Short Communication: Maraviroc Once-Daily: Experience in Routine Clinical Practice

Abstract

To assess the efficacy and safety of maraviroc (MVC) administered once-daily in routine clinical practice. A retrospective multicenter study (27 centers in Spain) was conducted. Data were collected from the records of patients starting a regimen with MVC. Laboratory and clinical data were recorded every 3 months the first year and every 6 months thereafter. Data are presented as median and interquartile range. Among 667 patients treated with MVC, 142 (21.3%) received MVC once-daily: 108 (76.1%), 150 mg and 34 (23.9%), and 300 mg. Age was 47 (42-45) years, there were 76.1% men, and 81 (57%) patients had baseline HIV-RNA <50 copies/mL. Viral tropism was R5 in 118 (83.1%) patients. Reasons for prescribing MVC: salvage therapy (36.6%), drug toxicity (31.2%), simplification (16.9%), and immunodiscordant response (7.1%). Median follow-up was 13 (9-16) months. In 95.8%, a PI/r was part of the regimen (67% on dual therapy). At months 12 and 24, 73.3% and 68.2% of patients had HIV-RNA <50 copies/mL, respectively (p = .041 and p < .001 vs. baseline). CD4 cell count increased by a median of 52 (-36,135) and 84 (-9.5,180) cells/mm at 12 and 24 months, respectively (p < .001 and p = .039 vs. baseline). Twenty-five (17.6%) patients discontinued MVC: virologic failure (6), medical decision (5), and other reasons (14). Two patients presented grade 3 adverse events (hypertransaminasemia, hypertriglyceridemia) without the need for MVC withdrawal, whereas MVC was discontinued in two patients due to gastrointestinal toxicity. In routine clinical practice, MVC once-daily combined with at least PI/r was virologically effective and well tolerated in a high percentage of pretreated patients.

No Clinical Impact of CYP3A5 Gene Polymorphisms on the Pharmacokinetics and/or Efficacy of Maraviroc in Healthy Volunteers and HIV‐1–Infected Subjects

“…Furthermore, maraviroc exposures when it was coadministered with a potent CYP3A inhibitor such as darunavir/cobicistat would be significantly higher if maraviroc were dosed at the approved dose of 150 mg twice daily (with potent CYP3A inhibitors) rather than 150 mg once daily. The once‐daily dose of maraviroc 150 mg in combination with boosted protease inhibitor regimens has been previously investigated for the treatment of HIV . As a result, maraviroc 150 mg once daily with darunavir/cobicistat was examined in this study to assess the worst‐case scenario for low maraviroc exposure where maraviroc C avg achieved exposures associated with near‐maximal maraviroc virologic response, with C avg ranging from 88 to 204 ng/mL in black EMs.…”

“…The once-daily dose of maraviroc 150 mg in combination with boosted protease inhibitor regimens has been previously investigated for the treatment of HIV. [29][30][31][32][33][34] As a result, maraviroc 150 mg once daily with darunavir/cobicistat was examined in this study to assess the worst-case scenario for low maraviroc exposure where maraviroc C avg achieved exposures associated with near-maximal maraviroc virologic response, with C avg ranging from 88 to 204 ng/mL in black EMs. The magnitude of the effect of CYP3A5 genotype on maraviroc exposures is expected to be comparable with exposures for maraviroc administered at the approved dose of 150 mg twice daily in combination with darunavir/cobicistat.…”

Two’s a Company, Three’s a Crowd: A Review of Initiating or Switching to a Two-Drug Antiretroviral Regimen in Treatment-Naïve and Treatment-Experienced Patients Living with HIV-1

“…It should be noted that these findings were not seen in a larger study comparing MVC with a boosted PI in participants with baseline HIV RNA [ 100,000 copies/ml [19]. Although data exist for once-daily maraviroc in treatment-experienced patients with R5 virus, the dose is 300 mg daily instead of 150 mg daily [26]. The lack of the typical 300 mg daily dosing of MVC may have reduced its efficacy and use in this setting.…”