title: A randomized clinical trial comparing ritonavir-boosted lopinavir versus raltegravir 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 two regimens.
  
  
  
  A prospective, open, randomized clinical trial was conducted at a tertiary hospital in Barcelona, Spain. Individuals attending the emergency room because of potential sexual exposure to HIV were randomized to tenofovir disoproxil/emtricitabine (245/200 mg) plus either ritonavir-boosted lopinavir (400/100 mg) or raltegravir (400 mg). 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: NCT01576731.
  
  
  
  One-hundred-and-twenty-one individuals were randomized to receive ritonavir-boosted lopinavir and 122 to raltegravir (n = 243). PEP non-completion at day 28 was 43% with no significant difference between arms. We performed a modified ITT analysis including only those patients who attended on day 1 (n = 191). PEP non-completion in this subgroup was higher in the ritonavir-boosted lopinavir arm than in the raltegravir arm (34.6% versus 20.4%, P = 0.04), as was the number of patients lost to follow-up at day 28 (32.6% versus 21.6%, P = 0.08) and the proportion of patients with low adherence (49.2% versus 30.8%, P = 0.03). Adverse events were significantly more common in the ritonavir-boosted lopinavir arm (73.4% versus 60.2%, P = 0.007). There was an HIV seroconversion at day 90 in the raltegravir arm in a patient who had multiple potential sexual risk exposures before and after receiving PEP.
  
  
  
  Although we found no differences between arms regarding PEP non-completion, poor adherence and adverse events were significantly higher in patients allocated to tenofovir disoproxil/emtricitabine plus ritonavir-boosted lopinavir. These data support the use of raltegravir as the preferred third drug in current PEP recommendations.
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: D000293:Adolescent; D000328:Adult; D000368:Aged; 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; D008875:Middle Aged; D056990:Post-Exposure Prophylaxis / Q000379:methods*; D011446:Prospective Studies; D013030:Spain; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents