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to Section One | to Arts & Entertainment
posted Friday, April 26, 2013 - Volume 41 Issue 17
Harlem Hospital launches Truvada PrEP study
Section One
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Harlem Hospital launches Truvada PrEP study

by Mike Andrew - SGN Staff Writer

Harlem Hospital has announced it is launching a new study to determine if Truvada remains effective as a PrEP drug even if it is taken less frequently than its suggested once-a-day dosage.

PrEP, or pre-exposure prophylaxis, is an HIV prevention method in which HIV-negative individuals take antiretroviral drugs usually prescribed to treat HIV in order to help prevent infection.

Truvada was approved by the FDA as a PrEP drug in June last year with a recommended regimen of one pill per day. At the time the drug was approved, some HIV/AIDS prevention activists worried that patients might continue risky behaviors while failing to adhere to the strict regimen, thinking themselves safe while actually increasing their risk of infection.

The Harlem Hospital study, called the ADAPT Study, will investigate whether a less-than-daily dosage of Truvada also confers significant PrEP benefits.

'The study is designed to identify PrEP pill-taking schedules that participants are more likely to follow and determine if these schedules influence healthier sexual practices,' a statement released April 22 said.

The ADAPT Study is coordinated by the HIV Prevention Trials Network (HPTN) and is sponsored and funded by the National Institute of Mental Health (NIMH), a division of the National Institutes of Health (NIH).

THREE SCENARIOS
Participants will be randomly divided into three groups: one group will take Truvada once a day, as suggested by the FDA; a second group will take Truvada twice a week, with an additional pill after sex; and the third group will take Truvada only before and after sex. All participants will be provided with HIV risk-reduction counseling and condoms.

Harlem Hospital is seeking 180 local men who have sex with men, and Transgender women, to participate. A similar study is being conducted in Thailand.

Critics of the FDA's approval of Truvada for PrEP use feared it might become a 'party drug' that at-risk individuals would take only when they expected to have sex. The ADAPT Study will now investigate whether that way of using the drug confers any preventative benefits.

Others worried that at-risk individuals might abandon condoms, which are considered a very effective method of preventing HIV infection, for a less effective and more expensive drug. The annual cost of a PrEP program using Truvada is estimated to be $14,000 per patient.

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