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

Abstract

BackgroundThe 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.MethodsThis 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.ResultsOverall, 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.ConclusionsStribild® seems to be a good option for HIV PEP due to the easiness of use, the side effects profile and the high completion rate.

Tolerability and Adherence of Antiretroviral Regimens Containing Long-Acting Fusion Inhibitor Albuvirtide for HIV Post-Exposure Prophylaxis: A Cohort Study in China

“…Among those with sexual exposure, vaginal intercourse was the most prevalent sexual method of exposure in our study. This observation differs from that of a prospective study conducted in Paris, in which the primary mode of sexual exposure was anal sex in 65% of patients, while vaginal intercourse accounted for only 26% of cases [ 12 ]. However, an observational, cross-sectional study of 678 patients in Spain found vaginal intercourse (99.2%) to be the commonest sexual method of HIV exposure [ 24 ].…”

“…There is a demand for PEP regimens that could overcome challenges of poor adherence, severe adverse events, and dosing convenience. Two previous overseas studies using co-formulated STRs (elvitegravir/cobicistat/tenofovir disoproxil fumarate/emtricitabine) of HIV PEP found that the majority of participants achieved a higher drug completion rate (> 70%) and favorable drug tolerance [ 11 , 12 ]. However, these studies did not include Chinese participants or cohorts, and the real-world usage of these STRs in China was low.…”

Prophylaxis by doravirine-lamivudine-tenofovir disoproxil fumarate or elvitegravir-cobicistat-emtricitabine-tenofovir alafenamide after sexual exposure to HIV

“…Foster et al investigated a single-tablet PEP regimen based on rilpivirine and estimated a completion rate of 92% [ 7 ]. Valin et al estimated a completeness rate > 95% with elvitegravir, cobicistat, FTC, and TDF among subjects with follow-up [ 8 ]. Gantner et al evaluated prospectively EVG/c/FTC/TAF and found an 82% completion rate, including those lost to follow-up [ 9 ].…”

Condicionantes da adesão à profilaxia pós-exposição de risco ao HIV em um serviço de saúde no município de São Paulo, Brasil

“…Em alguns estudos, não se estabeleceu um critério predeterminado para a adesão e não adesão à PEP (Mayer et al, 2017;Carneiro et al, 2018;Malinverni et al, 2018). Para avaliar o percentual de adesão, alguns estudos usaram o autorrelato sobre o uso dos ARV (Milinkovic et al;Hugo et al, 2016;Valin et al, 2016;Mayer et al, 2017), a contagem de comprimidos (Mayer et al, 2012;Milinkovic et al, 2017) e informações de prontuários dos serviços de saúde ou de farmácias (Malinverni et al, 2016;Carneiro et al, 2018;Rasoolinejad et al, 2018). Ademais, outros estudos empregaram a realização de exames de sangue para averiguar os níveis de droga circulante no plasma e o rastreio de usuários que não retornaram aos serviços, por meio de ligação telefônica (Granjeiro et al, 2019, McAllister et al, 2017Foster et al, 2015;Bogoch et al, 2014).…”