title: Randomized controlled trial of the tolerability and completion of maraviroc compared with Kaletra® in combination with Truvada® for HIV post-exposure prophylaxis (MiPEP Trial).
abstract: Post-exposure prophylaxis (PEP) for HIV is often poorly tolerated and not completed. Alternative PEP regimens may improve adherence and completion, aiding HIV prevention. We conducted a randomized controlled trial of a maraviroc-based PEP regimen compared with a standard-of-care regimen using ritonavir-boosted lopinavir.
  
  
  
  Patients meeting criteria for PEP were randomized to tenofovir disoproxil/emtricitabine (200/245 mg) once daily plus ritonavir-boosted lopinavir (Kaletra ® 400/100 mg) or maraviroc 300 mg twice daily. The composite primary endpoint was completion of 28 days of the allocated PEP regimen without grade 3 or 4 clinical or laboratory adverse events (AEs) related to the PEP medication.
  
  
  
  Two hundred and thirteen individuals were randomized (107 to maraviroc; 106 to Kaletra ® arm). Follow-up rates were high in both groups. There was no difference in the primary endpoint; 70 (71%) in the maraviroc and 64 (65%) in the Kaletra ® arm ( P  =   0.36) completed PEP without grade 3 or 4 AEs. Discontinuation of PEP was the same (18%) in both groups. There were no grade 3 or 4 clinical AEs in either arm, but more grade 1 or 2 clinical AEs in the Kaletra ® arm (91% versus 70%; P  < 0.001). Antidiarrhoeal medication use was higher in the Kaletra ® arm (67% versus 25%; P  < 0.001). There were no HIV seroconversions in the study period.
  
  
  
  The completion rate in the absence of grade 3 or 4 AEs was similar with both regimens. Maraviroc-based PEP was better tolerated, supporting its use as an option for non-occupational PEP.
authors.affiliation: Centre for Sexual Health and HIV Research, University College London, UK.
authors.forename: Ana
authors.initials: A
authors.lastname: Milinkovic
authors.affiliation: Central and North West London NHS Foundation Trust, The Mortimer Market Centre, UK.
authors.forename: Paul
authors.initials: P
authors.lastname: Benn
authors.affiliation: Centre for Sexual Health and HIV Research, University College London, UK.|Central and North West London NHS Foundation Trust, The Mortimer Market Centre, UK.
authors.forename: Alejandro
authors.initials: A
authors.lastname: Arenas-Pinto
authors.affiliation: Centre for Sexual Health and HIV Research, University College London, UK.
authors.forename: Nataliya
authors.initials: N
authors.lastname: Brima
authors.affiliation: Centre for Sexual Health and HIV Research, University College London, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Copas
authors.affiliation: The Claude Nicol Unit, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Clarke
authors.affiliation: The Claude Nicol Unit, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.
authors.forename: Martin
authors.initials: M
authors.lastname: Fisher
authors.affiliation: Manchester Centre for Sexual Health, Manchester Royal Infirmary, Manchester, UK.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Schembri
authors.affiliation: Chelsea and Westminster NHS Foundation Trust, The John Hunter Clinic, London, UK.
authors.forename: David
authors.initials: D
authors.lastname: Hawkins
authors.affiliation: Royal London Hospital, Ambrose King Centre, London, UK.
authors.forename: Andy
authors.initials: A
authors.lastname: Williams
authors.affiliation: Centre for Sexual Health and HIV Research, University College London, UK.|Central and North West London NHS Foundation Trust, The Mortimer Market Centre, UK.
authors.forename: Richard
authors.initials: R
authors.lastname: Gilson
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018791:CD4 Lymphocyte Count; D003510:Cyclohexanes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy / Q000517:prevention & control* / Q000821:virology; D017320:HIV Protease Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015497:HIV-1 / Q000187:drug effects; D006801:Humans; D061466:Lopinavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D000077592:Maraviroc; D055118:Medication Adherence; D056990:Post-Exposure Prophylaxis; D019438:Ritonavir / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014230:Triazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D003510:Cyclohexanes; D004338:Drug Combinations; D000069480:Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D017320:HIV Protease Inhibitors; D014230:Triazoles; C558899:lopinavir-ritonavir drug combination; D061466:Lopinavir; D000077592:Maraviroc; D019438:Ritonavir