title: A randomized clinical trial comparing ritonavir-boosted lopinavir versus maraviroc each with tenofovir plus emtricitabine for post-exposure prophylaxis for HIV infection.
abstract: The objective of this study was to assess post-exposure prophylaxis (PEP) non-completion at day 28, comparing ritonavir-boosted lopinavir versus maraviroc, both with tenofovir disoproxil/emtricitabine as the backbone.
  
  
  
  We conducted a prospective, open, randomized clinical trial. Individuals attending the emergency room because of potential sexual exposure to HIV and who met criteria for receiving PEP were randomized to one of two groups: tenofovir disoproxil/emtricitabine (245/200 mg) once daily plus either ritonavir-boosted lopinavir (400/100 mg) or maraviroc (300 mg) twice daily. Five follow-up visits were scheduled for days 1, 10, 28, 90 and 180. The primary endpoint was PEP non-completion at day 28. Secondary endpoints were adherence, adverse events and rate of seroconversions. This study was registered in ClinicalTrials.gov: NCT01533272.
  
  
  
  One-hundred-and-seventeen individuals were randomized to receive ritonavir-boosted lopinavir and 120 to maraviroc (n = 237). PEP non-completion at day 28 was 38% (n = 89), with significant differences between arms [ritonavir-boosted lopinavir 44% (n = 51) versus maraviroc 32% (n = 38), P = 0.05]. We performed a modified ITT analysis including only those patients who attended on day 1 (n = 182). PEP non-completion in this subgroup was also significantly higher in the ritonavir-boosted lopinavir arm (27% versus 13%, P = 0.004). The proportion of patients with low adherence was similar between arms (52% versus 47%, P = 0.56). Adverse events were reported by 111 patients and were significantly more common in the ritonavir-boosted lopinavir arm (72% versus 51%, P = 0.003). No seroconversions were observed during the study.
  
  
  
  PEP non-completion and adverse events were both significantly higher in patients allocated to ritonavir-boosted lopinavir. These data suggest that maraviroc is a well-tolerated antiretroviral that can be used in this setting.
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: Lorna
authors.initials: L
authors.lastname: Leal
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: Agathe
authors.initials: A
authors.lastname: León
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Berta
authors.initials: B
authors.lastname: Torres
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Alexy
authors.initials: A
authors.lastname: Inciarte
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Constanza
authors.initials: C
authors.lastname: Lucero
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Josep
authors.initials: J
authors.lastname: Mallolas
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Montserrat
authors.initials: M
authors.lastname: Laguno
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Martínez-Rebollar
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: González-Cordón
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Christian
authors.initials: C
authors.lastname: Manzardo
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Jhon
authors.initials: J
authors.lastname: Rojas
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Judit
authors.initials: J
authors.lastname: Pich
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.
authors.forename: Joan A
authors.initials: JA
authors.lastname: Arnaiz
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.
authors.forename: Josep M
authors.initials: JM
authors.lastname: Gatell
authors.affiliation: Infectious Diseases Unit, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain fgarcia@clinic.ub.es.
authors.forename: Felipe
authors.initials: F
authors.lastname: García
mesh_terms: D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018890:Chemoprevention / Q000009:adverse effects / Q000379:methods*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D008297:Male; D055118:Medication Adherence; D056990:Post-Exposure Prophylaxis / Q000379:methods*; D011446:Prospective Studies
chemical_list: D019380:Anti-HIV Agents