Review of Real‐World Implementation Data on Emtricitabine‐Tenofovir Disoproxil Fumarate as HIV Pre‐exposure Prophylaxis in the United States

Adams, Jessica; Shelley, Karishma; Nicol, Melanie R.

doi:10.1002/phar.2240

Cited by 20 publications

(9 citation statements)

References 49 publications

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“…Furthermore, barriers that prevent uptake are not universal, and can be population-specific, exacerbated by co-prevalent syndemic conditions such as racism, homophobia, poverty, inadequate education, and behavioral health issues. The findings presented here have also been identified by others, who have noted similar common barriers overall [102][103][104] and in population groups at highest risk [105][106][107][108][109][110][111][112].…”

Section: Potential Solutions To Barrierssupporting

confidence: 89%

Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review

2020

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Antiretroviral pre-exposure prophylaxis (PrEP) to prevent HIV transmission was first approved by the US Food and Drug Administration in 2012. Despite correlations of decreases in new HIV infections being greatest where PrEP has been deployed, the uptake of PrEP is lagging, particularly among populations with disproportionate HIV burden. This narrative review seeks to identify individual and systemic barriers to PrEP usage in the USA. A comprehensive search of recent literature uncovered a complex array of structural, social, clinical, and behavioral barriers, including knowledge/awareness of PrEP, perception of HIV risk, stigma from healthcare providers or family/partners/friends, distrust of healthcare providers/systems, access to PrEP, costs of PrEP, and concerns around PrEP side effects/medication interactions. Importantly, these barriers may have different effects on specific populations at risk. The full potential of PrEP for HIV prevention will not be realized until these issues are addressed. Strategies to achieve this goal should include educational interventions, innovative approaches to delivery of HIV care, financial support, and destigmatization of PrEP and PrEP users. Until then, PrEP uptake will continue to be suboptimal, particularly among those who need it most.

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Section: Potential Solutions To Barrierssupporting

confidence: 89%

Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review

2020

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“…PrEP has been shown to be highly effective in adherent patients in the real-world setting [ 45 ]. Factors contributing to its efficacy are numerous and include potent antiretroviral activity against most HIV subtypes, early activity in the HIV reproductive cycle, high-resistance barrier with few cases of resistant strain transmission, and long intracellular half-life allowing high concentrations of medication in the PBMCs.…”

Section: Discussionmentioning

confidence: 99%

“…It has few drug—drug interactions and a well-established safety profile. Nonetheless, in order for PrEP to be efficacious, the user must commit to taking it consistently during high HIV-risk exposures [ 45 ]. PrEP adherence and engagement in care are the biggest challenges in the real-life setting and are directly related to its effectiveness [ 45 , 115 , 116 ].…”

Section: Discussionmentioning

confidence: 99%

“…Rare cases of HIV transmission have been documented with sufficient levels of PrEP molecules. Mutations such as K65R, with or without M184V, Q151M, T69S insertion, and thymidine analog mutations (TAM) with M41L or L210W can render PrEP inefficacious [45][46][47][48][49][50][51][52][53][54].…”

Section: Efficacy Of Ftc/taf Compared With Ftc/tdf In the Discover Studymentioning

confidence: 99%

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Clinical Considerations in the Selection of Preexposure Prophylaxis for HIV Prevention in Canada

Knox

Pilarski

Dhunna

et al. 2022

Canadian Journal of Infectious Diseases and Medical Microbiolog

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According to the Public Health Agency of Canada, approximately 62,050 people were living with HIV in Canada in 2018, and of those, 13% were undiagnosed. Currently, no single strategy provides complete protection or is universally effective across all demographic groups at risk for HIV. However, HIV preexposure prophylaxis (PrEP) is the newest HIV prevention strategy that shows promise. To date, two products have received an indication for PrEP by Health Canada: emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF) and emtricitabine/tenofovir alafenamide (Descovy®; FTC/TAF). Despite the high efficacy of these PrEP intervention methods, access to PrEP in Canada remains low. Identifying and addressing barriers to PrEP access, especially in high-risk groups, are necessary to reduce HIV transmission in Canada. While guidelines published by the Center for Disease Control and Prevention (CDC) include FTC/TAF information, the efficacy of FTC/TAF for PrEP has not yet been considered in Canada’s clinical practice guidelines. Thus, the current paper reviews data regarding the use of FTC/TDF and FTC/TAF for PrEP, which may be useful for Canadian healthcare providers when counseling and implementing HIV prevention methods. The authors highlight these data in relation to various at-risk populations and review ongoing clinical trials investigating novel PrEP agents. Overall, FTC/TDF PrEP is effective for many populations, including men who have sex with men, transgender women, heterosexuals with partners living with HIV, and people who use drugs. While there is fewer data reported on the efficacy of FTC/TAF to date, recent clinical trials have demonstrated noninferiority of FTC/TAF in comparison to FTC/TDF. Notably, as studies have shown that FTC/TAF maintains renal function and bone mineral density to a greater extent than FTC/TDF, FTC/TAF may be a safer option for patients experiencing renal and/or bone dysfunction, for those at risk of renal and bone complications, and for those who develop FTC/TDF-related adverse events.

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“…Thirdly, studies projecting increased risk associated with PrEP use cited evidence of increased STI diagnoses. Two studies presented a con icting picture with one reporting that whilst STI rates were high, the increase was not necessarily linked with PrEP use, with the other concluding that increased STI incidence was attributable to risk compensation when taking PrEP: '30% of patients were diagnosed with a STI after 6 months and 50% after 12 months on PrEP…..there were no incidences of accompanying HIV infection' (31). Another used the increase in STIs to justify estimates of increased HIV incidence over the lifetime of PrEP users, whether or not they continued to use PrEP.…”

Section: Uses Of Evidencementioning

confidence: 99%

Modelling Risk Behaviour: The use of Behaviour Change Assumptions in Cost-Effectiveness Studies for Oral PrEP in the United Kingdom and United States

Koshkouei

Whitacre

Paparini

2022

Preprint

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Background HIV prevention policy and program implementation rely heavily on cost-effectiveness studies. They involve the use of some uncertain variables, serving as proxies for complex, emergent and unpredictable scientific, social and behavioural issues. The ongoing implementation and scale-up of oral pre-exposure prophylaxis (PrEP) requires the improvement and refinement of cost-effectiveness calculations, and the measures on which they are based. Methods We conducted a framework synthesis of the literature on cost-effectiveness for oral PrEP for men who have sex with men (MSM) in the US and UK between 2009 and 2021. Results Reviewing how behavioural risk variables were used in the studies, we found both significant increases and decreases in projected risk behaviour in MSM starting PrEP, and limited use of evidence for these variables. Studies that included increased ‘risk compensation’ scenarios inferred quantitative estimates from qualitative measures, appeared to group risk variables with assumptions about low adherence, and projected estimates of increased HIV incidence associated with PrEP use. Conversely, studies that included lower risk behaviour cited related research about behavioural risk reduction associated with treatment-as-prevention and referenced discussions about the importance of changing risk behaviour, rather than empirical evidence of changed behaviour. Conclusion Increased accuracy of cost-effectiveness models can be achieved through refining the use of behavioural risk variables, including reference to a common evidence base.

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Review of Real‐World Implementation Data on Emtricitabine‐Tenofovir Disoproxil Fumarate as HIV Pre‐exposure Prophylaxis in the United States

Cited by 20 publications

References 49 publications

Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review

Barriers to the Wider Use of Pre-exposure Prophylaxis in the United States: A Narrative Review

Clinical Considerations in the Selection of Preexposure Prophylaxis for HIV Prevention in Canada

Modelling Risk Behaviour: The use of Behaviour Change Assumptions in Cost-Effectiveness Studies for Oral PrEP in the United Kingdom and United States

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