Tag: PrEP

Community Manifesto for HIV Long-Acting Injectable PrEP in Europe

Posted on by Milutin

More than 40 global and regional civil society organisations endorsed a community manifesto calling for the introduction of long-acting injectable PrEP in Europe.

Oral PrEP has had a significant impact on population HIV incidence, especially in gay and bisexual men and other men who have sex with men (GBMSM), in high-income settings.

Oral HIV PrEP is highly efficacious when taken as prescribed, and is largely acceptable as an HIV prevention technology in those who use it. Oral PrEP has been a significant new addition to combination HIV prevention approaches, along with condoms, PEP, and treatment-as-prevention.

However, significant barriers to accessing oral PrEP remain and these barriers result in significant health inequalities. Further, taking a (daily) oral medication is not an acceptable or feasible method of HIV prevention for many who could benefit from PrEP. The development of multi-methods of PrEP will increase adherence as well as PrEP acceptability and choice, and thereby improve uptake of PrEP regionally and globally.

New formulations of PrEP have been studied, with a number of highly effective methods becoming approved for use. These include vaginal-ring formulations, and long-acting injectable PrEP. ViiV’s long-acting formulation of cabotegravir PrEP (LA-CAB) has been approved in, Australia, Botswana, Malawi, South Africa, US, and Zimbabwe and has been submitted for regulatory approval to the EMA and in over 10 countries thus far. Recent voluntary licensing agreements have been agreed, enabling generic LA-CAB to be manufactured and prescribed in over 90 countries, subject to pending regulatory approvals. However, due to a dearth of manufacturing facilities, drug stock is currently limited until new plants become fully functional in 2025.

This document results from a consensus meeting held in Paris in March 2023 between regional and international HIV prevention organisations and activists including: AIDES; AIDS Action Europe; AVAC; Coalition PLUS; EATG; Fundacja Edukacji Spolecznej; GSSG – Germany’s Charitable Foundation Sexuality and Health; and PrEPster at The Love Tank CIC.

To find out more, access the Manifesto, follow this link>>>.

 

A long-acting injectable pre-exposure prophylaxis for HIV prevention approved

Posted on by Milutin

The United States Food and Drug Administration announced its first approval of a long-acting HIV prevention medication on 20 December 2021. The long-acting injectable cabotegravir (CAB – LA) is approved as a pre-exposure prophylaxis (PrEP) for adults and adolescents who are at risk of acquiring HIV sexually in the United States of America. Apretude is given first as two initiation injections administered one month apart, and then every two months thereafter. Patients can either start their treatment with Apretude or take oral cabotegravir (Vocabria) for four weeks to assess how well they tolerate the drug.

This is the first time an injectable antiretroviral drug becomes available as a pre-exposure prophylaxis for prevention of HIV. The long-acting formula is a step forward and a valuable addition to the HIV prevention toolbox and will make acceptance and adherence easy.

Companies holding new technologies should share their knowledge and recipes with generic producers to ensure availability and affordability in low and middle-income countries. UNAIDS called for this new drug to quickly be made available and affordable to people who need it most not just in the United States of America but everywhere in the world. The mistakes of three decades ago when lifesaving drugs were only available to those who could afford it must not be repeated. Market strategies such as generic competition and public health-oriented management of intellectual property rights, either through voluntary agreements or the use of TRIPS flexibilities must be used to make this new drug widely available.

To make this drug available equitably across the world, a series of actions are essential. Firstly, the drug has to be approved by regional and national regulatory authorities in a speedy manner. It is encouraging to see that the developer of CAB-LA, has already submitted to the South African Health Products Regulatory Authority (SAHPRA) for approval and an outcome is expected in early 2022. However access must go much further. Secondly the selling price must come down through a combination of measures such as licencing and involvement of generic producers. Thirdly, national HIV prevention programmes must prepare roll out plans and prepare their health systems and communitiues to deploy this new HIV prevention option as soon as they are available.

Current pre-exposure prohylaxis – Tenofovir plus Emtricitabine – tablets have to be taken daily as oral PrEP. They are highly effective in preventing HIV acquisition among persons at substantial risk when taken as prescribed. However many find it challenging to take a daily tablet. Another option – dapiviringe vaginal ring – is becoming available as additional prevention option for women at substantial risk of HIV infection.

The CAB-LA option could be a game-changer for the HIV response, making PrEP simpler or less burdensome for all genders. This may also circumvent the stigma associated with daily oral therapy and improve correct dosing and adherence which is critical for PrEP effectiveness.