IAS 2013: New WHO Guidelines on HIV Treatment for Children Require Earlier Diagnosis

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New World Health Organization (WHO) guidelines recommending antiretroviral treatment for all children with HIV under the age of 5, and treatment for all older children and adolescents with CD4 counts below 500 cells/mm3, will need to be backed up by efforts to greatly improve early infant diagnosis, together with development of easier-to-take antiretrovirals for children, pediatric experts told the 7th International AIDS Society conference (IAS 2013) on Monday.

 

[Produced in collaboration with Aidsmap.com]

Two million children already eligible for treatment are still not receiving antiretroviral therapy (ART) in low- and middle-income countries, Maria Penezzata of WHO told a satellite meeting on treatment access for children organized by the Drugs for Neglected Diseases Initiative (DNDI), UNITAID, and the Medicines Patent Pool.

The new WHO recommendations issued on June 30 will increase the number of children in need of treatment by around 750,000, but Penezzata expressed concern about the slow speed at which the number of children being treated is growing. "ART coverage increased by less than 10% between 2011 and 2012," she told the meeting. In comparison, adult ART coverage grew at its fastest rate ever during the same period.

Although some countries in southern Africa have already achieved what UNAIDS defines as universal access -- treatment for greater than 80%-85% of those in need -- global coverage of treatment stood at 34% in 2012.

The biggest obstacle to early treatment for children is the failure to diagnose HIV in the first weeks of life. The proportion of children exposed to HIV who receive HIV DNA testing ranges from 81% in Swaziland and 88% in South Africa to just 4% in Nigeria.

Children may not be tested because their health records fail to note that they have been exposed to HIV, but important opportunities for testing are also missed at immunization clinics, attended by over 80% of mother and infant pairs in many countries in sub-Saharan Africa. A greater focus on integrating early infant diagnosis into immunization clinics -- together with better health information systems to ensure that HIV-exposed infants are not lost after delivery -- would be significant steps forward in improving rates of early infant diagnosis, said Chewe Luo, senior adviser on HIV/AIDS at UNICEF.

Better integration of adult and infant HIV care would also help in starting more children on treatment. In Thailand, for example, there are 1016 clinics where adults can start ART, but only 616 clinics where children can start treatment, and many children are still initiated on ART by a specialist physician at a hospital rather than a nurse at a local health clinic. More personnel trained in pediatric HIV care would allow children to start treatment at a wider range of treatment centers, said Thanyawee Puthanakit of the Department of Pediatric Medicine at Chulangakorn University in Bangkok.

Greater awareness in the community of HIV, its symptoms, and its treatment in children would also help to increase the number treated. Many parents believe that if a child born to parents with HIV is not sick within the first 2 years of life, there is little chance that the child is infected, and so they do not seek testing for the child, said Puthanakit.

New Drug Formulations for Children Still Needed

The development of new drug formulations will be essential for the achievement of wider access to treatment for children, experts agree.

Emma Hannay of UNITAID, the international drug and diagnostics purchase fund for HIV, TB, and malaria, told the meeting that despite the number of children already being treated for HIV worldwide, the pediatric HIV antiretroviral market amounted to only $36 million a year, making it difficult to attract new entrants into an already highly fragmented field. Numerous single-drug products are available for younger children, but there are no fixed-dose products that support the implementation of new WHO guidance.

The new WHO guidelines recommend that all children below the age of 3 years should be treated with lopinavir/ritonavir combined with abacavir and lamivudine (3TC) or with zidovudine (AZT) and lamivudine. In cases where lopinavir/ritonavir is not available, nevirapine should be used instead. In older children, efavirenz is preferred to nevirapine, although WHO acknowledges that the evidence to support this recommendation for older children is of low quality.

Although WHO sought to standardize treatment for all as much as possible, the lack of availability of pediatric formulations of some antiretrovirals in many countries means that a variety of drugs are recommended for use in combination with efavirenz for children aged 3 and over.

The only way to give lopinavir/ritonavir and other key antiretrovirals to small children is in liquid form. Lopinavir/ritonavir liquid has an unpleasant taste and each dose needs to be measured carefully with a syringe in order ensure that the child is not under-dosed. Unlike nevirapine-based ART, no tablet form exists that is suitable for small children.

DNDI is currently working with the Indian pharmaceutical company Cipla to develop 2 combination capsules containing granules of lopinavir/ ritonavir, lamivudine, and either abacavir or zidovudine. It hopes that these products will be ready for registration by 2015. The products are designed either to be swallowed or to be opened so that the granules can be mixed with liquid or soft food. Current tablet formulations of lopinavir/ritonavir cannot be split or ground to powder without the risk of inadequate dosing, making it difficult to adapt them for children who cannot swallow pills.

"We are racing against the clock to ensure rapid delivery of a new 4-in-1 ARV medicine for young children," said Marc Lallemant, head of DNDI’s Paediatric HIV Programme. "Yet getting from the recommendations to actual implementation and treatment 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 children."

7/2/13

Source

UNITAID, DNDI, and Medicines Patent Pool. Closing the Treatment Gap for Children Living with HIV. Satellite meeting. 7th International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention (IAS 2013). Kuala Lumpur, June 30-July 3, 2013.