EACS endorses EATG’s Belong project on inclusion of people living with HIV in non-HIV clinical trials

The European AIDS Clinical Society (EACS) has endorsed the European AIDS Treatment Group’s (EATG) Belong project, advocating for regulatory authorities in Europe to adopt clinical guidelines that include people living with HIV in trials relating to other health conditions that affect people living with HIV.

Building upon the EATG position paper on why people living with HIV must be included in non-HIV clinical trials, the first phase of the Belong project carried out the research and groundwork for the creation of more inclusive and representative clinical guidelines toward improving health outcomes for people living with HIV and other comorbidities. This included the identification of relevant stakeholders and the solidification of cross-cutting partnerships between people living with HIV, community and patient organisations, regulatory agencies and trial sponsors.

The necessity of joint advocacy efforts in such initiatives and the pivotal role played by a multistakeholder approach is also emphasised in Belong’s case study “What We Wanted was What We Needed” – A Model of Inclusive Community Advocacy: The Sitges Meetings, published in December 2023 and complementary to the film launched in January.

Both the case study and the film document experiences, results, and lessons learned from the Sitges meetings, held between 2007 and 2017 in Sitges, Spain. The Sitges Meetings were a series of community-owned multi-stakeholder meetings that advocated for the inclusion of people with HIV/hepatitis C coinfection in clinical trials for emerging hepatitis treatments, and rapid access to new, safe and effective treatments.

The endorsement from EACS underscores the importance of collaborative efforts in removing barriers that prevent the inclusion of people living with HIV in clinical research:

We, at EACS, have always been active in fighting any kind of stigma and discrimination against people living with HIV. We strongly support the EATG Belong project so that barriers to including people living with HIV in clinical research of potentially life-extending or life-saving drugs and treatments for non-HIV co-morbidities can be fully overcome not only in theory but also in practical terms.

Depending on further funding, the second phase of the project will aim to develop and build consensus among all the relevant stakeholders on a set of recommendations for European guidelines and regulations for the inclusion of people living with HIV in non-HIV clinical trials and raise awareness on why this systematic exclusion can no longer be justified.

The endorsement from EACS reaffirms the importance of collaborative efforts in addressing systemic barriers and highlights the critical role of initiatives like the Belong project in driving change in clinical practices to ensure more diverse and more representative trials.

Read the full statement on EACS site and below:

STATEMENT OF ENDORSEMENT OF THE EATG BELONG PROJECT

As people with HIV live longer, they may experience non-HIV-related co-morbidities more frequently than the general population. However, there is a lack of safety and efficacy data on the treatment for these non-HIV co-morbidities in people living with HIV. This information is missing in part because people living with HIV have historically been excluded from non-HIV clinical trials. Guidance on many prevention and treatment of non-HIV co-morbidities in people living with HIV remains similar to the general population, although it may not be always adequate.

While in the past there was evidence suggesting that some non-HIV treatments might have been associated with increased adverse effects in people living with HIV without controlled HIV infection or that symptoms associated with advanced HIV infection might have precluded accurate assessment of toxicity or response to those treatments, fortunately this is no longer the case for most people living with HIV. HIV is now considered a chronic and manageable condition when appropriate treatment is available, so the rationale to exclude people based solely on their HIV status is lacking. Yet, this is still often common practice in most studies of investigational drugs.

In September 2022, EATG developed a position paper detailing ‘Why people living with HIV should be included in non-HIV clinical trials’ (  https://www.eatg.org/position-papers/why-people-living-with-hiv-must-be-included-in-non-hiv-clinical-trials/), and in June 2023, EATG presented the Belong project, an initiative on why people living with HIV must be included in non-HIV clinical trials, at the Italian Conference on AIDS and Antiviral Research (ICAR 2023). The project brings together people living with HIV, patient organisations, clinical societies, regulatory agencies and industry partners.

We, at EACS, have always been active in fighting any kind of stigma and discrimination against people living with HIV. We strongly support the EATG Belong project so that barriers to including people living with HIV in clinical research of potentially life-extending or life-saving drugs and treatments for non-HIV co-morbidities can be fully overcome not only in theory but also in practical terms.