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The World Health Organization (WHO) today issued new guidelines for the use of long-acting injectable cabotesvir as HIV pre-exposure prophylaxis and called on countries to consider using this safe and effective prevention regimen for people at high risk of HIV infection .
Published ahead of the 24th International AIDS Conference (AIDS Conference 2022), the guidelines will support countries in planning the introduction of long-acting injectable cabotesvir as part of a comprehensive approach to HIV prevention , and will facilitate much-needed operational research work.
The launch of the guidelines comes at a critical time when HIV prevention efforts are stalling, with 1.5 million new HIV infections in 2021, the same as in 2020. In 2021, with 4,000 new infections per day, key groups (sex workers, men who have sex with men, people who inject drugs, prisoners and transgender people) and their sexual partners account for 70% of global HIV infections.
Dr Meg Doherty, Director of the WHO Global Programme on HIV, Hepatitis and Sexually Transmitted Infections, said: "Long-acting cabotesvir is a safe and highly effective tool for HIV prevention, but is not currently used outside of research settings. We hope these new guidelines will help accelerate national efforts to begin planning and delivering long-acting injectable cabotevir as well as other HIV prevention options, including oral PrEP and dapivirine vaginal rings."
Cabotevir for long-acting injection is a long-acting pre-exposure prophylaxis that can be injected intramuscularly, with a 4-week interval between the first 2 injections and every 8 weeks thereafter. In two randomized controlled trials (HPTN 083 and HPTN 084), long-acting injectable cabotvir was shown to be safe and effective in cisgender women, cisgender men who have sex with men, and transgender women who have sex with men. Taken together, these landmark studies found that the use of long-acting injectable cabotevir resulted in a 79% relative reduction in the risk of HIV infection compared with oral PrEP, which was consistently administered daily. Oral medication is often difficult. In studies examining community preferences for PrEP, long-acting injectables were also found to be acceptable, and sometimes listed as preferred.
Today's AIDS Conference 2022 press conference also marks the launch of a new coalition aimed at accelerating global access to long-acting injectable cabotesvir. Convened by WHO, UNITAID, UNAIDS and the Global Fund, the coalition will identify market interventions needed to facilitate near- and long-term access to long-acting injectable cabotevir, establish financing and procurement of the drug, Provide implementation support for global HIV prevention programmes and issue policy guidance, among others.
Rachel Baggaley, Head of Testing, Prevention and Population, WHO's Global HIV, Hepatitis and Sexually Transmitted Infections Programme, said: "To achieve the UN prevention goals, we must promote rapid and equitable access to all effective prevention tools, including long-acting pre-exposure Preventive medicines. This means overcoming key barriers in low- and middle-income countries, including implementation challenges and costs.”
WHO will continue to support evidence-based strategies to increase access to and uptake of pre-exposure prophylaxis, including the introduction of long-acting injectable cabotevir. Key actions include:
WHO will support countries and partners to safely and effectively integrate long-acting injectable cabotesvir into HIV prevention programmes.
WHO is working with UNITAID and other partners to develop implementation science projects to address outstanding safety concerns and implementation challenges, and to understand people's response to long-acting injectable cabotevir and other HIV prevention options. preference.
WHO is working with countries, communities and donors, including the Global Fund, the US President's AIDS Emergency Response Plan and the Bill & Melinda Gates Foundation, to support the inclusion of long-acting injectable cabotvir in planning activities , and promote the implementation of scientific and programmatic monitoring so that the use of long-acting cabotevir for injection can be implemented safely and effectively with maximum impact.
This year, the WHO Global Pre-Exposure Prevention Network will host a webinar on long-acting injectable cabotesvir to provide updated information and raise awareness for countries, communities and implementers.
In April 2022, long-acting cabotesvir for injection was included in the WHO's list of expressions of interest for prequalification assessment, and WHO is working with countries on regulatory approval.
Both oral pre-exposure prophylaxis and long-acting injectable cabotevir are very effective. WHO will continue to support prevention programmes. Long-acting injectable cabotevir increases the options available and should always be offered with oral PrEP. Some people may continue to opt for oral PrEP, while long-acting injectable cabotevir may be favored by those who have difficulty taking or do not want to take pills. WHO also released new guidance on differentiating and simplifying PrEP at the 2022 AIDS Conference to support easier access, including community delivery.
Like previous WHO guidelines, the new long-acting cabotevir for injection guideline is based on a public health approach that considers effectiveness, acceptability, feasibility and resource requirements in various settings. This guidance is intended to facilitate the delivery of long-acting cabotvir for injection and much-needed business research to address implementation and safety issues. This will inform decisions on how to successfully provide and expand the use of long-acting injectable cabotesvir. The guideline highlights key research gaps, including issues related to HIV drug resistance, HIV testing, service delivery models, resource needs, safety during pregnancy and breastfeeding, and providing long-term outcomes for sites and populations not included in trials Problems related to cabotevir for injection.
The guidelines also note that young people and key populations often face challenges in accessing current PrEP services. Communities must be involved in developing and delivering effective and acceptable HIV prevention services and supporting people's choices.
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