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Kaiser study shows no new HIV cases among PrEP 2-1-1 users

Gay and bisexual men taking PrEP before and after sex — known as the 2-1-1 regimen — reported good adherence and none were diagnosed with HIV, according to a new study from Kaiser Permanente San Francisco. Based on these findings, on-demand PrEP could be an attractive option for men who can plan ahead for sex.

"Some of our patients have been reluctant to take a daily medication, and enabling our patients to choose the dosing strategy that is right for them is very empowering," study co-author Dr. Jonathan Volk, of the Permanente Medical Group, said in a press release. "We now have different dosing strategies that can meet the needs of different patients."

PrEP 2-1-1 involves taking two doses of Truvada (tenofovir disoproxil fumarate/emtricitabine) between two and 24 hours before anticipated sex, one dose 24 hours after the initial double dose, and a final dose 24 hours after that.

A pair of French studies has shown that PrEP taken before and after sex is highly effective for men who have sex with men, regardless of whether they have sex frequently or less often. But so far, there has been little data from the United States.

Although the World Health Organization and the International Antiviral Society-USA have endorsed on-demand PrEP for gay and bi men, this regimen is not yet approved by the federal Food and Drug Administration. The 2-1-1 regimen has not yet been studied in women or transgender men who have vaginal or frontal sex. Study results for cisgender (non-trans) gay and bi men only apply to Truvada, not the Descovy (tenofovir alafenamide/emtricitabine) pill that was approved last year as a second daily PrEP option.

Kaiser San Francisco began offering on-demand PrEP in February 2019. Volk and his colleagues followed 279 men who were prescribed the new regimen through the end of August 2019. Clients who were already on daily PrEP were told about PrEP 2-1-1 and given the opportunity to switch, while those starting PrEP could choose between the on-demand or daily regimen.

More than half of the men (56%) were white, 22% were Asian, 12% were Latino and 3% were African American. (The proportions of these groups in the San Francisco population are about 52%, 36%, 15%, and 6%, respectively). Three-quarters had previously used PrEP, including 11 men who had used the 2-1-1 regimen before Kaiser started offering it and six who had used other nondaily schedules, such as taking PrEP only when on vacation.

The most common reason for wanting to use PrEP 2-1-1 was infrequent sex, reported by 58% of the men. Other less common reasons included concerns about the potential side effects of daily dosing, the cost of daily PrEP, and difficulty with daily adherence.

About 14% of the men reported challenges using the 2-1-1 regimen, including issues related to adherence or getting the dosing pattern right, difficulty planning sex in advance, and side effects. More than half of these men switched to daily dosing on their own. Twenty men discontinued PrEP altogether due to loss of health insurance, reduced sexual risk, or side effects.

All but six of the men who were prescribed on-demand PrEP completed their three-month follow-up visit. Of these, 51% exclusively used the 2-1-1 regimen during that period, while 19% opted to take Truvada daily, 15% used a combination of the two regimens and 3% never actually started PrEP.

Among the 181 men who used the 2-1-1 regimen exclusively or in combination with daily dosing, only 4% reported missing a dose of Truvada the last time they had sex. On average, they used one course of PrEP 2-1-1 — or four pills — during the past month. No one was newly diagnosed with HIV.

"Our findings suggest that 2-1-1 is an appealing alternative for some men, especially those who have infrequent sex," said study co-author Carlo Hojilla, RN, Ph.D. "Offering 2-1-1 alongside daily PrEP will help provide individuals with an additional option to tailor their HIV prevention strategy based on their needs."

Kaiser is not the only San Francisco provider offering PrEP 2-1-1 prior to FDA approval. As the Bay Area Reporter previously reported the San Francisco AIDS Foundation's Magnet sexual health service at Strut in the Castro began offering the new regimen in March 2019.

"In France, almost half of the people starting PrEP elect this strategy," former Strut director of nursing Pierre-Cédric Crouch, RN, NP, Ph.D., wrote in a Facebook post at the time. "We've been behind in the USA and we need to catch up!"

Since then, about 23% of Magnet clients have opted to use the 2-1-1 method at least part of the time, SFAF director of clinical services Janessa Broussard, NP, told the B.A.R.

"With proper counseling on how to take it, it's been easy for clients to understand and use," Broussard said. "During the shelter-in-place order [due to COVID-19], some clients have transitioned to 2-1-1 dosing with the intention of switching back to daily dosing once they feel safe to resume a more normal sexual routine."

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