Portugal's Directorate-General of Health (DGS) has simplified how people using HIV pre-exposure prophylaxis (PrEP) are monitored and has opened the door to prescribing the medication in primary health care and community-based organizations. The changes appear in an update to the DGS's Norma n.º 001/2024, published on the agency's website, according to Observador. The guidance covers adults and adolescents aged 16 and older who face a heightened risk of infection with the human immunodeficiency virus (HIV).
Why it matters
PrEP involves people who do not have HIV taking antiretroviral medicines to lower their chances of acquiring the virus. How closely users are followed and where they can obtain a prescription shape whether the strategy reaches the people who need it most. By easing the monitoring routine and widening who can prescribe, the DGS is signaling that prevention should be easier to access outside hospital-based specialist settings — a shift that could matter for uptake among groups at higher risk.
What the updated guidance says
Under the revised norm, people who are sexually active and at increased risk of HIV infection should receive information about the benefits of PrEP. They should also be told why a clinical assessment is needed before deciding whether to start, continue or stop the prophylaxis, and why sticking to the prevention plan matters, Observador reports.
For people on long-term PrEP who are adhering to the preventive regimen, clinical assessment should take place every three to six months, with the interval set according to each person's individual risk evaluation. Follow-up can be handled by doctors or nurses, in appointments held in person or remotely.
During those assessments, clinicians are expected to check how well the person is adhering to the prophylaxis, their motivation, how well they tolerate the medication and whether any adverse effects have appeared. The monitoring also includes fourth-generation HIV tests and syphilis serology, plus an evaluation of signs and symptoms of other sexually transmitted infections to determine whether further testing is needed.
The norm also calls for local procedures to be defined for unscheduled appointments and for remote consultations. Access to an appointment should be made easier when someone has symptoms that suggest acute HIV infection or other sexually transmitted infections (STIs).
When PrEP should be considered — and stopped
According to the guidance, PrEP should be weighed in several situations. These include certain sexual practices without consistent condom use that are tied to risk factors, a diagnosis of other STIs, prior use of post-exposure prophylaxis alongside continuing risk, and injection drug use without sterile equipment.
Before starting PrEP, a clinical assessment should cover the risk of HIV and other STIs, the person's ability to adhere to the preventive regimen, kidney function, possible drug interactions and any conditions that could raise the likelihood of adverse effects.
The norm also sets out when PrEP should be stopped. These situations include a diagnosis of HIV infection, intolerance or drug toxicity, failure to adhere to the prophylactic regimen, and the person's own decision to stop. After discontinuation, the result of a fourth-generation HIV test carried out at the time of stopping should be recorded in the clinical file, with the test repeated four weeks later. For people with chronic hepatitis B infection, the guidance provides for monitoring after PrEP is stopped because of the risk that the disease could reactivate.
The update reflects a broader effort to fold PrEP into routine care rather than treat it as an exception requiring specialist oversight. By allowing prescriptions in primary care and community organizations, the DGS is placing the service closer to the communities where ongoing prevention conversations already happen. The simplified monitoring schedule — anchored to individual risk rather than a single fixed interval — is intended to reduce the burden on both users and health services while keeping essential testing in place.
What to watch next is how quickly primary care units and community organizations begin issuing PrEP prescriptions under the updated norm, and whether the streamlined follow-up translates into more people starting and staying on the medication.
