PMID- 20498120 OWN - NLM STAT- MEDLINE DCOM- 20100916 LR - 20220408 IS - 1460-2091 (Electronic) IS - 0305-7453 (Linking) VI - 65 IP - 7 DP - 2010 Jul TI - Suboptimal adherence to darunavir/ritonavir has minimal effect on efficacy compared with lopinavir/ritonavir in treatment-naive, HIV-infected patients: 96 week ARTEMIS data. PG - 1505-9 LID - 10.1093/jac/dkq150 [doi] AB - OBJECTIVES: To examine how treatment adherence differences in ARTEMIS (96 week analysis) affected clinical outcome, and to assess factors impacting adherence. PATIENTS AND METHODS: ARTEMIS is a Phase III trial, in HIV-1-infected treatment-naive patients, comparing efficacy and safety of once-daily darunavir/ritonavir (800/100 mg) versus lopinavir/ritonavir (800/200 mg total daily dose), each with a fixed-dose background tenofovir and emtricitabine regimen. Self-reported treatment adherence was assessed using the Modified Medication Adherence Self-Report Inventory (M-MASRI). In post-hoc analyses, mean adherence from weeks 4-96 was used to assess overall adherence for each patient, and transformed into a binary variable (>95% , adherent; < or = 95% , suboptimally adherent). RESULTS: Overall adherence was high: 83% of darunavir/ritonavir-treated patients and 78% of lopinavir/ritonavir-treated patients were >95% adherent. The difference in virological response rate for adherent versus suboptimally adherent patients was smaller for darunavir/ritonavir (6% difference: 82% versus 76%, P = 0.3312) than for lopinavir/ritonavir (25% difference: 78% versus 53%, P < 0.0001). In suboptimally adherent patients, a higher virological response rate was seen with darunavir/ritonavir (76%) versus lopinavir/ritonavir (53%) (P < 0.01). Suboptimally adherent patients (both treatment groups) reported more adverse events (AEs), including gastrointestinal AEs, than adherent patients. Darunavir/ritonavir had a lower rate of AEs, including gastrointestinal AEs, than lopinavir/ritonavir, in adherent and suboptimally adherent patients. CONCLUSIONS: Suboptimal adherence had no significant effect on the virological response rate with once-daily darunavir/ritonavir treatment. In contrast, the lopinavir/ritonavir response rate was significantly reduced in suboptimally adherent patients compared with adherent patients. Once-daily darunavir/ritonavir resulted in a higher virological response rate in suboptimally adherent patients compared with lopinavir/ritonavir. FAU - Nelson, Mark AU - Nelson M AD - Chelsea and Westminster Hospital, London, UK. mark.nelson@chelwest.nhs.uk FAU - Girard, Pierre-Marie AU - Girard PM FAU - Demasi, Ralph AU - Demasi R FAU - Chen, Liddy AU - Chen L FAU - Smets, Erik AU - Smets E FAU - Sekar, Vanitha AU - Sekar V FAU - Lavreys, Ludo AU - Lavreys L LA - eng PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20100524 PL - England TA - J Antimicrob Chemother JT - The Journal of antimicrobial chemotherapy JID - 7513617 RN - 0 (Anti-HIV Agents) RN - 0 (Pyrimidinones) RN - 0 (Sulfonamides) RN - 2494G1JF75 (Lopinavir) RN - O3J8G9O825 (Ritonavir) RN - YO603Y8113 (Darunavir) SB - IM MH - Adult MH - Anti-HIV Agents/*administration & dosage/adverse effects MH - Darunavir MH - HIV Infections/*drug therapy/virology MH - HIV-1/isolation & purification MH - Humans MH - Lopinavir MH - Medication Adherence/statistics & numerical data MH - Pyrimidinones/*administration & dosage/adverse effects MH - Ritonavir/*administration & dosage/adverse effects MH - Sulfonamides/*administration & dosage/adverse effects MH - Treatment Outcome MH - Viral Load EDAT- 2010/05/26 06:00 MHDA- 2010/09/18 06:00 CRDT- 2010/05/26 06:00 PHST- 2010/05/26 06:00 [entrez] PHST- 2010/05/26 06:00 [pubmed] PHST- 2010/09/18 06:00 [medline] AID - dkq150 [pii] AID - 10.1093/jac/dkq150 [doi] PST - ppublish SO - J Antimicrob Chemother. 2010 Jul;65(7):1505-9. doi: 10.1093/jac/dkq150. Epub 2010 May 24.