XVIII International AIDS Conference

Abstract

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Effect of adherence on virological response to once-daily (qd) versus twice-daily (bid) darunavir/ritonavir (DRV/r) in treatment-experienced, HIV-1-infected patients with no DRV resistance-associated mutations (RAMs): ODIN 48-week data

C. Workman1, P. Benson2, J. Valdez Madruga3, A. Rieger4, T. Van de Casteele5, L. Lavreys5, S. Spinosa-Guzman5

1AIDS Research Initiative, Darlinghurst, Australia, 2Well Medical Center, Berkley, United States, 3Centro de Referência e Treinamento DST/AIDS, São Paulo, Brazil, 4Medical University of Vienna, Vienna, Austria, 5Tibotec BVBA, Mechelen, Belgium

Background: ODIN is a Phase IIIb, randomised, open-label study comparing DRV/r 800/100mg qd vs DRV/r 600/100mg bid at Week 48 in treatment-experienced, HIV-1-infected adult patients. Patients were included if they had no DRV RAMs at screening. In this analysis, adherence and its association with virological response to Week 48 were examined.
Methods: Mean adherence (Week 4-48) was assessed during the last 30 days prior to study visits over 48 weeks using (1) the Modified-Medication Adherence Self-Report Inventory (M-MASRI) questionnaire. Rates were transformed into binary variables of >95% (adherence) and ≤95% (suboptimal adherence). Adherence was also assessed by (2) DRV plasma concentrations (being above or below the detection limit of 10ng/mL), and (3) pill count (actual amount taken/amount to be taken).
Results: Across the three methods used, the percentage of patients who were adherent over the whole treatment period ranged from 57% to 83% (DRV/r qd) and 54% to 88% (DRV/r bid). Overall, adherent patients in both the DRV/r qd and bid groups achieved greater virological responses (HIV-1 RNA < 50 copies/mL intent-to-treat/time-to-loss of virological response) than suboptimally adherent patients (Table). In adherent patients, virological response to DRV/r qd was similar to that for DRV/r bid for each of the three adherence methods used.

 DRV/r 800/100mg qdDRV/r 600/100mg bidDRV/r qd - DRV/r bid
ParameterNNumber of responders, n (%)NNumber of responders, n (%)Difference in response (%)95% CI of difference in response (%)
Adherence measured by M-MASRI Adherent Suboptimally adherent

166
97


141 (84.9)
55 (56.7)


149
119


127 (85.2)
74 (62.2)


-0.3
-5.5


-8.2; 7.6
-18.7; 7.7
Adherence based on DRV plasma concentrations Adherent Suboptimally adherent


238
48



197 (82.8)
15 (31.3)



248
35



203 (81.9)
7 (20.0)



0.9
11.3



-5.9; 7.7
-8.1; 30.6
Adherence measured by pill count Adherent Suboptimally adherent

169
125


139 (82.2)
73 (58.4)


160
136


134 (83.8)
76 (55.9)


-1.5
2.5


-9.7; 6.7
-9.6; 14.6
[Virological response at W48 by adherence measure]

Conclusions: Regardless of the adherence methodology used, virological response was greater in adherent than suboptimally adherent patients in both DRV/r 800/100mg qd and 600/100mg bid arms. Adherent patients had comparable virological responses with DRV/r qd and DRV/r bid for each of the three adherence methods used.


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