Few new HIV cases among Polish PrEP users – most caused by errors with event-based PrEP

PrEP pills up close.
iStock: Pills used for HIV Pre-Exposure Prophylaxis (PrEP).

There have been almost no scientific studies of the effectiveness of HIV pre-exposure prophylaxis (PrEP) in central or eastern Europe. However, a recent study of 887 PrEP users, all gay and bisexual men, in the Polish city of Wroclaw, found only nine HIV infections (1% of PrEP users) over a three-year period from 2020 to 2023. 

All 887 PrEP users took oral tenofovir disoproxil/emtricitabine (TDF/FTC) pills. Strikingly, there were no HIV infections in men currently taking them daily; all were in men who had chosen to take event-based PrEP, apart from one in a man who had recently stopped daily use. As elsewhere, the prescribed regimen for event-based dosing is the ‘2-1-1’ pattern: a double dose taken before having sex, followed by a single dose 24 hours after that if sex does happen, and another 24 hours after that. 

There did not appear to be any infections in men who were taking 2-1-1 PrEP correctly at the time. Specifically, the authors say, seven of the nine infections were associated with failure to take the double dose of PrEP before sex.

Glossary

2-1-1

In relation to pre-exposure prophylaxis (PrEP), 2-1-1 dosing (and 2+1+1 dosing) are alternative terms for event-based dosing. 

subtype

In HIV, different strains which can be grouped according to their genes. HIV-1 is classified into three ‘groups,’ M, N, and O. Most HIV-1 is in group M which is further divided into subtypes, A, B, C and D etc. Subtype B is most common in Europe and North America, whilst A, C and D are most important worldwide.

event based

In relation to pre-exposure prophylaxis (PrEP), this dosing schedule involves taking PrEP just before and after having sex. It is an alternative to daily dosing that is only recommended for people having anal sex, not vaginal sex. A double dose of PrEP should be taken 2-24 hours before anticipated sex, and then, if sex happens, additional pills 24 hours and 48 hours after the double dose. In the event of sex on several days in a row, one pill should be taken each day until 48 hours after the last sexual intercourse.

strain

A variant characterised by a specific genotype.

 

event driven

In relation to pre-exposure prophylaxis (PrEP), this dosing schedule involves taking PrEP just before and after having sex. It is an alternative to daily dosing that is only recommended for people having anal sex, not vaginal sex. A double dose of PrEP should be taken 2-24 hours before anticipated sex, and then, if sex happens, additional pills 24 hours and 48 hours after the double dose. In the event of sex on several days in a row, one pill should be taken each day until 48 hours after the last sexual intercourse.

In Poland, PrEP is not publicly funded: people have to buy it at pharmacies. Nonetheless, a network of private PrEP clinics has sprung up, offering tests for HIV, STIs and viral hepatitis and, because TDF affects it, kidney function. The All Saints Clinic, whose director is Dr Bartosz Szetela, author of this study, is the only clinic in Poland that provides these diagnostic tests for free.

The Polish Health ministry estimates that there are between 6000 and 8000 PrEP users in the country. According to a study presented at the 2022 HIV Glasgow conference, this is about 20% of the number who would need to use PrEP for it to start producing a fall in HIV incidence.

The current study involved 887 PrEP users attending the All Saints Clinic between October 2017 and October 2023. On average, they were followed for just under three years, during which time most participants attended for between three and six appointments.

Nine participants were diagnosed with HIV, representing an annual incidence of 0.35%. Comparing that with local and national HIV incidence data among non-users, which estimates that annual HIV incidence in gay and bisexual men is about 3.8%, this represents an effectiveness of 91% – broadly in line with other PrEP programmes for gay men in Europe.

The characteristics of the nine men who did acquire HIV represent an interesting story. All were in their thirties apart from one in his fifties and one in his twenties. But other characteristics were evidence of changes in the outside world as well as of differences in behaviour.

The first three, for instance, all diagnosed in 2020, could not access PrEP during lockdown and had unplanned sexual encounters. One of these was the only person who had been on daily PrEP.

Nine study participants had their HIV genome sequenced to establish its subtype. Of five diagnosed before 2023, all but one had HIV subtype B, the most common one among western gay and bisexual men. Of the four diagnosed in 2023, all but one had the A6 subtype, which is the predominant one in Russia, Ukraine and most former Soviet countries.

Although Poland hosts the largest number of Ukrainian refugees in Europe, just one of the A6 viral strains had only ever been seen before in Ukraine. So though there was some evidence of an increase of A6 infections in Poland, there was no significant association with immigration from Ukraine. 

It is notable, however, that none of the infections were seen in people who acquired them while actually living in Wroclaw; in fact, in the All Saints Clinic cohort, HIV incidence has decreased over time, and Dr Szetela attributes this directly to the clinic’s free diagnostic and community-friendly services.

Three people associated their infections with disinhibition due to chemsex; one missed PrEP on a single occasion among many; and two relaxed their PrEP use because of partner characteristics, one because the person was a friend, though not monogamous, and one because he thought PrEP was unnecessary when he was the insertive partner. 

As noted above, on at least five occasions, the double dose before sex was the missed component of 2-1-1 PrEP; some took post-exposure doses that appear not to have worked. 

Event-driven PrEP has become more popular in Poland in recent years. In 2017 only 2% of the clinic users took 2-1-1 PrEP, increasing to 35% in 2021 and 53% in 2023.  This was driven largely by user preference; only 5% said they switched from daily because they couldn’t afford it and in a national survey, only 14% cited difficulties with PrEP adherence. 

Dr Szetela concludes by urging stronger support for PrEP and PrEP education in Poland, including of the correct 2-1-1 schedule. He also calls for the full reimbursement of the drugs and tests by the Polish national health fund.