In a new paper, researchers say that drug Truvada should remain the first choice for HIV prevention.
The research was conducted by Harvard Pilgrim Health Care Institute and elsewhere.
In October 2019, the U.S. Food and Drug Administration approved a second medication for use as HIV preexposure prophylaxis, also known as PrEP, sparking controversy about which drug should be prescribed.
Gilead Sciences, which manufactures both approved drugs, has argued that the new drug is safer and more effective than the old drug.
But these claims are overstated, say the team of clinical and public health experts.
PrEP, which is 99% effective in preventing HIV, exists in two forms: tenofovir disoproxil fumarate with emtricitabine (TDF/FTC) – best known as Truvada, its brand name in the U.S. – and tenofovir alafenamide with emtricitabine (TAF/FTC), known as Descovy.
TDF/FTC has been used for PrEP for more than 7 years, with ample evidence of its safety and effectiveness.
The team says these drugs are equally effective when used for PrEP in gay and bisexual men and transgender women, and the potential safety benefits of TAF/FTC over TDF/FTC have not yet been shown to be clinically significant.
The high cost of PrEP medications, around $24,000 per year in the U.S., has been a major barrier to PrEP use.
Activists have argued that taxpayer money funded the development of PrEP medications, and the U.S. Department of Health and Human Services recently sued Gilead Sciences over patent infringement.
The older PrEP medication, TDF/FTC, will be available as a generic as early as 2020, which could reduce costs and increase access.
But Gilead Sciences holds the exclusive rights to manufacture TAF/FTC until 2022 and has requested a patent extension to 2025.
If the generic version of TDF/FTC is perceived to be less safe, uptake of TAF/FTC would presumably rise—with cost ramifications.
The authors examined the available data on the safety, efficacy, and public health context for the two PrEP medications.
The data show the effectiveness of TDF/FTC in all priority populations at risk for HIV, including gay and bisexual men, transgender women, people who inject drugs, and heterosexuals whose partners are living with HIV.
In contrast, the only efficacy data for TAF/FTC come from the DISCOVER trial, which enrolled solely gay and bisexual men and a small number of transgender women.
The team says given the available clinical evidence and public health context, TDF/FTC should remain the first choice for the vast majority of PrEP users.
The lead author of the study is Douglas Krakower, MD, Assistant Professor at the Harvard Pilgrim Health Care Institute and elsewhere.
The study is published in the Annals of Internal Medicine.
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