Long Covid: Why It’s a Condition ‘Discovered’ by Patients (Who Are Now the New Protagonists of Research)

On September 3, the Italian newspaper Il Corriere della Sera published an article titled “Long Covid: Why It’s a Condition ‘Discovered’ by Patients (Who Are Now the New Protagonists of Research)” written by Danilo di Diodoro. This article describes the establishment of a new scientific journal, the “Patient-Generated Hypotheses Journal for Long Covid and Associated Conditions,” in which patients are co-authors alongside researchers and doctors. This initiative, managed by the “Patient-Led Research Collaborative,” a group of patients from various fields, including neuroscience, cognitive sciences, and public health policies, may mark a significant step towards improving the relationship between patients, researchers and healthcare professionals. The first issue of this journal contains six pathogenetic hypotheses and the results of a survey conducted with people affected by Long Covid. These articles, written by patient-researchers, have been cited by journals such as the “British Medical Journal” and the “Journal of American Medical Association.”

This collaboration model could pave the way for biomedical research in which priority objectives are identified through collaboration among citizens, patient associations, and researchers, and funding is allocated in a more targeted and equitable manner. These developments could significantly improve healthcare and the relationship between caregivers and patients, promoting research that meets the needs of the real population.

In this context, Alessandra Cerioli, EATG Member, and Rocco Pignata, EATG Programme Officer and Project Coordinator, were asked to share EATG’s experience with the Belong Project, a project that advocates better inclusion of people living with HIV in non-HIV clinical trials. Alessandra was invited to present EATG’s position paper and the Belong Project during a follow-up event on Sunday November 12, in Milan.

Below you will find their insights from the article, translated into English. The full article is available in Italian here.

The pivotal role in ethics committees

Introducing a systemic change in research practices to improve access to care and innovate the relationship between caregivers and patients is particularly important for people with HIV and related comorbidities. “This is why it is important that representatives of different stakeholder groups sit at the same table to raise awareness and create a dialogue that contributes to this change,” says Rocco Pignata, EATG Programme Officer & Project Coordinator. “And the presence of community representatives in Ethics Committees is crucial. Only this way, clinical trials can be designed and evaluated in line with community perspectives from the early stages of research. And particular attention must be given to those criteria that exclude participants from research trials”. Proper involvement of people living with HIV in clinical trials requires questioning the very concept of a ‘healthy population’.

“I think it is also important to make sure that all documents accompanying the research protocols are inclusive and accessible,” says Pignata, “with specific attention to transgender individuals and cisgender women living with HIV, who are still largely underrepresented in clinical trials. In other words, involving people with HIV from the earliest stages of clinical research is an opportunity for trust-building between the community, researchers and healthcare professionals. And it contributes to a global effort to empower community members by ensuring real research for a real population”.

The Belong Project for people living with HIV

Being able to participate in clinical trials is crucial for the development of better treatments. But people with HIV are still excluded from the majority of trials for other conditions and therefore demand an active role as patient representatives. “This is a historic exclusion, which needs to be addressed as soon as possible,” says Alessandra Cerioli, activist of the European Aids Treatment Group and LILA, the Italian League for the Fight against AIDS. This is precisely what Belong is aiming to do, a project that advocates the reduction of discrimination against people with HIV and an increased participation in clinical trials for conditions people living with HIV might experience. “The paradox is that today, in countries where antiretroviral treatments are available, people almost no longer die from AIDS, but they continue to die from other, often non-HIV-related health conditions which affect people with HIV more than the rest of the general population,” explains Cerioli. “But drugs and treatments for these diseases are not tested on us, because we are excluded from clinical trials that should prove their efficacy. This means that, when they are marketed, we will use these drugs without specific safety and efficacy data. The feeling is as if the medicine field has not realised that we are no longer in the 1980s and that today HIV can be controlled, that our immune systems are good, the therapies are well tolerated and with mild drug-drug interactions”.

An exclusion based on HIV status

The Belong Project was initiated by the European Aids Treatment Group (EATG), a community organisation led by people with HIV that advocates for the rights and interests of people living with or affected by HIV/AIDS and related co-infections within the WHO Europe region. “We are advocating for the removal of exclusion criteria solely based on being a person living with HIV, and their replacement with inclusion criteria primarily based on the absence of AIDS,” says Cerioli.

“We hope that people now understand the difference between AIDS and HIV. Today, when someone tests positive for HIV they can start treatment early, so that they do not develop any AIDS-related conditions. Regarding inclusion in clinical trials, the U.S. Food and Drug Administration (FDA) issued a series of recommendations in 2020, suggesting that being positive to HIV should not be the sole criterion for exclusion from clinical trials. Instead it should be replaced with eligibility criteria based on the absence of AIDS-defining opportunistic infections, alongside clinical judgement. With Belong, we aim for the European Medicines Agency (EMA) and other regulatory bodies to adopt a similar stance”.