Apr, 2006

A randomised controlled trial of genotypic HIV drug resistance testing in HIV-1 infected children: the PERA (PENTA 8)


Authors: Aboulker J-P, Babiker A, Bacheler L, et al. On behalf of the PENTA 8 study group

Published in: Antivir Ther. 2006;11(7):857-867

Objective To evaluate the longer-term utility of genotypic resistance testing in HIV-1-infected children with virological failure.

Methods Children aged 3 months-18 years switching antiretroviral therapy (ART) with HIV-1 RNA > 2,000 copies/ml were randomized between genotypic testing (Virtual Phenotype) and no testing at baseline and subsequent virological failures. Children were followed to at least 96 weeks.

Results One hundred and seventy eligible children, from 24 clinical centres in six countries, were randomized to resistance testing(n = 87) or no testing (n = 83) between June 2000-July 2003. At baseline, mean HIV-1 RNA and CD4+ T-cell percentage were 4.7 log10 copies/ml and 20%, respectively. Children had taken ART for a mean of 5 years; 24% had received all three classes, 53% nucleoside reverse transcriptase inhibitors (NRTIs)+protease inhibitors (PIs), 9% NRTIs+non-nucleoside reverse transcriptase inhibitors (NNRTIs) and 14% NRTIs only. There was no difference between the arms in the drug classes or the individual PIs/NNRTIs prescribed. However, 49% in the resistance test arm (RT) versus 19% in the no-test arm (NT) continued at least one NRTI from their failing regimen; 56% versus 19% were prescribed didanosine+stavudine as their NRTI backbone. Adjusting for baseline HIV-1 RNA, mean reductions in HIV-1 RNA at 48 weeks were 1.51 log10 copies/ml in the RT arm and 1.23 in the NT arm (P = 0.3); the difference between the arms was smaller at week 96 (RT: 1.50, NT: 1.47; P = 0.9).

Conclusion In this first paediatric trial of resistance testing, we observed a substantial difference in NRTI-prescribing behaviour across arms. However statistically significant evidence of a long-term virological or immunological benefit was not observed.


Jul, 2005

A randomised trial of resistance testing versus no resistance testing in children with virological failure: the PERA (PENTA 8) trial


Authors: Giaquinto C, Green H, De Rossi A, et al. On behalf of the PENTA 8 study group.

Published in: 3rd IAS Conference on HIV Pathogenesis and Treatment, 24-27 July 2005, Rio de Janerio. Oral and poster presentation WeOa0106

Abstract The development of resistance to antiretroviral drugs is considered to be an important cause of treatment failure in HIV infection. Many randomised trials and studies have been conducted to assess the clinical utility of resistance testing in adults, with mixed conclusions. However, current clinical guidelines recommend the routine use of resistance testing as part of patient management.