 to three percent.

The programme is a collaborative effort between the Romanian Health Ministry, a municipal hospital in the south-eastern city of Constanta and the Baylor International Pediatric AIDS Initiative, based in the American state of Texas. It provides what is called highly active antiretroviral therapy (HAART) to more than 500 children – the largest group of HIV-positive children in any single centre worldwide.

At the start of drug therapy, more than half the children were of a weight and height that indicated severe growth retardation, researchers say. But after about six months on HAART, these same children experienced restoration of normal height and weight.

Doctors involved in the programme are convinced that their model can be replicated around the world.

“We’ve learned from our work in Romania and elsewhere that it is vital to address comprehensively the medical, psychosocial and educational needs of children and families receiving antiretroviral treatment,” Mark Kline, director of the Baylor International Pediatric AIDS Initiative, told IPS.

“Programmes that view treatment in a narrow sense – simply prescribing and dispensing drugs – will not achieve desired levels of success,” he added. “Children are not just ‘small adults’. Unless they are specifically considered and targeted for enrollment in treatment programmes, HIV-infected children often are underrepresented.”

Baylor currently operates pediatric HIV/AIDS centres in Romania, Botswana, Mexico and Uganda.

According to latest figures from the Joint United Nations Programme on HIV/AIDS (UNAIDS), 700,000 children were infected with HIV last year alone. In total, more than three million children are now HIV-positive; the vast majority, 2.8 million, live in sub-Saharan Africa.

“With the large numbers of infected children around the world, we urgently need child-friendly diagnostics and treatments for HIV,” said Siobhan Crowley, a medical officer in the HIV department of the World Health Organisation (WHO).

The Romanian study “clearly demonstrates that it is both feasible and effective to provide ARVs (anti-retroviral drugs) to children, and is evidence that pediatric HAART can work as well as adult HAART treatment, even in resource poor settings,” he added.

According to Doctors Without Borders (Médecins Sans Frontières, MSF), which runs an ‘Access to Essential Medicines Campaign’, the success of efforts to block transmission of the virus from mother to child means that relatively few children are being born with HIV in wealthy countries.

The flip side, however, is that the resulting lack of a profitable market has left pediatric drug formulations in short supply, despite the growing demand for them in developing countries.

“Children with HIV are generally not interesting for pharmaceutical companies, but some generic companies are developing more child-friendly ARV treatments. International agencies need to push this issue higher up the agenda and governments will need to remove barriers to the use of generic products,” said David Wilson, the medical coordinator for MSF in Thailand.

Making drugs affordable and tailoring treatment to young children is key, because most of those infected at birth die before age five, and half before their second birthday. Globally, between seven and eight percent of deaths in children under five are now attributable to AIDS.

In the hardest-hit countries, AIDS causes between 30 and 50 percent of deaths among under-fives.

Experts note that drug therapy in young children is not without its special challenges. Even diagnosing HIV infection in children under 18 months of age is problematic, since there are still no cheap, feasible tests that are accurate for young infants.

And once HIV infection is confirmed, there is often little or no access to drug formulations that are appropriate for children, with health workers forced to use adult doses and pills. At best, bad-tasting syrups that are difficult to measure are used for children who weight less than 10 kilogrammes, Wilson said.

Another problem is that in many developing countries, there are no standardised dosing schedules, and doctors have no clear guidelines for treatment of HIV in children.

“We’ve learned how important it is to build human capacity for pediatric HIV/AIDS care and treatment in the developing world,” Kline said. “Until now, a critical mass of professionals with this kind of experience has not existed. This has proven to be a serious impediment to pediatric HIV/AIDS care and treatment.”

Children’s formulas are also much more expensive.

The fixed-dose version of the preferred ARV combination for adults costs about 200 dollars per patient per year, while the best price for similar drugs in pediatric formulations is approximately 1,300 dollars for oral solutions and syrups.

For the second-line regimen of drugs like AZT, the adult yearly price is about 1,228 dollars. However, for child dosages, the same regimen in powder and syrup formulations costs at least 2,846 dollars per patient per year. (Second-line regimens are drug cocktails that are administered in the event that the first combinations fail to improve the health of patients.)

“MSF’s experience treating children with HIV/AIDS clearly shows the benefits of antiretroviral medicines. These drugs do work on children, just as they do for adults,” said MSF pharmacist Fernando Pascual.

“But we have discovered many difficulties also,” he added. “There has been too little attention paid to pediatric AIDS treatment, and children are being neglected.”

Still, momentum seems to be growing to address pediatric treatment issues.

In November, the WHO plans to address the challenges specific to children suffering from HIV/AIDS at an international meeting that will develop recommendations on how best to use the AIDS treatments that are currently available. The gathering will also identify steps which need to be taken to increase the availability of child-friendly drugs.