The ALLIANCE trial is investigating the responses of treatment-naïve persons living with comorbid HIV (PLWH)/hepatitis B virus to a triplet regimen of bictegravir/emtricitabine/tenofovir alafenamide vs dolutegravir plus emtricitabine/tenofovir disoproxil fumarate.
Anchalee Avihingsanon, MD, PhD, HIV-NAT, Thai Red Cross AIDS Research Centre, Bangkok, Thailand, is principal investigator of the ALLIANCE trial, currently evaluating the responses of treatment-naïve persons living with comorbid HIV (PLWH)/hepatitis B virus to a triplet regimen of bictegravir/emtricitabine/tenofovir alafenamide (TAF) vs dolutegravir plus emtricitabine/tenofovir disoproxil fumarate (TDF).
To what do you attribute the differing results for the ALLIANCE trial’s HIV and HBV end points?
For HIV, it’s no different between the treatment groups, but for hepatitis B [HBV], at 48 weeks we see the difference. But we don’t know this for longer periods. I think we should wait for the 96-week results to see whether there is still a difference on this or not. Because when we look at the rate declining over time, [inaudible] there was no difference between the 2 groups. But just in terms of if we focus on the very sensitive test for hepatitis B, so focus on recognizing IU copies/mL, it’s different between TAF and TDF. But if we use a cut off higher than that—for example, 2000 IU/mL, it’s no different between the groups. I think maybe it will take time to see this. For example, s antigen [hepatitis B surface antigen] loss, it’s different between the groups at week 12 and week 24. But at week 48, it’s not different. So maybe we need some medication or need longer time to achieve that end point.
With the two differences, in part of this, I can say that maybe ]it is easier to treat] HIV compared to hepatitis B. There was a very good response [for the] HIV end point. But again, there was a lower rate for both TAF and TDF for hepatitis B. For me, I think, for this study, the HIV viral loss is just 4-lock, luck, but for hepatitis B, it is 8-lock. It’s very high, so it might take time.
But even in the population that has been treated longer term, we still have suboptimal treatment for hepatitis B, even though they have a very good response to HIV. So I think for hep B, we need more research to see what the cost on that [would be]and how we can improve the treatment response for this population. And again, if the patient has ongoing hepatitis B viremia, they still have an increased risk of cirrhosis and hepatocarcinoma. We need something. We need more data on this and more research on this.