Generic Pre-Exposure Prophylaxis Set to Debut
EXECUTIVE SUMMARY
Pre-exposure prophylaxis (PrEP), which consists of the anti-HIV drugs emtricitabine and tenofovir disoproxil fumarate (TDF/FTC, brand name Truvada), is recommended as a first-line resource in HIV prevention. A generic version of the drug combination is set to be released in 2020.
• In October 2019, the FDA approved a second drug combination, tenofovir alafenamide with emtricitabine (Descovy), for PrEP in men who have sex with men, and transgender women.
• At a list price of around $24,000 a year, the cost of branded emtricitabine and tenofovir disoproxil fumarate has created barriers to PrEP access at all levels of the U.S. healthcare system, according to a recent commentary on the subject.
Pre-exposure prophylaxis (PrEP), which consists of the anti-HIV drugs emtricitabine and tenofovir disoproxil fumarate (TDF/FTC, brand name Truvada), is recommended as a first-line resource for HIV prevention. However, the cost of Truvada, which averages around $24,000 per year in the United States, has been a major barrier to PrEP use. Estimates indicate that only about 270,000 people in the United States currently use PrEP.1 With the drug set to debut as a generic in 2020, what will be the ramifications for PrEP use?
The introduction of generic TDF/FTC could expand access to PrEP in the U.S., says Douglas Krakower, MD, assistant professor at the Harvard Pilgrim Health Care Institute, Beth Israel Deaconess Medical Center, and Harvard Medical School.
“Some people who are likely to benefit from PrEP use may be hesitant or unable to do so because of out-of-pocket costs, such as high deductibles and copays,” notes Krakower. “If the price of PrEP decreases substantially, which is most likely to occur once there are multiple generics available for prescribing, then it could be more affordable for larger numbers of people.”
Generics could provide a more cost-effective option for PrEP, which could accrue savings from a societal perspective, states Krakower. Such savings would ideally provide an opportunity to reallocate funds toward supporting the nonmedication costs of PrEP care, such as provider fees and clinical monitoring, which also could improve PrEP uptake and effects, he notes.
“Economically disadvantaged communities experience disproportionately high numbers of new HIV infections, and also have the greatest challenges in accessing PrEP. The cost savings from generic TDF/FTC could hopefully be used to address this inequity,” states Krakower.
New PrEP Option Approved
In October 2019, the FDA approved a second drug combination, tenofovir alafenamide with emtricitabine (TAF/FTC), for PrEP in men who have sex with men, and transgender women. It is marketed as Descovy by Gilead Sciences, which also markets Truvada.
Safety and efficacy were demonstrated in an international trial including 5,387 participants that compared tenofovir alafenamide against tenofovir disoproxil fumarate, when used in combination with emtricitabine for PrEP. Data indicated that the tenofovir alafenamide combination was noninferior compared to the tenofovir disoproxil fumarate combination in prevention of HIV infection (incidence rate ratio 0.54; 95% confidence interval 0.23, 1.26).2
Data from the DISCOVER trial indicated no difference in drug-related adverse events of any grade (21% on TAF/FTC and 24% on TDF/FTC), serious adverse events that were drug related (0.1% to 0.2%) or in adverse events leading to drug discontinuation (1% vs. 2%). Findings suggested a difference in kidney function: By week 96, the mean glomerular filtration rate for TAF/FTC users had dropped by 0.6 milliliters per minute (mL/min), compared to 4.1 mL/min in TDF/FTC users.2
Gilead Sciences holds market exclusivity to 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 — and bring cost ramifications, according to a new commentary co-authored by Krakower and Julia Marcus, PhD, assistant professor in the department of population medicine at Harvard Pilgrim Health Care Institute and Harvard Medical School.3
The authors pointed to a 2018 meta-analysis of 13 randomized clinical trials of PrEP in 15,678 participants, in which there were no significant differences in risk of grade 3/4 clinical adverse events or serious adverse events between TDF/FTC (or TDF) and the control. The meta-analysis also revealed no significant difference in risk of specific renal or bone adverse outcomes.4
Prevention Is the Goal
How have costs of branded TDF/FTC affected HIV prevention efforts in the United States? According to Marcus, the cost of branded TDF/FTC — around $24,000 a year — has created barriers to PrEP access at all levels of the U.S. healthcare system.
Some insurance companies require prior authorization for PrEP in an effort to reduce costs, making it more difficult for patients to access PrEP, explains Marcus. Assistance programs can help cover out-of-pocket costs for PrEP users, but accessing these programs is so complex that some clinics have hired “PrEP navigators” to help patients sort through the paperwork, she says. If PrEP were more affordable, most people would be able to pay out of pocket without needing to navigate a complex system of payment assistance, she states.
“These cost barriers have a real impact on health outcomes. We’ve seen HIV transmissions occur when people have stopped taking PrEP because of gaps in their insurance coverage,” explains Marcus. “We’ve surveyed people who recently contracted HIV to understand why they weren’t taking PrEP before their HIV diagnosis, and found that cost was one of the most common reasons for not having used PrEP, or for discontinuing it.”
REFERENCES
- DeBenedette V. Gilead makes years-long donation of Truvada to the CDC. Drug Topics May 10, 2019. Available at: https://bit.ly/2uKgndH.
- Ruane P, Clarke A, Post FA, et al. Phase 3 randomized, controlled DISCOVER study of daily emtricitabine/tenofovir alafenamide (F/TAF) or emtricitabine/tenofovir disoproxil fumarate (F/TDF) for HIV pre-exposure prophylaxis: Week 96 results. Presented at the 17th European AIDS Conference, Basel, Switzerland, November 2019.
- Krakower DS, Daskalakis DC, Feinberg J, et al. Tenofovir alafenamide for HIV prevention prophylaxis: What can we DISCOVER about its true value? Ann Intern Med 2020; doi:10.7326/M19-3337.
- Pilkington V, Hill A, Hughes S, et al. How safe is TDF/FTC as PrEP? A systematic review and meta-analysis of the risk of adverse events in 13 randomised trials of PrEP. J Virus Erad 2018;4:215-224.
Pre-exposure prophylaxis (PrEP), which consists of the anti-HIV drugs emtricitabine and tenofovir disoproxil fumarate (TDF/FTC, brand name Truvada), is recommended as a first-line resource in HIV prevention. A generic version of the drug combination is set to be released in 2020, which could expand access to PrEP in the United States.
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