Children

Nelfinavir (Viracept) is available in a powder form for children. It is safe and effective, and is approved for use in children aged three years and over.1 Children over 13 years should take nelfinavir tablets rather than the powder .

Each gram of the powder contains 50mg of nelfinavir. The recommended dose is 50 to 55mg/kg twice daily or 25 to 30mg/kg three times daily. Children over 13 years of age should take the adult dose of nelfinavir tablets.

The powder can be mixed with water, milk, jam or milk-based desserts, but mixing with fruit juice creates a bad taste. The PENTA 5 study found that most children did not like nelfinavir powder, which produces a lumpy consistency when mixed with milk or food.2 In that study and in PENTA 7, many children switched to nelfinavir tablets, which were crumbled and mixed with food or drinks.3 As nelfinavir powder contains aspartame, it is not suitable for patients with phenylketonuria.

Therapeutic drug monitoring can be conducted to check drug levels in the blood. One study has shown that maintaining drug concentrations above 0.8mg/l in children improves the likelihood of virological success.4 Children with a genetic polymorphism in the gene for poly-glycoprotein have higher blood levels of nelfinavir and are more likely to suppress viral loads.5

As in adults, the mutations D30N and L90M are associated with resistance to nelfinavir in children. However, younger children seem more likely to develop L90M, particularly if they have higher viral loads.6

Although nelfinavir has not been approved for use in children below three years of age, two recent studies have demonstrated that the following combinations are effective in infants below three months of age:

  • Nelfinavir, d4T (stavudine, Zerit) and ddI (didanosine, Videx / VidexEC), although this has a high rate of virological failure.4
  • Nelfinavir, d4T, 3TC (lamivudine, Epivir) and nevirapine (Viramune). This combination can bring about viral suppression for up to four years in the majority of infants treated.7

One small study has investigated the use of anti-HIV combinations including nelfinavir at 40mg/kg twice a day or 10mg/kg three times a day in infants aged less than six weeks. Although these doses were well tolerated, the doses were often too low to produce adequate blood levels of the drug.8

References

  1. Resino S et al. Effects of highly active antiretroviral therapy with nelfinavir in vertically HIV-1 infected children: 3 years of follow-up. Long-term response to nelfinavir in children. BMC Infect Dis 6: 107, 2006
  2. Paediatric European Network for Treatment of AIDS. Comparison of dual nucleoside analogue reverse-transcriptase inhibitor regimens with and without nelfinavir in children with HIV-1 who have not previously been treated: the PENTA 5 randomised trial. Lancet 359: 733-740, 2002
  3. Paediatric European Network for Treatment of AIDS. Highly active antiretroviral therapy started in infants under 3 months of age: 72-week follow-up for CD4 cell count, viral load and drug resistance outcome. AIDS 18: 237-245, 2004
  4. Burger DM et al. Maintaining the nelfinavir trough concentration above 0.8 mg/l improves virologic response in HIV-1-infected children. J Pediatr 145: 403-405, 2004
  5. Saitoh A et al. An MDR1-3435 variant is associated with higher plasma nelfinavir levels and more rapid virologic response in HIV-1 infected children. AIDS 19: 371-380, 2005
  6. Machado ES et al. Alternative, age- and viral load-related routes of nelfinavir resistance in human immunodeficiency virus type 1-infected children receiving highly active antiretroviral therapy. Pediatr Infect Dis J 23: 1057-1059, 2004
  7. Luzuriaga K et al. A trial of three antiretroviral regimens in HIV-1-infected children. N Engl J Med 350: 2471-2480, 2004
  8. Mirochnick M et al. Safety and pharmacokinetics of nelfinavir coadministered with zidovudine and lamivudine in infants during the first 6 weeks of life. J Acquir Immune Defic Syndr 39: 189-194, 2005
Community Consensus Statement on Access to HIV Treatment and its Use for Prevention

Together, we can make it happen

We can end HIV soon if people have equal access to HIV drugs as treatment and as PrEP, and have free choice over whether to take them.

Launched today, the Community Consensus Statement is a basic set of principles aimed at making sure that happens.

The Community Consensus Statement is a joint initiative of AVAC, EATG, MSMGF, GNP+, HIV i-Base, the International HIV/AIDS Alliance, ITPC and NAM/aidsmap
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This content was checked for accuracy at the time it was written. It may have been superseded by more recent developments. NAM recommends checking whether this is the most current information when making decisions that may affect your health.

NAM’s information is intended to support, rather than replace, consultation with a healthcare professional. Talk to your doctor or another member of your healthcare team for advice tailored to your situation.