Abstract
Oral pre-exposure prophylaxis (PrEP) containing tenofovir disoproxil fumarate (TDF) co-formulated with emtricitabine (FTC) or lamivudine (3TC) is recommended as an additional prevention option for persons at substantial risk of HIV infection by both the World Health Organization (WHO) and the US President’s Emergency Plan for AIDS Relief (PEPFAR). The WHO and PEPFAR consider 3TC clinically interchangeable with FTC for PrEP given comparable pharmacologic equivalence, resistance and toxicity patterns, and indirect clinical trial evidence from TDF-containing studies. Globally, FTC/TDF has been widely used in clinical trials, open-label extension studies and demonstration projects. Thus, most PrEP efficacy and safety data are based on FTC/TDF use in heterosexual women and men, men who have sex with men, and people who inject drugs. However, generic 3TC/TDF is less expensive than FTC/TDF, is already available in supply chains for HIV drugs, and has 60–70% of the global adult market share, making it particularly appealing in settings with limited availability or affordability of FTC/TDF. Compelling indirect evidence suggests that scaling up use of 3TC/TDF is potentially cost saving for HIV programs in settings where restricting drug choice to FTC/TDF would delay PrEP implementation. Guideline committees and public health decision-makers in countries should encourage flexibility in PrEP drug selection, support off-label use of 3TC/TDF, and approve use of generic formulations to decrease the cost of PrEP medications and accelerate PrEP delivery through the public and private sectors.
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This work was supported through research grants from National Institutes of Health (research grant number K43 TW010695 (AM) and K24 mentor award MH114732 (JEH)). This paper represents the opinions of the authors and does not necessarily represent the official views of the National Institutes of Health.
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JMB served as an advisor for Gilead Sciences, Janssen, and Merck. JEH is a consultant for Merck. AM received donated FTC/TDF from Gilead Sciences for an investigator-sponsored study.
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AM, JMB, and JEH conceptualized the paper. AM wrote the first draft along with JEH. IHM, JMB, JEH, and AM reviewed drafts and provided substantial edits. All authors read and approved the final manuscript.
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Mujugira, A., Baeten, J.M., Hodges-Mameletzis, I. et al. Lamivudine/Tenofovir Disoproxil Fumarate is an Appropriate PrEP Regimen. Drugs 80, 1881–1888 (2020). https://doi.org/10.1007/s40265-020-01419-4
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DOI: https://doi.org/10.1007/s40265-020-01419-4