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.