Dr. Luis Buzón, Specialist in Infectious Diseases, Internal Medicine and Microbiology, at the Hospital Universitario de Burgos and Spokesman for the Spanish Society of Infectious Diseases and Clinical Microbiology.
Sponsored by ViiV Healthcare
Seeing my father on the frontlines of the HIV epidemic in the 1980s, as the virus disrupted communities around the world, forever impacted my life. His compassion and desire to help people living with HIV stuck with me and inspired me to follow in his footsteps and become an infectious diseases doctor. Fast forward to now. We have new tools at our disposal to both treat and prevent the virus, and more ways to gather information on the challenges of the epidemic we face today.
Randomised clinical trials are critical to our understanding of how safe and effective medicines are, but the data come from strictly controlled environments. We can only learn so much from information collected in a laboratory, and if there’s one thing I’ve seen with my patients, life can sometimes get in the way of how and when they take a medicine. This is where real-world evidence comes in.
Real-world evidence refers to the data and insights we gather on a medicine after it has been approved. During a clinical trial, schedules for taking medicine are closely monitored. But in the “real world,” when no one is watching, work and school and family life can make it difficult for people to take their medicines as prescribed. In some cases, individuals experience side effects from medicines that didn’t occur in a clinical trial. This information helps fill in some of the gaps in clinical trial data and ultimately helps healthcare providers better care for our patients.
Real-world experience is critical, because clinical trials can’t last a lifetime
People living with HIV today can live long lives thanks to effective treatments, but that can mean taking medication for a lifetime. It’s simply not feasible for clinical trials to run for many years, so when it comes to understanding how a medication affects people in the long-term, we rely heavily on real-world studies. Long-term data on how new medicines interact with other drugs and the impact of other health issues a person living with HIV may have are critical to ensuring medicines remain safe and effective for real-life use.
Let’s apply real-world evidence in practice.
Real-world evidence gives me confidence that I’m using the right therapeutic approach for each of my patients. Many of them are keen to learn more about their medicines and being able to tell them about the experiences of hundreds, or even thousands, of other people similar to them can help them understand their own therapies, and make them feel more comfortable with the approach we’re taking.
I think about my 60-year-old patient wanting to know if his treatment would work as well for him as it does for a younger person. Based on real-world data in his age group, I could say with confidence that there should be no difference in outcomes between him or someone in their twenties using this medicine.
The number of real-world studies of people impacted by HIV is increasing, putting us in a stronger position to make data-driven decisions. I hope this continues so we can keep improving our understanding and address the remaining gaps in HIV care. This is particularly true as new, innovative ARV medicines become available, including new combinations, long acting formulations and medicines with alternative routes of administration. It’s important we keep generating more, longer-term data from real-world studies of newer therapies so that we can better support our patients’ evolving needs.
While tremendous progress has been made since my dad first started helping people impacted by HIV, there is still much work to be done. I look forward to learning even more directly from the people that I, my dad and our profession serve as we work toward ending the HIV epidemic for all.
References
1. AIDS Treatment Activist Coalition. Missing Data, Missing Diversity: Participant Demographics in Industry-Sponsored HIV Studies, 2010-2020. 2021