ARIES 144 week results: durable virologic suppression in HIV-infected patients simplified to unboosted atazanavir/abacavir/lamivudine.

AbstractBackground: The open-label study ARIES (http://ClinicalTrials.gov NCT00440947) utilized a ritonavir (/r)-boosted protease inhibitor treatment simplification strategy. Antiretroviral-naive subjects received abacavir/lamivudine (ABC/3TC) + atazanavir/ ritonavir (ATV/r) from baseline through randomization at week 36, then maintained or discontinued ritonavir for an additional 108 weeks. Non-inferiority of the unboosted regimen was demonstrated at week 84. In this optional extension phase, virologic suppression and adverse events were assessed through week 144.Methods: Patients were randomized at week 36 if they had confirmed HIV RNA <50 copies/mL by week 30 and no previous virologic failure (VF; defined as failure to achieve HIV RNA <400 copies/mL or confirmed rebound after achieving HIV RNA ≥400 copies/mL). Three hundred sixty-nine subjects who completed 84 weeks in ARIES participated in the extension phase and maintained their randomized regimen for an additional 60 weeks post randomization.Results...