September 4, 2015
Kaiser Permanente's San Francisco Medical Center has seen a dramatic increase in the number of members taking Truvada for pre-exposure prophylaxis (PrEP) since 2012. To date, there have been no new HIV diagnoses among PrEP users during the two and a half years of follow-up.
Some men taking PrEP did report a drop-off in condom use, and rates of sexually transmitted infections (STIs) were high. A total of 344 STI diagnoses were made among participants during the observation period with a PrEP protocol mandating frequent STI testing and prompt treatment.
Findings from the Kaiser PrEP study, which included 1,045 mostly gay and bisexual men who were referred for evaluation and 657 who decided to start PrEP, were reported in the September 1 advance edition of Clinical Infectious Diseases. Brad Hare, M.D., Kaiser's director of HIV care and prevention, presented preliminary findings about the Kaiser PrEP program at a World AIDS Day forum in December 2014.
"Our observations are important primarily because they extend what is known about PrEP from the controlled setting of clinical trials and show that it works in the 'real-world' as well," Hare told BETA. "It's remarkable to see that PrEP is so effective at preventing HIV in a setting like San Francisco, even as we're seeing high rates of STIs and other evidence of significant HIV risk."
Hare, Jonathan Volk, M.D., and their colleagues looked at patterns of PrEP use among members of the large Kaiser Permanente San Francisco healthcare system between July 2012 -- when the Food and Drug Administration approved Truvada (tenofovir + emtricitabine) for PrEP -- and February 2015.
The FDA approval was based in part on data from the large international iPrEx trial of mostly men who have sex with men, which showed that once-daily Truvada reduced the risk of HIV infection by 42% overall compared to placebo, rising to 92% among participants with blood drug levels indicating regular use.
At this summer's International AIDS Society conference in Vancouver, researchers reported that participants in a non-randomized PrEP Demonstration Project in San Francisco, Miami, and Washington, DC, had good medication adherence overall. The two new HIV infections that occurred during follow-up were in men with low drug levels at the time of seroconversion. Thus far, there has not been much data reported about PrEP use in regular clinical practice.
At Kaiser, primary care providers refer members to a specialized PrEP program after a risk assessment or when patients request it. Before beginning PrEP, in-person evaluations are conducted and then people interested in PrEP receive an intake visit where they are tested for HIV infection and STIs and screened for medical contraindications to Truvada such as pre-existing kidney or bone problems. The program provides adherence support and clinical monitoring including HIV and STI screenings every one to three months. Beginning in July 2014 participants were surveyed about changes in their sexual behavior after starting PrEP.
This excerpt was cross-posted with the permission of BETAblog.org. Read the full article.
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