There are studies where they have used maraviroc QD dosing, and from the data it seems ok to use it although you rarely see it in practice. Also depends on background regimen, if there is a NNRTI (i.e. efavirenz, etravirine or other potent 3A4 inducers) onboard, I dont see it practical to use QD dosing since you have to raise the maraviroc dose as it is.
Take a look at this study for more info (this is in tx experienced patients) -- Efficacy and safety of once-daily (QD) compared with twice-daily (BID) maraviroc plus optimized background therapy (OBT) in treatment-experienced patients infected with CCR5-tropic-HIV-1 in Europe, Australia and North America (MOTIVATE 2): 48-Week Results - GulickR.M., et al. which was presented at the 4th IAS.
Study Characteristics:
Trial design
474 patients were randomized 1:2:2 to placebo or maraviroc 150 mg once daily (qd) or maraviroc (mvc) twice daily (bid), all 3 groups along with OBT, optimized therapy background.
Patient eligibility criteria:
--R5 HIV-1 infection
--HIV-1 RNA ≥5,000 copies/ml
--Stable pre-study ARV regimen, or no ARVs for ≥ 4 weeks
--Resistance to and/or ≥ 6 months' experience with ≥ one ARV from three classes (≥ two for PIs)
Patients stratified by:
-- Enfuvirtide use in OBT </B>
-- HIV-1 RNA < and ≥100,000 copies/ml at screening
OBT = optimized background therapy of 3-6 ARVs (PK boosting doses of RTV not counted as an ARV)</B>
Patients receiving a PI (except TPV) and/or delavirdine in their OBT received 150 mg dose of MVC, all other patients received 300 mg dose of MVC
Demographics and Baseline Characteristics
Includes all patients who received at least one dose of study medication (full analysis set).
84-89% of patients are men; 82-87% are white. Median cd4 count is 174-182; mean viral load is 4.88 log. 45% in placebo and 38% in MVC arms had fuzeon in background therapy; 66% in placebo and 63% in MVC QD and 62% in MVC bid had 2 or less active drugs in OBT. Of note, Darunavir use was not permitted for this study.
Results:
Percentage of Patients with Undetectable HIV-1 RNA
At week 48, 45% in both the qd and bid groups had <50 copies/ml and 18% in the placebo group had <50 c/ml. After 24 weeks of study the authors report in this slide, 55% in bid MVC and 53% in MVC qd groups had <400 c/ml.
Mean Change from Baseline in CD4+ Count
Includes all patients who received at least one dose of study medication. Cd4 increas was a mean of 112 cells for qd MVC and 102 for MVC bid at week 24, and a 64 cell increase for placebo. After 48 weeks, mean cd4 increase was 69 for placebo, 121 for MVC qd, and 128 for MVC bid.
Not a whole lot different, is there a trully significant need for the selzentry to be qd vs bid? Most clinicians will choose to nonetheless go with the more conventionally recommended bid dosing.
