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PrEP study now enrolling at Strut in San Francisco

, by San Francisco AIDS Foundation

doctor with patientPeople at risk for HIV infection during sex currently have only one PrEP option available to them: A PrEP regimen that includes the drug Truvada, which is a combination of emtricitabine and tenofovir disoproxil fumarate (FTC/TDF) manufactured by Gilead Sciences. Daily use of the drug Truvada was approved, in combination with safer sex practices, for PrEP by the U.S. Food and Drug Administration in 2012.

Now, researchers are testing an investigational drug for PrEP, in a large study that will be enrolling thousands of people at sites across the U.S. and Europe. One of the study sites now enrolling is at the San Francisco AIDS Foundation center Strut, in the Castro.

San Francisco chief medical officer Dr. Robert Grant, MD, MPH, who was the lead investigator of the seminal iPrEx study, is the site principal investigator for the current study.

“The foundation’s mission is focused on service,” said Grant. “The reason we’re conducting this study [at San Francisco AIDS Foundation] is because it is consistent with our service mission. Everyone in the study will receive either Truvada or the investigational drug, in addition to regular HIV and STD testing, HIV counseling, and other types of care required as part of the study.”

The investigational medication being tested is a combination of emtricitabine and tenofovir alafenamide (FTC/TAF) that is taken as one pill once a day.

Research to evaluate the safety and effectiveness of FTC/TAF when used for PrEP is warranted as an earlier study with monkeys showed that the FTC/TAF regimen was effective in preventing infection. In a study with rhesus macaques, 6 were treated with FTC/TAF (1.5 and 20 mg/kg) and 6 received placebo. Then, the animals were rectally exposed to SHIV, a virus that is similar to HIV, once per week for 19 weeks. All of the monkeys given placebo were infected with SHIV, while none of the monkeys given FTC/TAF were infected.

“There are important differences between HIV and SHIV, and between monkeys and people, so we have to study the safety and effectiveness of FTC/TAF in people,” said Grant. It is not known if FTC/TAF is effective for PrEP in people.

The study, called DISCOVER, is enrolling adult HIV-negative men, and transgender women, who have sex with men. The study team encourages people who are considering PrEP, and interested in this study, to find out more.

For people who enroll in the trial, the medications are provided at no charge. All participants enrolled into the Discover trial will receive active medication: Half will receive Truvada, the other half will receive the investigational study drug (FTC/TAF). In addition, the study provides all of the laboratory testing and medical services at no charge, including the testing for sexually transmitted infections that is required as part of the study. Study participants will also receive a modest stipend to help reimburse for their study-related time and transportation costs.

“Developing a diversity of options for PrEP is a high priority for research,” explained Grant. “Having more options makes it more likely that everyone will find one or more prevention options that are right for them.”

To learn more about the study, or enroll, contact Tessa Swigart at tswigart@sfaf.org or call (415) 437-3409.

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