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Sir,

Long-term side effects and medication costs are driving research on antiretroviral therapy towards dose-optimization and dose-reduction strategies. Two main factors are supporting this trend: the knowledge that doses lower than those adopted for clinical use are equally effective (as seen in Phase II studies of most antiretrovirals),1 and the increasing evidence of immunovirological efficacy of simplified regimens consisting of fewer than three drugs, particularly in induction–maintenance strategies. One of the major interests in this setting is to validate regimens devoid of nucleoside/nucleotide reverse transcriptase inhibitors (N/NtRTIs), and several small-sized clinical studies are investigating the efficacy of different N/NtRTI-sparing combinations. The raltegravir and atazanavir dual combination was found to be effective in a comparative study in treatment-naive patients, but the trial was prematurely stopped following the excess of resistance to raltegravir in those who experienced virological failure.2 In this study, however, a non-conventional twice-daily unboosted atazanavir dosage was employed (300 mg), possibly resulting in raltegravir monotherapy in case of suboptimal adherence. Based on the results of the dose-finding Phase II study of raltegravir (in which twice-daily doses ranging from 100 to 600 mg were found to be immunovirologically equivalent at 48 weeks),3 on two small reports of once-daily dosing of 400 mg of raltegravir4,5 and on the property of atazanavir to increase raltegravir exposure (by UGT1A1 inhibition),6 we carried out a pilot clinical investigation to evaluate the raltegravir pharmacokinetic profile when administered at 400 mg once daily with boosted atazanavir-based regimens.

Issue Section:
Research Letters
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