Subgroup analysis of virological response rates with once- and twice-daily darunavir/ritonavir in treatment-experienced patients without darunavir resistance-associated mutations in the ODIN trial
Por:
Sension, M, Cahn, P, Domingo, P, Hodder, S, Opsomer, M, Lathouwers, E, Van de Casteele, T, Tomaka, F
Publicada:
1 ago 2013
Resumen:
BackgroundODIN (once-daily darunavir in treatment-experienced patients) was a 48-week, phase III, randomized, open-label trial comparing once-daily (qd) darunavir/ritonavir (DRV/r) 800/100mg with twice-daily (bid) DRV/r 600/100mg, both with an optimized background regimen [OBR; at least two nucleoside reverse transcriptase inhibitors (NRTIs)], in treatment-experienced, HIV-1-infected adults with no DRV resistance-associated mutations (RAMs) at screening. Week 48 analyses of virological response by subgroups are reported.
MethodsA total of 590 patients were randomized to receive qd (n=294) or bid (n=296) DRV/r. Virological response (HIV-1 RNA <50copies/mL) was assessed according to: screening HIV-1 RNA (or <50000copies/mL), CD4 cell count, prior protease inhibitor (PI) use, number of active NRTIs in the OBR, presence of mutations (primary PI mutations, PI RAMs or M184V/I), gender, age, race, HIV-1 clade and adherence.
ResultsBaseline characteristics were well balanced between arms and across subgroups. Response rates were comparable between qd and bid DRV/r treatments for all subgroups examined. Response rates were 78.4 and 76.8% in the qd and bid treatment arms, respectively, in patients with baseline HIV-1 RNA 50000copies/mL and 52.8% in both arms in those with >50000copies/mL. Response rates for the qd and bid treatment arms by baseline CD4 cell count were also similar (69.6 vs. 65.2% for <200cells/L; 72.2 vs. 74.8% for 200-<350cells/L; 77.0 vs. 74.3% for 350cells/L).
ConclusionsDRV/r administered either qd or bid provided effective treatment for antiretroviral treatment-experienced patients with no DRV RAMs, with comparable response rates across all subgroups studied. Low patient numbers in specific subgroups may limit interpretation of these specific subgroup results.
Filiaciones:
Sension, M:
Comprehens Care Ctr, Ft Lauderdale, FL 33311 USA
Cahn, P:
Huesped Fdn, Buenos Aires, DF, Argentina
Domingo, P:
Autonomous Univ Barcelona, Barcelona, Spain
Hodder, S:
Univ Med & Dent New Jersey, Newark, NJ 07103 USA
Opsomer, M:
Janssen Infect Dis BVBA, Beerse, Belgium
Lathouwers, E:
Janssen Infect Dis BVBA, Beerse, Belgium
Van de Casteele, T:
Janssen Infect Dis BVBA, Beerse, Belgium
Tomaka, F:
Janssen Res & Dev LLC, Titusville, NJ USA
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