** Injectable PrEP Effective in MSM and Transgender Women
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May 18, 2020

Dear Advocates,

We are writing with breaking PrEP news—data now show that bi-monthly injections of long-acting cabotegravir (CAB-LA) appears to be safe and effective in preventing HIV in cisgender men and transgender women who have sex with men.

The data come from a large-scale efficacy trial, HPTN 083 (www.avac.org/trial/hptn-083), which is ongoing in 4,500 participants at sites in the Americas, Asia and South Africa. These data were announced after a regularly scheduled review by its data and safety monitoring board (DSMB) found that CAB-LA provided significant protection against HIV. As reported, the DSMB recommended that all HPTN 083 trial participants be told which active drug (CAB-LA or oral TDF/FTC) they were receiving and that placebos be dropped from the study. The study will continue to completion with all participants receiving one of the two active products.

* Download the ViiV statement: www.businesswire.com/news/home/20200517005088/en/Global-HIV-prevention-study-stop-early-ViiV

* Download the HPTN statement: www.hptn.org/news-and-events/press-releases/long-acting-injectable-cabotegravir-highly-effective-prevention-hiv

* Download the AVAC statement: www.avac.org/press-release/trial-finds-long-acting-injectable-antiviral-safe-and-effective

Importantly, these data only apply to the population in HPTN 083—and there is an ongoing “sister” study, HPTN 084 (www.avac.org/trial/hptn-084), which is evaluating CAB-LA for prevention in cisgender women. This trial began after HPTN 083 and is still enrolling participants. The DSMB recommended that HPTN 084 continue per protocol with both the active and placebo products.

The data announced today by the HPTN and partners show the promise of CAB-LA as a prevention option for some people. This is an exciting development and welcome news for HIV prevention but questions remain, including whether it’s safe and effective in cisgender women, how a bi-monthly injection might be delivered if licensed, how these findings will affect ongoing HIV prevention trials and more.

Stay tuned for details on a global advocates’ call later this week to discuss the findings and related issues with the trial leadership and other stakeholders. We look forward to discussing and acting on these important developments with you!

Best,
AVAC

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