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      HIV Pre-Exposure Prophylaxis in Central and Eastern Europe-Gains and Challenges in An Ever-Changing World

      review-article
      1 , 2 , *
      Infectious Diseases & Clinical Microbiology
      DOC Design and Informatics Co. Ltd.
      pre-exposure prophylaxis, Central Europe, Eastern Europe, HIV infection, prevention

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          Abstract

          Pre-exposure prophylaxis (PrEP) is an effective prevention tool for controlling the HIV epidemic. Since its approval in the United States in 2012 and Europe in 2016, it has become available on a global scale offered as a registered strategy in clinical studies or demonstration projects with a slow and steady increase. In the second quarter of 2022, PrEP became available in 78 countries globally, with around 3 million people having started using PrEP. Europe has been much slower than the rest of the world to roll out PrEP; nevertheless, currently, PrEP is nationally available and reimbursed in 21 countries; generics are available but not reimbursed in 14 countries. PrEP is not formally implemented in 20 countries, which are mostly Central and Eastern European countries. There are significant disparities between countries in terms of PrEP availability, accessibility, and usage, most likely due to social, cultural, and political differences. The major barriers to PrEP use are reported to be lack of knowledge of people in need, not being reimbursed, and low perception of HIV. PrEP uptake globally and regionally still lacks the power to have an impact on controlling the epidemic. High prioritization of PrEP targets will offer us a realistic chance of reaching the Joint United Nations Programme on HIV/AIDS (UNAIDS) goal of a 90% reduction in HIV infections by 2030 compared to 2010.

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          Most cited references47

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          Preexposure Chemoprophylaxis for HIV Prevention in Men Who Have Sex with Men

          Antiretroviral chemoprophylaxis before exposure is a promising approach for the prevention of human immunodeficiency virus (HIV) acquisition. We randomly assigned 2499 HIV-seronegative men or transgender women who have sex with men to receive a combination of two oral antiretroviral drugs, emtricitabine and tenofovir disoproxil fumarate (FTC-TDF), or placebo once daily. All subjects received HIV testing, risk-reduction counseling, condoms, and management of sexually transmitted infections. The study subjects were followed for 3324 person-years (median, 1.2 years; maximum, 2.8 years). Of these subjects, 10 were found to have been infected with HIV at enrollment, and 100 became infected during follow-up (36 in the FTC-TDF group and 64 in the placebo group), indicating a 44% reduction in the incidence of HIV (95% confidence interval, 15 to 63; P=0.005). In the FTC-TDF group, the study drug was detected in 22 of 43 of seronegative subjects (51%) and in 3 of 34 HIV-infected subjects (9%) (P<0.001). Nausea was reported more frequently during the first 4 weeks in the FTC-TDF group than in the placebo group (P<0.001). The two groups had similar rates of serious adverse events (P=0.57). Oral FTC-TDF provided protection against the acquisition of HIV infection among the subjects. Detectable blood levels strongly correlated with the prophylactic effect. (Funded by the National Institutes of Health and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT00458393.).
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            Antiretroviral Prophylaxis for HIV Prevention in Heterosexual Men and Women

            New England Journal of Medicine, 367(5), 399-410
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              Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial

              Summary Background Randomised placebo-controlled trials have shown that daily oral pre-exposure prophylaxis (PrEP) with tenofovir–emtricitabine reduces the risk of HIV infection. However, this benefit could be counteracted by risk compensation in users of PrEP. We did the PROUD study to assess this effect. Methods PROUD is an open-label randomised trial done at 13 sexual health clinics in England. We enrolled HIV-negative gay and other men who have sex with men who had had anal intercourse without a condom in the previous 90 days. Participants were randomly assigned (1:1) to receive daily combined tenofovir disoproxil fumarate (245 mg) and emtricitabine (200 mg) either immediately or after a deferral period of 1 year. Randomisation was done via web-based access to a central computer-generated list with variable block sizes (stratified by clinical site). Follow-up was quarterly. The primary outcomes for the pilot phase were time to accrue 500 participants and retention; secondary outcomes included incident HIV infection during the deferral period, safety, adherence, and risk compensation. The trial is registered with ISRCTN (number ISRCTN94465371) and ClinicalTrials.gov (NCT02065986). Findings We enrolled 544 participants (275 in the immediate group, 269 in the deferred group) between Nov 29, 2012, and April 30, 2014. Based on early evidence of effectiveness, the trial steering committee recommended on Oct 13, 2014, that all deferred participants be offered PrEP. Follow-up for HIV incidence was complete for 243 (94%) of 259 patient-years in the immediate group versus 222 (90%) of 245 patient-years in the deferred group. Three HIV infections occurred in the immediate group (1·2/100 person-years) versus 20 in the deferred group (9·0/100 person-years) despite 174 prescriptions of post-exposure prophylaxis in the deferred group (relative reduction 86%, 90% CI 64–96, p=0·0001; absolute difference 7·8/100 person-years, 90% CI 4·3–11·3). 13 men (90% CI 9–23) in a similar population would need access to 1 year of PrEP to avert one HIV infection. We recorded no serious adverse drug reactions; 28 adverse events, most commonly nausea, headache, and arthralgia, resulted in interruption of PrEp. We detected no difference in the occurrence of sexually transmitted infections, including rectal gonorrhoea and chlamydia, between groups, despite a suggestion of risk compensation among some PrEP recipients. Interpretation In this high incidence population, daily tenofovir–emtricitabine conferred even higher protection against HIV than in placebo-controlled trials, refuting concerns that effectiveness would be less in a real-world setting. There was no evidence of an increase in other sexually transmitted infections. Our findings strongly support the addition of PrEP to the standard of prevention for men who have sex with men at risk of HIV infection. Funding MRC Clinical Trials Unit at UCL, Public Health England, and Gilead Sciences.
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                Author and article information

                Contributors
                Journal
                Infect Dis Clin Microbiol
                Infect Dis Clin Microbiol
                10.36519
                Infect Dis Clin Microbiol
                Infectious Diseases & Clinical Microbiology
                DOC Design and Informatics Co. Ltd.
                2667-646X
                December 2022
                21 December 2022
                : 4
                : 4
                : 223-228
                Affiliations
                [1 ]Department of Infectious Diseases and Clinical Microbiology, Ege University School of Medicine, İzmir, Turkey
                [2 ]Ege University HIV/AIDS Research and Practice Center, İzmir, Turkey
                Author notes
                [* ]Corresponding author at: Department of Infectious Diseases and Clinical Microbiology, Ege University School of Medicine, İzmir, Turkey
                Author information
                https://orcid.org/0000-0003-0704-2302
                Article
                10.36519/idcm.2022.199
                10986726
                38633717
                851d8744-50fd-45a5-9f31-064c6aeb607a
                Copyright © 2024 Infectious Diseases and Clinical Microbiology

                This work is licensed under a Creative Commons Attribution-Non Commercial 4.0 International License.

                History
                : 17 November 2022
                : 10 December 2022
                Categories
                Review Article
                HIV
                Pre-exposure Prophylaxis

                pre-exposure prophylaxis,central europe,eastern europe,hiv infection,prevention

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