Philadelphia, PA -- Frank Spinelli, Medical Director of Patient Affairs at US ViiV Healthcare started his career in private practice. The transition to industry was a big one. He said in private practice there aren’t that many layers, “it’s you and the patient; you and the pharmacists; you and your staff.” As he’s learned how the development process works, he’s found places to bring that patient intimacy to many aspects of it.
Spinelli shared several cases about how the patient voice is changing development of HIV / AIDS. But first he took us back to 1981 when we first saw appearances of a new “cancer” in men who had sex with other men. It was not until 1987 that the first FDA-approved drug became available. That drug was from Novartis. The investment and aggressive development process was driven by activists. Activists have a powerful history in driving change in HIV care and ViiV is giving them a strong voice today.
Aging and AIDS
Aging didn’t used to be part of the conversation in AIDs. People were told they had 5 – 10 years to live. ViiV engaged a community panel to learn more about the experience of living with the now-chronic disease into later and later decades. They found:
- Some co-morbidities, like frailty, loss of muscle and bone, weren’t fully addressed and were coming earlier than expected
- Doctors needed treatment guidelines for older patients
- There’s a need to redefine the risk / benefit equation for certain medication by age, gender, etc.
- Health literacy and awareness are issues. Spinelli shared an example in the Hamptons of a doctor who has a Ferrari out front and migrant workers in the waiting room who, as he talked to them, had real gaps in basic understanding of their disease
- Inclusion of older people in clinical trials is critical
- Action is needed to tackle stigma and discrimination – especially when you add in aging
Pills vs Injections
Some of ViiV’s new trails are investigating long-term injectable therapies. They first researched the patient need with doctors who said patients wouldn’t want them; people don’t like injections. Then, they engaged a patient panel that had a very different response. Patients said, “no pills and a shot once a month? Or every other month? I’ll do that.” They said it would be easier and it’s freeing because it's a regimen that’s not in your home and transparent for others to see.
Some of the findings led them to change the approach to the study design to produce data about the impact of removing pill fatigue.
Informed Consent Design
ViiV had patients review the ICF for the two drug regimen injectable treatment. They uncovered some simple improvements to make the form more useful and more comfortable:
- Patients wanted more graphics and pictures to help them navigate the content
- The animal study information was difficult to understand, too much information and just felt scary
- They wanted more information around needs and lifestyle impact implications
- Patients preferred detailed instructions rather than narratives – what do I have to do when?
- Finally, a more balanced approach was need to language that felt stigmatizing. Like changing HIV infected patients to people living with HIV
*Disclaimer: Mentions contained in these posts do not indicate any association between the products and companies and INC Research/inVentiv Health. All details, statistics and figures are taken from the noted presentation.