Advertisement cover the XIX International AIDS Conference (AIDS 2012)

Update on New Antiretrovirals for Children and Adolescents

July/August 2012

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An oral suspension of fosamprenavir/ritonavir (FPV/r) was also approved in the U.S. earlier this year in April for use in children 4 weeks to less than 6 years of age.

Jorg Sievers presented data from the APV20002 study that looked at PK, safety and antiviral activity of FPV/r twice daily in PI-naive and PI-experienced children 4 weeks to <2 years of age. This evaluation was across two age cohorts: cohort 1, 6 months to <2 years and cohort 2, 4 weeks to <6 months of age.

APV20002 was a phase 2, open label, multicentre study in which Intensive pharmacokinetic sampling was performed at 2 or 8 weeks and pre-dose samples were collected every 4-12 weeks. Safety and viral load were monitored every 4-12 weeks.


The older cohort was dosed at 45/7 mg/kg FPV/r twice daily and the younger 45/10 mg/kg twice daily.

Overall 54 children were included in the intent-to-treat-exposed analysis (28 in cohort 1 and 26 in cohort 2). At baseline the children were a median age of 6 months (range 2 - 24), with a median viral load of 5.6 log10 copies/mL (range 5 - 6.15) and CD4 percentage of 26% (range 18 - 34).

At 48 weeks, the median exposure to FPV/r was 640 days (range 8-1093), with 78% exposed >48 weeks and 50% >96 weeks.

When the investigators compared plasma amprenavir (APV) AUC0-t to historical adult data, the geometric mean ratios were 0.744 (90% CI 0.542 - 0.957) and 0.720 (90% CI 0.568 - 0.975) in cohort 1 and 2 respectively. For the Ct these values were, 1.00 (90% CI 0.833 - 1.21) and 0.397 90.298 - 0.528).

Despite lower Ct in the younger cohort, antiviral response was similar across the age groups: 64% percent of children in cohort 1 and 58% in cohort 2 achieved viral load < 50 copies/mL at 48 weeks. The median increase in CD4 percentage was 5% in both cohorts.

The most common AEs were diarrhoea (54%), gastroenteritis (36%) and upper respiratory tract infection (36%). Drug-related grade 2-4 AEs occurred in 20% of children, most frequently increased blood chlolesterol (10%) and gastroenteritis (3%). Twenty-two children experienced serious AEs, three were considered to be drug-related. Three children died following serious AEs including one two month old boy with traditional (herbal) medicine poisoning.


Although somewhat opaque in their approach, the EMA are expected to follow suit with these approvals in the not too distant future. More details on these drugs and others under investigation for children can be read in our paediatric antiretroviral pipeline report.


  1. Food and Drug Administration (U.S.). Isentress (raltegravir): pediatric dosing recommendations and 2 chewable tablet formulations for pediatric dosing. 21 December 2011.
  2. Food and Drug Administration (U.S.). Intelence (etravirine): pediatric dosing recommendations and new scored 25 mg tablet for pediatric dosing. 26 March 2012.
  3. Food and Drug Administration (U.S.). New pediatric Lexiva dosing regimen for patients from at least 4 weeks to less than 6 years of age. 27 April 2012.
  4. Raffi F et al. Once-daily dolutegravir (DTG; S/GSK1349572) is non-inferior to raltegravir (RAL) in antiretroviral-naive adults: 48 week results from SPRING-2 (ING113086). 19th International AIDS Conference. 22-27 July. Washington DC. Oral abstract THLBB04.
    View video
  5. Hazra R et al. Pharmacokinetics, safety and efficacy of dolutegravir (DTG; S/GSK1349572) in HIV-1-positive adolescents: preliminary analysis from IMPAACT P1093. 19th International AIDS Conference. 22-27 July 2012, Washington. Oral abstract TUAB0203.
    View video
  6. Nachman S et al. IMPAACT P1066: raltegravir (RAL) safety and efficacy in HIV infected (+) youth two to 18 years of age through week 48. 19th International AIDS Conference. 22-27 July 2012, Washington. Oral Abstract TUAB0205.
    View video
  7. Tudor-Williams G et al. Safety and efficacy of etravirine in HIV-1-infected, treatment-experienced children and adolescents: PIANO 48-week results. 19th International AIDS Conference. 22-27 July 2012, Washington. Oral abstract TUAB0204.
    View video
  8. Sievers J et al. Pharmacokinetics, safety and antiviral activity of fosamprenavir/ritonavir-containing regimens in HIV-positive four weeks to < two year-old children (48-week data, study APV20002, a prospective, open-label, multi-centre, 48-week cohort study). 19th International AIDS Conference. 22-27 July 2012, Washington. Oral abstract TUAB0202.
    View video

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