12:00 AM
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Jun 02, 2014
 |  BioCentury  |  Strategy

PrEPping for Truvada

Why CDC backing Truvada for HIV prevention won't trigger mass uptake

CDC's recommendation of Truvada for HIV pre-exposure prophylaxis is unlikely to trigger an explosion in prescriptions for the drug, despite estimates that as many as half a million people could be candidates in the U.S.

If all those candidates actually got the drug for one year, the cost would be $7.8 billion. But that is unlikely to happen, because CDC's recommendation does not address several of the barriers that have limited uptake.

Gilead Sciences Inc. began marketing Truvada emtricitabine/tenofovir to treat HIV infection in 2004. The drug was approved in the U.S. in July 2012 for pre-exposure prophylaxis (PrEP) to reduce risk of HIV-1 infection in adults.

Since then, PrEP has barely registered among Truvada prescriptions.

According to IMS Health, 1.52 million Truvada prescriptions were dispensed in 2013, down 3% from 1.58 million in both 2011 and 2012. Truvada sales were $3.1 billion in 2013.

Gilead reported that only 2,319 people started Truvada for PrEP from January 2012 to September 2013 based on a survey of 55% of U.S. retail pharmacies that dispensed the therapy for that indication.

Last month's recommendation from CDC identified several populations at high risk of HIV exposure who could benefit from PrEP: anyone in a sexual relationship with an HIV-infected partner; men who have sex with men and are not monogamous; heterosexuals whose partners are known to be at risk for HIV; and users of injectable illicit drugs.

CDC did not provide estimates for all the high-risk populations included in the recommendation. However, the agency said potential PrEP users include up to 275,000 uninfected gay men and 140,000 heterosexuals in mixed-HIV status (serodiscordant) relationships in the U.S.

Gilead declined to estimate the population of high-risk candidates for PrEP.

Advocacy groups that spoke to BioCentury generally agreed with media estimates of 500,000 in the U.S., but don't think CDC's recommendation will affect uptake in the near term because healthcare providers will need time to get comfortable recommending and prescribing the drug.

In addition, patients who do receive a prescription for PrEP may have trouble adhering to Truvada's dosing and monitoring regimen.

Finally, while most insurers cover Truvada for PrEP, some patients may have difficulty paying their share of the treatment costs, despite help from Gilead's access programs.

Slow to catch on

Advocacy...

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