J.P. Sommadossi, CEO and founder of Atea Pharmaceuticals. Just a reminder that this will be a 20-minute presentation with five minutes of Q&A.
Thank you, Sinead, and before I begin, I would like to thank Jefferies for the opportunity to present some of the latest progress at Atea Pharmaceuticals. As you can see in the first slide, this is our forward-looking statement, and further information can be found in our most recent regulatory filing. Since the founding of Atea, actually, our vision has not changed. With a focus on the discovery and development of antiviral drugs, oral antiviral drugs for the treatment, cure, and prophylaxis of serious viral diseases, where we can make a significant difference or where there is a major unmet medical need. In COVID, as you know, unfortunately, it's here to stay. And the area we believe we have, we have the greatest vulnerability, vulnerability is the urgent need for oral antivirals.
New, safe, well-tolerated, and needed to keep up with the evolution of the, of the virus. I'm going to show you a slide, in, in a few minutes that basically you see accumulation of mutations constantly, amino acid substitution, that are faster with any other endemic RNA viruses, including flu, including RSV, other respiratory infection, as you know, HIV, hepatitis C, you name it. So to prevent the emergence of potential cross-resistance as well, we need a broader, and more diversified arsenal, of oral antivirals, with obviously various mechanism of action that we don't have today. At Atea, we are pleased with the progression, of SUNRISE-3, which is a global phase III, of bemnifosbuvir in high-risk patients, and we look to important milestones in 2024.
We believe that this drug candidate has the potential to address the current limitations of COVID oral therapeutics with safety, tolerability, and lack of drug-drug interaction. Obviously, our goal is to deliver treatment to millions of individuals for whom the standard of care today is not adequate. Also, a part of the multipronged approach, we have a PI in preclinical, a highly differentiated, we will share very likely early next year. This is not the standard once a day or twice a day PI, but it's really a transformational drug candidate for COVID. In our HCV program, we are very pleased with the substantial progress with our phase II combination study of bemnifosbuvir and ruzasvir.
We have completed recently the lead-in cohort of 60 patients, and we anticipate to have the initial data early next year. So our goal with the program, despite that there is some cure, what is maybe less known is that there is still major issues with the current combination available, and we believe that we will have a better standard of care with a brief pangenotypic, protease inhibitor-free option for HCV patients. We believe that Atea has a compelling value proposition. We have strong conviction in our strategy, execution capabilities, experienced management team, and the opportunity to create meaningful value for our shareholders.
So we have two major clinical program in the multibillion-dollar target opportunities, with COVID-19 remaining definitely is there to stay, with about $10 billion, only two drugs that are not adequate today. For HCV, still in HCV in 2022, we had a global opportunity of $3.5 billion in net sales, more than 50% in the United States. Actually, if we look at the prevalence, we have an increase of 400% in the last ten years. Just to share with you, 75% of diagnosed patients in the United States are not treated today, and there is reason for that.
We are continuing to make notable clinical and operational progress across our two major program, and we believe that, with the upcoming milestones all the way the year of 2024, we will drive significant shareholder values. We are well capitalized, especially in these days. We know the importance of it. We can achieve all the key inflection points with the cash runway well into 2026, and as of September thirtieth, we had a balance sheet of $595.1 million without any debt. So let's go over our phase III program for COVID. As I was telling you, you can see here that how quickly those mutations arise based on the change of those genomic sequencing results.
As I said, those rates are faster than any other RNA virus. That's why basically we are caught in a perpetual game of catch up. Just to tell you, vaccine are very rapidly outdated, as you know, even when they become available. Actually, the latest booster was targeting the XBB.1.5. Well, guess what? There is no more XBB.1.5, neither in the United States or in Europe. And we know the first generation of monoclonal antibodies have quickly become obsolete, and that's why those authorization have been revoked for waning efficacy. So this is all to tell you that what we need is oral therapeutics that will be active against any of those mutations.
And so far, bemnifosbuvir are shown that we are basically the same potency in vitro against any of those variants, and we believe with future variants as well, because we target a highly conserved gene, which is the RNA polymerase. So, supported by our extensive global footprint, we have almost achieved 300 clinical sites in almost 30 countries. We start to see promising enrollment, essentially following the waves, the rate, the infections in every continent. I like to emphasize that we have a strong enrollment in the United States, right now, about 50%.
Telling you that even with the availability of current oral antivirals, the majority of these patients are enrolled in the monotherapy arm by the prescribers. And that tells you really why we need new drugs, new oral antiviral. The CDC predict a high infection rates in the winter season for all respiratory infections with COVID representing about 50%. And just to tell you, currently, there is less than 7% uptake in terms of COVID-19 booster in the United States, and I'm sure much less in Europe as well.
So there is really a major need for the most vulnerable individuals, and you are talking about the elderly, you are talking about the immunocompromised, and obviously those with underlying risk factors like obesity and diabetes for COVID. So let me go over quickly on the study design, just to remind you, this is a global phase III in high-risk COVID-19 outpatient. Actually, it's the only study in the United States in a high-risk patient for COVID. The primary endpoint is all-cause hospitalization or deaths through day 29 in the supportive care population. That mean that is the monotherapy arm, and we are targeting 2,200 patients for that.
The patients are randomized one to one, receiving either 550 mg BID of bemnifosbuvir or placebo, and we anticipate that two interim analyses early next year at 650 patients enrolled, and then 1,350 patients enrolled. Please note that those are DSMB for safety and futility. So we have received a U.S. Fast Track designation in April for COVID-19, reflecting really the unmet medical needs. We believe that bemnifosbuvir has a highly differentiated clinical and preclinical profile with an excellent safety so far and tolerability, and hopefully efficacy.
Although we have already shown clinical efficacy in the Morning Sky trial last year, when 225 patients we could demonstrate a 71% reduction in hospitalization against placebo. Even a subanalysis in high risk showed 82% reduction on hospitalization. So let's review now the market opportunity. And you will not be surprised that last year, the script demand for COVID-19 oral antiviral basically correlate with infections. And so you can see that it's quite significant with an average of about 580,000 script per month. So put in the context of almost $1,500 and $1,390 for pricing for Paxlovid, we don't know yet for Lagevrio, but that's very simple.
It's a $10 billion market. As we'll show you in the next slide, which, as you may know, from November one, the market for COVID-19 has been transitioned to a traditional payer with Medicare, Medicaid, and private commercial insurance. We believe that this is going to remain for quite some time around, as I said, $10 billion. So today you have only two product with significant key limitations. So that's why there is a major opportunity with better safety tolerability. If you took Paxlovid once, yeah, you understand very quickly what I mean.
Obviously lack of drug-drug interaction, where that's really is one of the major reason why prescriber actually are limiting the use of Paxlovid both in the U.S. and in Europe. So let's move now to our HCV program. We are very proud, even today, where there is cure, that we can still make a better standard of care. I think we don't sometime realize, and you have to talk to Kary Welles, that one month, especially the patient population that are needed today, when we are talking opioid crisis, we are talking about IV drug abusers, we are talking about HCV reinfection. One month difference in administration can be, have a huge impact there, especially when some of those patients cannot do not have the means to have food every day.
You want really the most simple combination possible with the best efficacy. So that mean a short term pangenotypic protease-free and obviously with excellent safety and tolerability, which we believe the combination of bemnifosbuvir and ruzasvir, which we have licensed from Merck, can achieve. We just completed the lead-in cohort of 60 patients, and the treatment will be completed by the end of this year. We expect data early next year, 2024. We're talking about the primary endpoint, safety, tolerability, and most importantly, I'm sure you can appreciate, sustained virological response or SVR, what we call cure.
This cohort will have, at SVR4, the primary endpoint at SVR12, but we know very well that we have a good correlation between SVR4 and SVR12, and therefore, we can accelerate the study without awaiting the SVR12 in all the patients. So, as I say, as I said, early next year, I think probably in January, we will share the data of this lead-in cohort. We already are expanding the sites to 50 clinical sites in 15 countries to complete rapidly this phase II, which is a total of 280 patients, and obviously moving into a global phase III.
This is just to remind you, the study design, 280, so, patients, so you can see robust, all genotype, cirrhosis or compensated cirrhosis, direct-acting antiviral naive. We just had a poster presentation at AASLD showing the better potency against all major variants as compared to the standard of care with Epclusa. Obviously, that's in vitro, and that's what we anticipate to have in the phase III head-to-head against Epclusa. So, patients, as you can see, in our combination, are given 550 mg of bemnifosbuvir in combination with 180 mg of ruzasvir, and this once daily for 8 weeks. Primary endpoint, as I said, is SVR12, and then some secondary endpoint with virological failure and resistance as well.
We believe, as I said, that this combination has the potential to really substantially improve the current standard of care by offering a protease inhibitor-free, eight-week duration option for HCV patients with and without cirrhosis. And mostly today, the market is really without cirrhosis, early infections. And reinfection, you have almost 20% of reinfection today. And that's basically it, it's being told in this slide. In 10 years, from 2010 to 2020, and unfortunately, this is not going down, you have an increase of 400% in newly diagnosed HCV cases.
So that's where we believe that the short-term duration with a highly competing profile will have a significant impact in the market, as I said, where you still have 75% of diagnosed patients in the U.S. untreated, where you have a major increase in the number of infected individuals with HCV, double in the last five years globally, and this is really the opioid crisis, IV drug abusers and reinfections. So, in closing... What? Okay, sorry about that. In closing, we anticipate a number of interim analysis and data readout starting in January, very likely. And we believe that next year will be transformational for Atea. We have made a great clinical and operational progress across our COVID-19 and HCV program.
We have published and presented significant scientific and clinical evidence in support of the potential of our clinical programs to HIV specialists at several scientific conferences. We are very excited about the opportunities and most importantly, to bring those key drugs to millions of patients today and create obviously a meaningful shareholder value. So again, thank you to Jefferies that is hosting us today, and for your continued interest and support. Thank you. I'll be happy to address any questions. Okay, thank you.