In a recent study published in The Lancet HIV, researchers investigated the human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) requirement, duration, uptake, and usage amongst sexual health services (SHS) attendees in England.

Study: HIV pre-exposure prophylaxis and its implementation within the PrEP Impact Trial in England: a realistic health technology assessment. Image Credit: Marc Bruxelle/Shutterstock.com

Background

From 2014 to 2021, England has seen a big reduction in HIV infection incidence, with gay, bisexual, and males who’ve sexual activity with males (MSM) experiencing a big decrease in disease incidence.

Oral tenofovir with emtricitabine for HIV PrEP has been effective in HIV infection prevention; nevertheless, data on PrEP duration, uptake, and usage is required for normal commissioning in England.

Concerning the study

In the current study, researchers assessed HIV PrEP requirements, duration, uptake, and usage amongst individuals attending sexual health clinics in England.

The Impact study was a single-arm, open-label, prospective, multicentric trial conducted across 157 sexual clinics in England from 13 October 2017 to 12 July 2020.

Health professionals evaluated HIV-negative participants’ risk of human immunodeficiency virus infection to find out who was eligible to participate in receiving on a regular basis or event-driven oral pre-exposure prophylaxis with tenofovir disoproxil maleate plus emtricitabine, as needed.

The study included sexual health clinic attendees aged ≥16 years who were HIV-negative. Participants were divided into three groups: HIV-negative males and transgender women who had condomless sexual activity with males within the previous three months; HIV-negative partners who had sexual activity with a HIV-positive individual without antiretroviral treatment (ART) and adequate immunosuppression; and HIV-negative individuals at equal risk of HIV infection.

The team excluded individuals with HIV seroconversion symptoms, contraindications to the PrEP regimen, HIV-positive individuals inside six weeks of enrollment, and people without PrEP prescription records.

Non-trial participants were HIV-negative, aged ≥16 years, visited sexual health clinics at least one time after recruitment began and before 29 February 2020, and weren’t enrolled at any time point. The first final result included PrEP requirements, uptake, usage, and HIV/STI incidence amongst PrEP users in England.

Secondary objectives included determining whether new-onset HIV infections were resulting from non-adherence or biological failure of PrEP, measuring changes in STI and HIV infection diagnoses and incidence rates over time, and describing PrEP requirement, uptake, and duration of use across different clinic throughput strata and regions.

The team obtained non-trial attendee data from the Genitourinary Medicine Clinic Activity Dataset (GUMCAD). Specific data obtained during clinical consultations was reported based on the UK Health Security Agency (UK HSA) guidelines.

The researchers tested for HIV, STIs, hepatitis B virus (HBV) and C virus (HCV) infections, and serological creatinine levels every three months. Data were presented until 29 February 2020 before implementing coronavirus disease 2019 (COVID-19) mitigation measures. Multivariate regression models were used for evaluation.

Results

The team included 21,356 (out of 24,268) individuals enrolled before 29 February 2020, of whom 20,403 (96%) were MSM. They excluded ten individuals who were HIV-positive inside six weeks of enrolment and 54 without PrEP receipt records through the study period.

The median participant age at enrolment was 33 years; 16,111 (75%) participants were white. PrEP coverage amongst MSM at increased risk of HIV infection was 22%, with the bottom coverage amongst those aged 16-19 years.

Women and other populations taking PrEP denoted 45% of the two,111 participants. PrEP uptake amongst clinically screened and eligible sexual health service attendees was 57% (n=21,292). PrEP coverage amongst MSM at increased risk of HIV infection was 20,349 out of 94,279 (22%).

Coverage was lowest amongst MSM individuals aged 16 to 19 [476 of 4,219 (11%)]. Amongst women and other populations, 939 (45%) of two,111 took up PrEP. Among the many participants, 18,499 had a number of post-enrolment visits and a 361-day follow-up (median).

Seventy-six percent of participants had adequate PrEP to guard them through three-quarters of the follow-up duration. The median percentage of follow-up spent in danger was 91% for all MSM individuals and 92% for those in a period of risk during follow-up.

The incidence of HIV infection was 0.1 per 100 individual years amongst MSM participants and 1.0 per 100 individual years amongst non-trial participants. Amongst MSM participants, 24% received diagnoses of no less than two sexually transmitted infections, representing 80% of the 18,607 cases diagnosed.

STI incidence in MSM non-trial participants was 25 per 100 individual years, with lower rates amongst those aged ≥40 years, Europeans, black Africans, mixed ethnicity individuals, London residents, and people in socioeconomically deprived locations.

A complete of 320,120 STI tests were documented, and 24,467 diagnoses were recorded. The danger of STI was 1.7-fold higher amongst trial participants in comparison with non-trial attendees. The general MSM SHS attendee need for PrEP was 100,800, including 20,349 participants, 73,541 non-trial attendees liable to HIV infection, 587 non-trial attendees who seroconverted, and 6,323 attendees sourcing PrEP elsewhere.

Conclusion

Overall, the study findings highlighted a big unmet requirement for PrEP in England, including MSM individuals, and that the requirement for cover was persistent throughout the trial. PrEP is very effective, with rare HIV infections and a high STI incidence.

Nevertheless, PrEP needs were higher than expected, and a big percentage of follow-up time covered by PrEP showed a seamless need for cover.

This study could inform routine commissioning and delivery of pre-exposure prophylaxis in England since October 2020, a vital step towards eliminating HIV transmission.