Dr Anchalee Avihingsanon Addresses Trial Diversity Recruitment Difficulties

The ALLIANCE trial, from Gilead, is investigating the triplet regimen of bictegravir/emtricitabine/tenofovir alafenamide vs dolutegravir plus emtricitabine/tenofovir disoproxil fumarate among treatment-naïve persons living with comorbid HIV/hepatitis B virus. In findings presented at AIDS 2022, the patient population was shown to be primarily of Asian ethnicity and male at birth, with 7% and 2% of the B/F/TAF and DTG/F/TDF groups, respectively, being female at birth.

Transcript

Can you discuss extrapolating your findings to a larger patient population?

In a clinical trial, it is essential to have a full understanding of how treatment works across all the relevant populations. It’s very important to engage females into the clinical trial. We try to do that, but in reality, in some situations, it’s quite difficult to enroll females. For example, for HIV, in some areas in Asia or in in Thailand, the majority of HIV now is from men having sex with men—it’s not from women.

And again, with the hepatitis B as well, it’s more in men compared to women. If we look at this, it’s quite difficult just waiting for females to engage in the study. This is because of the timing of the study as well. So I [hope], in the future, we can engage a more diverse population. Because each population, I think they might need specific treatment; for example, in females, it might be different from males.