Monday, 15 November 2010

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Children and HIV: Treatment options

Every year, 33,000 new-borns in India get HIV from their infected mothers. Though it is well known that early ART will prevent illness and death in infants, the lack of early testing, paediatric formulations and access to basic healthcare facilities come in the way of effective prevention and treatment, as Mariette Correa explains

Most paediatric HIV infections worldwide are attributable to mother-to-child transmission, with transmission occurring during pregnancy, or at the time of birth, or through breastfeeding. According to the National AIDS Control Organisation (NACO), 33,000 new-borns get HIV every year from their infected mothers. Over 50% of these children die within two years of birth while 80% of them die within five years (1).

It has been known for several years now that starting children on antiretroviral therapy (ART) at an early stage will prevent illness and death. So, why are these children dying? Why are they not getting effective treatment?

HIV testing for infants

While it is acknowledged that children with HIV need and respond well to treatment, one of the biggest hurdles to effective treatment is finding out whether the child is HIV-positive. Many infants and young children die before HIV is diagnosed and therapy can be given.

Unlike with adults, special tests are needed to diagnose HIV infection in infants and young children. Diagnosis of HIV infection in adults is made by identifying the antibodies to HIV in the person’s blood. In infants and children below the age of 18 months, on the other hand, the presence of maternal HIV antibodies means that they are likely to test positive even though they are not infected. This means that a definite diagnosis of HIV infection among infants and children younger than 18 months usually requires the use of tests that are able to detect the virus itself, rather than antibodies to the virus. These tests are very expensive, more complex to perform, and not available in many areas of the world, especially in poorer countries.

For the early identification of HIV infection in infants, appropriate virologic testing technologies must be made available in resource-limited settings. The lack of appropriate testing in the youngest age group, which has the highest risk of HIV-related death, means that ART is not being administered to the very group that would benefit the most from treatment with these drugs. Indeed, without ART, the progression of HIV infection in children is particularly aggressive, and many children die at a young age.(2, 3, 4)

For babies below 18 months, early diagnosis is done using DNA Polymerase Chain Reaction (PCR) tests following a protocol developed by the National AIDS Control Organisation (NACO), in consultation with the Indian Academy of Paediatrics.

In India, it is only since the third phase of the National AIDS Control Programme (2006-2011) that facilities for testing infants have been made available. Even now, over two decades into the epidemic, there are only 19 Qualitative PCR machines in the country, a number that can hardly test the growing number of infants born to HIV-positive mothers.

Psychological barriers to testing

In many cases, the mother's health care provider is different from her baby’s. Information about the mother's HIV status therefore may not be made available to the infant's doctor. There are also psychological barriers to testing infants which could lead to a delay in diagnosis. The social stigma of the diagnosis for mother and child, and the lack of treatment availability for children and women, prevents women from having themselves tested to learn their own HIV status and testing their children for a HIV.

Lack of paediatric formulations

For many years, one of the biggest obstacles to reaching ART to children was the lack of paediatric formulations. Paediatric formulations were not available in India for two years after the government launched its programme for ART. While adults (at least in some states) had access to ART from April 2004, it was only in December 2006 that ART was made available to children. This is despite NACO specifically stating in its guidelines that children would have priority for ART.

Till December 2006, antiretroviral drugs — the only treatment available for those infected with HIV/AIDS — given to children were pieces of the fixed dose combinations (FDCs) for adults. The size of the tablet piece for children was according to the child's age.

This created problems for children, including drug toxicity and early drug resistance. FDCs for adults cannot just be cut or directly scaled down for children; the component medications may be required in different proportions for children than for adults. Moreover, if the tablets are not formulated in equal layers, breaking the tablet is likely to result in unequal doses being administered.

The paediatric ART programme in India

Under the third phase of the NACP, 2006-2011, two initiatives were launched: First, a specific paediatric fixed-dose combination of antiretroviral drugs to infected children was made available. Second, access to a corpus of $14 million from the Global Fund for AIDS, TB and Malaria (GFATM) Round-IV, in 2007-08, has enabled the provision of a package of services including medical care for opportunistic infections, psycho-social support, supplementary nutrition, and education, over a period of five years.(5)

NACO, in consultation with the Indian Academy of Paediatrics, formulated the Paediatric ART Guidelines, Formulations and Dosing Guide, Protocol for Diagnosis & Operational Rollout. The treatment is expected to cost the National Aids Control Programme Rs 8,000 per child per year. The National Paediatric Antiretroviral Treatment Programme combines stavudine, lamivudine, nevirapine, and zidovudine to meet the needs of babies and young children, using combinations of these drugs depending on the weight of the baby. Monitoring of ART is done using CD4 counts for all infected children. Now, with the availability of FDCs for children with HIV in India, their caregivers find that paediatric fixed-dose combination tablets are easier to take, are better tolerated, and easier to administer compared to syrup formulations, modified adult doses, and paediatric single-drug formulations. (6)

NACO has identified 32,803 HIV-positive children in the country. It provides support and treatment to 8887 of them, through the 126 ART centres established in the country. This is far short of the goal of NACP-III to provide ART to more than 90% of children living with AIDS at the end of five years. (7) UNAIDS estimates of children with HIV are much higher than the number of children identified by NACO as HIV positive. According to UNAIDS, between 17,000 and 94,000 children in India are in need of treatment.(8)

The unequal distribution of these centres across the country also calls for attention. States in India are divided into GFATM-funded states and non-GFATM funded states. The former – Tamil Nadu, Maharashtra, Andhra Pradesh, Karnataka, Manipur and Delhi – are those with high prevalence (excluding Delhi). These seven states host 87 ART centres. The remaining states share a total of 39 centres. Clearly, apart from Kerala which has five centres and Uttar Pradesh which has three, the one or two centres in all the other states cannot possibly be accessible to the large numbers of HIV-positive children who need the drugs.

The interventions planned under NACP-III target both infected and affected children, including orphans, according to a report tabled in the Lok Sabha. The programme aims to reach all the 65,000 infected and affected children by 2012. (9)

The NACP-III Plan lays down a financial requirement of approximately Rs 1,340 crore ($3,045,000) for ART roll-out over a period of five years. The budget for paediatric ART is Rs 111 crore ($252,000) and Rs 15.6 crore ($35,450) for setting up paediatric centres of excellence. Support for the ART programme comes through the WHO (technical assistance and drugs), the Clinton Foundation (paediatric ART), UNICEF (Prevention of Parent to Child Transmission Programme), Medicins Sans Frontiers (implementing treatment roll-out in selected states) and the Global Fund (training, treatment literacy and counselling). NGOs like the AIDS Healthcare Foundation and the Elisabeth Glaser Foundation are also supporting the government by taking over the roll-out in some states. (10)


Another major concern with existing paediatric treatment programmes is the lack of training on the specialised counselling needed to deal with children. Counsellors at the ART centres are expected to focus on treatment adherence; they are not trained to provide quality child counselling or parent counselling. Even those children who are aware of their HIV status due to counselling at the ICTC, may be unaware about the ART treatment and why they need the medicines and the importance of adhering to treatment.

Much more needs to be done to provide intensive counselling to children and young people as well as emotional support for adolescents. The counselling services available at ART centres focus mainly on treatment adherence for people living with HIV and there are no formal programmes or structures designed to address the special needs of children.

Outreach to orphans and vulnerable children

Given the lack of access that vulnerable and marginalised children have to healthcare, it seems improbable that ART will reach them. For those in orphanages, on the streets or in the care of indifferent relatives, even if they have gained access to ART, treatment adherence is a major cause for concern.

Services that offer psycho-social support to children hardly exist. Orphans who are HIV-positive are rarely adopted and remain in institutions. Relatives and community members may provide basic necessities like food, shelter and clothing, or in some cases even education or skills’ training to orphans and affected children. However, they are not in a position to provide the emotional counselling that affected children need most. When the child starts falling sick, the symptoms, constant illnesses and failure to respond easily to treatment confuse a child. Carers are unable to provide the psychological support that the child needs at this time.

Access to treatment of opportunistic infections

It is clear that many of the AIDS deaths that occur in low- and middle-income countries are preventable by treating or preventing opportunistic fungal infections with the anti-fungal drug co-trimoxazole and with antiretrovirals. WHO recommends that co-trimoxazole be given as a preventive drug to children with HIV as well as to children born to HIV-infected mothers, particularly if testing facilities are not available for the infant. Estimates put the number of HIV-infected children worldwide in 2005 at about 2.1 million. UNICEF, WHO and partners estimated that in 2005, co-trimoxazole prophylaxis was given to only 4% of the children who needed it.(11). In India, the treatment has been made available to 1,200 children.


Various other barriers limit the access of ART for children with HIV infection. In a clear policy statement endorsed by several leading paediatric organisations throughout the world, the barriers listed include the lack of personnel trained in treatment of children with HIV, lack of availability of appropriate and easily usable paediatric formulations, and insufficient pharmacokinetic data to appropriately guide drug dosing.(12)

One way to reduce the burden of HIV among children is to reduce the number of infants getting infected. Towards this end, the Prevention of Parent to Child Transmission (PPTCT) programme has made enormous strides over the past decade. Providing all pregnant women with the most effective prevention services possible within local settings, including prenatal care, HIV diagnosis, ART prophylaxis, and appropriate feeding options, is essential to reduce the risk of HIV infection for their child. Still, the coverage of the programme is far from adequate, reaching a mere fraction of HIV-positive pregnant women. Though the Indian government is offering anti-HIV treatment to prevent mother-to-child transmission, not all infected women get the therapy.

For children infected with HIV, overcoming barriers that limit access to ART is critical, and the enormous scale of the problem makes this an issue of worldwide concern. It is important to overcome challenges associated with issues of ease and accuracy of drug administration in the effort to increase access to ART for children.

(Mariette Correa is an independent consultant who has been involved in HIV/AIDS programming for NGOs in Goa and South Asia)


  1. Press Trust of India: ‘Nearly 70,000 children living with HIV virus’, Hindustan Times, New Delhi, August 17, 2007. http://www.hindustantimes.com/storypage/storypage.aspx
  2. Newell ML et al: ‘Mortality of infected and uninfected infants born to HIV-infected mothers in Africa: a pooled analysis’, Lancet, 2004; 364(9441):1236−43.
  3. Taha TE et al: ‘Association of HIV-1 load and CD4 lymphocyte count with mortality among untreated African children over one year of age’, AIDS, March 2000; 14(4):453−9..
  4. Brahmbhatt H et al: ‘Mortality in HIV-infected and uninfected children of HIV-infected and uninfected mothers in rural Uganda’, Journal of Acquired Immune Deficiency Syndrome, 2006; 41(4):504−8.
  5. National AIDS Control Organisation, Ministry of Health and Family Welfare, Government of India. NACP III (2006-2011) Strategy Implementation Plan, November 30, 2006.
  6. Jongbloed Kate: ‘Fixed-dose combination tablets simplify antiretroviral treatment for children in India with HIV’, presented at AIDS 2008. http://www.docguide.com/news/content.nsf/news/
  7. National AIDS Control Organisation, Ministry of Health and Family Welfare, Government of India. NACP III (2006-2011) Strategy Implementation Plan, November 30, 2006.
  8. UNAIDS: ‘Towards universal access: scaling up priority HIV/AIDS interventions in the health sector’, Progress Report, April 2007.
  9. The Statesman, April 20, 2008.
  10. Panos (India), ‘Antiretroviral drugs for all? Obstacles in accessing treatment: Lessons from India’, March 2007.
  11. UNICEF/UNAIDS/WHO, ‘Children and AIDS: a stocktaking report’, UNICEF, UNAIDS, WHO; 2007.
  12. Pediatrics, April 2007; 119 (4): 838−45.

InfoChange News & Features, December 2008

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