GeSIDA presents an update of its recommendations document on PrEP and suggests to facilitate prophylaxis to anyone who can benefit from it and to make its therapeutic follow-up more flexible
GeSIDA, the AIDS Study Group of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), has presented an update of its recommendations document on pre-exposure prophylaxis (PrEP) as an HIV prevention tool, a guide that was published seven years ago and which in this new edition suggests, among the most relevant aspects, to facilitate access to PrEP for all those who could benefit from this preventive measure. It also proposes making therapeutic monitoring more flexible and adapting it to the characteristics of each user, in which primary care and nursing staff, among others, could also participate. Doctors Pep Coll, from the IrsiCaixa AIDS Research Institute, the Germans Trias i Pujol University Hospital in Badalona and BCN Checkpoint (Barcelona), and Oskar Ayerdi, from the Sandoval Medical Centre and San Carlos Hospital (Madrid), have been the coordinators of this update of the guide.
The first edition of this document - indicating the feasibility of implementing PrEP in Spain - was published in 2016, although it was not until 2019 that this prevention strategy was included in the National Health System's service portfolio. The initial indication targeted men who have sex with men (MSM), transgender women and sex workers, while in 2021 it was extended to adolescents from the age of 16, people who inject drugs, and cisgender men and women at risk of acquiring HIV.
Although in recent years there has been a reduction in the number of new HIV infections, especially among MSM - helped by the implementation of PrEP - there are still a significant number of infections that could be avoided with an optimal implementation of this prevention strategy, which has already shown great preventive efficacy, safety and cost-effectiveness in different population groups, always under the condition of proper adherence. In mid-2022 there were 13,652 people on PrEP in Spain, almost all of whom were MSM, which was less than the estimated number of candidates eligible for this prevention measure. Therefore, the main challenge now is to remove barriers to accessing PrEP programmes and to scale up their implementation across the country.
For this reason, the AIDS Study Group is now considering providing this preventive treatment to people who have been diagnosed with hepatitis C, to partners of people with HIV who are not undetectable (because they are not on antiretroviral treatment or have recently started it) and to people who at the time of the risk assessment do not present any of these criteria, but who express a change of situation in the immediate future, for example, to stop using condoms.
Promote close access and monitoring
In order to facilitate access to PrEP, whose regimen is based on hospital-prescribed drugs, GeSIDA also proposes to bring this treatment from hospital pharmacies to the health care facilities that provide care to these users: STI (Sexually Transmitted Infection) clinics or other out-of-hospital centres, such as primary care centres or community centres. PrEP should be prescribed and supervised by a health care provider who is experienced in the management of HIV and STIs, and who is also trained in cultural competencies for the care of sexual minorities.
Pharmacy depots, dependent on the Hospital Pharmacy services, may be an appropriate formula for facilitating access to treatment, also contemplating telematic monitoring carried out through telepharmacy programmes. The role of specialised nurses is fundamental and they could be responsible for the follow-up of non-complex users. For this proposal to be possible, hospital and outpatient units must be provided with sufficient staff and resources to be able to adequately meet the demand and care of PrEP users.
PrEP and other STIs beyond HIV
The results of scientific studies show some discordance regarding the possible increased incidence of STIs in PrEP users. However, PrEP is part of a programme that also includes a combination of measures such as condom promotion, sex education and counselling, substance use assessment, early detection and treatment of STIs, and updating of vaccination status.
Systematic STI screening allows early detection and treatment of other STIs, which can reduce the transmission of STIs. Therefore, the GeSIDA document recommends screening for syphilis, chlamydia and gonorrhoea every three to six months, depending on each person's risk, as well as HCV serology or PCR (in case of previous positive serology) every 6-12 months, depending on each person's risk.
The HIV situation in Spain today
More than 40 years after its emergence, and despite significant advances in diagnosis and, above all, treatment, HIV remains a major public health issue today. In 2020, 1,925 new HIV diagnoses were reported in Spain, a rate of 4.07 per 100,000 inhabitants, very similar to the European average of 5.4 per 100,000 inhabitants.
Despite the progress made in recent years in the field of HIV infection and, consequently, the reduction in the rates of new diagnoses, its elimination is still not effective. Condom promotion, counselling, early diagnosis and treatment, and post-exposure prophylaxis (PEP) are insufficient to achieve real control of the epidemic. In this context, PrEP has emerged as an additional tool to the measures in use. It is a strategy that is part of the combination prevention of HIV infection recommended by UNAIDS to achieve the proposed 95-95-95 targets and to reach the targets of goal 3 of the Sustainable Development Goals by 2030.
In other countries, such as the UK, their implementation has resulted in a marked decrease in HIV incidence among MSM. In addition, it has been shown that the set of interventions has a synergistic effect, such that they interact to produce a combined impact that is greater than the sum of their separate effects. In this context, it has been modelled that 'virtual elimination' of HIV transmission in MSM could be achieved in the next two decades, if current measures persist.
PrEP is not just about administering the drug, but should be part of a programme that includes individualised preventive counselling, assessment of possible adverse effects, screening for sexually transmitted infections (STIs), screening for substance use and updating vaccination. Cohort studies and clinical practice reinforce the safety data for this preventive measure, already observed in clinical trials.