HIV-1 Drug Resistance and Second-Line Treatment in Children Randomized to Switch at Low Versus Higher RNA Thresholds.

Journal of Acquired Immune Deficiency Syndromes : JAIDS
Linda HarrisonPENPACT-1 (PENTA 9PACTG 390) Study Team

Abstract

The PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy (ART). Using PENPACT-1 data, we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold. PENPACT-1 had a 2 × 2 factorial design, randomizing HIV-infected children to start protease inhibitor (PI) versus nonnucleoside reverse transcriptase inhibitor (NNRTI)-based ART, and switch at a 1000 copies/mL versus 30,000 copies/mL threshold. Switch criteria were not achieving the threshold by week 24, confirmed rebound above the threshold thereafter, or Center for Disease Control and Prevention stage C event. Resistance tests were performed on samples ≥1000 copies/mL before switch, resuppression, and at 4-years/trial end. Sixty-seven children started PI-based ART and were randomized to switch at 1000 copies/mL (PI-1000), 64 PIs and 30,000 copies/mL (PI-30,000), 67 NNRTIs and 1000 copies/mL (NNRTI-1000), and 65 NNRTI and 30,000 copies/mL (NNRTI-30,000). Ninety-four (36%) children reached the 1000 copies/mL switch criteria during 5-year follow-up. In 30,000 copies/mL threshold arms, median time from 1000 to 30,000 copies/mL switch criteria was 58 (PI) versus 80 (NNRTI) weeks (P = 0.81). I...Continue Reading

References

Aug 19, 2005·The Journal of Infectious Diseases·Deenan PillayUNKNOWN UK Collaborative Group on HIV Drug Resistance
Nov 3, 2009·HIV Medicine·UNKNOWN PENTA Steering CommitteeDiane Bastiaans
Aug 9, 2011·AIDS Research and Human Retroviruses·Kim C E SigaloffWendy S Stevens

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Citations

Sep 17, 2016·Journal of Tropical Pediatrics·Ragna S BoermaJob C J Calis
Oct 14, 2017·Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America·UNKNOWN European Pregnancy and Paediatric HIV Cohort Collaboration (EPPICC) Study Group in EuroCoord
Mar 7, 2018·Journal of Acquired Immune Deficiency Syndromes : JAIDS·Kara Wools-KaloustianConstantin T Yiannoutsos

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