Evaluation of tolerability with the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for post-HIV exposure prophylaxis

Nadia Valin (1) , Laurent Fonquernie (1) , Anne Daguenel (1) , Pauline Campa (1) , Theresita Anthony (1) , Marguerite Guiguet (2) , Pierre Marie Girard (1, 2) , Marie Caroline Meyohas (3, 1)

1 CHU Saint-Antoine [AP-HP]
2 iPLESP - Institut Pierre Louis d'Epidémiologie et de Santé Publique
3 UPMC - Université Pierre et Marie Curie - Paris 6

Background: 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. Methods 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. Results 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. Conclusions 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.

Domaines: Maladies infectieuses

Nadia Valin, Laurent Fonquernie, Anne Daguenel, Pauline Campa, Theresita Anthony, et al.. Evaluation of tolerability with the co-formulation elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate for post-HIV exposure prophylaxis. BMC Infectious Diseases, 2016, 16 (1), pp.718. ⟨10.1186/s12879-016-2056-3⟩. ⟨hal-01409081⟩