Pre-exposure prophylaxis for HIV with oral tenofovir disoproxil fumarate/emtricitabine in men who have sex with men: Slovenian national demonstration project

Abstract

Prevalence of HIV in Slovenia is low, and men who have sex with men (MSM) have the highest risk for infection. Rates of enrolment into HIV care, initiation of antiretroviral therapy and reaching an undetectable viral load in HIV-infected patients are very high. Prevention of HIV infection for MSM with PrEP is not formally available in Slovenia. The aim of this study was to demonstrate possible implementation of PrEP in Slovenia. Sixty-nine ( n = 69) MSM with increased risk for HIV received PrEP with oral tenofovir disproxil fumarate /emtricitabine and acquisition were followed for a mean of 566.6 days. They had 71 episodes of STIs (incidence 61.7 per 100 person-years). No one got acquired HIV infection. Estimated glomerular filtration rate (EGFR) was significantly lower 4 ( p = 0.014) and 19 ( p = 0.021) months after inclusion; however, there was no clinically significant renal failure (mean EGFR 110–115 mL/min). Self-reported body weight significantly increased after 7 months ( p < 0.05). Overall EGFR and self-reported body weight did not change significantly. No significant change in adherence (overall mean 81.0%; 95% CI 77.5%–84.6%; p = 0.728), condom use ( p = 0.077) and number of sexual partners (overall mean 2.36 per 30 days; 95% CI 2.06 to 2.65; p = 0.235) was found throughout the study. Participants reported 110 graded adverse effects (AE), 104 (94.5%) grade 1–2 and 6 (5.5%) grade 3–4. No participant discontinued PrEP due to AE. The study showed successful implementation of PrEP among MSM at high risk for HIV infection in Slovenia. Based on the results of our study, PrEP should be formally available in Slovenia.

Slovenia‘s national HIV PrEP programme: Evaluation of real-world implementation

“…The number of subjects who had previously used PEP was significantly lower in our cohort than in the Australian PrEPX study, where 40.7% had used PEP 7 and lower than in the pilot study, where this percentage was 24.6%. 14 Chemsex use was less common than in other European countries, with 38.4% of subjects using chemsex in our cohort, compared to 55% in Barcelona 19 and 42.6% in Paris, 15 consistent with data that Ljubljana ranks among the cities with a lower level of use of chemsex within the EU. 20 Adherence is vital for the effectiveness of PrEP.…”

“…The incidence is lower than in the pilot study, which detected an incidence of 61.7 per 100 person-years. 14 It is also significantly lower than the STI incidence in the Dutch AMPrEP study, where it was 90.4 per 100 personyears. According to data from the same survey, the lower incidence in our cohort could be influenced by the large proportion of people who use PrEP "on-demand" (79.5%), as they found that the incidence of STIs in this group was 41% lower compared to people who use PrEP daily.…”

“…[1][2][3] As in our pilot study, the most common risk factor was unprotected sexual intercourse. 14 The frequency of each inclusion criterion in percentages is shown in Table 3.…”

“…13 In 2021, the results of a Slovenian study which showed the successful and safe implementation of PrEP with TDF/ FTC among MSM at high risk of HIV infection were published. 14 The PrEP strategy has been included in the health insurance program in Slovenia since the beginning of 2022. People included in the PrEP program are monitored at the specialist outpatient centre of the Department of Infectious Diseases of the University Medical Centre of Ljubljana.…”

PrEP Use, Sexual Behaviour, and PrEP Adherence Among Men who have Sex with Men Living in Wales Prior to and During the COVID-19 Pandemic

“…To date, cohort studies enrolling PrEP users and measuring adherence longitudinally in high-income countries have used a range of methods to measure PrEP adherence, including self-report [ 11 ] and dried blood spots [ 12 ]. A minority of studies measured adherence via a combination of medication use and risk exposure, with those that did doing so via self-report and tending to report lower levels of adherence than studies relying on medication use alone [ 13 ].…”