Rosa Chen: This is Rosa Chen on for Roanna Ruiz, Leerink Partners. Just a quick one on COVID and then a follow-up on your HCV program. So do you have a sense for how much your recent trial amendments for SUNRISE-3 has maybe impacted your enrollment where you expanded your patient eligibility requirements?
Jean-Pierre Sommadossi: Janet? Do you want to address the question?
Janet Hammond: So the amendment is achieving regulatory approvals, and we are seeing in the places where the regulatory approvals have been achieved that we are certainly enrolling patients with a slightly broader profile than initially. But I think we have yet to see the full benefit of it as it takes a little while in some cases for the approvals to come all the way through. I think we’ve certainly benefited from the surge. We can see and also I think from the fact that we have as many sites open as we do. And so we’re well positioned, I think, to take advantage of these surges now as they come through. And we’re seeing enrollment moving forward quite well.
Rosa Chen: And regarding HCV, can you remind us who are the early adopters that you’re hoping to target in the market? And separately, do you see your combination as differentiated enough from what’s currently available to be able to possibly take larger market share in the future, if launched?
Jean-Pierre Sommadossi: John, do you want to address the question? .
John Vavricka: Yes. Thank you for the question. As you know, the global net sales market for hep C is large, and in 2022, I think the net sales of approximately $3.5 billion. So with the U.S. representing roughly 50% of that. So there’s definitely room for more than just 2 players. But for our profile that we believe we should be, hopefully, be able to achieve, it’s going to be pangenotypic, protease-free — protease inhibitor free and also to have no food effect. And being an AV therapy, it should be able to compete quite well within that market for share. And obviously, how much share will depend on the final clinical profile that is demonstrated. But we feel very confident that a market of that size can easily accommodate 3 products. .
Rosa Chen: That’s helpful. And if I could with a follow-up, do you have a sense for what the FDA is looking for in your Phase III trial design? Because previously, you mentioned the combo has the potential to be less than 8 weeks of treatment, which would be quite a differentiating factor. Is that something you’ll build into the Phase III trial design to be able to see that?
Jean-Pierre Sommadossi: Look, first, we never say that we are going to go to — unless we say that we have the potential possibly. So we don’t have even the data right now. So let’s await the data. We feel, as John has indicated, I shared with you, that there is not, I would say, bluntly an Epclusa for 8 weeks, which is considered today the standard care. When we know it’s a very different market, as John also indicated, as compared to 10 years ago, where the patients would . Now if they’re new patients, compliance is a major, actually, it’s a major issue. Mostly IV drug abusers, opioid, showed the opioid crisis, reinfection. Shorter time is highly differentiated, especially 8 weeks. We’ll see if we later on in parallel to the Phase III, if we will go to the potential 6 weeks.
But definitely, we anticipate that for Phase III, we will go 8 weeks, as we said, as a head-to-head against Epclusa which we believe considered and agree by all the hepatologists and IT specialists being the standard of care. At this time, I don’t think that we can share with you any of the interaction beyond the Phase II with the regulators. And when we do, we will share with you. But right now, it’s too early. Let’s see the data of the Phase II. And then after, as we mentioned, we’ll go head-to-head in one of the Phase III against Epclusa. And then let us discuss with the regulators about how they see this a study design, Phase III study design.
Operator: And last question will come from Tim Lugo with William Blair.
John Boyle: This is John on for Tim. I was just wondering if you could remind us on what you’ll announce for the interim DSMB analysis in the first quarter. Will you just announce that the DSMB either recommended continuing or stopping the study or will you provide some initial safety data as well?
Jean-Pierre Sommadossi: Janet, you want to address the question?
Janet Hammond: I think we’ll just really announce that we can continue or not. Yes.
Operator: And we have no further questions at this time. I will now turn the call back over to Jean-Pierre Sommadossi.
Jean-Pierre Sommadossi: Thank you again for joining us today. This is the end of our earning call. Thank you.
Operator: This concludes today’s conference call. Thank you for your participation. You may now disconnect.
