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PrEP effective in preventing HIV acquisition in MSM and transgender women

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PrEP is effective, but delivery needs to be optimized

Data show that PrEP is effective in preventing HIV infections in men who have sex with men (MSM), as well as in heterosexually active men and women. In intention-to-treat analyses, these studies showed reductions of infections between 44% and 75%, although compliance with daily therapy did not appear to be high. When investigators restricted the analysis to persons with detectable drug levels, effectiveness rates were greater than 90%. An open label extension study in follow-up to the iPrEX (Iniciativa Profilaxis Pre-Exposición) trial found100% protection for those who had sustained adherence at the level of four or more doses per week.

Whether adherence to daily or near-daily dosing can be achieved in real-world settings has been questioned. Moreover, there has been concern that PrEP will lead to increases in condomless sex with attendant risk of other sexually transmitted infections.

Overall, the news concerning PrEP dissemination is good, but there are sobering lessons. Of the 557 enrolled in the Demo Study, 78% were retained over the 48 weeks of follow-up. African Americans and participants from the Miami site were less likely to be retained, as were those with lower socioeconomic status and the uninsured. In an attempt to mimic clinical settings, missing participants were contacted only a maximum of three times in response to a missed visit, and incentives for visit attendance were nominal, although the drug was free.

Realizing the benefits of PrEP requires an optimal cascade of events that is remarkably similar to the Gardner Cascade of engagement in care for those infected with HIV. The so-called PrEP cascade requires identification of at-risk individuals, promotion of interest and knowledge of PrEP, linkage to PrEP-knowledgeable clinics, and PrEP initiation, persistence, and adherence. The benefits of PrEP will fully be realized only when we can identify ways of successfully moving persons at a high risk of HIV infection through this cascade.

Dr. Raphael J. Landovitz is the codirector of the Combination Prevention Core at the Center for HIV Identification, Prevention, and Treatment Services, and is currently at the UCLA Medical Center in Los Angeles. Dr. Landovitz disclosed having previously served as a consultant to Gilead Sciences, which supplied the study drug for the Demo Study.


 

FROM JAMA INTERNAL MEDICINE

References

A total of 622 YBMSM – mean age of 23 years, 39% with high school or equivalent level of education, 79% of whom reported annual income of less than $20,000, and only half of whom were both HIV-negative and reported having health coverage – were enrolled, based on eligibility requirements that they self-identified as African American or black, were born male, were between 16 and 29 years of age, and reported oral or anal sex with a male within the 24 months prior to enrollment.

PrEP of daily oral tenofovir disoproxil fumarate and emtricitabine was administered between June 2013 and July 2014. Baseline levels of PrEP awareness – 40.5% of participants knew about PrEP, and 12.1% knew of someone who had used PrEP – remained unchanged significantly at follow-up. Just over 72% of participants were not infected with HIV during the study period; only 3.6% of these individuals had previously used PrEP prior to enrollment.

“Ongoing work should include scientific assessment of strategies to mobilize networks of YBMSM around PrEP as part of a comprehensive health care program. Concomitantly, efforts to mitigate the structural barriers that prevent PrEP uptake among YBMSM may greatly improve the public health effect potential of this promising HIV prevention intervention,” conclude the authors, led by Dr. John A. Schneider of the University of Chicago.

The Demo Study was supported by the NIH’s National Institute for Allergies and Infectious Diseases, National Institute for Mental Health, the Miami Center for AIDS Research, and the Gladstone Institute of Virology & Immunology–University of California, San Francisco. Gilead Sciences supplied the study drugs and support for pharmacokinetic and resistance testing. Dr. Liu disclosed leading other trials in which study drugs were supplied by Gilead Sciences, but no other conflicts of interest. Several other coauthors reported potential conflicts of interest.

The uConnect study was supported by the NIH’s National Institutes of Health. Neither Dr. Schneider nor any coauthors reported any potential conflicts of interest.

dchitnis@frontlinemedcom.com

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