Real world and implementation studies carried out after a medicine is approved help us to bridge the gap between highly controlled clinical trials and the realities of everyday life for the different people impacted by HIV.
There is no doubt that we need clinical trials in HIV care, and that they are essential in the development of new and innovative HIV treatment and prevention options, but studying medicines in the real world for longer and in broader populations than clinical trials can cover, helps to ensure these medicines are meeting the different and evolving needs of people impacted by HIV.
Dr Vani Vannappagari Breaks Down RWE
WHAT IS REAL-WORLD EVIDENCE (RWE)?
RWE is the gathering of information and insights outside of clinical trials after a medicine is approved. It reveals how people respond to HIV medicines in everyday life, which can help to expand our knowledge of HIV treatment and prevention options and improve the experiences of people impacted by HIV. Through RWE, we can help to bridge the gap between clinical trials and day-to-day clinical practice by painting a more holistic picture of the long-term effectiveness, safety, and tolerability of HIV therapies.
HOW CAN REAL-WORLD EVIDENCE HELP TO CLOSE DATA GAPS IN HIV?
HIV affects a diverse group of people around the world which means tightly controlled clinical trial settings can result in certain populations being underrepresented, including older people, transgender people, pregnant women and children living with HIV. RWE, which is typically gathered from much broader patient populations, is helping to fill data gaps around the long-term safety, efficacy and tolerability of treatments and meet the needs of the different people impacted by HIV, across particular regions and populations.
Watch the video of Dr Vani Vannappagari and Dr Cristina Mussini where they delve deeper into the role real-world evidence plays in representative HIV research.
Real-world studies also tend to last a lot longer than clinical trials. People with HIV can now live long lives thanks to effective treatments, but this means taking medication for a lifetime – that’s why gathering insights on long-term safety and effectiveness is particularly important.
WHAT ROLE DOES REAL-WORLD EVIDENCE PLAY IN CARE DECISIONS FOR PEOPLE IMPACTED BY HIV?
Underrepresentation in clinical trials can leave clinicians with an incomplete picture of how a medicine works in practice, creating challenges for deciding on the right option for individual patients. There is no one size fits all approach to treatment or prevention for people impacted by HIV, and understanding those individual wants and needs is critical. Gathering data and insights through RWE can help provide clinicians with a comprehensive and representative picture of how individuals respond to certain medicines, helping people impacted by HIV to receive the right medicine for them, improving adherence and quality of life.
Watch the video between Dr Vani Vannappagari and Axel Bautista, who discuss why gathering real-world evidence is important for the HIV community and how this research is ultimately benefiting them, by giving their healthcare providers the knowledge and confidence that they need to make the best treatment decisions for their patients.
HOW ARE WE CHAMPIONING REAL-WORLD EVIDENCE AT ViiV HEALTHCARE?
ViiV Healthcare has been at the forefront of RWE generation and observational data for many years, dating back to programmes started in 1987. We are continuing to accelerate data generation to ensure diverse representation in both our RWE studies and clinical trials. Through a number of collaborations, we are building our existing knowledge base to ensure no one living with HIV is left behind. We conduct and support more than 140 RWE studies, covering 15 unique and diverse cohorts including women, paediatrics, older people and the transgender community, across more than 50 countries.
Real-World Evidence Infographic
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NP-GBL-HVX-COCO-250007 | June 2025
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