title: Evaluation of tolerability with the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for post-HIV exposure prophylaxis.
abstract: The preferred regimen for HIV post-exposure prophylaxis (PEP) is based mainly on safety and tolerability because it is given to immunocompetent people without HIV infection for a limited time (28 days). The frequency of adverse events (AEs) may be > 60%. Although AEs are generally not severe, they can lead to lack of adherence and failure to complete the regimen. We evaluated the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate (Stribild®) prescribed as one pill taken once daily for HIV PEP in terms of tolerability and adherence.
  
  
  
  This was a prospective cohort study conducted in one hospital in Paris (April to December 2015. Each participant receiving the PEP treatment (FTC-150 mg/TDF-245 mg/elvitegravir-200 mg/cobicistat 150 mg once daily) at the pharmacy of the hospital were recruited consecutively. A clinical visit was planned at 8 weeks after sexual exposure. Reminders were sent to participants who missed the appointment. A standardized questionnaire was administered to evaluate completeness and tolerability at week 8.
  
  
  
  Overall, 284 participants (86% men; 80% MSM; median age 30 years) were prescribed Stribild®; 50 stopped after reassessment of risk. Among 234 participants who effectively received PEP, 215 (92%) completed 28 days of PEP with only three who switched from Stribild®to another PEP because of side effects. More than 60% of participants reported at least one AE, which were mild to moderate. Fatigue, central neurological and abdominal side effects were the most frequently reported.
  
  
  
  Stribild®seems to be a good option for HIV PEP due to the easiness of use, the side effects profile and the high completion rate.
authors.affiliation: Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, 184 rue du Faubourg Saint-Antoine, F75571, Paris Cedex 12, France. nadia.valin@aphp.fr.
authors.forename: Nadia
authors.identifier: 0000-0001-5706-1195
authors.initials: N
authors.lastname: Valin
authors.affiliation: Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, 184 rue du Faubourg Saint-Antoine, F75571, Paris Cedex 12, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Fonquernie
authors.affiliation: Hôpital Saint-Antoine, Service Pharmacie, 184 rue du Faubourg Saint-Antoine, F75571, Paris Cedex 12, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Daguenel
authors.affiliation: Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, 184 rue du Faubourg Saint-Antoine, F75571, Paris Cedex 12, France.
authors.forename: Pauline
authors.initials: P
authors.lastname: Campa
authors.affiliation: Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, 184 rue du Faubourg Saint-Antoine, F75571, Paris Cedex 12, France.
authors.forename: Theresita
authors.initials: T
authors.lastname: Anthony
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'Epidemiologie et de Santé Publique (IPLESP UMRS 1136), F75013, Paris, France.
authors.forename: Marguerite
authors.initials: M
authors.lastname: Guiguet
authors.affiliation: Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, 184 rue du Faubourg Saint-Antoine, F75571, Paris Cedex 12, France.|Sorbonne Universités, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'Epidemiologie et de Santé Publique (IPLESP UMRS 1136), F75013, Paris, France.
authors.forename: Pierre Marie
authors.initials: PM
authors.lastname: Girard
authors.affiliation: Hôpital Saint-Antoine, Service des Maladies Infectieuses et Tropicales, 184 rue du Faubourg Saint-Antoine, F75571, Paris Cedex 12, France.|Sorbonne Universités, UPMC Univ Paris 06, F75005, Paris, France.
authors.forename: Marie Caroline
authors.initials: MC
authors.lastname: Meyohas
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019380:Anti-HIV Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D000069547:Cobicistat; D004338:Drug Combinations; D000069545:Elvitegravir, Cobicistat, 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*; D018451:Homosexuality, Male; D006801:Humans; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010297:Paris; D056990:Post-Exposure Prophylaxis / Q000379:methods*; D011446:Prospective Studies; D012725:Sexual Behavior; D055815:Young Adult
chemical_list: D019380:Anti-HIV Agents; D004338:Drug Combinations; D000069545:Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; D000069547:Cobicistat