Real-world evidence is an increasingly important aspect of data-driven science, but how can it be utilised to benefit the HIV community? I sat down with HIV specialist Dr Cristina Mussini to discuss real-world findings and their value in clinical practice
In the 40 years since the first cases of AIDS were officially reported, there has been significant progress in how we view HIV and the ways it can be treated. Today’s global population living with HIV is living longer and has different, evolving needs; and people living with HIV now have access to an expanding range of highly effective and safe treatment options that offer choices to suit individual needs, including 2-drug regimens, single-pill medications and long-acting treatments. As clinicians, we are always looking to expand our knowledge, continue to make the best treatment decisions and improve the experience of people living with HIV. A key tool to help us achieve this is real-world evidence (RWE).
“There are some questions that are impossible to answer with randomised clinical trials.”
Regional differences that may not be reflected in RCTs can also be picked up through RWE as they typically include a wider range of populations and subgroups than RCTs. Through taking an evidence-based approach in a real-world setting, we can capture findings that are unique to particular regions or patient populations.
“Many randomised clinical trials are conducted in the US,” explains Dr Mussini, “but the clinical and patient experience of people living with HIV there will be very different from those in other parts of the world. Take, for example, a simple parameter such as body mass index, or BMI. We might see quite different BMI rates between, say, Europe, the sub-Saharan region and the US, so it’s important to take this into consideration.”
Looking ahead to support the unmet needs of people living with HIV
When it comes to medicine, creativity is not a word that immediately springs to mind. But the curiosity of physicians, hypothesising about treatment options, testing these ideas out in RCTs and RWE studies – this creativity and innovation – is bringing about the greatest advances in managing patient care in HIV, according to Dr Mussini. “In the beginning, we tried everything, we couldn’t wait for RCTs. When trying new regimens, we were doing blood tests every two weeks to see what was happening,” says Dr Mussini, reflecting on the early days of the HIV epidemic. Today, we are in a much stronger position when it comes to data-driven decision-making. Building RWE into regulatory guidance is a significant step towards recognising the importance of these studies, but we need to keep looking ahead to identify how best to integrate RWE into the HIV evidence landscape fully. Priorities include using RWE studies to identify gaps in our knowledge, for example focusing on older people, pregnant women and children living with HIV, collecting and collating data from countries across the world, and ongoing collaboration between the pharmaceutical industry, clinicians and other stakeholders, such as non-governmental organisations (NGOs) and community advocacy groups. This will ensure that we have a more comprehensive and representative picture of how different treatments can most effectively meet the unmet needs of all people living with HIV, including those under-represented populations, to help us move closer towards meeting the UNAIDS goal of ending the AIDS epidemic.
NP-GBL-HVX-COCO-220066 June 2022