Anti-HIV Agents

Open Access Canadian guideline on HIV pre- and postexposure prophylaxis: 2025 update

Author/s: 
Darrell H.S. Tan, Mark W. Hull, Stanley O. Onyegbule, Wale Ajiboye, Camille Arkell, Jean-Guy Baril, Joseph Cox, Marianne Harris, Debbie Kelly, Michael Kwag, Gilles Lambert, Patrick O’Byrne, Shannon O’Donnell, Caley B. Shukalek, Ameeta Singh, Tatiana Sotindjo, Jaris Swidrovichv, Cécile Tremblay, Deborah Yoong

Background: New HIV infections occur annually in Canada, highlighting the need for pre- and postexposure prophylaxis (PrEP and PEP). Through the Canadian Institutes of Health Research (CIHR) Pan-Canadian Network for HIV/AIDS and STBBI (sexually transmitted and blood-borne infections) Clinical Trials Research, we have updated the 2017 guideline on clinical indications and drug regimens for PrEP and PEP in Canada.

Methods: Drawing on meetings with community-based organizations representing key populations affected by HIV in Canada, along with evidence from 3 systematic reviews on PrEP, PEP, and HIV risk assessment tools (searches to June 2024), our diverse panel of 19 experts formulated recommendations on PrEP and PEP. We used a formal evidence-to-decision-making framework and the Grading of Recommendations, Assessment, Development, and Evaluation system. We followed the Guidelines International Network principles for managing competing interests. Our guideline development and reporting adhere with Appraisal of Guidelines for Research and Evaluation II.

Recommendations: This guideline contains 31 recommendations and 10 good practice statements. Although it is appropriate to prescribe PrEP to adults and adolescents who request it, clinicians are also encouraged to assess HIV risk during routine health visits to identify people who would benefit from PrEP. Clinicians should elicit information about patients' anatomy and sexual partners in a culturally sensitive and affirming manner to determine which PrEP regimens - daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), on-demand TDF/FTC, daily oral tenofovir alafenamide/emtricitabine, or long-acting injectable cabotegravir - are suitable options. When assessing whether PEP is needed, clinicians should consider the likelihood that the source person has transmissible HIV, as well as the biological risk of HIV transmission based on exposure type. Preferred PEP regimens are dolutegravir plus TDF/FTC, or bictegravir/tenofovir alafenamide/emtricitabine.

Interpretation: Multiple safe, effective PrEP and PEP regimens are now available in Canada, making it increasingly possible to find suitable options for all who could benefit. Implementation of this guideline should expand access to biomedical HIV prevention interventions for those at risk and decrease the incidence of HIV in Canada.

Preexposure Prophylaxis (PrEP) for HIV

Author/s: 
Matthew A Spinelli, Kenneth Ngure, Monica Gandhi

Preexposure prophylaxis (PrEP) involves use of antiviral medication for HIV prevention in HIV-negative adults or adolescents at risk for HIV through sex or injection drug use. The United Nations Programme on HIV/AIDS (UNAIDS) recently set a goal for 95% of people at risk of HIV (approximately 10 million people worldwide) to have access to and use PrEP in 2025, although only 3.5 million individuals at risk of HIV were receiving PrEP as of 2023. The UNAIDS 2024 global AIDS update reported no decrease in HIV incidence since 2021, with an estimated 1.3 million new infections reported globally in 2023.

Antiretroviral Drugs for Treatment and Prevention of HIV Infection in Adults: 2022 Recommendations of the International Antiviral Society-USA Panel

Author/s: 
Gandhi, R. T., Bedimo, R., Hoy, J. F.

Importance: Recent advances in treatment and prevention of HIV warrant updated recommendations to guide optimal practice.

Objective: Based on a critical evaluation of new data, to provide clinicians with recommendations on use of antiretroviral drugs for the treatment and prevention of HIV, laboratory monitoring, care of people aging with HIV, substance use disorder and HIV, and new challenges in people with HIV, including COVID-19 and monkeypox virus infection.

Evidence review: A panel of volunteer expert physician scientists were appointed to update the 2020 consensus recommendations. Relevant evidence in the literature (PubMed and Embase searches, which initially yielded 7891 unique citations, of which 834 were considered relevant) and studies presented at peer-reviewed scientific conferences between January 2020 and October 2022 were considered.

Findings: Initiation of antiretroviral therapy (ART) is recommended as soon as possible after diagnosis of HIV. Barriers to care should be addressed, including ensuring access to ART and adherence support. Integrase strand transfer inhibitor-containing regimens remain the mainstay of initial therapy. For people who have achieved viral suppression with a daily oral regimen, long-acting injectable therapy with cabotegravir plus rilpivirine given as infrequently as every 2 months is now an option. Weight gain and metabolic complications have been linked to certain antiretroviral medications; novel strategies to ameliorate these complications are needed. Management of comorbidities throughout the life span is increasingly important, because people with HIV are living longer and confronting the health challenges of aging. In addition, management of substance use disorder in people with HIV requires an evidence-based, integrated approach. Options for preexposure prophylaxis include oral medications (tenofovir disoproxil fumarate or tenofovir alafenamide plus emtricitabine) and, for the first time, a long-acting injectable agent, cabotegravir. Recent global health emergencies, like the SARS-CoV-2 pandemic and monkeypox virus outbreak, continue to have a major effect on people with HIV and the delivery of services. To address these and other challenges, an equity-based approach is essential.

Conclusions and relevance: Advances in treatment and prevention of HIV continue to improve outcomes, but challenges and opportunities remain.

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