Welcome to the Atea team. JP, thank you guys so much for coming down. I know we have a presentation from you last minute to add to our fireside, so why don't you take it away to start?
Thank you. Thank you to allow us to share, to review the data that just came out from the print this morning. We had a press release, as you know, and we are very excited to report a very high SVR rate with a combination of bemnifosbuvir and ruzasvir with a short eight-week treatment across genotype, and you will see the data actually meet our criteria to rapidly move to our phase 3 program, and we have already submitted several abstracts to EASL, which deadlined yesterday, so you can see everything happened in the same time, and so all the full data set will be reported at EASL sometime in May, I think, so if the next slide is the usual forward-looking statement, let's move now, and as you may know, actually, today, infected patient profile has really changed since the approval of direct acting antiviral.
Today, what we have, especially in the United States, a younger population, 20-40 years old, very few cirrhotic, actually really declining, as indicated by several KOL, especially in the United States, and this is because it takes 20 years to develop a cirrhosis, but this population is very difficult, as our CMO can share with everyone, that it's poorly adherent to medication. We'll confirm with this trial due to substance abuse disorders, and in addition, in contrast to the early studies, they take a lot of concomitant medication for the substance abuse disorders or other necessary medication, so we believe that our combination of Bem and ruzasvir potentially addresses all the current unmet needs, so which combine this low risk of drug-drug interaction, we will report a detailed profile, J.P. Morgan, very likely, and we are finishing some DDI studies right now. Convenient short-term, eight weeks.
Already, eight weeks. You will see the adherence is not great and obviously not for the effects. So if we move to the next slide, John, just to remind you that this is a phase 2 open-label single-arm of a combination of bemnifosbuvir and ruzasvir in chronically infected hepatitis C patients. The dose was 550 milligrams of bemnifosbuvir, 180 milligrams once daily of the drugs, this for eight weeks. We enrolled 275 patients, direct-acting antiviral naive. And we had also patients with compensated cirrhosis. The primary endpoint is SVR at week 12 post-treatment in per protocol treatment adherent population. Obviously, you'll see evaluated all genotypes available one to four right now. So next, and this is really depict slide, the efficacy analysis population. So as I mentioned, the primary efficacy endpoint is in the per protocol treatment adherent population.
We have a secondary endpoint, and this is in the population regardless of adherence. This adherence was analyzed, was assessed by a very experienced clinical pharmacologist, which was not part of the Atea team. Totally independent party measured by pill count and PK. What's interesting to note, you probably may not remember, John, but we had a third-party market research shared with the Street about a year ago where 160 highest prescribers of HCV treatment indicated that 17% actually did not complete the treatment. It's amazing that we are in the same stat, even with a short eight-week treatment. We had, and these include all, so everyone that got an SVR 12. The primary efficacy endpoint is 98% in treatment adherent patients.
In all patients who achieve an SVR12, regardless of treatment adherence, still we have a 95% SVR12 in this efficacy evaluation population, which really demonstrates the robust potency and drug forgiveness with this combination. Let's move now. Now we analyze the study, the data by cirrhosis status. We can see non-cirrhotic patients across all genotype. Actually, we have only one patient that failed with a virological failure out of 179. We are higher than 99% if it's possible. It's the message with this drug, take the drug and you will be cured essentially 100% of the time when you don't have a cirrhosis. This was a robust pan-genotypic potency. When we look at now the cirrhotic patients, more difficult to treat, we have 88%.
What we noticed in this patient population, we had a very high rate of NS5A mutation, actually compared to 10 years ago, where usually trial you are about 40%-45%. We are essentially at 90% of patients in this trial at NS5A mutation and with a very high rate in cirrhosis. But still, you can see that while the viral kinetic acts slower in these cirrhotic patients, still we achieve 100% complete viral clearance after eight weeks, so to be very conservative, we are going to move into phase 3 with eight weeks in non-cirrhotic, fully supported by the data. I cannot do better than that, and in cirrhotic, being very conservative, we will move with a 12-week treatment duration, and we will definitely should have a great efficacy with very high rate, similarly to the non-cirrhotic, so let's move on.
Primary endpoint on safety, nothing basically to say, very nice safety, safe, well tolerated, no SAE, no treatment discontinuation due to drug-related adverse event, no trend observed, no safety basically issues on laboratory parameter. We are eager to discuss with the regulator, especially with the U.S. FDA. We already have end of phase two meeting granted for next month to finalize the global phase three program with the FDA. As you can see, we feel that now we have a global phase three ready program, fully de-risked with the highest SVR rates from this robust phase two study, essentially about the same size arm. We anticipate about 400 patients per arm in those phase three studies. Continued support of potential best-in-class profile. We have a fixed dose regimen tablet ready for the phase three.
Actually, we'll go to two pills instead of four fully that will help the convenience in terms of the adherence. We are essentially a commercial scale production. The path, the regulatory path is pretty straightforward with HCV. We have already finalized all global clinical trial sites, more than 250 with a selection of a global CRO, broad patent coverage until 2042. And in conclusion, I would like to thank the patients, the investigators, the Atea team that made this important study possible. And we look forward to promptly initiate the phase three and deliver to today's HCV patient a new regimen that will really make a critical impact for the eradication of HCV in the United States. Thank you.
Yeah. No, thank you very much, JP. That is exciting news from the whole phase two here. Now, obviously, we'd seen some lead-in data from the phase two with a much smaller cohort, but not only seem broadly consistent, might even seem incrementally a little bit better than that lead-in cohort, especially on those incremental non-adherent patients. In the lead-in cohort, there were, if I recall, two patients who had viral rebound due to non-adherence, where you saw essentially no drug in the bloodstream by PK.
Here you have obviously a larger proportion of non-adherent patients, and not all of them experienced viral rebound. Could you identify in that limited subset of non-adherent patients, how much efficacy are you getting? How many of those patients have--I couldn't do the calculation in my head in the one minute the slide was up. How many of those patients, the non-adherent patients, maintained SVR12 despite lack of adherence?
A pretty high percentage, actually.
The majority, in fact.
The majority.
Yeah. We have a lot of drug forgiveness in this regimen, even if you took for eight weeks. What happens is that, like in any infectious diseases, when you're given an antibiotic, the patients start taking it with a lot of emphasis at the beginning, and then the adherence starts dropping because people start forgetting taking the drug. So here, we're giving them only eight weeks, and they start dropping between a month and the second month. That's when you start seeing the dropout rates, and yet, if you really get the majority of them treated for that first month, you cure the majority of them anyway.
Fabulous.
And this even with a pretty high rate of NS5A mutations. So we'll have all the data, I think, in a couple of months, maybe sooner, about studying the baseline mutations and breakthrough, whether we have new mutation or not. We're still doing the sequencing as we speak. But where we are very pleased, actually, as Arantxa mentioned, is essentially we have patients that were fully compliant for a month and then didn't take the drug the second month and still get through.
Yeah, because you want to hit early with a very potent drug. That's why you want to do, because you want to drive all the viral load down at the same time very fast. So there is no emergence of rebound quasi-species. So that's exactly what we're seeing here.
Thank you. So no resistant rebound in the lead-in. Do you see any in the broader population?
Very few. We basically see in the adherent patients, we see five viral failure, one in the non-cirrhotic and four in the cirrhotic.
Are any of those, can you identify viral resistance mutations in any of those patients?
We are doing right now. Yes, we definitely have. We should have some viral resistance mutation, but we are finalizing. We don't have the full data set right now. Very likely the 93, the signature mutation, the 93 mutation of the NS5A is probably there.
That'll be the one. All right. Well, before we get too in the weeds on the clinical data, which is very exciting, I'd love to talk a little bit about the Hep C market. Now, you gave a little bit of overview about some of the unmet need there. But we have seen Hep C sales plateauing over the past handful of years from the established players. But your expectation is that this could be a $20 billion market even at this stage. So can you square that circle for me a little bit? What are the key dynamics there?
Take that.
Sure. So there's the two questions that you were talking about. So.
Speak up.
I am. So if you look at the sales plateauing, I think it's helpful to remember that, oh, sorry. It's helpful to remember that Epclusa and Mavyret still generate $3 billion in net sales a year. And that the market is actually not decreasing. It's growing because there's more cases and there are cures. And from the historic perspective, when Epclusa was first launched, it was, I'm sorry. When Epclusa was first launched, there was a bolus of patients that wanted and eager to get therapy. Then you also had the pandemic where therapeutic interventions were just not occurring at a great rate. But most importantly, when you look at Medicaid and you look at the commercial lives, there were many restrictions put on the use of these products, causing barriers to initiation.
So much so that if you looked at the time in the United States between when a patient would be diagnosed and treated, it's measured in months, not weeks, and so when we look at what is the true value of the market, you know you have $3 billion in net sales every year, but if you take a really conservative approach and say 2.2 million patients in the United States, and you take a really conservative approach of a cost of therapy of around $10,000, you get your $20 billion.
In aggregate.
If we want to--and there's been some discussion from the administration, we'll see what the future tells us. But it's definitely, we believe, cost-effectiveness to try to eradicate HCV in the United States. And that will take between $20 and $30 billion. So that's where--and being very conservative on the price and being very conservative on the number, because actually some entities report as much as four million individuals infected in the United States.
Now, JP, as you just sort of suggested, the government and government initiatives are going to play a major role in further development of this market. Do you still think that this is a likely, is it likely that we're going to see government initiatives trying to drive towards eradication in the near term, given the incoming administration's skepticism of government support for healthcare?
Who knows? The new administration has not started yet. The current administration was talking about $40 billion for weight loss drug in Medicaid. So we see here that we have, and it's very well known. I think what, and probably the new administration as well. And we have a former Surgeon General of the first Trump administration on our board, Jerome Adams. And it's critically important to understand that the opioid crisis is closely linked in the United States with hepatitis C. And so if we want to deal with the opioid crisis, we will have to deal also with the HCV. And that's something that resonates with Jerome and who was part of the first Trump administration. So I don't think that the new administration will have a negative impact here.
One of the things that you've mentioned in the past is the potential need for partnerships or BD to develop a mass market indication like this. What are the latest thoughts on your need for a partner or business development partner to drive Phase 3s as opposed to commercialization?
Look, we are going to go. We have a balance sheet that is very robust. We have already finalized the contract with the CROs. We are moving very rapidly. We have the team as we have demonstrated to execute on time and on budget on the COVID phase three. Unfortunately, we didn't get the response that we liked in terms of the outcome, but the execution was flawless. We have had flawless execution in the phase two, and this team will deliver, so we will go alone very likely, but we can prepare with the phase three and start to discuss with potential partners for the launch of the drug, which we anticipate could be as short as two to two and a half years from now.
Excellent. Well, we're reaching the end of time, but very exciting. Thank you so much for sharing this brand new data with us here.
Thank you, John. We really appreciate the opportunity. Thank you.