Lamivudine/Tenofovir Disoproxil Fumarate is an Appropriate PrEP Regimen
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CURRENT OPINION
Lamivudine/Tenofovir Disoproxil Fumarate is an Appropriate PrEP Regimen Andrew Mujugira1,2 · Jared M. Baeten3 · Ioannis Hodges‑Mameletzis4 · Jessica E. Haberer5
© Springer Nature Switzerland AG 2020
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.
1 Oral Pre‑exposure Prophylaxis (PrEP) is an Effective HIV Prevention Tool In 2018, an estimated 1.7 million people were newly infected with HIV, a 16% reduction from 2.1 million infections in 2010 [1]. While any decline in new infections is encouraging, the global community will not achieve its 2020 target of fewer than 500,000 new infections [2]. Delivery * Andrew Mujugira [email protected] 1
Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda
2
Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda
3
Departments of Global Health, Epidemiology and Medicine, University of Washington, Seattle, USA
4
Department of HIV/AIDS, World Health Organization, Geneva, Switzerland
5
Center for Global Health, Massachusetts General Hospital and Harvard Medical School, Boston, USA
of proven HIV-prevention tools—including condoms and lubricants, behavioral modification, voluntary male medical circumcision, antiretroviral therapy (ART) to eliminate the infectiousness of people with HIV, harm-reduction services, and pre-exposure prophylaxis (PrEP) for HIV negative persons—in combination and at scale—holds the potent
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